Background: Hepatitis C (HCV) is the most common indication for liver transplant in the United States representing more than 40% of all recipients. Availability of oral direct-acting antivirals has provided potential for dramatic improvements in management of recurrent HCV post-liver transplant. More information is needed regarding complications and HCV RNA clearance with these agents.

Aim: Assess sustained virologic response 12 weeks post-treatment (SVR12), rates of biopsy proven acute rejection (BPAR), and tolerability of LS post-liver transplant

Methods: Retrospective study of liver transplant recipients treated with LS+RBV for recurrent HCV. Thirty liver transplant recipients, transplanted between January 2014 and June 2015, were assessed. All patients received either 12 or 24 weeks of treatment. Rates of SVR12 and BPAR were documented. Patients were also assessed for response at end of treatment (EOT), side effects, drug discontinuation, and changes in immunosuppression.

Results: Patients were mostly male (83.3%) with mean age of 58.5 years. Eight patients (27%) were previously treated with interferon-containing therapy. Most patients (97%) had genotype-1A virus. Nine patients (30%) received ribavirin. Median time from transplant to treatment was 146 days (range, 37-421). All patients completed at least 4 weeks of treatment and 77% completed the full 12 or 24 weeks. Virologic reponse: SVR rate was 100% among patients with 12 weeks of post-treatment follow-up (n=11). EOT response was 91.3% (n=23) and was not significantly affected by use of RBV (100% vs. 88%, p=0.56). Tolerability: Mild BPAR occurred in 10% of patients, a rate similar to our overall HCV population. Common adverse effects were headache (20%), anemia (20%), and fatigue (17%); one patient discontinued RBV. No significant change in GFR was seen. No significant changes were made in immunosuppression during treatment. Seven patients are still being treated and 12 are awaiting post-treatment follow-up.

Conclusions: LS is a safe and effective treatment for HCV recurrence post-liver transplant with excellent rates of HCV cure. This regimen is well tolerated with mild side effects and does not appear to increase rates of BPAR. Given these results, LS can be a first-line therapy for genotype-1 HCV recurrence post-liver transplant.

CITATION INFORMATION: Gutierrez K, Scheuermann J, Goldvarg I, Joshi S, Tyson G, Bzowej N, Girgrah N, Anders S, Loss G, Therapondos G. Safety and Efficacy of Ledipasvir/Sofosbuvir (LS) with or without Ribavirin (RBV) for Treatment of Recurrent Hepatitis C Infection Post-Liver Transplant. Am J Transplant. 2016;16 (suppl 3).

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