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

Conditions: Hepatitis C; Human Immunodeficiency Virus

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

Keywords: hepatitis c chronic hcv hiv human immunodeficiency virus co-infected