A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Intervention: ombitasvir/paritaprevir/ritonavir; ribavirin
Intervention description: tablets; tablets
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Compensated Cirrhosis; Hepatitis C; Hepatitis C Genotype 4; Chronic Hepatitis C

Summary:

      The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis
      is to assess the safety and to compare the percentage of participants achieving a 12-week
      sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of
      quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold
      [based on SVR rates for HCV genotype 4-infected participants treated with pegylated
      interferon (pegIFN)/RBV].
    

Eligibility criteria:

        Inclusion Criteria:

        For Arms A, B and C:

        - Participants must meet one of the following:

          -  Treatment-naive: Participant has never received antiviral treatment for hepatitis C
             infection OR

          -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to
             IFN/RBV);

        For Arm D:

        - Participant must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet
        one of the following categories:

          -  Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with
             SOF/pegIFN/RBV or SOF/RBV;

          -  Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course
             SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following
             completion of therapy.

        For Arms A, B, C and D:

          -  Chronic HCV genotype 4 infection with cirrhosis.

          -  Participant has plasma HCV RNA level > 1,000 IU/mL at Screening

        Exclusion Criteria:

          -  Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          -  Current enrollment in another interventional clinical study, previous enrollment in
             this study, or previous use of any protease inhibitor, non-nucleoside polymerase
             inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational or
             commercially available (including previous exposure to paritaprevir or ombitasvir), or
             receipt of any investigational product within 6 weeks prior to study drug
             administration. Prior use of any direct-acting antiviral will not be allowed, except
             for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir
             with pegIFN/RBV or SOF with RBV is required.

          -  Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of liver decompensation including ascites, variceal bleeding, or hepatic
             encephalopathy.

          -  Confirmed presence of hepatocellular carcinoma.

          -  Any cause of liver disease other than chronic HCV infection.

          -  Abnormal laboratory tests.