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

Phase 2

Completed

• Conditions: Recurrent Chronic Hepatitis C Virus; Post Liver Transplant
• Interventions: Drug: Sofosbuvir; Drug: RBV

• Registration Number: NCT01687270
• Lead Sponsor: Gilead Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2014-08
• Status Verified: 2014-12
• Results First Submitted: 2014-12-11
• Results First Submitted QC: 2014-12-11
• Last Update Submitted: 2014-12-11
• Results First Posted: 2014-12-19
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF+RBV	RBV	Participants will receive sofosbuvir+RBV for 24 weeks.
SOF+RBV	Sofosbuvir	Participants will receive sofosbuvir+RBV for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event	Baseline to Week 24
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)	Posttreatment Weeks 4, 24, and 48	SVR4, SVR 24, and SVR 48 were defined as HCV RNA \< LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24	Weeks 12 and 24
HCV RNA and Change From Baseline at Weeks 2, 4, and 8	Baseline; Weeks 2, 4, and 8
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as on-treatment virologic failure or virologic relapse.; * On-treatment virologic failure: HCV RNA \< LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment; * Virologic relapse: HCV RNA \< LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)