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

Gilead Sciences40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Chronic Hepatitis C Virus Post Liver Transplant

Interventions

SofosbuvirDRUG

Sofosbuvir 400 mg tablet administered orally once daily

RBVDRUG

Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

San Francisco, California, United States

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Kansas City, Kansas, United States

Unnamed facility

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

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.

Time frame: Posttreatment Week 12

Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event

Time frame: Baseline to Week 24

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)

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.

Time frame: Posttreatment Weeks 4, 24, and 48

Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24

Time frame: Weeks 12 and 24

HCV RNA and Change From Baseline at Weeks 2, 4, and 8

Time frame: Baseline; Weeks 2, 4, and 8

Percentage of Participants With Virologic Failure

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)

Time frame: Up to Posttreatment Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.