A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
Condition: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Hepatitis, Chronic; Immunologic Deficiency Syndromes; Fibrosis
Intervention: ABT-493 coformulated with ABT-530
Intervention description: Tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HCV Genotype 3; Non-cirrhotic; HCV Genotype 1; HCV Genotype 6; Human Immunodeficiency Virus (HIV) Infection; HCV Genotype 5; HCV Treatment Naive; HCV Genotype 4; HCV Treatment Experienced; HCV Genotype 2; Hepatitis C Virus (HCV) Infection; Compensated Cirrhosis

Summary:

      The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults
      with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1
      co-infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, at least 18 years of age at time of Screening.

          2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-,
             3-, 4-, 5-, or 6-infection.

          3. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA)
             viral load greater than or equal to 1000 IU/mL at Screening visit.

          4. Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose
             of any approved or investigational anti-HCV medication) or HCV treatment-experienced
             (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without
             ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects
             must be HCV treatment-naïve. Previous HCV treatment must have been completed greater
             than or equal to 2 months prior to Screening.

          5. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or
             equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or
             Subjects on a stable ART regimen must have

               -  CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or
                  equal to 14%) at Screening; and

               -  Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at
                  least once during the 12 months prior to Screening.

        Exclusion Criteria:

          1. 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.

          2. Positive test result at Screening for hepatitis B surface antigen (HBsAg).

          3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.

          4. Receipt of any other investigational or commercially available direct acting anti-HCV
             agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir,
             grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).

          5. Consideration by the investigator, for any reason, that the subject is an unsuitable
             candidate to receive ABT-493/ABT-530.