Purpose: To determine if treatment of recurrent hepatitis C virus (HCV) post-liver transplant with the direct-acting antivirals (DAAs) sofosbuvir, simeprevir, and ledipasvir (in combination and/or with or without ribavirin and/or peginterferon alfa) is associated with a significant decrease in tacrolimus levels.

Methods: We performed a retrospective chart review of all post-liver transplant patients with recurrent HCV who were treated with DAAs at our institution from January 2014 to present. Patients were excluded if they had started HCV treatment but had not yet finished and if they were receiving an immunosuppression regimen that did not include tacrolimus. Eligible patients were identified through the electronic health record. Individual chart review was conducted to collect patient demographics, transplant data, labs, and HCV infection data. Data were collected using Microsoft Excel and analyzed using IBM SPSS software.

Results: A total of 60 patients were included in the analysis.

Mean tacrolimus levels at baseline were 7.2 mcg/L.

By week 4 of HCV treatment, mean tacrolimus levels were significantly lower than baseline at 5.9 mcg/L (p=0.007). Mean tacrolimus levels remained significantly lower than baseline at treatment week 12 and at 12 weeks after the completion of treatment with mean levels of 4.6 mcg/L (p<0.001) and 4.2 mcg/L (p<0.001), respectively. There were no statistically significant differences in tacrolimus levels between the different HCV treatment groups at any time point during HCV treatment. There were no episodes of biopsy-proven rejection for any patients while on HCV treatment.

Conclusion: Although there are no drug interactions reported between tacrolimus and the DAAs sofosbuvir, simeprevir, or ledipasvir, our study demonstrated significant decreases in tacrolimus levels starting as early as week 4 of HCV treatment and which continued throughout the duration of HCV treatment and at 12 weeks following the completion of HCV treatment.

CITATION INFORMATION: Wiegel J, Egbuka T. Tacrolimus Levels in Patients Treated with Direct Acting Antivirals Post-Transplant. Am J Transplant. 2016;16 (suppl 3).

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