Background/Aims: Controlled trials of direct acting antiviral therapy for Hepatitis C Virus (HCV) show impressive sustained virologic response (SVR) rates, but post-transplant data of sofosbuvir plus ledipasvir (SOF/LED) are lacking. Aim: To study the characteristics and outcomes in a large single-center post-transplant cohort receiving SOF/LED for HCV. Methods: All post-transplant patients with genotype (GT) 1, 4, or 6 HCV who began SOF/LED at our center from 10/2014 to 8/2015 were identified. Charts were reviewed for demographic and clinical variables and treatment response. SVR rates at 12 weeks after therapy (SVR12) were compared between subcohorts. Predictors of SVR12 were evaluated with logistic regression. Results: 77 post-transplant patients began SOF/LED during the study period. The cohort was 74% male, 66% white, 29% black, 77% GT 1a, 13% GT 1b, 3% GT 4, 1% GT 6, and 7% cirrhotic. Mean (SD) age was 60.9 (6.7). Calcineurin inhibitor (CNI) therapy was used in 95% of the cohort and rapamycin without CNI in 5%. 5 patients were treated with a creatinine (Cr) greater than 2.0 (GFR range 21-35). Treatment endpoints have been reached by 59 patients, and 56 (95%) achieved SVR12. The SVR12 rate was 95% for non-cirrhotics and 100% for cirrhotics (p=1.000). Of patients with a negative week 8 viral load (VL), 98% achieved SVR12 vs 50.0% of those who had a positive week 8 VL (p=0.072). Median (IQR) Cr was 1.1 (1.0-1.3) in patients who achieved SVR12 vs 2.0 (1.3-3.0) in those who did not (p=0.014). In univariate logistic regression, negative viral load at week 8 (OR 52.00, 95% CI 1.73->99.999, p=0.023), serum Cr (OR 0.06, 95%CI 0.01-0.60, p=0.017), serum Cr ≥ 1.75 mg/dL (OR 0.05, 95%CI 0.00-0.64, p=0.022), and GT 1 vs 4 (OR 27.00, 95%CI 1.20-605.62, p=0.038) were significant predictors of SVR12. In a multivariable regression model including Cr ≥ 1.75mg/dL and GT 1 vs 4, GT was no longer a significant predictor (p=0.151) while Cr ≥ 1.75 trended closely to significance (OR 0.07, 95%CI 0.00-1.00, p=0.050). Conclusion: In a large single-center experience of HCV therapy in post-transplant patients, SOF/LED was very effective with an SVR12 rate of 95%. In multivariable logistic regression including GT 1 vs 4 and Cr ≥ 1.75, Cr ≥ 1.75 trended toward significance. Given the few SVR12 failures, this result requires further investigation.

CITATION INFORMATION: Wedd J, Ford R, Norvell J, Parekh S, Cheng N, Young N, Patel A, Maheshwari R, Vora R, Mgbemena O, Spivey J, Pillai A. Large Single-Center Experience of Sofosbuvir and Ledipasvir Therapy for the Treatment of Post-Liver Transplant Patients with Hepatitis C Virus. Am J Transplant. 2016;16 (suppl 3).

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