Abstract
Purpose Donor-derived hepatitis C infection (dd-HCV) infection may increase risk of renal impairment (RI) among heart transplant (HT) recipients. Sofosbuvir, an integral component of anti-HCV direct-acting antivirals (DAAs), has also been linked to RI. To date, no prior study has examined the trends in renal function for HT recipients of dd-HCV infection, and assessed safety and efficacy of sofosbuvir-based DAAs. Methods Between September 2016 and June 2018, 46 HCV-naive patients and 1 with a history of treated-HCV pre-HT underwent HT from HCV-positive donors (follow-up through October 10th, 2018). Patients were treated with ledipasvir-sofosbuvir (genotype 1) or sofosbuvir-velpatasvir (genotype 3) for 12 or 24 weeks; no dose adjustments were made for renal function. Data on renal function were available for 23 patients who achieved a sustained virologic response at 12 weeks after the end of treatment (SVR12; cohort A) and 18 patients who completed 1-year of follow-up (cohort B). Results Treatment of dd-HCV infection was initiated after a median of 6 weeks post-HT. In both cohorts, a non-significant change in median eGFR was noted (Cohort A: pre-transplant eGFR: 62 (IQR 51,84) to SVR12 eGFR: 49 ((IQR: 37, 82), p=0.43); Cohort B: pre-transplant eGFR: 65 (IQR: 54, 84) to 1-year post-HT eGFR: 56 ((IQR: 39, 75); p=0.29). Pre-treatment renal function or early initiation of DAAs post-transplant had no significant impact on changes in renal function during treatment. All patients tolerated DAAs well with 100% completion rate to the assigned therapy and duration, and 100% success at achieving SVR12. Conclusion In this first and largest reported case series to date of HT recipients with dd-HCV infection, we observed that neither the dd-HCV infection nor its treatment with Sofosbuvir-based DAAs increased the risk of RI. Sofosbuvir-based DAAs appear safe, tolerable and effective for HCV treatment even in presence of severe RI.
Published Version
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