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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Cirrhosis Portal Hypertension With or Without Liver Decompensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF+RBV

Participants will receive SOF+RBV for 48 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Observation, then SOF+RBV

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

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Interventions

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SOF

SOF 400 mg tablet administered orally once daily

Intervention Type DRUG

RBV

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Intervention Type DRUG

Other Intervention Names

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Sovaldi® GS-7977

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No