1. Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant.
- Author
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Pungpapong S, Aqel B, Leise M, Werner KT, Murphy JL, Henry TM, Ryland K, Chervenak AE, Watt KD, Vargas HE, and Keaveny AP
- Subjects
- Aged, Female, Genotype, Hepatitis C genetics, Heterocyclic Compounds, 3-Ring therapeutic use, Humans, Immunosuppression Therapy, Male, Middle Aged, Recurrence, Retrospective Studies, Ribavirin therapeutic use, Simeprevir, Sofosbuvir, Sulfonamides therapeutic use, Treatment Outcome, Uridine Monophosphate analogs & derivatives, Uridine Monophosphate therapeutic use, Antiviral Agents therapeutic use, Hepatitis C drug therapy, Liver Transplantation, Postoperative Complications drug therapy
- Abstract
Unlabelled: Treatment with an all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without ribavirin (RBV) for 12 weeks resulted in high sustained virologic response (SVR) rates along with minimal adverse events in non-liver transplant (LT) patients with hepatitis C virus (HCV) genotype 1 infection. This is the first multicenter report on the efficacy, safety, and tolerability of this regimen in LT recipients. A total of 123 patients (76% male, 74% white, 60% genotype 1a, 30% METAVIR F3-F4, 4% decompensation, 11% cholestatic recurrence, 7% had kidney transplant, and 82% previously failed pegylated interferon/RBV-based regimens) received treatment and were followed for a median of 30 weeks (range 12-53 weeks). The median time from LT to treatment was 32 months (range 2-317 months). Tacrolimus was the primary immunosuppression in 91% of patients. Minimal immunosuppression dose adjustments were required. An SVR 12 weeks after treatment completion (SVR12) was achieved in 90% of patients (95% confidence interval 84%-96%). In patients with genotype 1a infection, the SVR12 rate was significantly lower in those with METAVIR F3-F4 (71%) compared to those with F0-F2 (91%). Half of the patients achieved undetected HCV RNA at treatment week 4, and their SVR12 rate was significantly higher (96%) compared to those with detectable HCV RNA (83%). Treatment was very well tolerated with mild degrees of adverse events, except for one death possibly due to drug-induced lung injury. In the 25 patients who received RBV, 72% developed anemia requiring intervention., Conclusion: An all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without RBV for 12 weeks was very well tolerated and resulted in excellent SVR12 rates in LT recipients with HCV genotype 1 infection., (© 2015 by the American Association for the Study of Liver Diseases.)
- Published
- 2015
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