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    Clinical Trial Results:
    A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin.

    Summary
    EudraCT number
    		 2012-003984-23
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2025
    First version publication date
    27 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BOC-HIV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01718301
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per a la Recerca Biomèdica
    Sponsor organisation address
    C/ Rossello 143, Barcelona, Spain,
    Public contact
    CTU Clinic, CTU clinic (Clinical Trial Unit). Farmacología Clínica. hospital clinic, +34 9322754009838, mallolas@clinic.ub.es
    Scientific contact
    CTU Clinic, CTU clinic (Clinical Trial Unit). Farmacología Clínica. hospital clinic, +34 9322754009838, mallolas@clinic.ub.es
    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
    30 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed TID orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy .
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and Spanish legislation (Royal Decree 223/2004). Ethics Committee and regulatory approvals were obtained prior to initiation. Informed consent was provided in writing and orally, and patient confidentiality was ensured following data protection laws. A liability insurance policy was in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 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
    Spain: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    102
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening included informed consent, eligibility check, medical history, physical exam, vital signs, lab tests (HCV RNA, CD4, HIV VL), and imaging (Fibroscan or biopsy, ultrasound for cirrhotics) to confirm genotype 1 and stable HIV infection.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Boceprevir + Ribavirin + Peginterferon
    Arm description
    		 Participants received 4 weeks of Peginterferon/Ribavirin (lead-in), followed by response-guided therapy with Boceprevir added. Cirrhotic patients received a fixed 44-week regimen. Boceprevir 800 mg three times a day (v.o.) in combination with Peginterferon (alfa-2b or alfa-2a) and Ribavirin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    Victrelis®, BOC
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Boceprevir (BOC) 800 mg (4 capsules) three times a day . Total 2400 mg/day (12 capsules). Boceprevir is administered three times a day using a dosing schedule of 4 capsules every 8 hours

    Investigational medicinal product name
    Peginterferon (alpha-2b or alpha-2a)
    Investigational medicinal product code
    Other name
    Pegasys® (alfa-2a) o Pegintron® (alfa-2b)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alfa-2b: 80-150mcg or peginterferon alfa-2a: 180 micrograms Injectable solution, administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribavirin Teva®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    ribavirin: 200 mg capsules, administered orally, dose adjusted by weight.

    Number of subjects in period 1 [1]
    		Boceprevir + Ribavirin + Peginterferon
    Started
    98
    Completed
    76
    Not completed
    22
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    2
         Physician decision
    12
         Adverse event, non-fatal
    6
         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: Four subjects were enrolled but did not start treatment due to screening failure (2) or early withdrawal before first dose administration (2).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 98 98
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49 ( 6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 72 72

    End points

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    End points reporting groups
    Reporting group title
    Boceprevir + Ribavirin + Peginterferon
    Reporting group description
    		 Participants received 4 weeks of Peginterferon/Ribavirin (lead-in), followed by response-guided therapy with Boceprevir added. Cirrhotic patients received a fixed 44-week regimen. Boceprevir 800 mg three times a day (v.o.) in combination with Peginterferon (alfa-2b or alfa-2a) and Ribavirin

    Primary: Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment

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    End point title
    		 Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment [1]
    End point description
    Achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
    End point type
    Primary
    End point timeframe
    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: The primary endpoint was assessed using descriptive statistics only. No formal statistical comparison was planned due to the single-arm design of the study.
    End point values
    		 Boceprevir + Ribavirin + Peginterferon
    Number of subjects analysed
    98
    Units: Subjects
        Number of participants achieving SVR
    66
        Number of participants not achieving SVR 32
    32
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent until 30 days after study completion or discontinuation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Boceprevir + Ribavirin + Peginterferon
    Reporting group description
    		 -

    Serious adverse events
    		 Boceprevir + Ribavirin + Peginterferon
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 98 (19.39%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Thrombocytopenia, neutropenia, anemia
         subjects affected / exposed
    16 / 98 (16.33%)
         occurrences causally related to treatment / all
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Other SAEs
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Boceprevir + Ribavirin + Peginterferon
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 98 (92.86%)
    General disorders and administration site conditions
    Other
    Additional description: Most AEs were mild and known to be related to PEG-IFN/RBV and BOC therapy (flu-like symptoms, asthenia, neuropsychiatric symptoms, hematological toxicity, dysgeusia, and rash).
         subjects affected / exposed
    91 / 98 (92.86%)
         occurrences all number
    633

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The main limitation of this study is the absence of a control group.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27815225
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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