Ledipasvir and Sofosbuvir +/- Ribavirin in Post-hepatic Transplant Patients Reinfected with Genotype 1 Hepatitis C at University Hospitals Case Medical Center

Abstract

Introduction: Hepatitis C Virus (HCV) is a major cause of orthotropic liver transplants. However, nearly all patients who are viremic at the time of transplant experience HCV re-infection after liver transplant. Newer treatments such as ledipasvir/sofosbuvir have produced sustained virologic response of roughly 96%, in specific patient groups, however only the SOLAR-1 trial has really shown efficacy of ledipasvir/sofosbuvir in post-transplant patients. The purpose of this study is to assess post-transplant HCV patients being treated with ledipasvir/sofosbuvir at a single-center hospital and analyze their progress thus confirming the results of the SOLAR-1 trial in our subset of patients. Methods: Design: Non-randomized retrospective/prospective chart review of patient's receiving ledipasvir/sofosbuvir. Setting: Single Center. # of Patients: 12 patients. Entry Criteria: Post-Liver Transplant Adults with HCV type 1 who are being treated with ledipasvir/sofosbuvir. Primary End Points: Virologic Response at 4 weeks, 12 weeks, and Sustained Virologic Response at 4 weeks, and 12 weeks. Results: Of the twelve patients, three are on a 24-week duration therapy. Their response will be compared to those patients on a 12-week reigmen. All twelve of our patients had undetectable viral loads at 4 weeks after initiating treatment. Two of those patients had stage 4 fibrosis while three others had stage 3 fibrosis. Three patients have completed treatment and have obtained sustained virologic response of at least 4 weeks. One patient after having obtained SVR at 12 weeks developed graft rejection. Notable side effects of sleep disturbances, and fatigue were reported. Though only three patients have completed treatment, SVR4 and SVR12 data will be reported in the rest of our patients as they complete treatment. Conclusion: Our results show that post-transplant HCV patients started on ledipasvir/sofosbuvi have promising responses in regards to drastically decreased viral loads at 4 weeks in treatment. Based on the 3 patients who have completed treatment, we suspect that nearly all of our patient's will obtain SVR at 12 weeks. Even patients with stage 3 or 4 fibrosis are responding well to treatment. It is interesting that one patient developed rejection after completion of treatment and he will be further monitored for HCV recurrence due to increased immunosuppression.Table 1: Patient CharacteristicsTable 2: Results