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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

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