Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Condition: Hepatitis C; Human Immunodeficiency Virus
MeSH terms: Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Intervention: SOF; RBV
Intervention description: Sofosbuvir (SOF) 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: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; Chronic; HCV; HIV; Human Immunodeficiency Virus; Co-Infected

Summary:

      This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)
      plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are
      coinfected with HIV-1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection

          -  HCV RNA > 1 x 10^4 IU/mL at screening

          -  Infection with HCV genotype 1, 2 or 3 as determined at screening

          -  HIV-1 infection confirmed with positive ELISA or Western blot at screening

          -  Medical records must be sufficient to be categorized on interferon (IFN) eligibility
             or prior treatment history with PEG/RBV.

          -  Confirmation of chronic HCV infection

          -  Ability to determine presence/absence of cirrhosis.

          -  HIV antiretroviral therapy (ARV) criteria of one of the following:

               -  ARV untreated with a CD4 T-cell count > 500 cells/mm^3

               -  On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4
                  T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA
                  level for ≥ 8 weeks preceding the screening visit

          -  Approved HIV antiretroviral medications based on drug interaction studies

          -  Not been treated with any investigational drug or device within 30 days of the
             screening visit

          -  Females if confirmed that she is not pregnant or nursing of non-childbearing potential
             or of childbearing potential but has a negative serum pregnancy test at screening and
             agrees to use protocol approved method of birth control from screening through 6
             months after the last dose of RBV

          -  Males who agree to consistently and correctly use a condom while their female partner
             agrees to use protocol approved method of birth control from screening through 7
             months after the last dose of RBV

          -  Must be of generally good health as determined by the investigator.

          -  Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients
             only, to exclude hepatocellular carcinoma (HCC)

        Exclusion Criteria:

          -  Non-genotype 1/2/3 or mixed genotype at screening

          -  Genotype 1 with prior treatment for HCV

          -  Poor control with ARV regimen

          -  Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein
             (NS)5B polymerase

          -  Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1
             antitrypsin deficiency, cholangitis)

          -  A new AIDS-defining condition diagnosed within 30 days prior to screening

          -  Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics,
             antivirals or antifungals within 30 days prior to baseline

          -  Infection with hepatitis B virus (HBV)

          -  Contraindication to RBV therapy

          -  Chronic use of systemically administered immunosuppressive agents (eg, prednisone
             equivalent > 10 mg/day)

          -  History of solid organ transplantation or malignancy diagnosed or treated within 5
             years

          -  Current or prior history of clinical hepatic decompensation or other significant
             gastrointestinal disorder