A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/ritonavir, ABT-267
Intervention description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Intervention MeSH terms: Ritonavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Japanese; Hepatitis C; Genotype 2; Genotype 1b; paritaprevir; ombitasvir; ritonavir; VIEKIRAX Combination Tablets

Summary:

      This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)
      or genotype 2 (HCV GT2) infection who were previous treated with pegylated
      interferon/ribavirin (pegIFN/RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA
             level greater than 10,000 IU/mL at screening) previously treated with pegylated
             interferon/ribavirin (pegIFN/RBV).

          -  Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null
             responder or partial responder, OR

          -  Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null
             responder, partial responder, or relapser (Null responder: received at least 10 weeks
             of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction
             in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV
             for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12,
             but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [<
             LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV
             for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was
             detectable within 24 weeks of treatment follow-up).

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive screen for drugs or alcohol.

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Previous use of any investigational or commercially available anti-Hepatitis C virus
             agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.