A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis; Hepatitis, Chronic; Immunologic Deficiency Syndromes
Intervention: Placebo; Glecaprevir/Pibrentasvir
Intervention description: Matching placebo tablet for oral administration; Coformulated tablet for oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 546.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Virus (HCV); Genotype 1 to 6; Asian; non-cirrhotic; Human Immunodeficiency Virus; co-infection; Treatment-naïve; Treatment-experienced; interferon

Summary:

      This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir
      (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to
      GT6-infected Asian participants with or without human immunodeficiency virus (HIV)
      co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with
      or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be of Asian descent

          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3,
             4, 5 or 6 infection.

          -  Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU/
             mL at Screening Visit.

          -  Chronic HCV infection defined as one of the following:

               -  Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or

               -  A liver biopsy consistent with chronic HCV infection

          -  HCV treatment-naïve to any approved or investigational HCV treatment or
             treatment-experienced with interferon (IFN) (alpha, beta or pegylated
             interferon[pegIFN] with or without ribavirin, OR sofosbuvir with RBV with or without
             IFN. Previous treatment must have been completed ≥ 8 weeks prior to screening.

          -  Participant must be documented as non-cirrhotic.

          -  Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection
             must also meet the following criteria:

               -  Positive test result for human immunodeficiency virus antibody (HIV Ab) at
                  Screening

               -  Naïve to treatment with any antiretroviral therapy (ART) with a cluster of
                  differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+
                  percent ≥ 29%)

               -  On a stable, qualifying HIV-1 ART regimen with CD4+ count ≥ 200 cells/mm³ (or
                  CD4+ % ≥ 14%) at Screening and plasma HIV-1 RNA below lower limit of
                  quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at
                  Screening and at least once during the 12 months prior to Screening.

        Exclusion Criteria:

          -  Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result
             for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.

          -  Any cause of liver disease other than chronic HCV-infection.

          -  HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype

          -  Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection

          -  Chronic human immunodeficiency virus, type 2 (HIV-2) infection

        Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:

          -  For participants on stable ART, taking anti-retroviral agent(s) other than those
             permitted

          -  Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic
             infection within 12 months of Screening or prophylaxis for an AIDS-associated
             opportunistic infection within 6 months of screening

          -  Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.