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    Clinical Trial Results:
    An open label, randomised, pilot trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection

    Summary
    EudraCT number
    		 2012-005525-75
    Trial protocol
    		 GB  
    Global end of trial date
    29 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2017
    First version publication date
    16 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SSAT052
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02006745
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St Stephens Aids Trust
    Sponsor organisation address
    Chelsea Chambers, 262a Fulham Road, London, United Kingdom, SW10 9NH
    Public contact
    Marita Marshall, Head of Project Management, St Stephen's Clinical Research, +44 0203 828 0567, marita.marshall@ststcr.com
    Scientific contact
    Prof Mark Nelson, St Stephan’s Centre, Chelsea & Westminster Hospital, +44 0203 315 5610 , mark.nelson@chelwest.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To find out whether treating acute hepatitis C infection with PEGylated interferon, ribavirin and telaprevir gets rid of the virus as effectively as when acute hepatitis C infection is treated with PEGylated interferon and ribavirin alone
    Protection of trial subjects
    The protocol was written, and the study was conducted according to ICH GCP & the principles of the Declaration of Helsinki. The protocol was approved by the National Regulator & an Independent Ethics Committee as required by national legislation. Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. The inclusion/exclusion criteria were designed to eliminate subjects who may have been put at risk by participating in the study. Safety & tolerability of medications were assessed by questions, physical examination & laboratory parameters. Any changes in health status during the study were recorded and followed up by the clinical team. Female patients of childbearing potential & their male partners were required to use 2 effective contraceptive methods during treatment (as agreed by the investigator including a barrier method of contraception) and for at least 6 months after the last treatment (i.e. 6 months after week 12, 24 or 48, depending on study arm and treatment response). Routine monthly pregnancy tests were also required during this time and for 6 months after the end of treatment. Heterosexually active male participants or their female partners were required to use 2 effective contraceptive methods during the trial and for at least 7 months after the last dosage of treatment. Glucose monitoring was added to study procedures in line with information arising in an update to the SPC for Pegasys® during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 20 adult male & female HIV-1 positive patients with current documented acute hepatitis C genotype 1 infection with an estimated duration of <24 weeks at diagnosis, were recruited from the out-patient clinics at Chelsea & Westminster Hospital NHS Foundation Trust between 21/01//2014 & 20/10/2016.

    Pre-assignment
    Screening details
    		 24 patients were screened. There were a total of 6 screen failures. 2 of the screen failures underwent a second screening and were recruited to the study. Following successful screening, eligible patients were randomised at the baseline visit to treatment arm 1 or 2 in a 1:1 ratio.

    Pre-assignment period milestones
    Number of subjects started
    		 24
    Number of subjects completed
    		 20

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 4
    Period 1
    Period 1 title
    Experimental (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 PEG-IFN and weight-based ribavirin (RBV): 24 weeks in those achieving rapid virologic response (RVR (>2 log drop within 100 days of infection)) (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    J05AB04
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 – 1200 mg daily (body mass-dependent) in two divided doses, to be taken orally

    Investigational medicinal product name
    PEG-IFN
    Investigational medicinal product code
    L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180mcg once weekly

    Arm title
    		 Arm 2
    Arm description
    		 PEG-IFN and weight-based RBV plus telaprevir (TPV): 12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA >25 but <1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA >1000 iU/mL at week 4) Patients achieving HCV RNA <25 iU/mL at week 4 (RVR) were treated for 12 weeks. Patients with HCV RNA above 25 but below 1000 iU/mL at week 4 were treated for 24 weeks (12 weeks of TPV/Peg-IFN/RBV followed by 12 weeks of Peg-IFN/RBV). Patients in arm 2 with HCV RNA > 1000 iU/mL at week 4 discontinued Telaprevir, continuing with PEG-IFN/RBV for an additional 44 weeks beyond week 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PEG-IFN
    Investigational medicinal product code
    L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180mcg once weekly

    Investigational medicinal product name
    telaprevir
    Investigational medicinal product code
    J05AE11
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2x 375mg tablets q8hrly or 3x375mg tablets BID

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    J05AB04
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 – 1200 mg daily (body mass-dependent) in two divided doses, to be taken orally

    Number of subjects in period 1 [1]
    		Arm 1 Arm 2
    Started
    10
    10
    Completed
    10
    9
    Not completed
    0
    1
         Lost to follow-up
    -
    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: 4 subjects failed the screening period and so were not included in the baseline period

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 PEG-IFN and weight-based ribavirin (RBV): 24 weeks in those achieving rapid virologic response (RVR (>2 log drop within 100 days of infection)) (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR

    Reporting group title
    Arm 2
    Reporting group description
    		 PEG-IFN and weight-based RBV plus telaprevir (TPV): 12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA >25 but <1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA >1000 iU/mL at week 4) Patients achieving HCV RNA <25 iU/mL at week 4 (RVR) were treated for 12 weeks. Patients with HCV RNA above 25 but below 1000 iU/mL at week 4 were treated for 24 weeks (12 weeks of TPV/Peg-IFN/RBV followed by 12 weeks of Peg-IFN/RBV). Patients in arm 2 with HCV RNA > 1000 iU/mL at week 4 discontinued Telaprevir, continuing with PEG-IFN/RBV for an additional 44 weeks beyond week 4.

    Reporting group values
    		 Arm 1 Arm 2 Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 10 10 20
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 38.7 (26.9 to 58.7) 39.2 (31.6 to 49.7) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 10 10 20
    Self Described Ethnicity
    Units: Subjects
        English/Welsh/Scottish/Northern Irish/British
    		 3 3 6
        Irish
    		 1 1 2
        Any other white background
    		 4 5 9
        Chinese
    		 1 0 1
        African
    		 0 1 1
        Caribbean
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 PEG-IFN and weight-based ribavirin (RBV): 24 weeks in those achieving rapid virologic response (RVR (>2 log drop within 100 days of infection)) (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR

    Reporting group title
    Arm 2
    Reporting group description
    		 PEG-IFN and weight-based RBV plus telaprevir (TPV): 12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA >25 but <1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA >1000 iU/mL at week 4) Patients achieving HCV RNA <25 iU/mL at week 4 (RVR) were treated for 12 weeks. Patients with HCV RNA above 25 but below 1000 iU/mL at week 4 were treated for 24 weeks (12 weeks of TPV/Peg-IFN/RBV followed by 12 weeks of Peg-IFN/RBV). Patients in arm 2 with HCV RNA > 1000 iU/mL at week 4 discontinued Telaprevir, continuing with PEG-IFN/RBV for an additional 44 weeks beyond week 4.

    Primary: Comparison of rates of sustained virologic response (SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy.

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    End point title
    		 Comparison of rates of sustained virologic response (SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy. [1]
    End point description
    Comparison of SVR between arms by intention to treat analysis. Last observation HepC PCR <1000 iU/mL carried forward if data unavailable at a visit day. Where success is defined as any patient who achieves HepC PCR <1000 iU/mLn at a study visit time point and these results are assumed and retained for subsequent visits
    End point type
    Primary
    End point timeframe
    24 weeks after planned completion of therapy.
    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: Descriptive statistics only performed
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: Subjects
        <1000 iU/mL
    9
    10
        >1000 iU/mL
    1
    0
    No statistical analyses for this end point

    Secondary: Comparison of proportion of treated patients achieving sustained virological response after 12 weeks of therapy (SVR12) between treatment arms; defined as HCV RNA not detected at 12 weeks after planned completion of therapy

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    End point title
    		 Comparison of proportion of treated patients achieving sustained virological response after 12 weeks of therapy (SVR12) between treatment arms; defined as HCV RNA not detected at 12 weeks after planned completion of therapy
    End point description
    Comparison of the parameters between arms by intention to treat analysis. . Last observation HepC PCR <1000 iU/mL carried forward if data unavailable at a visit day. Where success is defined as any patient who achieves HepC PCR <1000 iU/mL at a study visit time point and these results are assumed and retained for subsequent visits
    End point type
    Secondary
    End point timeframe
    12 weeks after planned completion of therapy
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: Subjects
        <1000 iU/mL
    9
    10
        >1000 iU/mL
    1
    0
    No statistical analyses for this end point

    Secondary: Comparison of proportion of treated patients with HCV RNA not detected at the planned end of treatment (EOT) between treatment arms

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    End point title
    		 Comparison of proportion of treated patients with HCV RNA not detected at the planned end of treatment (EOT) between treatment arms
    End point description
    Comparison of the parameters between arms by intention to treat analysis.
    End point type
    Secondary
    End point timeframe
    Baselines to 48 weeks
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: # Subjects with HCV RNA PCR <1000 iU/mL
        Baseline
    0
    1
        12 weeks
    9
    10
        24 weeks
    9
    10
        48 weeks
    9
    10
    No statistical analyses for this end point

    Secondary: Comparison of reduction in HCV RNA from baseline to week 4 between treatment arms

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    End point title
    		 Comparison of reduction in HCV RNA from baseline to week 4 between treatment arms
    End point description
    Comparison of the parameters between arms by intention to treat analysis.
    End point type
    Secondary
    End point timeframe
    Baseline to week 4
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: # Subjects with HCV RNA PCR <1000 iU/mL
        Baseline
    0
    1
        Week 4
    4
    7
    No statistical analyses for this end point

    Secondary: Comparison of change in CD4 cell count between baseline and EOT between treatment arms

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    End point title
    		 Comparison of change in CD4 cell count between baseline and EOT between treatment arms
    End point description
    Comparison of the parameters between arms by intention to treat analysis.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: CD4 %
    median (inter-quartile range (Q1-Q3))
        Post Week 4
    36.85 (27.80 to 41.50)
    42.35 (38.65 to 43.60)
        Post Week 12
    33.25 (31.10 to 36.20)
    37.40 (36.20 to 39.30)
        Post week 24
    36.75 (30.6 to 39.6)
    34.90 (32.05 to 40.65)
    No statistical analyses for this end point

    Secondary: Summary comparison of adverse events of grade III / IV intensity between treatment arms

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    End point title
    		 Summary comparison of adverse events of grade III / IV intensity between treatment arms
    End point description
    Comparison of the parameters between arms by intention to treat analysis.
    End point type
    Secondary
    End point timeframe
    Adverse events were captured from the point of consent to the end of study participation for each subject
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: Subjects
        Baseline
    1
    0
        Week 24
    1
    1
        Week 36
    1
    0
    No statistical analyses for this end point

    Secondary: Adherence to medication (as measured by adherence questioning and pill counts)

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    End point title
    		 Adherence to medication (as measured by adherence questioning and pill counts)
    End point description
    Comparison of the parameter between arms by intention to treat analysis
    End point type
    Secondary
    End point timeframe
    Compliance was measured during the treatment phases of the study
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    10
    10
    Units: # Non Compliant Subjects
        Week 2
    0
    1
        Week 4
    3
    1
        Week 8
    2
    1
        Week 12
    1
    2
        Week 24
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to Last visit for each patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 -

    Reporting group title
    Arm 2
    Reporting group description
    		 -

    Serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    RUPTURED COLON
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    10 / 10 (100.00%)
    Surgical and medical procedures
    Dental Extraction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 10 (90.00%)
    7 / 10 (70.00%)
         occurrences all number
    9
    7
    Febrile illness
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Flu like illness
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    3
    Flu like symptoms
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Lethargy
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Loss of appetite
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Low appetite
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Shiver
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Tiredness
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    3
    Tiredness / 1 episode of synope
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Immune system disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dry Skin
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Hayfever
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Sore Throat
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Erectile Dysfunction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    SUPERFICIAL THROMBOPHLEBITIS (DORSAL PENILE VEINS)
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Viral URTI
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    EPITAXIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Left side chest discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Shortness of breath on exertion
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    0
    4
    LOW MOOD
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mood swings
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sleep disturbances
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Worsening anxiety
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Worsening Insomnia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 10 (20.00%)
         occurrences all number
    2
    2
    Lack of concentration
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    low hemoglobin
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Acute gastroenteritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    COLOSTOMY
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 10 (20.00%)
    4 / 10 (40.00%)
         occurrences all number
    2
    4
    Diffuse itchiness
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Doxycycline related nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dry Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    E. Coli UTI
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Early Satiety
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Frequency stool
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastroenteritis acute
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Heartburn
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Loose stool
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    0
    4
    Oesophageal reflux
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Post surgical bowel occlusion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Shigellosis
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Soft stool
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Stomach Cramp
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Aplithris mouth ulcer
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Arthralgia knee
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dermatitis oricomieosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dry thickened skin both ankles
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Itch
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Itchy rash
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Itchy skin
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    3
    Middle finger L. hand itching swelling
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Mosquito bites
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Mouth ulcer
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Pruritis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Red spot on face
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    SKIN SCALP INFECTION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin tag removal
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Wasp sting
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Worsening proteinuria (renoprotective)
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Aches and pains
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Acne/Back + neck
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Bone aches Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Left hip burisitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Left upper arm bruise. Mechanical fall
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mild discomfort right flank
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    right 3RD metacarphalagial joint pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Right knee pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Anal Gonorhoea
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Anxiety (worsening)
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Chlamydia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dental Abscess
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dental infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Herpatic lip ulcer
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Onychomycose left toe nail
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Peritonitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Secondary syphilis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Syphilis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2013
    This amendment was generated in order to clarify points raised by the ethics committee in their letter dated 16th July 2013, and to add that viral load plasma samples will be stored for possible further testing.
    07 Jan 2014
    Addition of fibroscans, clarify the study follow up visits, remove the hepatitis C risk factors questionnaire, increase the volume of blood taken for stored samples and update the dosing information, as well as to make a number of administrative changes.
    01 Sep 2014
    Updated in line with new safety information from Pegasys® SPC. Addition of glucose testing and Hep-B Testing. Updated contraception advice
    26 Nov 2015
    Data to be combined with that from a similar study (An open label, randomised, non-inferiority trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection (CHAT Study) ) which was being concurrently carried out by the University of Bonn, Germany. The PIs from the 2 studies were to lead the combined analysis.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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