A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 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; sofosbuvir (SOF); ribavirin (RBV)
Intervention description: Co-formulated tablet; Tablet; Capsule
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Non-cirrhotic; Hepatitis C Genotype 2; Chronic Hepatitis C Virus; Hepatitis C

Summary:

      The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530
      in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2
      (GT2) infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females were postmenopausal for at least 2 years prior to screening; 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 indicating HCV GT-2 infection without co-infection
             of any other genotype.

          -  Participant has positive anti-HCV antibody (Ab) and plasma HCV RNA viral load greater
             than or equal to 1000 IU/mL at Screening Visit.

          -  Chronic HCV infection defined as one of the following:

               -  Positive for anti-HCV Ab and/or HCV RNA at least 6 months before Screening; or

               -  A liver biopsy consistent with chronic HCV infection.

          -  Participant must be HCV treatment-naïve (i.e., patient has not received a single dose
             of any approved or investigational DAA) and non-cirrhotic. Prior HCV treatment using
             IFNs with or without ribavirin is acceptable. Previous HCV Interferon (IFN) based
             treatment must have been completed greater than or equal to 2 months prior to
             screening.

        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.

          -  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.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti
             human immunodeficiency virus antibody (HIV Ab).

          -  Requirement for and inability to safely discontinue contraindicated medications or
             supplements at least 2 weeks or 10 half-lives (whichever is longer) prior to the first
             dose of any study drug.

          -  Clinically significant abnormalities, other than HCV-infection, based upon the results
             of a medical history, physical examination, vital signs, laboratory profile, and a
             12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for
             this study in the opinion of the investigator, including, but not limited to:

               -  Uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin A1C) level
                  > 8.5% at the Screening Visit.

               -  Active or suspected malignancy or history of malignancy (other than basal cell
                  skin cancer or cervical carcinoma in situ) in the past 5 years, or any history of
                  hepatocellular carcinoma (HCC).

               -  Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic,
                  psychiatric, or other medical disease or disorder, which is unrelated to the
                  existing HCV infection.

          -  Any cause of liver disease other than chronic HCV-infection, including but not limited
             to the following:

               -  Hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune
                  hepatitis, alcoholic liver disease, or steatohepatitis considered to be the
                  primary cause of the liver disease rather than concomitant/incidental with HCV
                  infection.