A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r; ABT-267; pegylated interferon alpha-2a (pegIFN); Ribavirin (RBV)
Intervention description: ABT-450 (tablets) dosed with ritonavir (capsules or tablets); ABT-267 (tablets); pegIFN alpha-2a (syringe); Ribavirin (tablets)
Intervention MeSH terms: Interferons; Ritonavir; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 71 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus (HCV); Hepatitis C Genotype 1; Chronic Hepatitis C; HCV

Summary:

      A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
      combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
      did not respond to treatment in a previous AbbVie/Abbott combination study.
    

Eligibility criteria:

        Inclusion Criteria:

        Main Inclusion: To be enrolled in this protocol, subjects must meet all of the following
        inclusion criteria:

          -  Subject must have experienced virologic failure as defined in a previous AbbVie/Abbott
             direct-acting antiviral (DAA) combination trial.

          -  Female subjects of childbearing potential must be willing to use two effective forms
             of birth control (not including oral contraceptives or contraceptives containing
             ethinyl estradiol) while receiving study drug and for 7 months (or per local ribavirin
             label) after stopping study drug.

          -  Males must be surgically sterile or have male partners only or agree to practice two
             effective forms of birth control throughout the course of the study, starting with
             Study Day 1 and for 7 months (or per local ribavirin label) after the last dose of
             study drug, unless abstinent from sexual intercourse.

          -  Subject must be considered an appropriate candidate for peginterferon (pegIFN)
             alpha-2a, ribavirin (RBV), ABT-450/ritonavir (r) and ABT-267 therapy in the opinion of
             the investigator.

          -  Subject is infected with hepatitis C virus (HCV) genotype 1 at screening.

        Subjects diagnosed with cirrhosis must also meet the following criteria:

          -  Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening.

          -  Absence of hepatocellular carcinoma based on a negative ultrasound, computed
             tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months
             prior to Screening or during the Screening period.

        Exclusion Criteria:

          -  In subjects with a prior null or partial response to pegIFN/RBV treatment at any time
             prior to pre-screening for this study or any prior failure with pegIFN/RBV plus
             telaprevir, the presence of variants relative to the appropriate prototypic reference
             sequence (H77 for 1a or Con1 for 1b) at any of the following positions: NS3 155, 156,
             or 168; or NS5A 28, 29, 30, 31, 32, 58, or 93.

          -  Females who are pregnant or plan to become pregnant, or breast-feeding, or males whose
             partners are pregnant or planning to become pregnant within 7 months (or per local RBV
             label) after their last dose of RBV.

          -  Use of known strong inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's
             Wort) of Cytochrome P450 3A (CYP3A) within 2 weeks prior to study drug administration.

          -  Use of any medications contraindicated for use with pegIFN alpha-2a, RBV or ritonavir
             within 2 weeks prior to study drug administration. Prior to entering the study,
             subjects must be able to safely discontinue the contraindicated medication or switch
             to an acceptable alternative under supervision of the investigator.

          -  Discontinuation of antiviral therapy due to intolerance or a DAA- or RBV-associated
             adverse event in a previous AbbVie/Abbott DAA combination study.

        Subjects with compensated cirrhosis must also not meet the following criteria:

          -  Any current or past clinical evidence of Child-Pugh B or C Classification or clinical
             history of liver decompensation such as ascites (noted on physical exam), variceal
             bleeding or hepatic encephalopathy.

          -  Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.

          -  A screening ultrasound suspicious for hepatocellular carcinoma and confirmed with a
             subsequent CT scan or MRI during the screening period.