Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL

• Individuals with cirrhosis with Child-Pugh score < 10

• Esophageal or gastric varices on endoscopy within 6 months prior to or at screening

• Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg

• Body mass index (BMI) ≥ 18 kg/m^2

• Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

• Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance

• HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)

• Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening

• Refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening

• Active variceal bleeding within 6 months of screening

• Expected survival of < 1 year

• History of hepatorenal, or hepatopulmonary syndrome.

• Evidence of renal impairment (CrCl < 50 mL/min)

• History of major organ transplantation, including liver transplant.