A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus; HCV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493; ABT-530
Intervention description: Tablet; Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HCV GT4; Hepatitis C virus; HCV GT1; HCV; Compensated Cirrhosis; HCV GT6; Hepatitis C Genotype 4 (GT 4); Hepatitis C Genotype 1 (GT1); RBV; Cirrhotic; Hepatitis C; Interferon (IFN) Free; IFN free; HCV GT5; Chronic Hepatitis C; Ribavirin; Child Pugh A; Hepatitis C Genotype 5 (GT 5); Hepatitis C Genotype 6 (GT 6); ABT-493; ABT-530; glecaprevir; pibrentasvir

Summary:

      The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the
      efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and
      without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1
      (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated
      cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially
      planned in the protocol, it was not administered in any of the study arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between 18 and 70 years of age, inclusive, at time of screening

          2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and
             2) or GT4, GT5, or GT6 (Study Part 2) infection

          3. Chronic HCV infection defined as one of the following:

               -  Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before
                  screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or

               -  Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy
                  consistent with chronic HCV infection (or a liver biopsy performed prior to
                  enrollment with evidence of chronic HCV infection)

          4. Participant had to meet one of the following criteria:

               -  Treatment-naïve: participant had never received treatment for HCV infection

               -  Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin
                  (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or
                  prior relapse) (for Study Part 2)

          5. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study
             Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only),
             per local standard

        Exclusion Criteria:

          1. History of severe, life-threatening or other significant sensitivity to any drug

          2. Female who is pregnant, planning to become pregnant during the study or breastfeeding;
             or male whose partner is pregnant or planning to become pregnant during the study

          3. 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

          4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab)

          5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection
             with more than one HCV genotype

          6. Any cause of liver disease other than chronic HCV infection

          7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or
             unquantifiable or undetectable HCV RNA at screening

          8. Previous use of an HCV direct-acting antiviral agent (DAA)

          9. Consideration by the investigator, for any reason, that the participant was an
             unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects
             only)

         10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past
             clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical
             history of liver decompensation, including ascites (noted on physical exam), bleeding
             varices, use of beta-blockers for portal hypertension or ascites, or hepatic
             encephalopathy