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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Portal Hypertension; With or Without Liver Decompensation; Cirrhosis; Hepatitis C

Treatments: Drug: RBV; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01687257

GS-US-334-0125

2012-002457-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

SOF+RBV

Experimental group

Description:

Participants will receive SOF+RBV for 48 weeks.

Treatment:

Drug: SOF

Drug: RBV

Observation, then SOF+RBV

Experimental group

Description:

Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.

Treatment:

Drug: SOF

Drug: RBV