Background: Reports on efficacy, safety, and tolerability of sofobuvir-based antiviral regimens in liver transplant recipients with recurrent hepatitis C are limited. Methods: We performed a single-center prospective cohort study including all liver transplant recipients with recurrent hepatitis C undergoing antiviral therapy with sofosbuvir-based regimens. Treatment-related data and efficacy were evaluated in all patients who initiated therapy. Sustained virologic response (SVR) was defined by negative serum HCV RNA at 4 or 12 weeks following completion of therapy. Results: A total of 27 patients initiated a course of antiviral therapy. Patient characteristics included median age 59 (range 36-59), 85% male, median BMI 28.9 (range 21.1-40.9), 67% Caucasian, and 81% genotype 1. Most patients (67%) were treatment experienced, 22% had cirrhosis, 26% had ≥stage 3 chronic kidney disease, and 2 patients had end-stage renal disease. To date, 22 have completed at least 12 weeks of therapy and 20 patients completed their course. All patients cleared HCV RNA within 12 weeks. In patients with genotype 1 infection, 73% received combination sofosbuvir/simeprevir. In 14 patients with available data, overall SVR was 64%, with SVR 67% in patients receiving sofosbuvir/simeprevir. In patients with detectable HCV RNA >15 IU/mL at week 4, SVR was low at 40% vs. 78%. Anemia was present in 35% and occurred almost exclusively in patients receiving ribavirin (88%, p<0.001) Anemia led to ribavirin dose reductions in 75% and erythropoietin stimulating agent use in 75%. Treatment was well-tolerated and characterized by a high level of compliance with no early discontinuations, acute cellular rejection, or clinical decompensation. Requirement of dose changes to immunosuppression was infrequent (7%). Only one patient receiving simeprevir developed significant hyperbilirubinemia (peak level 10.8 mg/dL) which normalized after discontinuation. Conclusions: Sofosbuvir-based antiviral regimens are safe and effective in liver transplant recipients with recurrent hepatitis C. Inability to clear virus within 4 weeks may be predictive of poor response in this population. Although anemia was frequent, no treatment-discontinuations or severe adverse events were reported, including acute cellular rejection or on-treatment clinical decompensation.

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