@article{62ebad75397c4e7a871dab5838a12ac2,
title = "Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation",
abstract = "BACKGROUND & AIMS: Interferon alfa-based regimens used to treat recurrent hepatitis C virus (HCV) infection after liver transplantation are poorly tolerated, associated with generally modest efficacy, and can interact with immunosuppressive agents. We evaluated the efficacy and safety of an interferon-free regimen of the nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 24 weeks in treating post-transplantation HCV infection. METHODS: In a prospective, multicenter, open-label pilot study, we enrolled patients with compensated recurrent HCV infection of any genotype after a primary or secondary liver transplantation. All patients received 24 weeks of sofosbuvir 400 mg daily and ribavirin starting at 400 mg daily, which was adjusted according to creatinine clearance and hemoglobin values. The primary end point was sustained virologic response 12 weeks after treatment. RESULTS: Of the 40 patients enrolled and treated, 78% were male, 85% were white, 83% had HCV genotype 1, 40% had cirrhosis (based on biopsy), and 88% had been previously treated with interferon. Sustained virologic response 12 weeks after treatment was achieved by 28 of 40 patients (70%; 90% confidence interval: 56%-82%). Relapse accounted for all cases of virologic failure. No patients had detectable viral resistance during or after treatment. The most common adverse events were fatigue (30%), diarrhea (28%), and headache (25%). In addition, 20% of the subjects experienced anemia. Two patients discontinued study treatment because of adverse events, which were considered unrelated to study treatment. No deaths, graft losses, or episodes of rejection occurred. No interactions with any concomitant immunosuppressive agents were reported. CONCLUSIONS: Sofosbuvir and ribavirin combination therapy for 24 weeks is an effective and well-tolerated interferon-free treatment for post-transplantation HCV infection.",
keywords = "Antiviral Agent, Clinical Trial, DAA, NS5B Polymerase Inhibitor",
author = "Michael Charlton and Edward Gane and Manns, {Michael P.} and Brown, {Robert S.} and Curry, {Michael P.} and Kwo, {Paul Y.} and Fontana, {Robert J.} and Richard Gilroy and Lewis Teperman and Muir, {Andrew J.} and McHutchison, {John G.} and Symonds, {William T.} and Diana Brainard and Brian Kirby and Hadas Dvory-Sobol and Jill Denning and Sarah Arterburn and Didier Samuel and Xavier Forns and Terrault, {Norah A.}",
note = "Funding Information: Funding This work was supported by Gilead Sciences, Inc . Funding Information: Conflicts of interest These authors disclose the following: Michael Charlton has received grant and research support from Gilead, Merck, Janssen, and Novartis and is a consultant for Gilead, Janssen, AbbVie, BMS, and Sanofi-Aventis. Edward Gane is on the advisory boards of Gilead, Novartis, Merck, Achillion, Idenix, and AbbVie and is a speaker for Gilead, Achillion, Novartis, and AbbVie. Robert S. Brown Jr has received grant and research support from Gilead and is a consultant for Gilead. Michael P. Curry has received grant and research support from Gilead, Salix, Merck, and MassBiologics, is on the advisory board of Gilead, and is a consultant for Gilead. Paul Y. Kwo has received grant and research support from AbbVie, BMS, Conatus, Janssen, Merck, Roche, and Vertex and is a consultant for AbbVie, BMS, Boehringer Ingelheim, GSK, Janssen, Merck, Novartis, and Vertex. Robert J. Fontana has received grant and research support from Vertex, Gilead, BMS, and Janssen. Richard Gilroy has been a speaker for Gilead, NPS, and Salix. Andrew J. Muir has received grant and research support from AbbVie, Achillion, BMS, Gilead, Merck, Roche, Santarus, and Vertex and is on the advisory boards of AbbVie, BMS, Gilead, and Merck. Didier Samuel is a consultant for Astellas, BMS, Gilead, Janssen-Cilag, LFB, MSD, Novartis, Roche, and Biotest. Xavier Forns has received grant and research support from Merck, Roche and is a consultant for AbbVie, Gilead, and Janssen. Norah A. Terrault has received grant and research support from Gilead and is on the advisory board at Gilead. All other authors are current employees of Gilead Sciences. Publisher Copyright: {\textcopyright} 2015 AGA Institute.",
year = "2015",
month = jan,
day = "1",
doi = "10.1053/j.gastro.2014.10.001",
language = "English (US)",
volume = "148",
pages = "108--117",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "1",
}