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Clinical Trial Results:
A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.

Summary
EudraCT number	2012-000523-40
Trial protocol	BE DE BG
Global end of trial date	16 Jul 2014

Results information
Results version number	v2(current)
This version publication date	25 Mar 2016
First version publication date	21 May 2015
Other versions	v1
Version creation reason	Correction of full data set Minor corrections required.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

HAI115879

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

19 Aug 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

16 Jul 2014

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study are: • To evaluate the 12-week safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA). • To evaluate 12-week antiviral activity of 40 and 60 mg of GSK2336805 when given in combination with PEG and RIBA as measured by eRVR (defined as undetectable plasma HCV RNA at Weeks 4 and 12)

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

07 Aug 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 9

Country: Number of subjects enrolled

Bulgaria: 48

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Germany: 10

Country: Number of subjects enrolled

United States: 172

Country: Number of subjects enrolled

Puerto Rico: 44

Worldwide total number of subjects

286

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

280

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Participants (par.) with treatment-naïve (TN) chronic Genotype 1 (G1) hepatitis C virus (HCV) infection were randomly allocated on a 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, par. with TN genotype 4 (G4) chronic HCV infection were enrolled in parallel at the dose level of 60 mg of GSK2336805.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

GSK2336805 40 mg, Genotype 1 HCV

Arm description

Participants with chronic G1 HCV infection received GSK2336805 40 milligrams (mg) orally (20 mg x 2 tablets) once daily (OD) in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.

Arm type

Experimental

Investigational medicinal product name

GSK2336805

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

40 mg, 2 tablets per day in morning with food

Investigational medicinal product name

Peginterferon alfa-2a (PEGASYS)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

180 micrograms per week by subcutaneous injection in the abdomen or thigh

Investigational medicinal product name

Ribavirin (Ripasphere)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

GSK2336805 60 mg, Genotype 1 HCV

Arm description

Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

Arm type

Experimental

Investigational medicinal product name

GSK2336805

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60 mg, 2 tablets per day in morning with food

Investigational medicinal product name

Peginterferon alfa-2a (PEGASYS)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

180 micrograms per week by subcutaneous injection in the abdomen or thigh

Investigational medicinal product name

Ribavirin (Ripasphere)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

Telaprevir, Genotype 1 HCV

Arm description

Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

Arm type

Experimental

Investigational medicinal product name

Telaprevir

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 x 375 mg tablets taken orally 3 times a day (7-9 hours apart) with food

Investigational medicinal product name

Peginterferon alfa-2a (PEGASYS)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

180 micrograms per week by subcutaneous injection in the abdomen or thigh

Investigational medicinal product name

Ribavirin (Ripasphere)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

GSK2336805 60 mg, Genotype 4 HCV

Arm description

Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

Arm type

Experimental

Investigational medicinal product name

GSK2336805

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60 mg, 2 tablets per day in morning with food

Investigational medicinal product name

Peginterferon alfa-2a (PEGASYS)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

180 micrograms per week by subcutaneous injection in the abdomen or thigh

Investigational medicinal product name

Ribavirin (Ripasphere)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

Number of subjects in period 1 ^[1]	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Started	41	40	17	13
Completed	29	28	9	11
Not completed	12	12	8	2
Consent withdrawn by subject	2	3	3	2
Physician decision	1	-	-	-
Adverse event, non-fatal	3	1	2	-
Lost to follow-up	2	1	2	-
Lack of efficacy	4	7	1	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 286 participants were screened for enrollment and the eligible subjects were randomly assigned to the treatment groups. Of the 118 randomly assigned participants, the analysis populations included 111 participants in the Safety Population, 111 participants in the ITT Population.

Baseline characteristics

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Reporting group title

GSK2336805 40 mg, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 1 HCV

Reporting group description

Reporting group title

Telaprevir, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 4 HCV

Reporting group description

Reporting group values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV	Total
Number of subjects	41	40	17	13	111
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	43.7 ± 13.23	40.8 ± 9.87	39.4 ± 12.02	45.3 ± 11.46	-
Gender categorical
Units: Subjects
Female	13	16	6	3	38
Male	28	24	11	10	73
Race
Units: Subjects
African American/African Heritage	6	6	2	3	17
Asian - South East Asian Heritage	0	0	0	1	1
White - Arabic/North African Heritage	1	0	0	5	6
White - White/Caucasian/European Heritage	33	33	15	4	85
Mixed Race	1	1	0	0	2

End points

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Reporting group title

GSK2336805 40 mg, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 1 HCV

Reporting group description

Reporting group title

Telaprevir, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 4 HCV

Reporting group description

Subject analysis set title

GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

Primary: Number of participants achieving extended rapid virologic response (eRVR)

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End point title

Number of participants achieving extended rapid virologic response (eRVR) ^[1]

End point description

Extended rapid virologic response (eRVR) is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders. Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.

End point type

Primary

End point timeframe

Week 4 and Week 12

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The primary comparison of eRVR was performed using a Bayesian probability model.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[2]	40 ^[3]	17 ^[4]	13 ^[5]
Units: Participants	23	21	9	9

Notes
[2] - ITT Population
[3] - ITT Population
[4] - ITT Population
[5] - ITT Population

No statistical analyses for this end point

Primary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12

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End point title

Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12 ^[6]

End point description

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).

End point type

Primary

End point timeframe

From the start of study treatment up to Week 12

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[7]	40 ^[8]	17 ^[9]	13 ^[10]
Units: Participants
Any AE	39	37	17	13
Any SAE	0	2	3	1

Notes
[7] - Safety Population
[8] - Safety Population
[9] - Safety Population
[10] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12

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End point title

Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12 ^[11]

End point description

Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 4, 6, 8, and 12

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[12]	40 ^[13]	17 ^[14]	13 ^[15]
Units: Millimeters of mercury (mmHg)
arithmetic mean (standard deviation)
DBP; Day2; n=41, 40, 17, 13	-1.2 ± 6.63	-1 ± 7.03	-3 ± 9.03	-1.5 ± 10.45
DBP; Week1; n=41, 39, 15, 13	-0.4 ± 7.98	-2.2 ± 9.13	1 ± 10.54	-1 ± 7.99
DBP; Week2; n=41, 39, 14, 13	-0.4 ± 10.41	-1.7 ± 9.52	-0.3 ± 8.8	-2.8 ± 11.09
DBP; Week4; n=41, 39, 14, 13	-1.2 ± 7.73	-4.4 ± 9.78	-3.9 ± 9.74	0.8 ± 9.92
DBP; Week6; n=41, 39, 13, 13	-1.2 ± 7.65	-4.8 ± 9.86	-5.9 ± 7.82	-1.6 ± 10.1
DBP; Week8; n=41, 39, 13, 13	-2.1 ± 10	-2.9 ± 9.11	-4.4 ± 7.63	-2.4 ± 9.02
DBP; Week12; n=38, 35, 12, 13	0.3 ± 8.48	-4.4 ± 10.24	-3.5 ± 9.2	-1 ± 9.11
SBP; Day2; n=41, 40, 17, 13	-1.4 ± 10.1	-0.8 ± 12.85	-3.3 ± 10.46	-1.3 ± 13.95
SBP; Week1; n=41, 39, 15, 13	0.9 ± 12.99	-3 ± 11.24	-4.5 ± 12.67	-2.6 ± 11.84
SBP; Week2; n=41, 39, 14, 13	-2 ± 10.57	-0.7 ± 11.67	-4.1 ± 12.67	-4.2 ± 17.35
SBP; Week4; n=41, 39, 14, 13	-3.6 ± 11.56	-4.2 ± 16.2	-3.8 ± 9.73	-5.2 ± 15.3
SBP; Week6; n=41, 39, 13, 13	-0.4 ± 14.47	-3.8 ± 13.28	-5.9 ± 11.39	0.2 ± 14.47
SBP; Week8; n=41, 39, 13, 13	-3.7 ± 12.15	-1.5 ± 12.64	-2.9 ± 10.36	-4.2 ± 12.95
SBP; Week12; n=38, 35, 12, 13	-1.9 ± 13.65	-1.4 ± 11.72	-5.2 ± 5.81	-2.6 ± 19.16

Notes
[12] - Safety Population
[13] - Safety Population
[14] - Safety Population
[15] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in heart rate at the indicated time points up to Week 12

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End point title

Mean change from Baseline in heart rate at the indicated time points up to Week 12 ^[16]

End point description

Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 4, 6, 8, and 12

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[17]	40 ^[18]	17 ^[19]	13 ^[20]
Units: Beats per minute
arithmetic mean (standard deviation)
Heart Rate; Day2; n=41, 40, 17, 13	6.5 ± 8.65	5.4 ± 9.96	9.3 ± 11.74	3.8 ± 5.79
Heart Rate; Week1; n=41, 39, 15, 13	1.5 ± 8.33	3.1 ± 8.75	8.1 ± 6.32	7.7 ± 10.11
Heart Rate; Week2; n=41, 39, 14, 13	3.8 ± 9.02	4.2 ± 12.14	8.7 ± 8.17	7.8 ± 8.6
Heart Rate; Week4; n=41, 39, 14, 13	6.8 ± 9.42	4.2 ± 11.78	10.7 ± 11.39	5.5 ± 8.35
Heart Rate; Week6; n=41, 39, 13, 13	8 ± 10.15	5 ± 10.98	13.8 ± 9.75	10.2 ± 8.2
Heart Rate; Week8; n=41, 39, 13, 13	4.7 ± 9.91	6.8 ± 12.42	14.2 ± 10.36	12.8 ± 12.27
Heart Rate; Week12; n=38, 35, 12, 13	7 ± 9.2	5.3 ± 12.1	11 ± 8.02	8.4 ± 9.47

Notes
[17] - Safety Population
[18] - Safety Population
[19] - Safety Population
[20] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12

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End point title

Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12 ^[21]

End point description

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[22]	40 ^[23]	17 ^[24]	13 ^[25]
Units: Giga per liter
arithmetic mean (standard deviation)
Basophils; Week1; n=38, 38, 14, 11	-0.011 ± 0.0191	-0.011 ± 0.0193	-0.012 ± 0.0105	-0.013 ± 0.0119
Basophils; Week2; n=40, 38, 14, 10	-0.014 ± 0.0175	-0.01 ± 0.0192	-0.009 ± 0.0107	-0.009 ± 0.0179
Basophils; Week4; n=41, 38, 14, 13	-0.017 ± 0.0184	-0.012 ± 0.0187	-0.01 ± 0.0118	-0.015 ± 0.0113
Basophils; Week6; n=41, 37, 12, 12	-0.015 ± 0.021	-0.013 ± 0.0205	-0.013 ± 0.0114	-0.013 ± 0.0106
Basophils; Week8; n=38, 39, 13, 13	-0.019 ± 0.0155	-0.016 ± 0.018	-0.009 ± 0.0132	-0.012 ± 0.0142
Basophils; Week12; n=37, 36, 12, 12	-0.018 ± 0.0184	-0.013 ± 0.0187	-0.011 ± 0.0124	-0.012 ± 0.0153
Eosinophils; Week1; n=38, 38, 14, 11	-0.051 ± 0.0874	-0.075 ± 0.106	-0.059 ± 0.0578	-0.085 ± 0.1052
Eosinophils; Week2; n=40, 38, 14, 10	-0.08 ± 0.1004	-0.111 ± 0.0912	-0.059 ± 0.104	-0.114 ± 0.1247
Eosinophils; Week4; n=41, 38, 14, 13	-0.105 ± 0.0872	-0.132 ± 0.1057	-0.079 ± 0.1089	-0.108 ± 0.0923
Eosinophils; Week6; n=41, 37, 12, 12	-0.117 ± 0.0929	-0.134 ± 0.1182	-0.113 ± 0.0607	-0.109 ± 0.1208
Eosinophils; Week8; n=38, 39, 13, 13	-0.121 ± 0.0897	-0.134 ± 0.1061	-0.13 ± 0.0965	-0.104 ± 0.0916
Eosinophils; Week12; n=37, 36, 12, 12	-0.118 ± 0.0916	-0.112 ± 0.1594	-0.106 ± 0.1152	-0.102 ± 0.1428
Lymphocytes; Week1; n=38, 38, 14, 11	-0.319 ± 0.5006	-0.282 ± 0.5698	-0.608 ± 0.5466	-0.371 ± 0.4332
Lymphocytes; Week2; n=40, 38, 14, 10	-0.448 ± 0.5385	-0.603 ± 0.5921	-0.675 ± 0.5639	-0.553 ± 0.4346
Lymphocytes; Week4; n=41, 38, 14, 13	-0.787 ± 0.5055	-0.854 ± 0.5114	-0.989 ± 0.5293	-0.773 ± 0.4104
Lymphocytes; Week6; n=41, 37, 12, 12	-0.963 ± 0.5313	-1.043 ± 0.5928	-1.334 ± 0.4906	-0.93 ± 0.4955
Lymphocytes; Week8; n=38, 39, 13, 13	-0.953 ± 0.4624	-1.061 ± 0.6021	-1.256 ± 0.3509	-0.964 ± 0.5098
Lymphocytes; Week12; n=37, 36, 12, 12	-1.118 ± 0.5139	-1.074 ± 0.5883	-1.438 ± 0.4773	-1.048 ± 0.6612
Monocytes; Week1; n=38, 38, 14, 11	-0.103 ± 0.1418	-0.056 ± 0.145	0.034 ± 0.1502	-0.025 ± 0.0808
Monocytes; Week2; n=40, 38, 14, 10	-0.122 ± 0.227	-0.061 ± 0.1785	-0.091 ± 0.1562	-0.034 ± 0.1687
Monocytes; Week4; n=41, 38, 14, 13	-0.151 ± 0.1771	-0.129 ± 0.158	-0.126 ± 0.1471	-0.055 ± 0.2103
Monocytes; Week6; n=41, 37, 12, 12	-0.182 ± 0.1664	-0.171 ± 0.1326	-0.245 ± 0.1786	-0.135 ± 0.1088
Monocytes; Week8; n=38, 39, 13, 13	-0.229 ± 0.167	-0.165 ± 0.1779	-0.185 ± 0.1344	-0.124 ± 0.2164
Monocytes; Week12; n=37, 36, 12, 12	-0.185 ± 0.1715	-0.183 ± 0.1438	-0.219 ± 0.1493	-0.133 ± 0.2048
Total Neutrophils; Week1; n=38, 38, 14, 11	-2.338 ± 1.4959	-1.871 ± 1.5089	-1.158 ± 1.2688	-1.378 ± 0.598
Total Neutrophils; Week 2; n=40, 38, 14, 10	-2.114 ± 1.9189	-2.121 ± 1.6445	-1.186 ± 1.3343	-1.468 ± 0.584
Total Neutrophils; Week4; n=41, 38, 14, 13	-2.487 ± 1.9145	-2.333 ± 1.5497	-1.412 ± 1.5704	-1.603 ± 0.5953
Total Neutrophils; Week6; n=41, 37, 12, 12	-2.51 ± 1.8144	-2.247 ± 1.5132	-1.413 ± 1.4303	-1.683 ± 0.661
Total Neutrophils; Week8; n=38, 39, 13, 13	-2.706 ± 1.7553	-2.168 ± 1.6902	-1.222 ± 1.3481	-1.613 ± 0.6882
Total Neutrophils; Week12; n=37, 36, 12, 12	-2.894 ± 1.8124	-2.188 ± 1.7297	-1.649 ± 0.8749	-1.483 ± 0.5873
Platelet Count; Week1; n=38, 39, 14, 11	-58.5 ± 36.23	-51.4 ± 36.42	-59.5 ± 36.29	-33.1 ± 33.32
Platelet Count; Week2; n=41, 38, 14, 11	-58 ± 43.92	-57.8 ± 44.02	-41.4 ± 37.44	-34.4 ± 41.74
Platelet Count; Week4; n=41, 38, 14, 13	-54.4 ± 49.18	-55.9 ± 47.19	-56.2 ± 50.99	-33.8 ± 61.79
Platelet Count; Week6; n=41, 38, 12, 13	-66.8 ± 50.43	-71.9 ± 38.6	-71.3 ± 47.07	-46 ± 46.05
Platelet Count; Week8; n=39, 39, 13, 13	-74.9 ± 42.31	-75.7 ± 45.82	-60.1 ± 43.26	-52.6 ± 43.54
Platelet Count; Week12; n=38, 34, 12, 12	-73.4 ± 45.3	-85.3 ± 40.42	-58.8 ± 58.77	-53 ± 39.49
White Blood Cell count; Week1; n=38, 38, 14, 11	-2.83 ± 1.705	-2.3 ± 1.872	-1.81 ± 1.516	-1.87 ± 0.508
White Blood Cell count; Week2; n=40, 38, 14, 10	-2.77 ± 2.178	-2.92 ± 1.81	-2.01 ± 1.869	-2.17 ± 0.886
White Blood Cell count; Week4; n=41, 38, 14, 13	-3.55 ± 2.183	-3.47 ± 1.712	-2.61 ± 2.055	-2.55 ± 0.919
White Blood Cell count; Week6; n=41, 37, 12, 12	-3.78 ± 2.051	-3.62 ± 1.682	-3.09 ± 1.69	-2.85 ± 0.923
White Blood Cell count; Week8; n=38, 39, 13, 13	-4.03 ± 2.028	-3.55 ± 1.896	-2.8 ± 1.477	-2.8 ± 1.04
White Blood Cell count; Week12; n=37, 36, 12, 12	-4.33 ± 2.149	-3.58 ± 1.934	-3.42 ± 1.104	-2.77 ± 0.963

Notes
[22] - Safety Population
[23] - Safety Population
[24] - Safety Population
[25] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in red blood cell count at the indicated time points up to Week 12

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End point title

Mean change from Baseline in red blood cell count at the indicated time points up to Week 12 ^[26]

End point description

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[27]	40 ^[28]	17 ^[29]	13 ^[30]
Units: Trillion per liter
arithmetic mean (standard deviation)
Red Blood Cell count; Week1; n=38, 39, 14, 12	-0.15 ± 0.226	-0.04 ± 0.279	-0.18 ± 0.212	-0.13 ± 0.303
Red Blood Cell count; Week2; n=41, 38, 14, 12	-0.48 ± 0.376	-0.44 ± 0.508	-0.57 ± 0.312	-0.28 ± 0.361
Red Blood Cell count; Week4; n=41, 38, 14, 13	-0.88 ± 0.507	-0.64 ± 0.623	-1.03 ± 0.441	-0.72 ± 0.559
Red Blood Cell count; Week6; n=41, 38, 12, 13	-0.97 ± 0.504	-0.78 ± 0.563	-1.28 ± 0.49	-0.86 ± 0.52
Red Blood Cell count; Week8; n=39, 39, 13, 13	-1.01 ± 0.506	-0.82 ± 0.534	-1.45 ± 0.357	-0.85 ± 0.412
Red Blood Cell count; Week12; n=38, 36, 12, 12	-1.08 ± 0.48	-0.79 ± 0.56	-1.61 ± 0.464	-0.92 ± 0.459

Notes
[27] - Safety Population
[28] - Safety Population
[29] - Safety Population
[30] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in hemoglobin at the indicated time points up to Week 12

Top of page

End point title

Mean change from Baseline in hemoglobin at the indicated time points up to Week 12 ^[31]

End point description

Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[32]	40 ^[33]	17 ^[34]	13 ^[35]
Units: Grams per liter
arithmetic mean (standard deviation)
Hemoglobin; Week1; n=38, 39, 14, 12	-5.2 ± 6.98	-2.3 ± 9.38	-6.6 ± 5.83	-5.3 ± 8.85
Hemoglobin; Week2; n=41, 38, 14, 12	-16.7 ± 12.54	-14.9 ± 16.21	-20.5 ± 10.66	-9.9 ± 11.5
Hemoglobin; Week4; n=41, 38, 14, 13	-28.6 ± 15.38	-22.1 ± 18.98	-34.4 ± 13.55	-22.5 ± 14.89
Hemoglobin; Week6; n=41, 38, 12, 13	-30.1 ± 14.54	-24.7 ± 16	-40.8 ± 14.11	-25.2 ± 12.28
Hemoglobin; Week8; n=39, 39, 13, 13	-30.5 ± 13.29	-25.5 ± 14.22	-44.9 ± 11.73	-25.2 ± 8.66
Hemoglobin; Week12; n=38, 36, 12, 12	-33 ± 12.88	-24.1 ± 13.41	-47.4 ± 14.12	-27.6 ± 12.05

Notes
[32] - Safety Population
[33] - Safety Population
[34] - Safety Population
[35] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in hematocrit at the indicated time points up to Week 12

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End point title

Mean change from Baseline in hematocrit at the indicated time points up to Week 12 ^[36]

End point description

Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[37]	40 ^[38]	17 ^[39]	13 ^[40]
Units: Percentage of RBC in blood
arithmetic mean (standard deviation)
Hematocrit; Week1; n=38, 39, 14, 12	-0.0196 ± 0.02345	-0.0069 ± 0.02751	-0.0201 ± 0.01921	-0.0166 ± 0.0298
Hematocrit; Week2; n=41, 38, 14, 12	-0.0539 ± 0.03653	-0.0465 ± 0.04738	-0.0609 ± 0.03007	-0.0335 ± 0.03625
Hematocrit; Week4; n=41, 38, 14, 13	-0.0848 ± 0.04576	-0.0621 ± 0.05468	-0.0999 ± 0.03967	-0.0668 ± 0.04445
Hematocrit; Week6; n=41, 38, 12, 13	-0.0859 ± 0.0411	-0.0685 ± 0.04487	-0.1203 ± 0.04463	-0.074 ± 0.03316
Hematocrit; Week8; n=39, 39, 13, 13	-0.0838 ± 0.03955	-0.0663 ± 0.04144	-0.1235 ± 0.03288	-0.07 ± 0.02758
Hematocrit; Week12; n=38, 36, 12, 12	-0.0843 ± 0.04038	-0.0589 ± 0.03648	-0.1318 ± 0.03847	-0.0688 ± 0.03298

Notes
[37] - Safety Population
[38] - Safety Population
[39] - Safety Population
[40] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12

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End point title

Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12 ^[41]

End point description

Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[42]	40 ^[43]	17 ^[44]	13 ^[45]
Units: Femtoliters
arithmetic mean (standard deviation)
Mean corpuscle volume; Week1; n=38, 39, 14, 12	-1.1 ± 1.21	-0.8 ± 1.37	-0.4 ± 1.15	-0.7 ± 1.37
Mean corpuscle volume; Week2; n=41, 38, 14, 12	-2 ± 1.84	-1.4 ± 1.59	-1.4 ± 1.09	-1.5 ± 1.45
Mean corpuscle volume; Week4; n=41, 38, 14, 13	0.3 ± 3.33	0.2 ± 3.4	-0.8 ± 1.58	-0.2 ± 2.94
Mean corpuscle volume; Week6; n=41, 38, 12, 13	2.3 ± 4.76	1.8 ± 4.67	-0.2 ± 2.37	1.4 ± 4.63
Mean corpuscle volume; Week8; n=39, 39, 13, 13	3.8 ± 5.39	3 ± 5.2	3.1 ± 2.78	2.2 ± 3.75
Mean corpuscle volume; Week12; n=38, 34, 12, 12	5.7 ± 6	4.2 ± 6.3	5.3 ± 4.14	3.8 ± 4.28

Notes
[42] - Safety Population
[43] - Safety Population
[44] - Safety Population
[45] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in albumin at the indicated time points up to Week 12

Top of page

End point title

Mean change from Baseline in albumin at the indicated time points up to Week 12 ^[46]

End point description

Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[47]	40 ^[48]	17 ^[49]	13 ^[50]
Units: Grams per liter
arithmetic mean (standard deviation)
Albumin; Week1; n=40, 39, 15, 13	-0.6 ± 2.67	-0.3 ± 2.46	-1.1 ± 1.6	-1 ± 1.87
Albumin; Week2; n=41, 38, 14, 13	-1.3 ± 2.98	-1.5 ± 2.68	-2 ± 2.6	-0.2 ± 2.39
Albumin; Week4; n=41, 39, 14, 13	-1.9 ± 2.48	-1.5 ± 2.52	-3 ± 3.21	-1.2 ± 1.46
Albumin; Week6; n=41, 38, 13, 13	-2.2 ± 2.65	-1.5 ± 2.27	-3.5 ± 3.36	-2.1 ± 2.22
Albumin; Week8; n=40, 39, 13, 13	-2.6 ± 2.99	-1.7 ± 2	-3.7 ± 4.71	-1.5 ± 1.94
Albumin; Week12; n=37, 35, 12, 13	-2.1 ± 3.03	-1.3 ± 2.84	-3.3 ± 3.02	-1.6 ± 2.1

Notes
[47] - Safety Population
[48] - Safety Population
[49] - Safety Population
[50] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12

Top of page

End point title

Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12 ^[51]

End point description

Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK) and gamma glutamyl transferase (GGT) at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[52]	40 ^[53]	17 ^[54]	13 ^[55]
Units: International units per liter
arithmetic mean (standard deviation)
ALP; Week1; n=40, 39, 15, 13	0 ± 7.73	1.5 ± 10.21	3.9 ± 19.36	-0.2 ± 17.45
ALP; Week2; n=41, 38, 14, 13	4.6 ± 9.26	3.8 ± 16.22	9.4 ± 21.15	3.8 ± 12.43
ALP; Week4; n=41, 39, 14, 13	8.6 ± 11.12	7.1 ± 13.76	11.7 ± 26.61	7.2 ± 15.3
ALP; Week6; n=41, 38, 13, 13	9.1 ± 13.73	7.2 ± 17.1	16.6 ± 31.03	6.6 ± 16.38
ALP; Week8; n=40, 39, 13, 13	6.9 ± 15.59	6.5 ± 15.91	15.5 ± 25.83	5.6 ± 14.72
ALP; Week12; n=37, 35, 12, 13	6.7 ± 15.56	6.4 ± 20.78	11.7 ± 25.09	7.3 ± 18.33
ALT; Week1; n=40, 39, 15, 13	-26.8 ± 31.64	-24.4 ± 32.39	-30.7 ± 30.1	-25.6 ± 20.74
ALT; Week2; n=41, 38, 14, 13	-28.2 ± 40.33	-24.9 ± 47.49	-35.4 ± 36.38	-26.8 ± 24.25
ALT; Week4; n=41, 39, 14, 13	-32.5 ± 44.5	-25.3 ± 50.87	-40.4 ± 38.73	-33 ± 28.79
ALT; Week6; n=41, 38, 13, 13	-36 ± 49.77	-30.3 ± 50.74	-40.8 ± 41.51	-38.4 ± 29.11
ALT; Week8; n=40, 39, 13, 13	-36.8 ± 55.75	-25.4 ± 55.92	-39.9 ± 40.27	-39.5 ± 29.92
ALT; Week12; n=37, 35, 12, 13	-38.9 ± 59.7	-23.5 ± 59.69	-43.7 ± 40.45	-36.8 ± 24.75
AST; Week1; n=40, 39, 15, 13	-12.3 ± 16.28	-15.2 ± 21.55	-18.1 ± 21.77	-13.9 ± 10.52
AST; Week2; n=41, 38, 14, 13	-10 ± 20.84	-11.6 ± 26.3	-18.4 ± 23.52	-10.2 ± 12.56
AST; Week4; n=41, 39, 14, 13	-12.8 ± 21.45	-10.6 ± 27.4	-20.9 ± 25.86	-15.8 ± 11.92
AST; Week6; n=41, 38, 13, 13	-13.8 ± 21.56	-13.8 ± 25.01	-21.6 ± 28.43	-19.5 ± 12.99
AST; Week8; n=40, 39, 13, 13	-13.1 ± 26.01	-7.6 ± 38.38	-21.8 ± 26.38	-18.6 ± 12.38
AST; Week12; n=37, 35, 12, 13	-14.4 ± 25.58	-6.5 ± 36.17	-25.7 ± 27.32	-17.3 ± 12.68
CK; Week1; n=40, 39, 15, 13	18.2 ± 82.13	-10.9 ± 103.31	-3.3 ± 32.1	-43.5 ± 82.73
CK; Week2; n=41, 38, 14, 13	-0.7 ± 53.87	-22.6 ± 77.26	-9.6 ± 36.26	-28.5 ± 54.43
CK; Week4; n=41, 39, 14, 13	4.5 ± 141.46	-32.1 ± 59.61	-14.4 ± 22.06	-47.7 ± 59.52
CK; Week6; n=41, 38, 13, 13	-26 ± 63.11	56.1 ± 566.79	-21.5 ± 48.49	-64.5 ± 110.82
CK; Week8; n=40, 39, 13, 13	-21.3 ± 95.03	-33.2 ± 65.96	-30.3 ± 51.17	-66.8 ± 107.3
CK; Week12; n=37, 35, 12, 13	-36.3 ± 75.56	-33.9 ± 47.72	-20.9 ± 59.82	-48.5 ± 61.63
GGT; Week1; n=40, 39, 15, 13	-3.7 ± 20.79	-2 ± 16.83	-10.3 ± 19.38	-6.4 ± 23.77
GGT; Week2; n=41, 38, 14, 13	-11.7 ± 33.78	-17.1 ± 45.23	-19.9 ± 29.59	-7.2 ± 29.11
GGT; Week4; n=41, 39, 14, 13	-24.5 ± 52.93	-25.5 ± 59.64	-27.7 ± 36.64	-16.2 ± 36.59
GGT; Week6; n=41, 38, 13, 13	-28.1 ± 67.33	-30.5 ± 72.27	-30.5 ± 44.3	-23.8 ± 39.91
GGT; Week8; n=40, 39, 13, 13	-32.1 ± 70.41	-27.2 ± 80.33	-30.5 ± 45.05	-28.5 ± 45.5
GGT; Week12; n=37, 35, 12, 13	-29.7 ± 80.2	-20.7 ± 73.43	-33.6 ± 49.61	-30 ± 53.44

Notes
[52] - Safety Population
[53] - Safety Population
[54] - Safety Population
[55] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12

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End point title

Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12 ^[56]

End point description

Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.Note too few par. or no par. were analyzed at the indicated test/time point; therefore, the value of 99999 was entered which represents NA.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[57]	40 ^[58]	17 ^[59]	13 ^[60]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Total Bilirubin; Week1; n=40, 39, 15, 13	6.9 ± 8.74	6.7 ± 8.93	8.1 ± 11.81	4.2 ± 8.36
Total Bilirubin; Week2; n=41, 38, 14, 13	5.8 ± 6.62	5.5 ± 6.84	5.6 ± 9.8	6.5 ± 9.34
Total Bilirubin; Week4; n=41, 39, 14, 13	2.2 ± 5.03	2.9 ± 3.52	0.7 ± 8.94	2.5 ± 5.97
Total Bilirubin; Week6; n=41, 38, 13, 13	1.5 ± 4.14	2.7 ± 3.97	-0.5 ± 9.09	2.1 ± 6.87
Total Bilirubin; Week8; n=40, 39, 13, 13	1.4 ± 4.63	2.3 ± 4.93	-0.3 ± 9.83	1.8 ± 6.39
Total Bilirubin; Week12; n=37, 35, 12, 13	0.4 ± 4.46	1.4 ± 5.61	-2.8 ± 10.04	1.2 ± 5.31
Direct Bilirubin; Week1; n=1, 1, 1, 1	0 ± 99999	2 ± 99999	-8 ± 99999	-1 ± 0
Direct Bilirubin; Week2; n=1, 1, 1, 1	0 ± 99999	0 ± 99999	-14 ± 99999	1 ± 0
Direct Bilirubin; Week4; n=1, 1, 0, 0	0 ± 99999	2 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin; Week6; n=1, 1, 0, 0	0 ± 99999	0 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine; Week1; n=40, 39, 15, 13	-1.41 ± 5.983	0.23 ± 5.446	5.12 ± 7.883	-3.85 ± 5.868
Creatinine; Week2; n=41, 38, 14, 13	-2.47 ± 7.966	-2.78 ± 5.725	4.13 ± 6.518	-1.17 ± 7.692
Creatinine; Week4; n=41, 39, 14, 13	-3.4 ± 5.894	-1.33 ± 6.403	5.35 ± 10.16	-3.57 ± 9.599
Creatinine; Week6; n=41, 38, 13, 13	-2.15 ± 6.18	-0.34 ± 7.667	7.1 ± 7.905	-2.05 ± 9.365
Creatinine; Week8; n=40, 39, 13, 13	-1.88 ± 5.724	-0.51 ± 5.425	9.43 ± 10.839	-0.08 ± 10.23
Creatinine; Week12; n=38, 35, 12, 13	-1.49 ± 8.411	-1.99 ± 8.704	6.85 ± 10.363	-2.41 ± 12.239

Notes
[57] - Safety Population
[58] - Safety Population
[59] - Safety Population
[60] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12

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End point title

Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12 ^[61]

End point description

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/blood urea nitrogen (BUN) at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment until Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[62]	40 ^[63]	17 ^[64]	13 ^[65]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Chloride; Week1; n=40, 39, 15, 13	0.5 ± 2.1	-0.4 ± 2.03	0.6 ± 2.61	-0.2 ± 1.95
Chloride; Week2; n=41, 38, 14, 13	0.7 ± 2.37	0.1 ± 1.9	0.5 ± 1.61	-0.7 ± 2.21
Chloride; Week4; n=41, 39, 14, 13	1.7 ± 2.31	1 ± 2.46	1.6 ± 2.21	0.1 ± 2.5
Chloride; Week6; n=41, 38, 13, 13	1.6 ± 2.62	0.8 ± 2.57	0.8 ± 2.73	-0.1 ± 1.38
Chloride; Week8; n=40, 39, 13, 13	2 ± 3.49	0.7 ± 2.36	2.2 ± 3	-0.8 ± 2.77
Chloride; Week12; n=37, 35, 12, 13	1.5 ± 2.36	0.1 ± 3.35	1.9 ± 2.61	1.2 ± 2.95
Bicarbonate; Week1; n=40, 39, 15, 13	0 ± 3.05	-0.9 ± 2.57	-1.2 ± 2.54	-0.7 ± 2.56
Bicarbonate; Week2; n=41, 38, 14, 13	-0.3 ± 2.2	-0.8 ± 3.1	-1.5 ± 2.98	-0.2 ± 3.65
Bicarbonate; Week4; n=41, 39, 14, 13	-0.9 ± 1.91	-0.8 ± 2.55	-1.4 ± 1.86	-0.5 ± 2.67
Bicarbonate; Week6; n=41, 38, 13, 13	-0.4 ± 2	-0.7 ± 2.23	-1.5 ± 2.18	0.6 ± 2.6
Bicarbonate; Week8; n=40, 39, 13, 13	-0.7 ± 2.41	-0.8 ± 2.35	-1.2 ± 2.19	0 ± 2.2
Bicarbonate; Week12; n=37, 35, 12, 13	-0.6 ± 2.42	-0.9 ± 2.37	-1.1 ± 2.23	-0.5 ± 2.76
Glucose; Week1; n=40, 39, 15, 13	-0.37 ± 1.485	-0.34 ± 0.761	-0.03 ± 0.616	0.36 ± 1.619
Glucose; Week2; n=41, 38, 14, 13	-0.22 ± 1.467	-0.17 ± 0.791	0.11 ± 0.52	0.13 ± 1.765
Glucose; Week4; n=41, 39, 14, 13	-0.03 ± 1.162	0.02 ± 1.054	-0.11 ± 0.601	-0.48 ± 0.832
Glucose; Week6; n=41, 38, 13, 13	-0.15 ± 1.315	-0.18 ± 1.154	0.18 ± 0.772	-0.55 ± 0.755
Glucose; Week8; n=40, 39, 13, 13	-0.05 ± 1.165	-0.06 ± 0.835	0.04 ± 0.675	-0.36 ± 1.191
Glucose; Week12; n=38, 35, 12, 13	-0.3 ± 1.877	-0.39 ± 1.047	-0.23 ± 0.757	-0.45 ± 1.063
Potassium; Week1; n=40, 39, 15, 13	-0.02 ± 0.392	-0.06 ± 0.339	-0.11 ± 0.376	-0.02 ± 0.313
Potassium; Week2; n=41, 38, 14, 13	-0.1 ± 0.428	-0.12 ± 0.453	-0.39 ± 0.417	-0.02 ± 0.316
Potassium; Week4; n=41, 39, 14, 13	-0.16 ± 0.411	-0.11 ± 0.455	-0.34 ± 0.497	-0.05 ± 0.499
Potassium; Week6; n=41, 38, 13, 13	-0.15 ± 0.483	-0.16 ± 0.387	-0.45 ± 0.355	-0.21 ± 0.38
Potassium; Week8; n=40, 39, 13, 13	-0.11 ± 0.49	-0.19 ± 0.42	-0.51 ± 0.348	-0.14 ± 0.348
Potassium; Week12; n=37, 35, 12, 13	-0.15 ± 0.394	-0.21 ± 0.362	-0.38 ± 0.447	-0.1 ± 0.428
Sodium; Week1; n=40, 39, 15, 13	-0.4 ± 1.85	-0.8 ± 1.76	-0.2 ± 2.46	-0.8 ± 2.08
Sodium; Week2; n=41, 38, 14, 13	-0.1 ± 2.15	-0.6 ± 1.81	0 ± 1.8	-1.3 ± 2.25
Sodium; Week4; n=41, 39, 14, 13	0.1 ± 2.16	-0.1 ± 2.2	0.4 ± 1.78	-0.8 ± 1.95
Sodium; Week6; n=41, 38, 13, 13	0.2 ± 2.39	-0.3 ± 2.39	0.2 ± 2.91	0 ± 2
Sodium; Week8; n=40, 39, 13, 13	0.3 ± 3.28	-0.6 ± 2.24	1.1 ± 2.18	-0.6 ± 2.22
Sodium; Week12; n=37, 35, 12, 13	0.1 ± 1.91	-0.3 ± 2.36	0.8 ± 2.66	0.5 ± 2.18
Inorganic Phosphorus; Week1; n=40, 39, 15, 13	-0.13 ± 0.1599	-0.086 ± 0.1415	-0.122 ± 0.1353	-0.087 ± 0.1489
Inorganic Phosphorus; Week2; n=41, 38, 14, 13	-0.141 ± 0.181	-0.108 ± 0.1754	-0.081 ± 0.1194	-0.105 ± 0.1159
Inorganic Phosphorus; Week4; n=41, 39, 14, 13	-0.151 ± 0.1666	-0.125 ± 0.1421	-0.077 ± 0.1669	-0.078 ± 0.1871
Inorganic Phosphorus; Week6; n=41, 38, 13, 13	-0.171 ± 0.1939	-0.181 ± 0.1823	-0.121 ± 0.1549	-0.159 ± 0.121
Inorganic Phosphorus; Week8; n=40, 39, 13, 13	-0.169 ± 0.2025	-0.23 ± 0.1937	-0.112 ± 0.1563	-0.14 ± 0.167
Inorganic Phosphorus; Week12; n=37, 35, 12, 13	-0.172 ± 0.1708	-0.168 ± 0.2047	-0.117 ± 0.1123	-0.136 ± 0.1943
Urea/BUN; Week1; n=40, 39, 15, 13	0.24 ± 0.996	0.04 ± 1.002	0.19 ± 1.287	-0.01 ± 1.188
Urea/BUN; Week2; n=41, 38, 14, 13	0.2 ± 1.012	-0.13 ± 1.05	0.08 ± 1.309	-0.12 ± 1.244
Urea/BUN; Week4; n=41, 39, 14, 13	0.03 ± 1.145	-0.4 ± 1.047	0.11 ± 1.436	-0.88 ± 1.137
Urea/BUN; Week6; n=41, 38, 13, 13	-0.04 ± 1.09	-0.29 ± 1.13	-0.39 ± 0.883	-1.02 ± 0.667
Urea/BUN; Week8; n=40, 39, 13, 13	-0.16 ± 1.088	-0.46 ± 1.337	-0.07 ± 1.206	-0.85 ± 1.067
Urea/BUN; Week12; n=37, 35, 12, 13	-0.08 ± 1.164	-0.31 ± 1.276	-0.11 ± 1.272	-0.64 ± 1.81

Notes
[62] - Safety Population
[63] - Safety Population
[64] - Safety Population
[65] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12

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End point title

Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12 ^[66]

End point description

Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 2, 4, 6, 8 and 12

Notes
[66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[67]	40 ^[68]	17 ^[69]	13 ^[70]
Units: Milliliter per minute (mL/min)
arithmetic mean (standard deviation)
Creatinine Clearance; Week1; n=40, 39, 15, 13	1.5 ± 9.79	-2.1 ± 19.51	-9.5 ± 10.09	5.7 ± 10.18
Creatinine Clearance; Week2; n=41, 38, 14, 13	3.3 ± 13.48	4.7 ± 11.33	-9 ± 12.55	-1.8 ± 15.27
Creatinine Clearance; Week4; n=41, 39, 14, 13	5 ± 12.45	1.9 ± 14.72	-9.1 ± 13.42	4.5 ± 16.19
Creatinine Clearance; Week6; n=41, 38, 13, 13	2.7 ± 11.93	-0.7 ± 16.25	-19.1 ± 20.54	1.5 ± 13.12
Creatinine Clearance; Week8; n=40, 39, 13, 13	1.9 ± 10.49	3.4 ± 19.94	-17.8 ± 16.1	-3 ± 14.54
Creatinine Clearance; Week12; n=38, 35, 12, 13	-0.2 ± 15.06	2.2 ± 17.27	-14.3 ± 16.99	1.2 ± 20.49

Notes
[67] - Safety Population
[68] - Safety Population
[69] - Safety Population
[70] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with shift from Baseline in urinalysis data up to Week 12

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End point title

Number of participants with shift from Baseline in urinalysis data up to Week 12 ^[71]

End point description

Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC), white blood cells (WBC). Other urinalysis parameter included urine pH (UpH), urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety populat

End point type

Primary

End point timeframe

Baseline, Weeks 2 and 12

Notes
[71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[72]	40 ^[73]	17 ^[74]	13 ^[75]
Units: Participants
Week 2, UBIL, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UBIL, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, UBIL, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UBIL, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, UGLU, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UGLU, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, UGLU, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UGLU, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, UKET, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UKET, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, UKET, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UKET, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, ULET, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, ULET, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, ULET, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, ULET, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, UMBT, BL NL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL NL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL NL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL ANL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL ANL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL ANL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL MIS to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL MIS to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMBT, BL MIS to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 12, UMBT, BL NL to PBL NL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL NL to PBL ANL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL NL to PBL MIS, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL ANL to PBL NL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL ANL to PBL ANL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL ANL to PBL MIS, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL MIS to PBL NL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL MIS to PBL ANL, n=1, 1, 0, 0	0	0	0	0
Week 12, UMBT, BL MIS to PBL MIS, n=1, 1, 0, 0	1	1	0	0
Week 2, UMRBC, BL NL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL NL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL NL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL ANL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL ANL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL ANL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL MIS to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL MIS to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMRBC, BL MIS to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 12, UMRBC, BL NL to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL NL to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL NL to PBL MIS, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL ANL to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL ANL to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL ANL to PBL MIS, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL MIS to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL MIS to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMRBC, BL MIS to PBL MIS, n=4, 5, 2, 2	4	5	2	2
Week 2, UMWBC, BL NL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL NL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL NL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL ANL to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL ANL to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL ANL to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL MIS to PBL NL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL MIS to PBL ANL, n=0, 0, 0, 0	0	0	0	0
Week 2, UMWBC, BL MIS to PBL MIS, n=0, 0, 0, 0	0	0	0	0
Week 12, UMWBC, BL NL to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL NL to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL NL to PBL MIS, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL ANL to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL ANL to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL ANL to PBL MIS, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL MIS to PBL NL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL MIS to PBL ANL, n=4, 5, 2, 2	0	0	0	0
Week 12, UMWBC, BL MIS to PBL MIS, n=4, 5, 2, 2	4	5	2	2
Week 2, UNIT, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UNIT, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, UNIT, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UNIT, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, UOB, BL NL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UOB, BL MIS to PBL MIS, n=1, 0, 0, 0	1	0	0	0
Week 12, UOB, BL NL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UOB, BL MIS to PBL MIS, n=37, 34, 12, 13	37	34	12	13
Week 2, UPH, BL NL to PBL NL, n=1, 0, 0, 0	1	0	0	0
Week 2, UPH, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, UPH, BL MIS to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 12, UPH, BL NL to PBL NL, n=37, 34, 12, 13	36	34	12	13
Week 12, UPH, BL NL to PBL ANL, n=37, 34, 12, 13	1	0	0	0
Week 12, UPH, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, UPH, BL MIS to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 2, USG, BL NL to PBL NL, n=1, 0, 0, 0	1	0	0	0
Week 2, USG, BL NL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL NL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL ANL to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL ANL to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL ANL to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL MIS to PBL NL, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL MIS to PBL ANL, n=1, 0, 0, 0	0	0	0	0
Week 2, USG, BL MIS to PBL MIS, n=1, 0, 0, 0	0	0	0	0
Week 12, USG, BL NL to PBL NL, n=37, 34, 12, 13	37	34	12	12
Week 12, USG, BL NL to PBL ANL, n=37, 34, 12, 13	0	0	0	1
Week 12, USG, BL NL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL ANL to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL ANL to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL ANL to PBL MIS, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL MIS to PBL NL, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL MIS to PBL ANL, n=37, 34, 12, 13	0	0	0	0
Week 12, USG, BL MIS to PBL MIS, n=37, 34, 12, 13	0	0	0	0

Notes
[72] - Safety Population
[73] - Safety Population
[74] - Safety Population
[75] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12

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End point title

Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12 ^[76]

End point description

The electrocardiographic (ECG) parameters heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1 and 12

Notes
[76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[77]	40 ^[78]	17 ^[79]	13 ^[80]
Units: Beats per minute
arithmetic mean (standard deviation)
Week 1, n=41, 40, 15, 12	3.3 ± 8.28	0.8 ± 8.49	4.1 ± 9.52	4.8 ± 10.62
Week 12, n=38, 35, 12, 13	8.3 ± 8.37	5.1 ± 10.86	9.3 ± 10.15	8.5 ± 8

Notes
[77] - Safety Population
[78] - Safety Population
[79] - Safety Population
[80] - Safety Population

No statistical analyses for this end point

Primary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12

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End point title

Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12 ^[81]

End point description

The electrocardiographic (ECG) parameters including PR interval, QRS duration, uncorrected QT interval, QT interval corrected Bazett's formula (QTcB), QT interval corrected using Fridericia’s formula (QTcF) were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

End point type

Primary

End point timeframe

Baseline, Weeks 1 and 12

Notes
[81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[82]	40 ^[83]	17 ^[84]	13 ^[85]
Units: Milliseconds
arithmetic mean (standard deviation)
PR interval, Week 1, n=41, 40, 15, 12	0.5 ± 19.43	1.2 ± 13.57	2.7 ± 7.27	-1.6 ± 20.92
PR interval, Week 12, n=38, 35, 12, 13	2.9 ± 13.36	3.2 ± 12.07	5.5 ± 8.73	0.2 ± 14.68
QRS duration, Week 1, n=41, 40, 15, 12	-6.6 ± 50.28	0.4 ± 7.69	2.9 ± 6.61	0.4 ± 4.03
QRS duration, Week 12, n=38, 35, 12, 13	-8.2 ± 51.69	-1.8 ± 6.44	0.4 ± 7.54	-2 ± 4.4
Uncorrected QT Interval, Week 1, n=41, 40, 15, 12	-2.3 ± 27.29	-2.6 ± 22.29	-2.1 ± 22.39	5.9 ± 25.68
Uncorrected QT interval, Week 12, n=38, 35, 12, 13	-11.8 ± 31.28	-12 ± 25.22	-17 ± 18.01	-4.6 ± 23.36
Corrected QTcB interval, Week 1, n=41, 40, 15, 12	7.7087 ± 25.63001	0.2491 ± 22.90285	9.8112 ± 20.6771	19.8879 ± 40.13504
Corrected QTcB interval, Week 12, n=38, 35, 12, 13	11.5512 ± 26.5644	1.7615 ± 20.3859	11.2801 ± 25.54652	18.9943 ± 16.76576
Corrected QTcF interval, Week 1, n=41, 40, 15, 12	4.1995 ± 23.18239	-0.7151 ± 19.69091	5.7676 ± 17.06472	14.9187 ± 32.2737
Corrected QTcF interval, Week 12, n=38, 35, 12, 13	3.3516 ± 26.34546	-3.1442 ± 17.38368	1.6147 ± 18.38188	10.7637 ± 17.07259

Notes
[82] - Safety Population
[83] - Safety Population
[84] - Safety Population
[85] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12

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End point title

Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12

End point description

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

End point type

Secondary

End point timeframe

From Week 12 up to Post-Treatment (PT) Week 24 Follow-up (FU)

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[86]	40 ^[87]	17 ^[88]	13 ^[89]
Units: Participants
Any AE	21	22	8	9
Any SAE	0	2	3	1

Notes
[86] - Safety Population
[87] - Safety Population
[88] - Safety Population
[89] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)

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End point title

Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)

End point description

Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. Very rapid virologic response (vRVR) is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. Rapid virologic response (RVR) is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. Complete early virologic response (cEVR) is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. Sustained virologic response 12 (SVR12) is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. Sustained virologic response 24 (SVR24) is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.

End point type

Secondary

End point timeframe

From the start of the treatment up to PT FU Week 24

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[90]	40 ^[91]	17 ^[92]	13 ^[93]
Units: Participants
vRVR	8	12	8	6
RVR	23	23	10	9
cEVR	33	30	11	13
SVR12	30	26	10	11
SVR24	27	25	10	12
SVR24 with RGT	17	17	9	9

Notes
[90] - ITT Population
[91] - ITT Population
[92] - ITT Population
[93] - ITT Population

No statistical analyses for this end point

Secondary: Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12

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End point title

Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12 ^[94]

End point description

Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Day 1, Day 2, Week 4, and Week 12

Notes
[94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	41 ^[95]	53 ^[96]
Units: nanogram per milliliter (ng/mL)
arithmetic mean (standard deviation)
Day 1 (0h-1h), n=1, 3	99999 ± 99999	604 ± 392.763
Day 1 (1h-4h), n=35, 42	290.39 ± 241.05	445.18 ± 314.624
Day 1 (4h-8h), n=0, 3	99999 ± 99999	221.33 ± 191.996
Day 1 (8h-20h), n=0, 1	99999 ± 99999	99999 ± 99999
Day 2 Predose (20-28h), n=36, 43	53.79 ± 52.629	123.89 ± 257.575
Week 4 Predose (20-28h), n=33, 42	81.18 ± 153.462	146.85 ± 243.331
Week 4 (0h-1h), n=2, 6	198.4 ± 242.679	553 ± 536.451
Week 4 (1h-4h), n=46, 52	392.78 ± 275.504	591.07 ± 402.442
Week 4 (4h-8h), n=22, 19	215.55 ± 127.737	411.68 ± 251.604
Week 4 (8h-20h), n=1, 2	99999 ± 99999	192.5 ± 94.045
Week 4 (20h-28h), n=11, 10	51.24 ± 57.261	66.29 ± 53.604
Week 12 (Predose [20-28h]), n=26, 35	45.99 ± 42.034	142.59 ± 178.252

Notes
[95] - PK Population
[96] - PK Population

No statistical analyses for this end point

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4

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End point title

Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4 ^[97]

End point description

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose. : Intensive PK Summary Population is comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).

End point type

Secondary

End point timeframe

Week 4

Notes
[97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	11 ^[98]	10 ^[99]
Units: ng/mL
geometric mean (geometric coefficient of variation)
Cmax, n=11, 10	335.35 ± 69.4	618.75 ± 46.1
Ctau, n=11, 10	31.37 ± 135.9	49.31 ± 97.6

Notes
[98] - Intensive PK Summary Population
[99] - Intensive PK Summary Population

No statistical analyses for this end point

Secondary: Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4

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End point title

Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4 ^[100]

End point description

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.

End point type

Secondary

End point timeframe

Week 4

Notes
[100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	11 ^[101]	10 ^[102]
Units: hour
median (full range (min-max))	2 (1 to 4)	2 (1 to 7)

Notes
[101] - Intensive PK Summary Population
[102] - Intensive PK Summary Population

No statistical analyses for this end point

Secondary: Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12

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End point title

Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12 ^[103]

End point description

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.

End point type

Secondary

End point timeframe

Week 12

Notes
[103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	11 ^[104]	10 ^[105]
Units: hournanogram per milliliter(hrng/mL)
geometric mean (geometric coefficient of variation)	2733.34 ± 82	4948.23 ± 66.3

Notes
[104] - Intensive PK Summary Population
[105] - Intensive PK Summary Population

No statistical analyses for this end point

Secondary: Apparent clearance (CL/F) at Week 12

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End point title

Apparent clearance (CL/F) at Week 12 ^[106]

End point description

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Apparent clearance is calculated as dose divided by AUC(0-tau).

End point type

Secondary

End point timeframe

Week 12

Notes
[106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	11 ^[107]	10 ^[108]
Units: Liter per hour (L/hr)
geometric mean (geometric coefficient of variation)	14.63 ± 82	12.13 ± 66.3

Notes
[107] - Intensive PK Summary Population
[108] - Intensive PK Summary Population

No statistical analyses for this end point

Secondary: Apparent volume of distribution (Vz/F) at Week 12

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End point title

Apparent volume of distribution (Vz/F) at Week 12 ^[109]

End point description

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Apparent volume of distribution is calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.

End point type

Secondary

End point timeframe

Week 12

Notes
[109] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	11 ^[110]	10 ^[111]
Units: Liter per hour (L/hr)
geometric mean (geometric coefficient of variation)	172.81 ± 76.6	125.09 ± 67.9

Notes
[110] - Intensive PK Summary Population
[111] - Intensive PK Summary Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12

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End point title

Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. System value of 99999 indicates NA (too few participants).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[112]	40 ^[113]	17 ^[114]	13 ^[115]
Units: Giga per liter
arithmetic mean (standard deviation)
Basophils; Week18; n=37, 33, 13, 12	-0.019 ± 0.0178	-0.01 ± 0.0194	-0.014 ± 0.0112	-0.012 ± 0.0119
Basophils; Week24; n=34, 32, 12, 11	-0.018 ± 0.0177	-0.01 ± 0.0166	-0.013 ± 0.0129	-0.013 ± 0.011
Basophils; Week30; n=13, 10, 2, 2	-0.018 ± 0.0142	-0.012 ± 0.0148	-0.02 ± 0	-0.02 ± 0
Basophils; Week36; n=12, 7, 1, 2	-0.02 ± 0.0165	-0.006 ± 0.019	-0.02 ± 99999	-0.01 ± 0.0141
Basophils; Week42; n=10, 6, 2, 2	-0.015 ± 0.0242	-0.005 ± 0.0187	0 ± 0.0424	-0.015 ± 0.0071
Basophils; Week48; n=7, 6, 1, 2	-0.007 ± 0.0214	-0.007 ± 0.0197	0.02 ± 99999	0.005 ± 0.0119
Basophils; PT Week4; n=32, 34, 11, 11	-0.007 ± 0.0162	-0.003 ± 0.0189	-0.001 ± 0.0181	-0.003 ± 0.0189
Eosinophils; Week18; n=37, 33, 13, 12	-0.119 ± 0.1006	-0.127 ± 0.1207	-0.087 ± 0.0507	-0.068 ± 0.0746
Eosinophils; Week24; n=34, 32, 12, 11	-0.128 ± 0.101	-0.131 ± 0.1103	-0.118 ± 0.0612	-0.041 ± 0.1003
Eosinophils; Week30; n=13, 10, 2, 2	-0.124 ± 0.0982	-0.116 ± 0.1117	-0.13 ± 0.0849	-0.04 ± 0.0141
Eosinophils; Week36; n=12, 7, 1, 2	-0.081 ± 0.1459	-0.123 ± 0.1003	-0.06 ± 99999	-0.05 ± 0.0141
Eosinophils; Week42; n=10, 6, 2, 2	-0.105 ± 0.074	-0.1 ± 0.12	-0.02 ± 0.0424	-0.04 ± 0
Eosinophils; Week48; n=8, 6, 1, 2	-0.071 ± 0.0889	-0.11 ± 0.1223	0.13 ± 99999	-0.05 ± 0.0141
Eosinophils; PT Week4; n=32, 34, 11, 11	-0.069 ± 0.0925	-0.085 ± 0.1208	-0.07 ± 0.0694	-0.018 ± 0.0808
Lymphocytes; Week18; n=37, 33, 13, 12	-1.081 ± 0.5533	-1.157 ± 0.5373	-0.999 ± 0.4672	-0.973 ± 0.5328
Lymphocytes; Week24; n=34, 32, 12, 11	-1.181 ± 0.4795	-1.092 ± 0.5598	-1.405 ± 0.5912	-1.057 ± 0.4832
Lymphocytes; Week30; n=13, 10, 2, 2	-1.225 ± 0.7588	-1.085 ± 0.798	-1.905 ± 0.1768	-1.845 ± 0.2899
Lymphocytes; Week36; n=12, 7, 1, 2	-1.267 ± 0.6828	-1.286 ± 0.8983	-1.97 ± 99999	-1.92 ± 0.4808
Lymphocytes; Week42; n=10, 6, 2, 2	-1.135 ± 0.8657	-1.22 ± 0.9909	-1.125 ± 1.0253	-1.93 ± 0.1414
Lymphocytes; Week48; n=7, 6, 1, 2	-0.779 ± 1.0639	-1.4 ± 1.0384	0.09 ± 99999	-2.2 ± 0.0424
Lymphocytes; PT Week4; n=32, 34, 11, 11	-0.681 ± 0.4594	-0.7 ± 0.6163	-0.756 ± 0.5874	-0.737 ± 0.5666
Monocytes; Week18; n=37, 33, 13, 12	-0.186 ± 0.1588	-0.141 ± 0.1339	-0.088 ± 0.1663	-0.143 ± 0.1776
Monocytes; Week24; n=34, 32, 12, 11	-0.206 ± 0.1692	-0.156 ± 0.1574	-0.151 ± 0.1474	-0.121 ± 0.1902
Monocytes; Week30; n=13, 10, 2, 2	-0.151 ± 0.1655	-0.135 ± 0.091	-0.4 ± 0.3111	-0.06 ± 0.0141
Monocytes; Week36; n=12, 7, 1, 2	-0.255 ± 0.1474	-0.18 ± 0.0987	-0.2 ± 99999	0.015 ± 0.1061
Monocytes; Week42; n=10, 6, 2, 2	-0.184 ± 0.234	-0.093 ± 0.1743	-0.025 ± 0.2192	-0.01 ± 0.099
Monocytes; Week48; n=7, 6, 1, 2	-0.066 ± 0.1744	-0.147 ± 0.088	0.02 ± 99999	-0.085 ± 0.1909
Monocytes; PT Week4; n=32, 34, 11, 11	-0.047 ± 0.1773	-0.031 ± 0.165	0.032 ± 0.1543	-0.053 ± 0.1536
Total Neutrophils; Week18; n=37, 33, 13, 12	-2.702 ± 1.9136	-2.378 ± 1.6735	-1.652 ± 0.852	-1.463 ± 0.7174
Total Neutrophils; Week24; n=34, 32, 12, 11	-2.527 ± 1.9492	-2.187 ± 1.7758	-1.308 ± 0.7148	-1.3 ± 0.9956
Total Neutrophils; Week30; n=13, 10, 2, 2	-2.402 ± 1.7954	-2.252 ± 2.3658	-2.24 ± 1.2869	-2.085 ± 0.1909
Total Neutrophils; Week36; n=12, 7, 1, 2	-2.503 ± 1.6709	-2.777 ± 2.4215	-1.61 ± 99999	-1.63 ± 0.297
Total Neutrophils; Week42; n=10, 6, 2, 2	-2.23 ± 2.0311	-3.085 ± 2.7313	-0.565 ± 0.7849	-1.815 ± 0.4455
Total Neutrophils; Week48; n=7, 6, 1, 2	-1.129 ± 2.2597	-2.488 ± 3.397	0.02 ± 99999	-1.445 ± 0.4596
Total Neutrophils; PT Week4; n=32, 34, 11, 11	-1.158 ± 1.8855	-0.808 ± 1.6104	-0.744 ± 1.1276	-0.671 ± 0.8001
Platelet Count; Week18; n=38, 34, 13, 12	-73.7 ± 43.93	-87.5 ± 38.4	-55.7 ± 56.96	-52.1 ± 39.87
Platelet Count; Week24; n=35, 33, 12, 11	-67.5 ± 43.22	-78.8 ± 44.15	-60.3 ± 56.5	-51.9 ± 44.19
Platelet Count; Week30; n=13, 10, 1, 2	-70 ± 60.5	-71.9 ± 59.35	-112 ± 99999	-36.5 ± 47.38
Platelet Count; Week36; n=12, 7, 1, 2	-64.1 ± 41.52	-75.7 ± 65.89	-115 ± 99999	-34 ± 52.33
Platelet Count; Week42; n=10, 6, 2, 2	-56.1 ± 53.01	-67.3 ± 62.09	-112 ± 0	-22 ± 52.33
Platelet Count; Week48; n=9, 6, 1, 2	-37.7 ± 66.18	-68.8 ± 65.74	33 ± 99999	-14 ± 22.63
Platelet Count; PT Week4; n=32, 34, 11, 11	-20.4 ± 44.37	-28.9 ± 45.92	-12.4 ± 34.3	-12.9 ± 42.3
White Blood Cell count; Week18; n=37, 33, 13, 12	-4.1 ± 2.258	-3.81 ± 1.884	-2.84 ± 0.961	-2.65 ± 0.923
White Blood Cell count ; Week24; n=34, 32, 12, 11	-4.06 ± 2.251	-3.58 ± 1.977	-3 ± 1.047	-2.52 ± 1.272
White Blood Cell count ; Week30; n=13, 10, 2, 2	-3.92 ± 2.258	-3.59 ± 3.051	-4.7 ± 1.838	-4.05 ± 0.495
White Blood Cell count ; Week36; n=12, 7, 1, 2	-4.13 ± 2.188	-4.39 ± 3.168	-3.9 ± 99999	-3.55 ± 0.919
White Blood Cell count ; Week42; n=10, 6, 2, 2	-3.67 ± 2.807	-4.52 ± 3.68	-1.75 ± 2.051	-3.8 ± 0.707
White Blood Cell count; Week48; n=7, 6, 1, 2	-2.09 ± 3.304	-4.17 ± 4.172	0.2 ± 99999	-3.8 ± 0.141
White Blood Cell count; PT Week4; n=32, 34, 11, 11	-1.97 ± 1.938	-1.64 ± 1.907	-1.54 ± 1.638	-1.45 ± 0.884

Notes
[112] - Safety Population
[113] - Safety Population
[114] - Safety Population
[115] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in red blood cell count at the indicated time points after Week 12

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End point title

Mean change from Baseline in red blood cell count at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[116]	40 ^[117]	17 ^[118]	13 ^[119]
Units: Trillion per liter
arithmetic mean (standard deviation)
Red Blood Cell count; Week 18; n=38, 34, 13, 12	-1.13 ± 0.494	-0.88 ± 0.591	-1.19 ± 0.638	-0.99 ± 0.498
Red Blood Cell count; Week 24; n=35, 33, 12, 11	-1.13 ± 0.482	-0.94 ± 0.513	-1.19 ± 0.552	-1.14 ± 0.528
Red Blood Cell count; Week 30; n=13, 10, 2, 2	-1.05 ± 0.511	-0.75 ± 0.809	-1.45 ± 0.071	-1.45 ± 0.354
Red Blood Cell count; Week 36; n=12, 7, 1, 2	-0.88 ± 0.67	-1.06 ± 0.761	-1 ± 99999	-1.3 ± 0.283
Red Blood Cell count; Week 42; n=10, 6, 2, 2	-0.91 ± 0.674	-1.17 ± 0.769	-0.55 ± 0.636	-1.45 ± 0.354
Red Blood Cell count; Week 48; n=9, 6, 1, 2	-0.83 ± 0.791	-1.03 ± 0.794	-0.4 ± 99999	-1.5 ± 0.566
Red Blood Cell count; PT Week 4; n=32, 34, 11, 11	-0.57 ± 0.435	-0.37 ± 0.353	-0.66 ± 0.437	-0.65 ± 0.474

Notes
[116] - Safety Population
[117] - Safety Population
[118] - Safety Population
[119] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in hemoglobin at the indicated time points after Week 12

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End point title

Mean change from Baseline in hemoglobin at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[120]	40 ^[121]	17 ^[122]	13 ^[123]
Units: Grams per liter
arithmetic mean (standard deviation)
Hemoglobin; Week 18; n=38, 34, 13, 12	-33.6 ± 12.34	-26.7 ± 14.65	-35 ± 16.38	-29 ± 10.61
Hemoglobin; Week 24; n=35, 33, 12, 11	-33.4 ± 12.16	-28 ± 12.44	-35.6 ± 13.48	-32.3 ± 14.98
Hemoglobin; Week 30; n=13, 10, 2, 2	-30.2 ± 16.13	-21 ± 20.02	-40 ± 12.73	-40 ± 1.41
Hemoglobin; Week 36; n=12, 7, 1, 2	-26.7 ± 18.86	-30 ± 16.37	-37 ± 99999	-35 ± 1.41
Hemoglobin; Week 42; n=10, 6, 2, 2	-27.1 ± 18.51	-31.7 ± 19.82	-25 ± 22.63	-40 ± 1.41
Hemoglobin; Week 48; n=9, 6, 1, 2	-25.9 ± 21.47	-29.3 ± 20.33	-18 ± 99999	-41 ± 8.49
Hemoglobin; PT Week 4; n=32, 34, 11, 11	-16.5 ± 11.43	-11.7 ± 9.57	-21.4 ± 8.59	-16.8 ± 11.99

Notes
[120] - Safety Population
[121] - Safety Population
[122] - Safety Population
[123] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in hematocrit at the indicated time points after Week 12

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End point title

Mean change from Baseline in hematocrit at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[124]	40 ^[125]	17 ^[126]	13 ^[127]
Units: Percentage of RBC in blood
arithmetic mean (standard deviation)
Hematocrit; Week 18; n=38, 34, 13, 12	-0.083 ± 0.03831	-0.0622 ± 0.04289	-0.0776 ± 0.04313	-0.0699 ± 0.02801
Hematocrit; Week 24; n=35, 33, 12, 11	-0.0782 ± 0.04021	-0.0635 ± 0.03499	-0.0808 ± 0.03543	-0.0823 ± 0.03968
Hematocrit; Week 30; n=13, 10, 2, 2	-0.0713 ± 0.0486	-0.0397 ± 0.05793	-0.0955 ± 0.03323	-0.1125 ± 0.00636
Hematocrit; Week 36; n=12, 7, 1, 2	-0.0567 ± 0.05031	-0.069 ± 0.04724	-0.087 ± 99999	-0.0895 ± 0.00354
Hematocrit; Week 42; n=10, 6, 2, 2	-0.0623 ± 0.05449	-0.0802 ± 0.0562	-0.0535 ± 0.07	-0.111 ± 0.00566
Hematocrit; Week 48; n=9, 6, 1, 2	-0.0624 ± 0.06203	-0.0753 ± 0.05285	-0.047 ± 99999	-0.1095 ± 0.03041
Hematocrit; PT Week 4; n=32, 34, 11, 11	-0.0293 ± 0.03575	-0.0135 ± 0.03178	-0.0362 ± 0.02907	-0.0354 ± 0.0358

Notes
[124] - Safety Population
[125] - Safety Population
[126] - Safety Population
[127] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12

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End point title

Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[128]	40 ^[129]	17 ^[130]	13 ^[131]
Units: Femtoliters
arithmetic mean (standard deviation)
Mean Corpuscle Volume ; Week 18; n=38, 34, 13, 12	7.5 ± 6.37	6.2 ± 8.19	8.5 ± 5.78	5.3 ± 5.28
Mean Corpuscle Volume ; Week 24; n=35, 33, 12, 11	8.5 ± 6.14	7.5 ± 8.89	7.6 ± 5.9	5.8 ± 5.08
Mean Corpuscle Volume ; Week 30; n=13, 10, 2, 2	7.8 ± 7.24	9.5 ± 12.02	11.5 ± 7.78	3 ± 2.83
Mean Corpuscle Volume ; Week 36; n=12, 7, 1, 2	8.1 ± 5.92	11.4 ± 13.6	2 ± 99999	5.5 ± 2.12
Mean Corpuscle Volume ; Week 42; n=10, 6, 2, 2	6.9 ± 5.7	10.7 ± 14.47	1 ± 2.83	4 ± 2.83
Mean Corpuscle Volume ; Week 48; n=9, 6, 1, 2	5.2 ± 5.76	9 ± 14.04	-1 ± 99999	5 ± 1.41
Mean Corpuscle Volume; PT Week 4; n=32, 34, 11, 11	6.1 ± 5.56	5.1 ± 4.86	5.8 ± 3.79	5.3 ± 5.1

Notes
[128] - Safety Population
[129] - Safety Population
[130] - Safety Population
[131] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in albumin at the indicated time points after Week 12

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End point title

Mean change from Baseline in albumin at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[132]	40 ^[133]	17 ^[134]	13 ^[135]
Units: Grams per liter
arithmetic mean (standard deviation)
Albumin; Week 18; n=38, 34, 13, 12	-2.3 ± 2.78	-1.4 ± 2.65	-1.8 ± 2.86	-1 ± 2.89
Albumin; Week 24; n=35, 33, 12, 11	-2.1 ± 3.08	-1.6 ± 2.82	-2.3 ± 2.81	-1.1 ± 2.81
Albumin; Week 30; n=13, 10, 3, 2	-1.8 ± 2.09	-0.7 ± 4.22	-3 ± 2.65	-4.5 ± 0.71
Albumin; Week 36; n=10, 7, 2, 2	-1.7 ± 3.92	-1.1 ± 2.85	2 ± 1.41	-2 ± 0
Albumin; Week 42; n=9, 6, 1, 2	-1.3 ± 2.5	-1.3 ± 1.63	-1 ± 99999	-3 ± 0
Albumin; Week 48; n=6, 6, 0, 2	-1.3 ± 3.61	-0.3 ± 2.16	99999 ± 99999	-4 ± 1.41
Albumin; PT Week 4; n=33, 34, 11, 11	-0.7 ± 3.93	-0.2 ± 2.84	0.5 ± 2.3	-0.7 ± 1.79

Notes
[132] - Safety Population
[133] - Safety Population
[134] - Safety Population
[135] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12

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End point title

Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of Alkaline Phosphatase (ALP) , Alanine Amino Transferase (ALT) , Aspartate Amino Transferase (AST) , Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. System value of 99999 indicates NA (too few participants).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[136]	40 ^[137]	17 ^[138]	13 ^[139]
Units: International units per liter
arithmetic mean (standard deviation)
ALP; Week 18; n=38, 34, 13, 12	2.5 ± 17.25	1.1 ± 16.95	2.2 ± 21.77	6.4 ± 20.08
ALP; Week 24; n=35, 33, 12, 11	0.8 ± 19.71	3.3 ± 18.83	2.1 ± 20.24	4.5 ± 22.82
ALP; Week 30; n=13, 10, 3, 2	1.8 ± 15.79	-6.4 ± 18.62	-8 ± 8.54	22.5 ± 14.85
ALP; Week 36; n=10, 7, 2, 2	2 ± 17.49	2.7 ± 9.45	2.5 ± 0.71	18 ± 7.07
ALP; Week 42; n=9, 6, 1, 2	5.3 ± 13.4	3.3 ± 8.45	-2 ± 99999	17.5 ± 2.12
ALP; Week 48; n=6, 6, 0, 2	9.8 ± 17.36	4.2 ± 9.62	99999 ± 99999	30 ± 24.04
ALP; PT Week 4; n=33, 34, 11, 11	-4.9 ± 19.71	-6.3 ± 17.88	-7 ± 17.93	-3.9 ± 22.15
ALT; Week 18; n=38, 34, 13, 12	-38.9 ± 61.39	-22.9 ± 61.65	-38.6 ± 40.89	-38.4 ± 32.63
ALT; Week 24; n=35, 33, 12, 11	-43.9 ± 62.25	-31.3 ± 56.12	-39.7 ± 38.19	-41.7 ± 28.32
ALT; Week 30; n=13, 10, 3, 2	-34.8 ± 30.82	-45.1 ± 95.76	-57.7 ± 58.31	-26 ± 22.63
ALT; Week 36; n=10, 7, 2, 2	-30.2 ± 28.15	-16.6 ± 13.7	-69 ± 74.95	-20.5 ± 16.26
ALT; Week 42; n=9, 6, 1, 2	-34.3 ± 35.15	-14.3 ± 20.07	-122 ± 99999	-28 ± 25.46
ALT; Week 48; n=6, 6, 0, 2	-38.8 ± 42.1	-10.8 ± 27.11	99999 ± 99999	-26.5 ± 26.16
ALT; PT Week 4; n=33, 34, 11, 11	-45.5 ± 62.76	-33.3 ± 56.81	-31.5 ± 22.68	-43.9 ± 27.71
AST; Week 18; n=38, 34, 13, 12	-13.1 ± 27.49	-3.5 ± 37.25	-18.8 ± 27.32	-16.3 ± 15.11
AST; Week 24; n=35, 33, 12, 11	-16.5 ± 26.86	-11.8 ± 30.51	-23.8 ± 26.91	-15.7 ± 18.91
AST; Week 30; n=13, 10, 3, 2	-15.1 ± 17.35	-18.7 ± 43.89	-27.7 ± 20.13	-6.5 ± 7.78
AST; Week 36; n=10, 7, 2, 2	-11.8 ± 13.81	-7.3 ± 9.5	-27.5 ± 31.82	-2.5 ± 2.12
AST; Week 42; n=9, 6, 1, 2	-14.2 ± 16.81	-5.8 ± 10.03	-54 ± 99999	-9 ± 7.07
AST; Week 48; n=6, 6, 0, 2	-12.8 ± 18.65	-2.2 ± 13.61	99999 ± 99999	-6.5 ± 9.19
AST; PT Week 4; n=33, 34, 11, 11	-19.5 ± 26.41	-15.6 ± 34.38	-17.7 ± 14.67	-16 ± 31.8
CK; Week 18; n=38, 34, 13, 12	-44 ± 55.77	-28.3 ± 36.59	-38.7 ± 45.46	-60.7 ± 75.8
CK; Week 24; n=35, 33, 12, 11	-34.5 ± 66.48	-18.7 ± 77.24	-39 ± 36.68	60.1 ± 475.39
CK; Week 30; n=13, 10, 3, 2	-33 ± 83.25	-15.8 ± 51.92	-30 ± 24.27	-78.5 ± 55.86
CK; Week 36; n=10, 7, 2, 2	-18.9 ± 34.18	-26.7 ± 32.22	-37.5 ± 6.36	-69 ± 53.74
CK; Week 42; n=9, 6, 1, 2	-0.2 ± 51.5	-29.7 ± 43.42	-32 ± 99999	-81 ± 57.98
CK; Week 48; n=6, 6, 0, 2	10.5 ± 71.39	22.3 ± 77.32	99999 ± 99999	-82.5 ± 70
CK; PT Week 4; n=33, 34, 11, 11	-17.9 ± 48.82	-26.4 ± 49.42	-21.7 ± 42.62	258.7 ± 994.88
GGT; Week 18; n=38, 34, 13, 12	-37.3 ± 71.19	-12.3 ± 60.35	-30.2 ± 42.04	-34.2 ± 56.52
GGT; Week 24; n=35, 33, 12, 11	-38.3 ± 72.79	-12.5 ± 86.73	-37.4 ± 45.44	-35.7 ± 59.63
GGT; Week 30; n=13, 10, 3, 2	-44.2 ± 41.3	-32.8 ± 31.81	-38.7 ± 36.02	-12 ± 4.24
GGT; Week 36; n=10, 7, 2, 2	-51.5 ± 45.03	-19.7 ± 24.52	-40.5 ± 33.23	-10 ± 4.24
GGT; Week 42; n=9, 6, 1, 2	-44.6 ± 46.61	-19.7 ± 25.06	-17 ± 99999	-9 ± 1.41
GGT; Week 48; n=6, 6, 0, 2	-37.8 ± 28.74	-16.8 ± 24.38	99999 ± 99999	-9.5 ± 6.36
GGT; PT Week 4; n=33, 34, 11, 11	-43.4 ± 78.29	-17.7 ± 78.22	-30.7 ± 41.91	-41.4 ± 61.06

Notes
[136] - Safety Population
[137] - Safety Population
[138] - Safety Population
[139] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12

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End point title

Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[140]	40 ^[141]	17 ^[142]	13 ^[143]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Total bilirubin; Week 18; n=38, 34, 13, 12	0.5 ± 5.01	1.7 ± 5.32	-1.4 ± 11.37	0.6 ± 6.49
Total bilirubin; Week 24; n=35, 33, 12, 11	-0.1 ± 5.73	1 ± 4.08	-1.3 ± 11.9	1.3 ± 6.26
Total bilirubin; Week 30; n=13, 10, 3, 2	-0.2 ± 5.99	0.8 ± 4.76	-2.3 ± 9.29	-4 ± 5.66
Total bilirubin; Week 36; n=10, 7, 2, 2	0 ± 4.29	1.9 ± 4.95	-3 ± 11.31	-3 ± 7.07
Total bilirubin; Week 42; n=9, 6, 1, 2	0.1 ± 5.11	1.5 ± 5.79	-14 ± 99999	-4 ± 5.66
Total bilirubin; Week 48; n=6, 6, 0, 2	-0.7 ± 4.72	3.5 ± 7.2	99999 ± 99999	-4 ± 2.83
Total bilirubin PT Week 4; n=33, 34, 11, 11	-4.6 ± 3.57	-2.4 ± 3.3	-0.4 ± 5.68	-2.2 ± 2.71
Creatinine; Week 18; n=38, 34, 13, 12	-2.24 ± 9.186	-1.97 ± 9.65	-1.75 ± 9.874	0.09 ± 10.668
Creatinine; Week 24; n=35, 33, 12, 11	-1.55 ± 9.507	-2.4 ± 8.413	-3.12 ± 9.408	1.31 ± 10.377
Creatinine; Week 30; n=13, 10, 3, 2	0.66 ± 4.603	2.82 ± 8.123	-8.47 ± 8.693	-8.85 ± 3.748
Creatinine; Week 36; n=10, 7, 2, 2	2.33 ± 11.096	2.99 ± 8.179	-5.5 ± 16.829	-8 ± 1.273
Creatinine; Week 42; n=9, 6, 1, 2	1.23 ± 10.32	4.97 ± 11.697	-14.3 ± 99999	-7.55 ± 5.586
Creatinine; Week 48; n=6, 6, 0, 2	-2.35 ± 4.222	10.07 ± 17.173	99999 ± 99999	-7.1 ± 1.273
Creatinine; PT Week 4; n=33, 34, 11, 11	1.23 ± 8.22	-0.34 ± 7.624	-1.7 ± 6.897	-1.25 ± 6.228

Notes
[140] - Safety Population
[141] - Safety Population
[142] - Safety Population
[143] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12

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End point title

Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12

End point description

Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. All abnormal values were also provided in separate by-subject data listings. Therefore, no statistical summary table is available after week 12.

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	0 ^[144]	0 ^[145]	0 ^[146]	0 ^[147]
Units: Millimeters of mercury (mmHg)
arithmetic mean (standard deviation)	±	±	±	±

Notes
[144] - Safety Population
[145] - Safety Population
[146] - Safety Population
[147] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in heart rate at the indicated time points after Week 12

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End point title

Mean change from Baseline in heart rate at the indicated time points after Week 12

End point description

Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. All abnormal values were also provided in separate by-subject data listings. Therefore, no statistical summary table is available after week 12.

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	0 ^[148]	0 ^[149]	0 ^[150]	0 ^[151]
Units: Beats per minute
arithmetic mean (standard deviation)	±	±	±	±

Notes
[148] - Safety Population
[149] - Safety Population
[150] - Safety Population
[151] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in ECG heart rate values at the indicated time points after Week 12

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End point title

Mean change from Baseline in ECG heart rate values at the indicated time points after Week 12

End point description

The electrocardiographic (ECG) data was only collected “Perform as needed”, therefore, no such summary table was generated.

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	0 ^[152]	0 ^[153]	0 ^[154]	0 ^[155]
Units: Beats per minute
arithmetic mean (standard deviation)	±	±	±	±

Notes
[152] - Safety Population
[153] - Safety Population
[154] - Safety Population
[155] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points after Week 12

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End point title

Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points after Week 12

End point description

The electrocardiographic (ECG) data was only collected “Perform as needed”, therefore, no such summary table was generated.

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	0 ^[156]	0 ^[157]	0 ^[158]	0 ^[159]
Units: Milliseconds
arithmetic mean (standard deviation)	±	±	±	±

Notes
[156] - Safety Population
[157] - Safety Population
[158] - Safety Population
[159] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/Bun at the indicated time points after Week 12

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End point title

Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/Bun at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. System value of 99999 indicates NA (too few participants).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[160]	40 ^[161]	17 ^[162]	13 ^[163]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Chloride; Week 18; n=38, 34, 13, 12	1.9 ± 2.75	1 ± 2.5	1.8 ± 2.41	0.5 ± 2.94
Chloride; Week 24; n=35, 33, 12, 11	2 ± 2.33	0.7 ± 2.73	2.9 ± 2.81	-0.2 ± 3.52
Chloride; Week 30; n=13, 10, 3, 2	1.9 ± 2.72	0.3 ± 2.87	5.3 ± 3.21	3 ± 0
Chloride; Week 36; n=10, 7, 2, 2	1.3 ± 2.11	-0.1 ± 2.54	4.5 ± 6.36	1 ± 0
Chloride; Week 42; n=9, 6, 1, 2	1.3 ± 2.78	0 ± 2	10 ± 99999	0.5 ± 0.71
Chloride; Week 48; n=6, 6, 0, 2	1.3 ± 2.34	-1 ± 3.16	99999 ± 99999	0 ± 0
Chloride; PT Week 4; n=33, 34, 11, 11	0.5 ± 2.69	0.2 ± 2.54	0.6 ± 2.29	-1.5 ± 2.25
Bicarbonate; Week 18; n=38, 34, 13, 12	-0.3 ± 2.18	-1 ± 2.16	-1.2 ± 2.27	0 ± 2.95
Bicarbonate; Week 24; n=35, 33, 12, 11	-1 ± 2.41	-1.2 ± 2.21	-1.8 ± 2.41	-0.4 ± 3.35
Bicarbonate; Week 30; n=13, 10, 3, 2	0.4 ± 2.33	-2.2 ± 4.02	-1.3 ± 1.53	-2 ± 2.83
Bicarbonate; Week 36; n=10, 7, 2, 2	-0.9 ± 2.92	0.1 ± 1.86	-2.5 ± 2.12	-1.5 ± 2.12
Bicarbonate; Week 42; n=9, 6, 1, 2	-0.7 ± 1.73	-0.2 ± 2.04	-4 ± 99999	-1 ± 2.83
Bicarbonate; Week 48; n=6, 6, 0, 2	-1 ± 1.67	-1.3 ± 2.66	99999 ± 99999	-0.5 ± 3.54
Bicarbonate; PT Week 4; n=33, 34, 11, 11	-0.7 ± 2.1	-0.5 ± 2.46	-0.9 ± 2.43	1 ± 3.07
Glucose; Week 18; n=38, 34, 13, 12	-0.28 ± 1.326	-0.13 ± 1.188	-0.06 ± 0.702	-0.23 ± 2.134
Glucose; Week 24; n=35, 33, 12, 11	-0.33 ± 1.552	0.27 ± 2.986	-0.23 ± 0.672	-0.22 ± 1.349
Glucose; Week 30; n=13, 10, 3, 2	0.03 ± 1.383	-0.26 ± 0.587	-0.13 ± 0.252	0.9 ± 0.707
Glucose; Week 36; n=10, 7, 2, 2	-0.38 ± 0.758	-0.37 ± 1.09	-0.1 ± 0.99	-0.7 ± 0.283
Glucose; Week 42; n=9, 6, 1, 2	-0.28 ± 1.663	-0.12 ± 0.794	0.4 ± 99999	-0.15 ± 0.919
Glucose; Week 48; n=6, 6, 0, 2	0.25 ± 1.358	-0.3 ± 0.867	99999 ± 99999	4.55 ± 4.596
Glucose; PT Week 4; n=33, 34, 11, 11	0.24 ± 3.122	0.18 ± 0.684	-0.12 ± 0.735	-0.07 ± 1.234
Potassium; Week 18; n=38, 34, 13, 12	-0.19 ± 0.399	-0.24 ± 0.376	-0.41 ± 0.236	-0.2 ± 0.424
Potassium; Week 24; n=35, 33, 12, 11	-0.13 ± 0.452	-0.12 ± 0.459	-0.34 ± 0.403	-0.32 ± 0.494
Potassium; Week 30; n=13, 10, 3, 2	-0.03 ± 0.48	-0.23 ± 0.377	-0.1 ± 0.2	-0.1 ± 0.424
Potassium; Week 36; n=10, 7, 2, 2	0.24 ± 0.599	-0.1 ± 0.365	0.15 ± 0.071	0.2 ± 0.424
Potassium; Week 42; n=9, 6, 1, 2	-0.1 ± 0.555	-0.2 ± 0.415	-0.1 ± 99999	0.1 ± 0.566
Potassium; Week 48; n=6, 6, 0, 2	0.1 ± 0.566	-0.3 ± 0.322	99999 ± 99999	0.05 ± 0.495
Potassium; PT Week 4; n=33, 34, 11, 11	-0.16 ± 0.382	-0.13 ± 0.398	-0.25 ± 0.532	-0.1 ± 0.316
Sodium; Week 18; n=38, 34, 13, 12	0.7 ± 2.04	0.1 ± 2.27	0.7 ± 2.32	0.4 ± 3.37
Sodium; Week 24; n=35, 33, 12, 11	0.4 ± 1.86	-0.1 ± 2.61	1.5 ± 2.24	0.4 ± 3.53
Sodium; Week 30; n=13, 10, 3, 2	1.1 ± 3.25	-1.4 ± 2.72	1.3 ± 1.53	0 ± 1.41
Sodium; Week 36; n=10, 7, 2, 2	0.4 ± 2.67	-0.7 ± 1.98	2 ± 2.83	-0.5 ± 0.71
Sodium; Week 42; n=9, 6, 1, 2	0.4 ± 2.07	-0.5 ± 1.38	3 ± 99999	-1.5 ± 0.71
Sodium; Week 48; n=6, 6, 0, 2	-0.2 ± 2.14	-1.2 ± 2.79	99999 ± 99999	-2.5 ± 3.54
Sodium; PT Week 4; n=33, 34, 11, 11	-0.1 ± 2.3	0.1 ± 2.45	1.1 ± 2.47	-0.5 ± 2.7
Inorganic phosphorus; Week 18; n=38, 34, 13, 12	-0.161 ± 0.1971	-0.13 ± 0.1928	-0.092 ± 0.1537	-0.111 ± 0.2648
Inorganic phosphorus; Week 24; n=35, 33, 12, 11	-0.139 ± 0.2268	-0.13 ± 0.2354	-0.119 ± 0.1991	-0.107 ± 0.2205
Inorganic phosphorus; Week 30; n=13, 10, 3, 2	-0.156 ± 0.1644	-0.118 ± 0.2071	-0.267 ± 0.2023	-0.225 ± 0.1768
Inorganic phosphorus; Week 36; n=10, 7, 2, 2	-0.121 ± 0.2564	-0.167 ± 0.1906	-0.195 ± 0.0495	-0.125 ± 0.2475
Inorganic phosphorus; Week 42; n=9, 6, 1, 2	-0.08 ± 0.2248	-0.108 ± 0.0794	-0.15 ± 99999	-0.1 ± 0.3536
Inorganic phosphorus; Week 48; n=6, 6, 0, 2	-0.167 ± 0.1715	-0.108 ± 0.1665	99999 ± 99999	-0.35 ± 0.0707
Inorganic phosphorus; PT Week 4; n=33, 34, 11, 11	-0.084 ± 0.2375	-0.003 ± 0.2162	0.009 ± 0.0798	-0.085 ± 0.2247
Urea/BUN; Week 18; n=38, 34, 13, 12	-0.19 ± 1.166	-0.23 ± 1.403	-0.49 ± 1.233	-0.25 ± 1.688
Urea/BUN; Week 24; n=35, 33, 12, 11	-0.22 ± 1.263	-0.55 ± 1.252	-0.43 ± 1.106	0.02 ± 2.007
Urea/BUN; Week 30; n=13, 10, 3, 2	0.69 ± 1.107	-0.16 ± 1.027	-0.5 ± 1.082	-0.5 ± 0
Urea/BUN; Week 36; n=10, 7, 2, 2	0.65 ± 1.775	0.04 ± 1.172	-0.15 ± 0.636	-0.25 ± 1.061
Urea/BUN; Week 42; n=9, 6, 1, 2	0.34 ± 1.65	0.5 ± 1.239	0.5 ± 99999	-0.5 ± 1.414
Urea/BUN; Week 48; n=6, 6, 0, 2	0.67 ± 1.353	0.4 ± 1.607	99999 ± 99999	-0.5 ± 0.707
Urea/BUN; PT Week 4; n=33, 34, 11, 11	0.35 ± 1.284	-0.19 ± 1.311	-0.62 ± 1.012	-0.47 ± 0.969

Notes
[160] - Safety Population
[161] - Safety Population
[162] - Safety Population
[163] - Safety Population

No statistical analyses for this end point

Secondary: Mean change from Baseline in creatinine clearance at the indicated time points after Week 12

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End point title

Mean change from Baseline in creatinine clearance at the indicated time points after Week 12

End point description

Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).

End point type

Secondary

End point timeframe

Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Number of subjects analysed	41 ^[164]	40 ^[165]	17 ^[166]	13 ^[167]
Units: mL/min
arithmetic mean (standard deviation)
Creatinine clearance; Week 18; n=38, 34, 13, 12	-0.1 ± 17.36	-1.1 ± 20.69	-2.5 ± 16.25	-4.3 ± 19.37
Creatinine clearance; Week 24; n=35, 33, 12, 11	-1.9 ± 16.77	-1 ± 18.53	-4.1 ± 15.11	-6.1 ± 19.05
Creatinine clearance; Week 30; n=13, 10, 3, 2	-4.8 ± 13.91	-10.4 ± 14.41	-3.7 ± 13.58	7 ± 0
Creatinine clearance; Week 36; n=10, 7, 2, 2	-11 ± 23.3	-8.1 ± 13.28	-1 ± 29.7	1.5 ± 9.19
Creatinine clearance; Week 42; n=9, 6, 1, 2	-6.1 ± 16.86	-13.3 ± 16.13	9 ± 99999	-1.5 ± 0.71
Creatinine clearance; Week 48; n=6, 6, 0, 2	3.2 ± 10.23	-15.8 ± 16.18	99999 ± 99999	-4 ± 11.31
Creatinine clearance; PT Week 4; n=33, 34, 11, 11	-1.5 ± 34.53	-1.3 ± 23.85	-2.7 ± 11.38	-5.3 ± 13.95

Notes
[164] - Safety Population
[165] - Safety Population
[166] - Safety Population
[167] - Safety Population

No statistical analyses for this end point

Secondary: Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus eRVR Status

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End point title

Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus eRVR Status ^[168]

End point description

Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.

End point type

Secondary

End point timeframe

Week 4 and Week 12

Notes
[168] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[169]	0 ^[170]
Units: hr*ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[169] - Intensive PK Population
[170] - Intensive PK Population

No statistical analyses for this end point

Secondary: Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus eRVR status

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End point title

Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus eRVR status ^[171]

End point description

Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.

End point type

Secondary

End point timeframe

Week 4 and Week 12

Notes
[171] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[172]	0 ^[173]
Units: ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[172] - Intensive PK Population
[173] - Intensive PK Population

No statistical analyses for this end point

Secondary: Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus RVR Status

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End point title

Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus RVR Status ^[174]

End point description

Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available..

End point type

Secondary

End point timeframe

Week 4

Notes
[174] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[175]	0 ^[176]
Units: hr*ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[175] - Intensive PK Population
[176] - Intensive PK Population

No statistical analyses for this end point

Secondary: Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus RVR status

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End point title

Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus RVR status ^[177]

End point description

Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.

End point type

Secondary

End point timeframe

Week 4

Notes
[177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[178]	0 ^[179]
Units: ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[178] - Intensive PK Population
[179] - Intensive PK Population

No statistical analyses for this end point

Secondary: Correlation of Individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status

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End point title

Correlation of Individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status ^[180]

End point description

Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.

End point type

Secondary

End point timeframe

Week 4 and Week 12

Notes
[180] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[181]	0 ^[182]
Units: ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[181] - PK/PD Analysis Population
[182] - PK/PD Analysis Population

No statistical analyses for this end point

Secondary: Correlation GSK2336805 pre-dose plasma concentration on Day 2 versus reduction in HCV RNA on Day 2

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End point title

Correlation GSK2336805 pre-dose plasma concentration on Day 2 versus reduction in HCV RNA on Day 2 ^[183]

End point description

Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.

End point type

Secondary

End point timeframe

Day 2

Notes
[183] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis is not applicable for this Outcome Measure.

End point values	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Number of subjects analysed	0 ^[184]	0 ^[185]
Units: ng/mL
arithmetic mean (standard deviation)	±	±

Notes
[184] - PK/PD Analysis Population
[185] - PK/PD Analysis Population

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).

Adverse event reporting additional description

SAEs and non-SAEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

GSK2336805 40 mg, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 1 HCV

Reporting group description

Reporting group title

Telaprevir, Genotype 1 HCV

Reporting group description

Reporting group title

GSK2336805 60 mg, Genotype 4 HCV

Reporting group description

Serious adverse events	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 41 (4.88%)	2 / 40 (5.00%)	3 / 17 (17.65%)	1 / 13 (7.69%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Overdose
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Haemorrhoids
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injection site abscess
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperglycaemia
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Total subjects affected by non serious adverse events
subjects affected / exposed	41 / 41 (100.00%)	38 / 40 (95.00%)	17 / 17 (100.00%)	13 / 13 (100.00%)
Vascular disorders
Hypertension
subjects affected / exposed	3 / 41 (7.32%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	3	1	0	0
Hypotension
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	5 / 41 (12.20%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	7	1	0	2
Chills
subjects affected / exposed	5 / 41 (12.20%)	0 / 40 (0.00%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	5	0	1	1
Drug withdrawal syndrome
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Fatigue
subjects affected / exposed	9 / 41 (21.95%)	12 / 40 (30.00%)	7 / 17 (41.18%)	4 / 13 (30.77%)
occurrences all number	9	13	8	4
Feeling hot
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Influenza like illness
subjects affected / exposed	8 / 41 (19.51%)	9 / 40 (22.50%)	3 / 17 (17.65%)	8 / 13 (61.54%)
occurrences all number	16	10	3	8
Injection site bruising
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	0	0	1	1
Injection site erythema
subjects affected / exposed	6 / 41 (14.63%)	3 / 40 (7.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	7	5	2	0
Injection site pain
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	0	0	1
Injection site pruritus
subjects affected / exposed	0 / 41 (0.00%)	2 / 40 (5.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	0	2	0	0
Injection site reaction
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Injury associated with device
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Irritability
subjects affected / exposed	4 / 41 (9.76%)	0 / 40 (0.00%)	0 / 17 (0.00%)	2 / 13 (15.38%)
occurrences all number	5	0	0	2
Mucosal dryness
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Non-cardiac chest pain
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Pain
subjects affected / exposed	4 / 41 (9.76%)	0 / 40 (0.00%)	2 / 17 (11.76%)	0 / 13 (0.00%)
occurrences all number	4	0	2	0
Pyrexia
subjects affected / exposed	11 / 41 (26.83%)	8 / 40 (20.00%)	5 / 17 (29.41%)	2 / 13 (15.38%)
occurrences all number	17	16	7	2
Temperature intolerance
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Reproductive system and breast disorders
Erectile dysfunction
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	1	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 41 (12.20%)	3 / 40 (7.50%)	2 / 17 (11.76%)	2 / 13 (15.38%)
occurrences all number	5	3	3	2
Dyspnoea
subjects affected / exposed	1 / 41 (2.44%)	3 / 40 (7.50%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	1	3	1	2
Dyspnoea exertional
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	0	0	1
Epistaxis
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	1	0	2
Oropharyngeal pain
subjects affected / exposed	0 / 41 (0.00%)	2 / 40 (5.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	2	0	1
Wheezing
subjects affected / exposed	2 / 41 (4.88%)	2 / 40 (5.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	2	2	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	5 / 41 (12.20%)	3 / 40 (7.50%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	6	3	1	2
Depressed mood
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Depression
subjects affected / exposed	4 / 41 (9.76%)	3 / 40 (7.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	4	3	1	0
Insomnia
subjects affected / exposed	7 / 41 (17.07%)	8 / 40 (20.00%)	0 / 17 (0.00%)	3 / 13 (23.08%)
occurrences all number	7	9	0	3
Libido decreased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Mood swings
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	1	0	1
Nervousness
subjects affected / exposed	3 / 41 (7.32%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	3	1	0	0
Nightmare
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Panic attack
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	1	2	0
Investigations
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Body temperature increased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
International normalised ratio decreased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Weight decreased
subjects affected / exposed	1 / 41 (2.44%)	2 / 40 (5.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	2	0	1
White blood cell count increased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Injury, poisoning and procedural complications
Gingival injury
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Laceration
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Post procedural complication
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Procedural pain
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	2	0	0	1
Road traffic accident
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Tachycardia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Nervous system disorders
Disturbance in attention
subjects affected / exposed	1 / 41 (2.44%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	1	0	1
Dizziness
subjects affected / exposed	1 / 41 (2.44%)	5 / 40 (12.50%)	2 / 17 (11.76%)	1 / 13 (7.69%)
occurrences all number	1	6	2	1
Dysgeusia
subjects affected / exposed	2 / 41 (4.88%)	2 / 40 (5.00%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	2	2	1	1
Headache
subjects affected / exposed	15 / 41 (36.59%)	14 / 40 (35.00%)	5 / 17 (29.41%)	4 / 13 (30.77%)
occurrences all number	21	25	10	4
Hyperaesthesia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Restless legs syndrome
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Syncope
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	22 / 41 (53.66%)	14 / 40 (35.00%)	9 / 17 (52.94%)	2 / 13 (15.38%)
occurrences all number	29	17	13	2
Coagulopathy
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	1	0	1
Eosinopenia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Leukopenia
subjects affected / exposed	6 / 41 (14.63%)	10 / 40 (25.00%)	6 / 17 (35.29%)	1 / 13 (7.69%)
occurrences all number	10	19	6	1
Lymphadenopathy
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Lymphopenia
subjects affected / exposed	5 / 41 (12.20%)	2 / 40 (5.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	8	2	0	2
Monocytopenia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Neutropenia
subjects affected / exposed	12 / 41 (29.27%)	12 / 40 (30.00%)	2 / 17 (11.76%)	3 / 13 (23.08%)
occurrences all number	16	27	2	4
Thrombocytopenia
subjects affected / exposed	11 / 41 (26.83%)	5 / 40 (12.50%)	4 / 17 (23.53%)	1 / 13 (7.69%)
occurrences all number	13	5	4	1
Ear and labyrinth disorders
Ear discomfort
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Ear pain
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Tinnitus
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Vertigo
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	3
Eye disorders
Conjunctivitis
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	0	0	1
Dry eye
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	2	0	0	1
Eye pain
subjects affected / exposed	1 / 41 (2.44%)	1 / 40 (2.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	1	1	0
Eye pruritus
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Vision blurred
subjects affected / exposed	0 / 41 (0.00%)	3 / 40 (7.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	0	3	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 41 (4.88%)	3 / 40 (7.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	2	4	0	0
Abdominal pain upper
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	1 / 17 (5.88%)	3 / 13 (23.08%)
occurrences all number	2	0	1	3
Anal pruritus
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Constipation
subjects affected / exposed	3 / 41 (7.32%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	4	1	0	0
Diarrhoea
subjects affected / exposed	6 / 41 (14.63%)	2 / 40 (5.00%)	4 / 17 (23.53%)	3 / 13 (23.08%)
occurrences all number	11	6	7	3
Dry mouth
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	1 / 17 (5.88%)	2 / 13 (15.38%)
occurrences all number	2	0	1	2
Dyspepsia
subjects affected / exposed	2 / 41 (4.88%)	1 / 40 (2.50%)	0 / 17 (0.00%)	3 / 13 (23.08%)
occurrences all number	2	1	0	3
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Gingival bleeding
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	0	0	1	1
Lip swelling
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Nausea
subjects affected / exposed	7 / 41 (17.07%)	8 / 40 (20.00%)	7 / 17 (41.18%)	4 / 13 (30.77%)
occurrences all number	8	11	8	4
Stomatitis
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	2 / 13 (15.38%)
occurrences all number	0	0	0	2
Toothache
subjects affected / exposed	1 / 41 (2.44%)	2 / 40 (5.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	2	0	1
Vomiting
subjects affected / exposed	3 / 41 (7.32%)	4 / 40 (10.00%)	4 / 17 (23.53%)	2 / 13 (15.38%)
occurrences all number	4	7	6	2
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	1 / 41 (2.44%)	1 / 40 (2.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	1	2	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	2 / 41 (4.88%)	4 / 40 (10.00%)	3 / 17 (17.65%)	2 / 13 (15.38%)
occurrences all number	2	4	3	2
Dermal cyst
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Dermatitis
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	0	2	0	0
Dermatitis allergic
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	2	0
Dry skin
subjects affected / exposed	2 / 41 (4.88%)	5 / 40 (12.50%)	1 / 17 (5.88%)	1 / 13 (7.69%)
occurrences all number	3	5	1	1
Erythema
subjects affected / exposed	1 / 41 (2.44%)	1 / 40 (2.50%)	2 / 17 (11.76%)	0 / 13 (0.00%)
occurrences all number	1	1	3	0
Pruritus
subjects affected / exposed	3 / 41 (7.32%)	5 / 40 (12.50%)	2 / 17 (11.76%)	1 / 13 (7.69%)
occurrences all number	4	7	3	3
Pruritus generalised
subjects affected / exposed	6 / 41 (14.63%)	4 / 40 (10.00%)	7 / 17 (41.18%)	0 / 13 (0.00%)
occurrences all number	7	4	7	0
Rash
subjects affected / exposed	8 / 41 (19.51%)	5 / 40 (12.50%)	7 / 17 (41.18%)	3 / 13 (23.08%)
occurrences all number	9	6	10	4
Rash generalised
subjects affected / exposed	0 / 41 (0.00%)	4 / 40 (10.00%)	2 / 17 (11.76%)	0 / 13 (0.00%)
occurrences all number	0	4	2	0
Rash macular
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Rash maculo-papular
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Rash pruritic
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	0	3	0	0
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	1	1	0
Hypothyroidism
subjects affected / exposed	2 / 41 (4.88%)	2 / 40 (5.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	2	2	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 41 (4.88%)	3 / 40 (7.50%)	2 / 17 (11.76%)	1 / 13 (7.69%)
occurrences all number	3	4	2	1
Arthritis
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Back pain
subjects affected / exposed	3 / 41 (7.32%)	3 / 40 (7.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	3	4	0	0
Costochondritis
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Myalgia
subjects affected / exposed	5 / 41 (12.20%)	7 / 40 (17.50%)	2 / 17 (11.76%)	3 / 13 (23.08%)
occurrences all number	6	8	4	3
Pain in extremity
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	3	0	0	0
Infections and infestations
Asymptomatic bacteriuria
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Body tinea
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	1	0	0	1
Herpes simplex
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	1	1	0
Hordeolum
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Influenza
subjects affected / exposed	1 / 41 (2.44%)	1 / 40 (2.50%)	0 / 17 (0.00%)	2 / 13 (15.38%)
occurrences all number	1	1	0	2
Nasopharyngitis
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	2	0	0	1
Oral herpes
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	2	0
Periodontitis
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 17 (0.00%)	0 / 13 (0.00%)
occurrences all number	0	2	0	0
Pharyngitis
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Tooth abscess
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 17 (0.00%)	1 / 13 (7.69%)
occurrences all number	0	0	0	1
Upper respiratory tract infection
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Urinary tract infection
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	2 / 17 (11.76%)	0 / 13 (0.00%)
occurrences all number	2	0	3	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	4 / 41 (9.76%)	3 / 40 (7.50%)	2 / 17 (11.76%)	3 / 13 (23.08%)
occurrences all number	4	3	2	3
Dehydration
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	1	0	1	0
Hyperphosphataemia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Hypokalaemia
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	0	0	1	0
Hypophosphataemia
subjects affected / exposed	2 / 41 (4.88%)	2 / 40 (5.00%)	1 / 17 (5.88%)	0 / 13 (0.00%)
occurrences all number	3	2	1	0

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants achieving extended rapid virologic response (eRVR)

Primary: Number of participants achieving extended rapid virologic response (eRVR)

Primary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12

Primary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12

Primary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12

Primary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12

Primary: Mean change from Baseline in heart rate at the indicated time points up to Week 12

Primary: Mean change from Baseline in heart rate at the indicated time points up to Week 12

Primary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12

Primary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12

Primary: Mean change from Baseline in red blood cell count at the indicated time points up to Week 12

Primary: Mean change from Baseline in red blood cell count at the indicated time points up to Week 12

Primary: Mean change from Baseline in hemoglobin at the indicated time points up to Week 12

Primary: Mean change from Baseline in hemoglobin at the indicated time points up to Week 12

Primary: Mean change from Baseline in hematocrit at the indicated time points up to Week 12

Primary: Mean change from Baseline in hematocrit at the indicated time points up to Week 12

Primary: Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12

Primary: Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12

Primary: Mean change from Baseline in albumin at the indicated time points up to Week 12

Primary: Mean change from Baseline in albumin at the indicated time points up to Week 12

Primary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12

Primary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12

Primary: Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12

Primary: Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12

Primary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12

Primary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12

Primary: Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12

Primary: Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12

Primary: Number of participants with shift from Baseline in urinalysis data up to Week 12

Primary: Number of participants with shift from Baseline in urinalysis data up to Week 12

Primary: Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12

Primary: Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12

Primary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12

Primary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12

Secondary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12

Secondary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12

Secondary: Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)

Secondary: Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)

Secondary: Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12

Secondary: Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4

Secondary: Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4

Secondary: Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4

Secondary: Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12

Secondary: Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12

Secondary: Apparent clearance (CL/F) at Week 12

Secondary: Apparent clearance (CL/F) at Week 12

Secondary: Apparent volume of distribution (Vz/F) at Week 12

Secondary: Apparent volume of distribution (Vz/F) at Week 12

Secondary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12

Secondary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12

Secondary: Mean change from Baseline in red blood cell count at the indicated time points after Week 12

Secondary: Mean change from Baseline in red blood cell count at the indicated time points after Week 12

Secondary: Mean change from Baseline in hemoglobin at the indicated time points after Week 12

Secondary: Mean change from Baseline in hemoglobin at the indicated time points after Week 12

Secondary: Mean change from Baseline in hematocrit at the indicated time points after Week 12

Secondary: Mean change from Baseline in hematocrit at the indicated time points after Week 12

Secondary: Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12

Secondary: Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12

Secondary: Mean change from Baseline in albumin at the indicated time points after Week 12

Secondary: Mean change from Baseline in albumin at the indicated time points after Week 12

Secondary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12

Secondary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12

Secondary: Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12

Secondary: Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12

Secondary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12

Secondary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12

Secondary: Mean change from Baseline in heart rate at the indicated time points after Week 12

Secondary: Mean change from Baseline in heart rate at the indicated time points after Week 12

Secondary: Mean change from Baseline in ECG heart rate values at the indicated time points after Week 12