Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Post Liver Transplant

Recurrent Chronic Hepatitis C Virus

Treatments

Drug: Sofosbuvir

Drug: RBV

Study type

Interventional

Funder types

Industry

Identifiers

NCT01687270

GS-US-334-0126

2012-002417-19 (EudraCT Number)

Details and patient eligibility

About

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
HCV RNA ≥ 10,000 IU/mL at screening
Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
Liver transplant ≥ 6 months and ≤ 12 years prior to screening
Naive to all nucleotide/nucleoside treatments for chronic HCV infection

Exclusion criteria

Multiorgan transplant that includes heart or lung recipient
Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
Infection with hepatitis B virus (HBV) or HIV at screening
Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis