A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Condition: Chronic Hepatitis C; Human Immunodeficiency Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Intervention: Sofosbuvir; RBV
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV
      infection who are co-infected with HIV-1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection

          -  HCV RNA > 10,000 IU/mL at screening

          -  HCV treatment history:

               -  Treatment-naive for HCV genotypes 1, 2, 3, or 4, or

               -  Treatment-experienced for HCV genotypes 2 or 3

          -  HIV antiretroviral (ARV) criteria:

               -  On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8
                  weeks prior to screening, or

               -  ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500
                  cells/mm^3

          -  Presence or absence of cirrhosis; a liver biopsy may be required

          -  Healthy according to medical history and physical examination with the exception of
             HCV and HIV diagnosis

          -  Agree to use two forms of highly effective contraception for the duration of the study
             and 6 months after the last dose of study medication

        Exclusion Criteria:

          -  HCV genotype 1 or 4 with previous HCV treatment

          -  Poor control with HIV ARV regimen requiring a possible dose modification of therapy
             within 4 weeks of study medication dosing

          -  A new AIDS-defining condition diagnosed within 30 days prior to screening

          -  Prior use of any other inhibitor of the HCV NS5B polymerase

          -  History of any other clinically significant chronic liver disease

          -  Evidence of or history of decompensated liver disease

          -  Chronic hepatitis B virus (HBV) infection

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of immunosuppressive agents or immunomodulatory agents

          -  Clinically relevant drug or alcohol abuse within 12 months of screening

          -  History or current evidence of any condition, therapy, laboratory abnormality or other
             circumstance that might confound the results of the study, or interfere with the
             participant's participation for the full duration of the study or not be in the best
             interest of the participant in the opinion of the investigator