Efficacy and Safety of Sofosbuvir-Based Anti-viral Therapies for the Treatment of Recurrent Hepatitis C Post Liver Transplantation: A “Real-Life” Single-Center Experience

Abstract

Introduction: Recent introduction of Interferon free regimens with Direct Acting Antiviral agents have yielded excellent results in clinical trials for the treatment of HCV. However, data in the real world setting in post liver transplant patients is limited and focused primarily on HCV infections with genotype 1. We report the efficacy and safety of various Sofosbuvir-based antiviral therapies for the treatment of recurrent hepatitis C infection with different genotypes in liver transplant recipients. Methods: This is a Retrospective analysis of patients with recurrent HCV infection after liver transplantation treated with Sofosbuvir-based antiviral therapy. Primary endpoint was achievement of sustained virological response 12 weeks after the end of treatment (SVR-12). Results: 80 patients, transplanted between 2003 and 2016, were treated. Mean age was 58.4 years; and 62.5% of patients were male. Treatment combinations included Sofosbuvir (SOF), Simeprevir (SIM), Ribavirin (RBV) and Ledipasvir (LDV). Mean time from LT to treatment was 42.1 months. Duration of therapy was 12 weeks for 43.24% of the patients and 24 weeks for the remainder. Treatment was discontinued on two patients due to severe anemia on the SOB + RBV regimen. 4 patients were lost to follow up. Overall, SVR-12 was achieved in 91.9% of the patients who completed treatment. SVR-12 rates per treatment regimen were - SOF + SIM (97.06% n=37), SOF + RBV (80.95% n=24), SOF + RBV + SIM (100% n=1) and SOF + LDV (94.12% n=17). SVR-12 rates per genotype (GT) were - GT1a (95%), GT1b (88.24%), GT1a/1b (100%), GT2 (85.71%), GT3 (87.5%), GT4 (100%), GT1a/2 (100%) and GT1b/2 (100%).Figure 1Figure 2Figure 3Conclusion: To our knowledge, our study is one of the few studies that have comprehensively studied the safety and efficacy of different Sofosbuvir based treatment regimens for HCV infections in LT recipients with different genotypes in a “real-life” setting. Our findings for GT1 were comparable with the COSMOS clinical trials for non-LT patients. SVR-12 rates were lowest for patients on SOF+RIB regimen (81%) and highest for patients on SOF+SIM (+/-RIB) regimen (97-100%). SVR-12 rates were highest for HCV GT4 (100%) and lowest for GT2 (86%). In conclusion, Sofosbuvir-based anti-viral therapies are safe, effective and well tolerated for the treatment of HCV recurrence post transplantation. In our experience, the SOF + RBV regimen had a higher rate of treatment failure and increased risk of side effects requiring treatment discontinuation.