Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation.
Charlton M, Gane E, et al.Gastroenterology 2015; 148(1): 108-117.
Aims
To evaluate the efficacy and safety of 24 weeks of sofosbuvir plus ribavirin in treating post-transplantation hepatitis C virus (HCV) infection.
Interventions
All participants received sofosbuvir 400 mg and ribavirin 200–1200 mg orally every day for 24 weeks.
Participants
40 primary or secondary liver, or combined liver/kidney transplant recipients aged ≥18 years with chronic HCV.
Outcomes
The primary measured outcome was sustained virologic response 12 weeks after treatment (SVR12). HCV RNA plasma concentration, virologic failure, viral resistance, adverse events, deaths, graft losses and episodes of rejection were also measured.
Follow-up
48 weeks
CET Conclusions
This small, non-comparative pilot study investigates the safety and efficacy of an interferon-alfa free regimen of sofosbuvir and ribavirin in patients with well compensated recurrent hepatitis C following liver transplant. In the 40 low-risk (Child-Pugh < 7, MELD <17) patients recruited, sustained virological response was seen in 70% with a low incidence of adverse events. Sofosbuvir may provide a safe and effective alternative to existing strategies – larger, comparative randomised studies are required to confirm the findings of this pilot study.
Quality notes
Quality Assessment not appropriate
Trial registration
EudraCT - 2012-002417-19; ClinicalTrials.gov -NCT01687270