A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

Date de début de l'étude : 1 juillet 2012

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