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    Clinical Trial Results:
    A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Peg-Interferon Alfa-2a and Ribavirin in Previously Untreated HCV Patients co-infected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV).

    Summary
    EudraCT number
    		 2011-003067-30
    Trial protocol
    		 DE   ES   GB   BE   IT  
    Global end of trial date
    10 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    01 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI444-043
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01471574
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    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
    10 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of daclatasvir plus peg interferon-alfa 2a and ribavirin in untreated hepatitis C virus in subjects co-infected with HIV.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 75
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    France: 36
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Italy: 54
    Country: Number of subjects enrolled
    Argentina: 27
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Brazil: 24
    Country: Number of subjects enrolled
    Canada: 47
    Country: Number of subjects enrolled
    Puerto Rico: 22
    Country: Number of subjects enrolled
    Russian Federation: 60
    Country: Number of subjects enrolled
    United States: 143
    Worldwide total number of subjects
    549
    EEA total number of subjects
    207
    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)
    533
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 84 sites in 13 countries.

    Pre-assignment
    Screening details
    		 Of 549 subjects enrolled, 301 were randomised to receive treatment. Of the 248 subjects who were not randomised, 204 no longer met study criteria, and 44 discontinued due to other reasons.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Arm description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa­-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa­-2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects ≥75 kg) with meals.

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Arm description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 60 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa­-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa-­2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and (for subjects ≥75 kg) with meals.

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Arm description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 and 60 mg tablets was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa-­2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa­-2a 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects < 75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects >= 75 kg) with meal.

    Arm title
    		 Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Arm description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 60 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa-­2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalpha-2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects ≥75 kg) with meals.

    Number of subjects in period 1 [1]
    		Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Started
    132
    39
    106
    24
    Completed
    101
    29
    82
    21
    Not completed
    31
    10
    24
    3
         Subject no Longer Meets Study Criteria
    1
    -
    -
    -
         Consent withdrawn by subject
    5
    1
    1
    -
         Not specified
    1
    -
    -
    -
         Adverse event
    7
    3
    6
    1
         Lost to follow-up
    1
    2
    2
    -
         Subject Requested Discontinue Study drug
    4
    -
    1
    1
         Lack of efficacy
    12
    4
    14
    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: The number of subjects reported in the baseline period are different from the worldwide number enrolled in the trial, as 204 subjects no longer met study criteria and 44 discontinued due to other reasons.
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Arm description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa­-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa­-2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects ≥75 kg) with meals.

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Arm description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 60 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa­-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa-­2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and (for subjects ≥75 kg) with meals.

    Arm title
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Arm description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 and 60 mg tablets was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa-­2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa­-2a 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects < 75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects >= 75 kg) with meal.

    Arm title
    		 Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Arm description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 60 mg tablet was administered orally once daily.

    Investigational medicinal product name
    PegIFNalfa-­2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalpha-2a solution of 180 µg was administered subcutaneously once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered as 400 mg in morning and 600 mg in evening (for subjects <75 kg) or 1200 mg total daily dose was administered orally as 600 mg in morning and evening (for subjects ≥75 kg) with meals.

    Number of subjects in period 2
    		Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Started
    101
    29
    82
    21
    Completed
    114
    32
    95
    21
    Not completed
    7
    2
    7
    3
         Consent withdrawn by subject
    3
    -
    3
    1
         Death
    -
    -
    1
    -
         Lost to follow-up
    4
    1
    3
    2
         Follow-up no longer required
    -
    1
    -
    -
    Joined
    20
    5
    20
    3
         Rejoined for follow-up
    20
    5
    20
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Reporting group description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Reporting group description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group values
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Total
    Number of subjects
    		 132 39 106 24 301
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 125 39 104 24 292
        From 65-84 years
    		 7 0 2 0 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 9.72 ) 47.9 ( 9.03 ) 46.5 ( 9.42 ) 36 ( 9.02 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 7 27 11 72
        Male
    		 105 32 79 13 229

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Reporting group description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Reporting group description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Reporting group description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Reporting group description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Subject analysis set title
    HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNα-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNα-2a and ribavirin for a total duration of 48 weeks.

    Primary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) [1]
    End point description
    SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. The analysis was performed in all subjects who received at least 1 dose of study therapy.
    End point type
    Primary
    End point timeframe
    Follow-up Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed.
    End point values
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    132
    39
    106
    24
    277
    Units: Percentage of subjects
        number (confidence interval 95%)
    75 (67.6 to 82.4)
    71.8 (57.7 to 85.9)
    71.7 (63.1 to 80.3)
    87.5 (74.3 to 100)
    73.3 (68.1 to 78.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)

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    End point title
    		 Percentage of Subjects Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND) [2]
    End point description
    Subjects who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. The analysis was performed in all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 24
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for prespecified reporting group: Non-HAART Therapy and HAART Therapy Total.
    End point values
    		 Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    24
    277
    Units: Percentage of subjects
    number (not applicable)
        Week 1
    41.7
    39.7
        Week 2
    91.7
    71.5
        Week 4
    95.8
    82.7
        Week 6
    87.5
    84.1
        Week 8
    95.8
    84.1
        Week 12
    91.7
    85.2
        Week 4 and 12
    91.7
    78.7
        End of treatment
    95.8
    84.8
        Follow-up Week 24
    83.3
    70.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)

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    End point title
    		 Percentage of Subjects Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) [3]
    End point description
    Subjects who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. The analysis was performed in all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for prespecified reporting group: Non-HAART Therapy and HAART Therapy Total.
    End point values
    		 Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    24
    277
    Units: Percentage of subjects
    number (not applicable)
        Week 1
    16.7
    9
        Week 2
    50
    33.9
        Week 4
    91.7
    64.3
        Week 6
    87.5
    74.4
        Week 8
    95.8
    78
        Week 12
    91.7
    81.2
        Week 4 and 12
    87.5
    61.4
        End of treatment
    91.7
    81.2
        Follow-up Week 12
    87.5
    70.8
        Follow-up Week 24
    83.3
    70.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL

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    End point title
    		 Percentage of Subjects Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL [4]
    End point description
    Subjects who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥400 copies/mL were determined. The analysis was performed in all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    End of treatment
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for prespecified reporting group: HAART Therapy: Daclatasvir 30mg, HAART Therapy: Daclatasvir 60 mg and HAART Therapy: Daclatasvir 90 mg.
    End point values
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    132
    39
    106
    277
    Units: Percentage of subjects
    number (confidence interval 95%)
        HIV RNA < 40 copies/mL
    88.6 (83.2 to 94.1)
    89.7 (80.2 to 99.3)
    93.4 (88.7 to 98.1)
    90.6 (87.2 to 94.1)
        HIV RNA >= 400 copies/mL
    0 (0 to 0)
    2.6 (0 to 7.5)
    0 (0 to 0)
    0.4 (0 to 1.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
    End point description
    Percentages calculated as number of responders/number who received treatment. All subjects who received at least 1 dose of study drug. Here 'n' signifies number of subjects evaluable at the specified time-point.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 12
    End point values
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    132
    39
    106
    24
    277
    Units: Percentage of Subjects
    number (confidence interval 95%)
        CC Genotype (n=36, 14, 39, 89, 6)
    94.4 (87 to 100)
    92.9 (79.4 to 100)
    79.5 (66.8 to 92.2)
    100 (100 to 100)
    87.6 (80.8 to 94.5)
        CT Genotype (n=72, 22, 50,144, 15)
    66.7 (55.8 to 77.6)
    63.6 (43.5 to 83.7)
    70 (57.3 to 82.7)
    93.3 (80.7 to 100)
    67.4 (59.7 to 75)
        TT Genotype (n=22, 3, 12, 37, 2)
    68.2 (48.7 to 87.6)
    33.3 (0 to 86.7)
    58.3 (30.4 to 86.2)
    50 (0 to 100)
    62.2 (46.5 to 77.8)
        Not reported (n=2, 0, 5, 7, 1)
    100 (100 to 100)
    0 (0 to 0)
    60 (17.1 to 100)
    0 (0 to 0)
    71.4 (38 to 100)
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation

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    End point title
    		 Number of Subjects Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
    End point description
    Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. The analysis was performed in all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 to 7 days post last dose of study treatment (up to Week 48)
    End point values
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
    Number of subjects analysed
    132
    39
    106
    24
    277
    Units: Subjects
        Deaths
    0
    1
    1
    0
    2
        SAEs
    12
    6
    6
    0
    24
        Grade 3 to 4 AEs
    46
    12
    35
    4
    93
        AEs Leading to Discontinuation of Study Therapy
    7
    4
    6
    1
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 to 7 days post last dose of study treatment (up to Week 48)
    Adverse event reporting additional description
    On-treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg
    Reporting group description
    		 Subjects taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects taking other Highly Active Anti-Retroviral Therapy (HAART), including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg
    Reporting group description
    		 Subjects taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Reporting group title
    Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Reporting group description
    		 Subjects not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for subjects weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Subjects without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.

    Serious adverse events
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 132 (9.09%)
    6 / 39 (15.38%)
    6 / 106 (5.66%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Vascular disorders
    Venous thrombosis
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Laryngeal cyst
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 132 (1.52%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Nausea
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Vomiting
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Meningitis
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (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
    Hypokalaemia
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Highly Active Anti-Retroviral Therapy: Daclatasvir, 30 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg Highly Active Anti-Retroviral Therapy: Daclatasvir, 90 mg Non- Highly Active Anti-Retroviral Therapy: Daclatasvir, 60 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 132 (92.42%)
    38 / 39 (97.44%)
    100 / 106 (94.34%)
    23 / 24 (95.83%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 132 (2.27%)
    2 / 39 (5.13%)
    4 / 106 (3.77%)
    0 / 24 (0.00%)
         occurrences all number
    3
    2
    4
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    45 / 132 (34.09%)
    16 / 39 (41.03%)
    47 / 106 (44.34%)
    6 / 24 (25.00%)
         occurrences all number
    47
    17
    50
    6
    Asthenia
         subjects affected / exposed
    40 / 132 (30.30%)
    7 / 39 (17.95%)
    19 / 106 (17.92%)
    12 / 24 (50.00%)
         occurrences all number
    41
    7
    20
    12
    Pyrexia
         subjects affected / exposed
    28 / 132 (21.21%)
    6 / 39 (15.38%)
    19 / 106 (17.92%)
    12 / 24 (50.00%)
         occurrences all number
    41
    7
    25
    18
    Influenza like illness
         subjects affected / exposed
    28 / 132 (21.21%)
    14 / 39 (35.90%)
    6 / 106 (5.66%)
    1 / 24 (4.17%)
         occurrences all number
    33
    14
    7
    1
    Chills
         subjects affected / exposed
    5 / 132 (3.79%)
    4 / 39 (10.26%)
    6 / 106 (5.66%)
    1 / 24 (4.17%)
         occurrences all number
    5
    4
    7
    1
    Pain
         subjects affected / exposed
    6 / 132 (4.55%)
    3 / 39 (7.69%)
    4 / 106 (3.77%)
    0 / 24 (0.00%)
         occurrences all number
    6
    3
    4
    0
    Chest pain
         subjects affected / exposed
    0 / 132 (0.00%)
    2 / 39 (5.13%)
    2 / 106 (1.89%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Hyperthermia
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    1 / 106 (0.94%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    1
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 132 (8.33%)
    4 / 39 (10.26%)
    8 / 106 (7.55%)
    5 / 24 (20.83%)
         occurrences all number
    11
    4
    9
    5
    Dyspnoea
         subjects affected / exposed
    11 / 132 (8.33%)
    2 / 39 (5.13%)
    6 / 106 (5.66%)
    0 / 24 (0.00%)
         occurrences all number
    11
    2
    6
    0
    Dyspnoea exertional
         subjects affected / exposed
    7 / 132 (5.30%)
    2 / 39 (5.13%)
    7 / 106 (6.60%)
    1 / 24 (4.17%)
         occurrences all number
    7
    2
    7
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 39 (2.56%)
    2 / 106 (1.89%)
    2 / 24 (8.33%)
         occurrences all number
    1
    1
    2
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    36 / 132 (27.27%)
    10 / 39 (25.64%)
    17 / 106 (16.04%)
    3 / 24 (12.50%)
         occurrences all number
    39
    10
    17
    3
    Depression
         subjects affected / exposed
    20 / 132 (15.15%)
    5 / 39 (12.82%)
    17 / 106 (16.04%)
    0 / 24 (0.00%)
         occurrences all number
    23
    5
    17
    0
    Irritability
         subjects affected / exposed
    16 / 132 (12.12%)
    3 / 39 (7.69%)
    14 / 106 (13.21%)
    1 / 24 (4.17%)
         occurrences all number
    16
    3
    15
    1
    Mood swings
         subjects affected / exposed
    4 / 132 (3.03%)
    5 / 39 (12.82%)
    2 / 106 (1.89%)
    0 / 24 (0.00%)
         occurrences all number
    4
    5
    2
    0
    Anxiety
         subjects affected / exposed
    5 / 132 (3.79%)
    3 / 39 (7.69%)
    2 / 106 (1.89%)
    0 / 24 (0.00%)
         occurrences all number
    5
    3
    2
    0
    Sleep disorder
         subjects affected / exposed
    4 / 132 (3.03%)
    1 / 39 (2.56%)
    2 / 106 (1.89%)
    3 / 24 (12.50%)
         occurrences all number
    4
    1
    2
    3
    Depressed mood
         subjects affected / exposed
    3 / 132 (2.27%)
    2 / 39 (5.13%)
    1 / 106 (0.94%)
    2 / 24 (8.33%)
         occurrences all number
    3
    2
    1
    2
    Abnormal dreams
         subjects affected / exposed
    1 / 132 (0.76%)
    2 / 39 (5.13%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    14 / 132 (10.61%)
    3 / 39 (7.69%)
    8 / 106 (7.55%)
    1 / 24 (4.17%)
         occurrences all number
    14
    3
    8
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    29 / 132 (21.97%)
    13 / 39 (33.33%)
    28 / 106 (26.42%)
    7 / 24 (29.17%)
         occurrences all number
    32
    15
    36
    8
    Dizziness
         subjects affected / exposed
    11 / 132 (8.33%)
    3 / 39 (7.69%)
    7 / 106 (6.60%)
    2 / 24 (8.33%)
         occurrences all number
    11
    3
    7
    2
    Dysgeusia
         subjects affected / exposed
    9 / 132 (6.82%)
    4 / 39 (10.26%)
    7 / 106 (6.60%)
    0 / 24 (0.00%)
         occurrences all number
    9
    4
    7
    0
    Sciatica
         subjects affected / exposed
    0 / 132 (0.00%)
    2 / 39 (5.13%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    42 / 132 (31.82%)
    7 / 39 (17.95%)
    35 / 106 (33.02%)
    4 / 24 (16.67%)
         occurrences all number
    74
    7
    59
    7
    Anaemia
         subjects affected / exposed
    32 / 132 (24.24%)
    10 / 39 (25.64%)
    34 / 106 (32.08%)
    4 / 24 (16.67%)
         occurrences all number
    35
    12
    39
    5
    Thrombocytopenia
         subjects affected / exposed
    9 / 132 (6.82%)
    1 / 39 (2.56%)
    8 / 106 (7.55%)
    0 / 24 (0.00%)
         occurrences all number
    14
    1
    8
    0
    Leukopenia
         subjects affected / exposed
    8 / 132 (6.06%)
    3 / 39 (7.69%)
    3 / 106 (2.83%)
    0 / 24 (0.00%)
         occurrences all number
    13
    3
    3
    0
    Lymphopenia
         subjects affected / exposed
    2 / 132 (1.52%)
    2 / 39 (5.13%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 132 (2.27%)
    2 / 39 (5.13%)
    2 / 106 (1.89%)
    1 / 24 (4.17%)
         occurrences all number
    3
    2
    2
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    24 / 132 (18.18%)
    10 / 39 (25.64%)
    21 / 106 (19.81%)
    4 / 24 (16.67%)
         occurrences all number
    27
    11
    22
    4
    Diarrhoea
         subjects affected / exposed
    19 / 132 (14.39%)
    6 / 39 (15.38%)
    18 / 106 (16.98%)
    2 / 24 (8.33%)
         occurrences all number
    22
    7
    19
    2
    Vomiting
         subjects affected / exposed
    12 / 132 (9.09%)
    5 / 39 (12.82%)
    9 / 106 (8.49%)
    0 / 24 (0.00%)
         occurrences all number
    13
    6
    9
    0
    Dry mouth
         subjects affected / exposed
    11 / 132 (8.33%)
    1 / 39 (2.56%)
    9 / 106 (8.49%)
    0 / 24 (0.00%)
         occurrences all number
    11
    1
    9
    0
    Constipation
         subjects affected / exposed
    6 / 132 (4.55%)
    4 / 39 (10.26%)
    4 / 106 (3.77%)
    0 / 24 (0.00%)
         occurrences all number
    6
    4
    4
    0
    Abdominal pain upper
         subjects affected / exposed
    8 / 132 (6.06%)
    0 / 39 (0.00%)
    4 / 106 (3.77%)
    1 / 24 (4.17%)
         occurrences all number
    8
    0
    4
    1
    Dyspepsia
         subjects affected / exposed
    4 / 132 (3.03%)
    2 / 39 (5.13%)
    3 / 106 (2.83%)
    0 / 24 (0.00%)
         occurrences all number
    4
    2
    3
    0
    Abdominal pain
         subjects affected / exposed
    2 / 132 (1.52%)
    3 / 39 (7.69%)
    3 / 106 (2.83%)
    0 / 24 (0.00%)
         occurrences all number
    2
    3
    3
    0
    Cheilitis
         subjects affected / exposed
    2 / 132 (1.52%)
    3 / 39 (7.69%)
    2 / 106 (1.89%)
    1 / 24 (4.17%)
         occurrences all number
    2
    3
    2
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    8 / 132 (6.06%)
    0 / 39 (0.00%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    10
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    20 / 132 (15.15%)
    3 / 39 (7.69%)
    14 / 106 (13.21%)
    4 / 24 (16.67%)
         occurrences all number
    20
    3
    14
    4
    Pruritus
         subjects affected / exposed
    18 / 132 (13.64%)
    3 / 39 (7.69%)
    14 / 106 (13.21%)
    6 / 24 (25.00%)
         occurrences all number
    21
    3
    15
    6
    Rash
         subjects affected / exposed
    20 / 132 (15.15%)
    4 / 39 (10.26%)
    10 / 106 (9.43%)
    5 / 24 (20.83%)
         occurrences all number
    21
    4
    10
    6
    Alopecia
         subjects affected / exposed
    19 / 132 (14.39%)
    4 / 39 (10.26%)
    8 / 106 (7.55%)
    5 / 24 (20.83%)
         occurrences all number
    19
    4
    8
    5
    Skin lesion
         subjects affected / exposed
    1 / 132 (0.76%)
    2 / 39 (5.13%)
    2 / 106 (1.89%)
    0 / 24 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    26 / 132 (19.70%)
    5 / 39 (12.82%)
    14 / 106 (13.21%)
    5 / 24 (20.83%)
         occurrences all number
    28
    6
    16
    5
    Arthralgia
         subjects affected / exposed
    18 / 132 (13.64%)
    2 / 39 (5.13%)
    6 / 106 (5.66%)
    3 / 24 (12.50%)
         occurrences all number
    19
    2
    6
    3
    Back pain
         subjects affected / exposed
    6 / 132 (4.55%)
    2 / 39 (5.13%)
    3 / 106 (2.83%)
    0 / 24 (0.00%)
         occurrences all number
    6
    2
    3
    0
    Bone pain
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 39 (0.00%)
    2 / 106 (1.89%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    4
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    8 / 132 (6.06%)
    0 / 39 (0.00%)
    3 / 106 (2.83%)
    0 / 24 (0.00%)
         occurrences all number
    9
    0
    3
    0
    Bronchitis
         subjects affected / exposed
    4 / 132 (3.03%)
    4 / 39 (10.26%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences all number
    4
    4
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 132 (3.03%)
    2 / 39 (5.13%)
    2 / 106 (1.89%)
    0 / 24 (0.00%)
         occurrences all number
    4
    2
    3
    0
    Pharyngitis
         subjects affected / exposed
    3 / 132 (2.27%)
    2 / 39 (5.13%)
    1 / 106 (0.94%)
    0 / 24 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 132 (1.52%)
    1 / 39 (2.56%)
    0 / 106 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    2
    1
    0
    2
    Cellulitis
         subjects affected / exposed
    0 / 132 (0.00%)
    2 / 39 (5.13%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Genital herpes
         subjects affected / exposed
    1 / 132 (0.76%)
    2 / 39 (5.13%)
    0 / 106 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    32 / 132 (24.24%)
    9 / 39 (23.08%)
    27 / 106 (25.47%)
    5 / 24 (20.83%)
         occurrences all number
    32
    9
    28
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2012
    1. Clarified the exclusion criteria for those subjects who required changes in their HIV treatment to comply with the protocol requirements 2. Addition of rilpivirine to allowable HAART regimen
    25 Nov 2013
    The primary endpoint was updated for using the next value carried backwards imputation technique to provide a robust and clinically meaningful analysis of SVR12 for subjects within this study.

    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
    For support, Contact us.
    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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