Phase 2
N=50
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
Hepatitis C · Cirrhosis · Portal Hypertension · With or Without Liver Decompensation
Bottom Line
View on ClinicalTrials.gov: NCT01687257 ↗Enrolled (actual)
50
Serious AEs
18.3%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 72.0; 0; 71.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SOF (Drug); RBV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
72.0; 0; 71.4 | — |
| SECONDARY Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) |
72.0; 76.2; 68.0; 71.4; 94.1; 100.0 | — |
| SECONDARY Percentage of Participants Experiencing On-Treatment Virologic Failure |
8.0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
17.4; 23.8 | — |
| SECONDARY Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment |
-1.6; 0.5; -0.4; -1.0 | — |
| SECONDARY Change From Baseline in Child-Pugh-Turcotte (CPT) Score |
65.2; 10.0; 38.9; 53.7; 26.1; 75.0 | — |
| SECONDARY Change From Baseline in Model for End Stage Liver Disease (MELD) Scores |
33.3; 20.0; 5.9; 22.0; 54.2; 75.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL
- Individuals with cirrhosis with Child-Pugh score 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.
Data sourced from ClinicalTrials.gov (NCT01687257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.