On
average patients completed 11 weeks of therapy at the time of data analysis. None of the pts died while on therapy, one patient (5%) on ribavirin discontinued all treatment due to AKI and severe anemia and one patient who was listed PXD101 purchase for chronic rejection received re-transplantation while on therapy and his HCV RNA remained negative after transplant. In the SOF+SMV group median (IQR) creatinine levels were significantly worse at week 8 of therapy compared to BL(1.00 (0.95-1.5) to 1.7 (1.05, 1.95)), p=0.026.There was a trend towards an increase in tacrolimus level in this group (4.5 (3.9, 4.85) at baseline to 5.5 (4.1 to 6.45) on week 4), p = 0.066. There was no decline in hemoglobin level in the SOF + SMV group at weeks 4 or 8. In the SOF + RBV group, there was no effect on creatinine or TAC levels. All patients had undetectable HCV RNA with normalization of ALT/AST at week 4(Median ALT 56 to 19 and AST 78 to 22, p=0.008). Conclusion: In our experience, SOF-based regimens
were safe and effective in treating HCV recurrence. The combination of SOF+SMV was associated with an increase in creatinine levels and a mild increase in TAC levels which requires further RG7420 monitoring. Disclosures: John J. Fung – Advisory Committees or Review Panels: Astellas, Novartis; Consulting: Vital Therapies; Grant/Research Support: Sanofi Naim Alkhouri – Advisory Committees or Review Panels: Gilead
Sciences The following people have nothing to disclose: Mohammed Eyad Yaseen Alsab-bagh, Ibrahim A. Hanouneh, Binu V. John, John K. Guirguis, Bijan Eghtesad, Nizar N. Zein Background: Non-interferon based therapy for chronic hepatitis C genotype 1 is a global goal. To date, there is limited data on the use of an all-oral treatment regimen in the post-liver transplant population. Methods: Thirty seven patients transplanted for genotype 1 chronic HCV were treated using an off-label combination of sofosbuvir, simeprevir, +/− ribavirin for 12 weeks. We collected data on patient characteristics, viral response, laboratory next values, and adverse events. The decision to treat patients for recurrent HCV post-transplant was made by one of 6 transplant hepatologists. Patients were monitored with monthly clinic visits and lab testing every 2-4 weeks during treatment. Results: Twenty five patients had genotype 1a, 7 patients had genotype 1b, and 5 patients were undifferen-tiated. There were 27 males (73%) and 14 African Americans (38%). The average age was 57 years (range 32-69) and the average time from transplant was 4 years (range 4-334 months). Twenty patients (54%) were treatment-experienced. Eight patients (22%) had recurrent cirrhosis. Sixteen patients (43%) were treated with ribavirin;13 started ribavirin at onset of treatment and 3 had ribavirin added due to slow viral response.