Phase 2
Completed N=40
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
Recurrent Chronic Hepatitis C Virus · Post Liver Transplant
Source: ClinicalTrials.gov NCT01687270 ↗
Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 70.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
70.0 | — |
| PRIMARY Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event |
5.0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) |
72.5; 70.0; 70.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 |
100.00; 100.00 | — |
| SECONDARY HCV RNA and Change From Baseline at Weeks 2, 4, and 8 |
1.65; -4.89; 1.38; -5.17; 1.38; -5.17 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 30.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01687270). 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. Informational only — not medical advice.