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Clinical Trial Results:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection

Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.

Summary
EudraCT number	2013-002169-21
Trial protocol	GB ES BE
Global end of trial date	04 Dec 2014

Results information
Results version number	v1(current)
This version publication date	30 Jan 2016
First version publication date	30 Jan 2016
Other versions

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

5172-047

ISRCTN number

US NCT number

NCT01932762

WHO universal trial number (UTN)

Other trial identifiers

Merck Registration: MK-5172-047

Sponsor organisation name

Merck Sharp & Dohme Corp.

Sponsor organisation address

2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033

Public contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

Scientific contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

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

04 Dec 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Dec 2014

Global end of trial reached?

Yes

Global end of trial date

04 Dec 2014

Was the trial ended prematurely?

Main objective of the trial

This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or RBV in treating non-cirrhotic treatment-naïve participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection. In Part A there is no randomization or stratification; all GT2 participants will be assigned to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with stratification by genotype.

Protection of trial subjects

This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Oct 2013

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

3 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 13

Country: Number of subjects enrolled

Belgium: 4

Country: Number of subjects enrolled

France: 20

Country: Number of subjects enrolled

Israel: 21

Country: Number of subjects enrolled

Spain: 6

Country: Number of subjects enrolled

United Kingdom: 10

Country: Number of subjects enrolled

United States: 24

Worldwide total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

98 participants were assigned to treatment at 28 sites worldwide and all enrolled participants received ≥1 dose of study therapy. 30 participants enrolled in Part A and 68 were enrolled and randomized in Part B of the study. Enrollment in Part C, an evaluation of a fixed-dose combination of grazoprevir and elbasvir, was never initiated.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

GT2: Grazoprevir + Elbasvir + RBV (Arm A1)

Arm description

During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

100 mg every day (QD) orally

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol®, Copegus®, Ribasphere®

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant weight on Day 1

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

50 mg QD orally

GT2: Grazoprevir + RBV (Arm B1)

Arm description

During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol®, Copegus®, Ribasphere®

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant weight on Day 1

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

100 mg every day (QD) orally

GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)

Arm description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

100 mg every day (QD) orally

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

50 mg QD orally

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol®, Copegus®, Ribasphere®

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant weight on Day 1

GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)

Arm description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

50 mg QD orally

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

100 mg every day (QD) orally

Number of subjects in period 1	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Started	30	30	19	19
Completed	24	28	19	18
Not completed	6	2	0	1
Consent withdrawn by subject	1	2	-	-
Physician decision	1	-	-	-
Lost to follow-up	4	-	-	1

Baseline characteristics

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Reporting group title

GT2: Grazoprevir + Elbasvir + RBV (Arm A1)

Reporting group description

During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.

Reporting group title

GT2: Grazoprevir + RBV (Arm B1)

Reporting group description

During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.

Reporting group values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)	Total
Number of subjects	30	30	19	19	68
Age categorical
Units: Subjects
Age Continuous \|
Units: years
arithmetic mean (standard deviation)	47.3 ± 13.6	48.3 ± 14.6	52.2 ± 9.3	52.8 ± 12.3	-
Gender, Male/Female
Units: participants
Female	11	13	11	7	42
Male	19	17	8	12	56

End points

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Reporting group title

GT2: Grazoprevir + Elbasvir + RBV (Arm A1)

Reporting group description

During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.

Reporting group title

GT2: Grazoprevir + RBV (Arm B1)

Reporting group description

During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.

Primary: Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

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End point title

Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12) ^[1]

End point description

SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population, which was composed of all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations.

End point type

Primary

End point timeframe

12 weeks after end of all therapy (Study Week 24)

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: There was no formal efficacy hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	27 ^[2]	24 ^[3]	17 ^[4]	13 ^[5]
Units: percentage of participants
number (confidence interval 95%)	85.2 (66.3 to 95.8)	75 (53.3 to 90.2)	94.1 (71.3 to 99.9)	76.9 (46.2 to 95)

Notes
[2] - All participants in the PP Population with available data.
[3] - All participants in the PP Population with available data.
[4] - All participants in the PP Population with available data.
[5] - All participants in the PP Population with available data.

No statistical analyses for this end point

Primary: Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE

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End point title

Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE ^[6]

End point description

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. Drug-related AEs were those determined by the investigator to be possibly, probably, or definitely related to the treatment

End point type

Primary

End point timeframe

Treatment period plus the first 14 days of follow-up (up to 14 weeks)

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: There was no formal safety hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	30	30	19	19
Units: percentage of participants
number (confidence interval 95%)
AEs	86.7 (69.3 to 96.2)	86.7 (69.3 to 96.2)	94.7 (74 to 99.9)	78.9 (54.4 to 93.9)
SAEs	3.3 (0.1 to 17.2)	3.3 (0.1 to 17.2)	0 (0 to 17.6)	0 (0 to 17.6)
Drug-related AE	63.3 (43.9 to 80.1)	63.3 (43.9 to 80.1)	57.9 (33.5 to 79.7)	36.8 (16.3 to 61.6)
Drug-related SAE	0 (0 to 11.6)	3.3 (0.1 to 17.2)	0 (0 to 17.6)	0 (0 to 17.6)
Discontinuation due to AE	0 (0 to 11.6)	0 (0 to 11.6)	0 (0 to 17.6)	5.3 (0.1 to 26)

No statistical analyses for this end point

Secondary: Mean Time to First Achievement of Undetectable HCV RNA During Treatment

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End point title

Mean Time to First Achievement of Undetectable HCV RNA During Treatment

End point description

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).

End point type

Secondary

End point timeframe

From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	30 ^[7]	26 ^[8]	19 ^[9]	18 ^[10]
Units: days
arithmetic mean (standard error)	25.2 ± 2.8	26.9 ± 3	27.4 ± 4.5	21.3 ± 1.7

Notes
[7] - Participants in the FAS not achieving TND were censored from the analysis.
[8] - Participants in the FAS not achieving TND were censored from the analysis.
[9] - Participants in the FAS not achieving TND were censored from the analysis.
[10] - Participants in the FAS not achieving TND were censored from the analysis.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

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End point title

Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

End point description

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.

End point type

Secondary

End point timeframe

From TW 2 through TW 12 (up to 12 weeks)

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	28 ^[11]	24 ^[12]	17 ^[13]	15 ^[14]
Units: percentage of participants
number (confidence interval 95%)
Week 2 (n=28, 24, 16, 15)	42.9 (24.5 to 62.8)	50 (29.1 to 70.9)	50 (24.7 to 75.3)	53.3 (26.6 to 78.7)
Week 4 (n=28, 24, 17, 15)	85.7 (67.3 to 96)	79.2 (57.8 to 92.9)	88.2 (63.6 to 98.5)	80 (51.9 to 95.7)
Week 12 (n=28, 24, 17, 14)	96.4 (81.7 to 99.9)	83.3 (62.6 to 95.3)	100 (80.5 to 100)	78.6 (49.2 to 95.3)

Notes
[11] - All participants in the PP Population with available data.
[12] - All participants in the PP Population with available data.
[13] - All participants in the PP Population with available data.
[14] - All participants in the PP Population with available data.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

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End point title

Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

End point description

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.

End point type

Secondary

End point timeframe

From TW 2 through TW 12 (up to 12 weeks)

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	28 ^[15]	24 ^[16]	17 ^[17]	15 ^[18]
Units: percentage of participants
number (confidence interval 95%)
Week 2 (n=28, 24, 16, 15)	96.4 (81.7 to 99.9)	79.2 (57.8 to 92.9)	87.5 (61.7 to 98.4)	93.3 (68.1 to 99.8)
Week 4 (n=28, 24, 17, 15)	100 (87.7 to 100)	91.7 (73 to 99)	100 (80.5 to 100)	93.3 (68.1 to 99.8)
Week 12 (n=28, 24, 17, 14)	96.4 (81.7 to 99.9)	87.5 (67.6 to 97.3)	100 (80.5 to 100)	85.7 (57.2 to 98.2)

Notes
[15] - All participants in the PP Population with available data.
[16] - All participants in the PP Population with available data.
[17] - All participants in the PP Population with available data.
[18] - All participants in the PP Population with available data.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving SVR4

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End point title

Percentage of Participants Achieving SVR4

End point description

SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.

End point type

Secondary

End point timeframe

4 weeks after end of all therapy (Study Week 16)

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	27 ^[19]	24 ^[20]	17 ^[21]	14 ^[22]
Units: percentage of participants
number (confidence interval 95%)	88.9 (70.8 to 97.6)	83.3 (62.6 to 95.3)	94.1 (71.3 to 99.9)	78.6 (49.2 to 95.3)

Notes
[19] - All participants in the PP Population with available data.
[20] - All participants in the PP Population with available data.
[21] - All participants in the PP Population with available data.
[22] - All participants in the PP Population with available data.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving SVR24

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End point title

Percentage of Participants Achieving SVR24

End point description

SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.

End point type

Secondary

End point timeframe

24 weeks after end of all therapy (Study Week 36)

End point values	GT2: Grazoprevir + Elbasvir + RBV (Arm A1)	GT2: Grazoprevir + RBV (Arm B1)	GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)	GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Number of subjects analysed	26 ^[23]	24 ^[24]	17 ^[25]	13 ^[26]
Units: percentage of participants
number (confidence interval 95%)	84.6 (65.1 to 95.6)	75 (53.3 to 90.2)	94.1 (71.3 to 99.9)	76.9 (46.2 to 95)

Notes
[23] - All participants in the PP Population with available data.
[24] - All participants in the PP Population with available data.
[25] - All participants in the PP Population with available data.
[26] - All participants in the PP Population with available data.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From Treatment Week (TW) 1 through Follow-Up Week (FW) 24 (up to 36 weeks)

Adverse event reporting additional description

AEs were reported for the ASAT Population (all randomized participants who received ≥ 1 dose of study therapy) for both the treatment and follow-up periods.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

GT2: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm A1)

Reporting group description

During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT4,5,6: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm B2)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.

Reporting group title

GT4,5,6: MK-5172 100 mg + MK-8742 50 mg (Arm B3)

Reporting group description

During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.

Reporting group title

GT2: MK-5172 100 mg + RBV (Arm B1)

Reporting group description

During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.

Serious adverse events	GT2: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm A1)	GT4,5,6: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm B2)	GT4,5,6: MK-5172 100 mg + MK-8742 50 mg (Arm B3)	GT2: MK-5172 100 mg + RBV (Arm B1)
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	0 / 19 (0.00%)	1 / 30 (3.33%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Vascular disorders
Flushing
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)	1 / 30 (3.33%)
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
Renal and urinary disorders
Renal failure acute
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	0 / 19 (0.00%)	0 / 30 (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
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	0 / 19 (0.00%)	0 / 30 (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

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

Non-serious adverse events	GT2: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm A1)	GT4,5,6: MK-5172 100 mg + MK-8742 50 mg + RBV (Arm B2)	GT4,5,6: MK-5172 100 mg + MK-8742 50 mg (Arm B3)	GT2: MK-5172 100 mg + RBV (Arm B1)
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 30 (86.67%)	18 / 19 (94.74%)	15 / 19 (78.95%)	25 / 30 (83.33%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	1	0	0
Hypotension
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	5 / 30 (16.67%)	3 / 19 (15.79%)	4 / 19 (21.05%)	6 / 30 (20.00%)
occurrences all number	5	3	4	6
Chest pain
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	1	1	0	1
Fatigue
subjects affected / exposed	12 / 30 (40.00%)	5 / 19 (26.32%)	3 / 19 (15.79%)	6 / 30 (20.00%)
occurrences all number	13	5	3	7
Feeling cold
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1	0	1
Influenza like illness
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Pyrexia
subjects affected / exposed	2 / 30 (6.67%)	0 / 19 (0.00%)	2 / 19 (10.53%)	1 / 30 (3.33%)
occurrences all number	2	0	2	1
Thirst
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	2
Reproductive system and breast disorders
Genital tract inflammation
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 30 (16.67%)	4 / 19 (21.05%)	4 / 19 (21.05%)	1 / 30 (3.33%)
occurrences all number	5	4	5	1
Dyspnoea
subjects affected / exposed	4 / 30 (13.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	4	1	0	1
Dyspnoea exertional
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	1	0	0
Oropharyngeal pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	3 / 19 (15.79%)	1 / 30 (3.33%)
occurrences all number	1	0	3	2
Rhinorrhoea
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	1	0
Psychiatric disorders
Depressed mood
subjects affected / exposed	2 / 30 (6.67%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	2	0	1	0
Depression
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Insomnia
subjects affected / exposed	2 / 30 (6.67%)	3 / 19 (15.79%)	2 / 19 (10.53%)	1 / 30 (3.33%)
occurrences all number	3	3	3	1
Irritability
subjects affected / exposed	3 / 30 (10.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	3	1	1	1
Sleep disorder
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	2
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	2 / 19 (10.53%)	0 / 30 (0.00%)
occurrences all number	0	0	2	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Blood bilirubin increased
subjects affected / exposed	2 / 30 (6.67%)	0 / 19 (0.00%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	2	0	0	0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	4 / 30 (13.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	4 / 30 (13.33%)
occurrences all number	7	1	0	6
Foot fracture
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	0	0	1	1
Inflammation of wound
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	1	0	0
Nervous system disorders
Disturbance in attention
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	1	0	0
Dizziness
subjects affected / exposed	7 / 30 (23.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	8	0	2	2
Dysgeusia
subjects affected / exposed	2 / 30 (6.67%)	0 / 19 (0.00%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	2	0	0	0
Headache
subjects affected / exposed	6 / 30 (20.00%)	6 / 19 (31.58%)	5 / 19 (26.32%)	4 / 30 (13.33%)
occurrences all number	8	8	20	5
Hypoaesthesia
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Lethargy
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Memory impairment
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	1	0
Poor quality sleep
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	1	0
Somnolence
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	4 / 30 (13.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	5	1	0	2
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	1	1	0
Abdominal pain
subjects affected / exposed	1 / 30 (3.33%)	2 / 19 (10.53%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	1	2	0	1
Abdominal pain upper
subjects affected / exposed	2 / 30 (6.67%)	0 / 19 (0.00%)	2 / 19 (10.53%)	0 / 30 (0.00%)
occurrences all number	3	0	2	0
Abdominal tenderness
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	0	0	1	1
Constipation
subjects affected / exposed	3 / 30 (10.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	3	0	1	0
Diarrhoea
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	4 / 19 (21.05%)	1 / 30 (3.33%)
occurrences all number	1	1	4	2
Dry mouth
subjects affected / exposed	2 / 30 (6.67%)	3 / 19 (15.79%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	2	3	1	1
Dyspepsia
subjects affected / exposed	2 / 30 (6.67%)	1 / 19 (5.26%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	2	1	0	2
Enteritis
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Faeces pale
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)	2 / 30 (6.67%)
occurrences all number	0	1	1	2
Haemorrhoids
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	2 / 19 (10.53%)	0 / 30 (0.00%)
occurrences all number	0	0	2	0
Lip dry
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Mouth ulceration
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Nausea
subjects affected / exposed	5 / 30 (16.67%)	2 / 19 (10.53%)	1 / 19 (5.26%)	4 / 30 (13.33%)
occurrences all number	5	3	1	6
Stomatitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	3	0
Vomiting
subjects affected / exposed	5 / 30 (16.67%)	0 / 19 (0.00%)	1 / 19 (5.26%)	2 / 30 (6.67%)
occurrences all number	6	0	1	3
Hepatobiliary disorders
Hepatomegaly
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	3 / 30 (10.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	3	0	0	0
Dry skin
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	1	1	0	1
Eczema
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	0	0	2	1
Pruritus
subjects affected / exposed	2 / 30 (6.67%)	2 / 19 (10.53%)	1 / 19 (5.26%)	1 / 30 (3.33%)
occurrences all number	3	3	2	1
Rash
subjects affected / exposed	2 / 30 (6.67%)	3 / 19 (15.79%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	2	5	0	2
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	3 / 19 (15.79%)	3 / 30 (10.00%)
occurrences all number	1	1	9	4
Back pain
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	2 / 19 (10.53%)	0 / 30 (0.00%)
occurrences all number	0	1	3	0
Bone pain
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Flank pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Joint swelling
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	1	0	0
Muscle contracture
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Myalgia
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Neck pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	2 / 19 (10.53%)	0 / 30 (0.00%)
occurrences all number	1	0	2	0
Pain in extremity
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1	0	1
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	1	0
Influenza
subjects affected / exposed	3 / 30 (10.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)	1 / 30 (3.33%)
occurrences all number	3	0	0	1
Laryngitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Nasopharyngitis
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	1	0	2
Oral herpes
subjects affected / exposed	1 / 30 (3.33%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	1	0	1	0
Rhinitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	2 / 30 (6.67%)
occurrences all number	0	0	1	2
Sinusitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0
Skin infection
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Urinary tract infection
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)	0 / 30 (0.00%)
occurrences all number	0	1	1	0
Viral infection
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 30 (3.33%)	1 / 19 (5.26%)	0 / 19 (0.00%)	2 / 30 (6.67%)
occurrences all number	1	1	0	2
Dyslipidaemia
subjects affected / exposed	0 / 30 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

13 Sep 2013

Protocol amendment 1 (AM1) included changes to the inclusion and exclusion criteria, added electrocardiographs to TW 4 and TW12 visits, and added collection of vital signs to every visit.

14 Oct 2013

AM2 revised the study design to add Part B (included 3 additional arms for treating participants with genotypes 4, 5, and 6 infection), revised the study objectives, hypotheses, and statistical analysis plan to include Part B, and added Part B-specific eligibility and early trial termination criteria.

08 May 2014

AM3 revised the study design to add Part C, revised the study objectives, hypotheses, and statistical analysis plan to include Part C and added a primary hypothesis for Part C, added Part C-specific eligibility criteria and added new early trial termination criteria for Part B.

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

Clinical Trial Results:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

Primary: Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

Primary: Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE

Primary: Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE

Secondary: Mean Time to First Achievement of Undetectable HCV RNA During Treatment

Secondary: Mean Time to First Achievement of Undetectable HCV RNA During Treatment

Secondary: Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

Secondary: Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

Secondary: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

Secondary: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

Secondary: Percentage of Participants Achieving SVR4

Secondary: Percentage of Participants Achieving SVR4

Secondary: Percentage of Participants Achieving SVR24

Secondary: Percentage of Participants Achieving SVR24

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
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Romania
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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

Primary: Percentage of Participants with Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

Primary: Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE

Primary: Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE

Secondary: Mean Time to First Achievement of Undetectable HCV RNA During Treatment

Secondary: Mean Time to First Achievement of Undetectable HCV RNA During Treatment

Secondary: Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

Secondary: Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

Secondary: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

Secondary: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

Secondary: Percentage of Participants Achieving SVR4

Secondary: Percentage of Participants Achieving SVR4

Secondary: Percentage of Participants Achieving SVR24

Secondary: Percentage of Participants Achieving SVR24

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection