Objectives:

Evaluate outcomes of Ledipasvir-Sofosbuvir based hepatitis C therapy in liver transplant patients at a single center.

Methods:

All post-liver transplant patients started on Ledipasvir-Sofosbuvir therapy between January 1 and October 1 2015 were evaluated for treatment response using HCV RNA levels at initiation of treatment, 4 weeks, 12 weeks, and end of treatment. Sustained viral response (SVR) was evaluated at weeks 4 (SVR4) and 12 (SVR12) post-treatment. Peak total bilirubin, HCV genotype, initial laboratory parameters, and hemoglobin nadir were collected.

Results:

85 patients started treatment, 29 reached the 12 week post-treatment timepoint. Treatment started an average of 4.5 years post-transplant (range 1 mo to 11 yrs). 23 were male, mean age was 62 years (49-72), and average BMI was 28.2 (19.7-38.9). 62% of the patients were white and 34% were African American. 17 (59%) patients had genotype 1a, 9 (31%) patients had genotype 1b. Four patients (14%) had Ishak score of 4 or greater. 19 (66%) patients were treated for 12 weeks using Ledipasvir-Sofosbuvir with ribavirin, 10 (34%) were treated for 24 weeks using only Ledipasvir-Sofosbuvir. Mean ribavirin starting dose was 800 mg/daily (range 200-1200 mg).

28/29 patients (96%) achieved SVR12. The single failure had HIV co-infection, Ishak score of 6, previously failed sofosbuvir/ribavirin therapy, was on PPI, and developed rejection while on treatment. This was the only rejection episode among those who completed therapy. Average hemoglobin drop with ribavirin used was 2.58, compared to 0.96 without ribavirin. Five of 19 patients with ribavirin (26%) required ribavirin dose reduction.

Three patients had pre-existing hyperbilirubinemia (total bilirubin ≥2.5), none of whom experienced increased bilirubin levels on treatment. Three patients had new onset hyperbilirubinemia, one did not resolve by end of treatment.

Discussion:

Combination therapy of Ledipasvir-Sofosbuvir seems to be well tolerated in our post-transplant population. Twelve weeks of treatment seems to be adequate when using ribavirin. We saw only one episode of rejection and five instances of ribavirin dose reduction, with no treatment discontinuation. This regimen was 96% effective at achieving SVR12 in our experience.

CITATION INFORMATION: Weick A, Sadiq O, Jafri S.-M, Moonka D. Initial Experience with Ledipasvir-Sofosbuvir Based Therapy for Recurrent Hepatitis C After Liver Transplantation. Am J Transplant. 2016;16 (suppl 3).

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