A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Virus; Hepatitis C Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530; OBV/PTV/r
Intervention description: Co-formulated tablet; Co-formulated tablet
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Compensated cirrhosis; Non-cirrhotic; Renal impairment; Hepatitis C virus (HCV); Hepatitis C; Chronic Hepatitis C; Hepatitis C Genotype 1; Hepatitis C Genotype 2; Hepatitis C Genotype 3; Hepatitis C Genotype 4; Hepatitis C Genotype 5; Hepatitis C Genotype 6; DAA-experienced

Summary:

      The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of
      ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV
      direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese
      adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females were postmenopausal for at least 2 years; surgically sterile or had a
             vasectomized partner; or, if of childbearing potential and sexually active with a male
             partner, were currently using at least 1 effective method of birth control at the time
             of Screening and agreed to practice 1 effective method of birth control from Screening
             through 30 days after stopping study drug. Sexually active males were surgically
             sterile or, if sexually active with a female partner of childbearing potential, agreed
             to practice 1 effective form of birth control from Screening through 30 days after
             stopping study drug.

          -  Screening central laboratory result indicated HCV single genotype infection for the
             appropriate treatment arm, without co-infection of any other genotype.

          -  Chronic HCV infection is defined as one of the following:

               -  Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before
                  Screening.

               -  A liver biopsy consistent with chronic HCV infection.

          -  Agreed to voluntarily sign and date an informed consent form, approved by an
             Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the
             initiation of any screening or study specific procedures.

          -  Participants who were able to understand and adhere to the study visit schedule and
             all other protocol requirements.

          -  Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed
             tomography (CT) scan or magnetic resonance imaging (MRI).

        Exclusion Criteria:

          -  Females who were pregnant or planned to become pregnant, or breastfeeding or males
             whose partner was pregnant or planning to become pregnant during the study.

          -  Participants co-infected with hepatitis B virus or human immunodeficiency virus.

          -  Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if
             known), whichever was longer, prior to the first dose of any study drug.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Any cause of liver disease other than chronic HCV infection.

          -  Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of decompensated liver disease.

          -  Consideration by the investigator, for any reason, that the participant is an
             unsuitable candidate to receive ABT-493/ABT-530.