Use of sofosbuvir-based direct-acting antiviral therapy for hepatitis C viral infection in patients with severe renal insufficiency

Abstract

Sofosbuvir-based direct-acting antiviral therapy revolutionized the treatment of hepatitis C virus (HCV) infection. However, sofosbuvir use is not approved for patients with severe renal insufficiency (estimated glomerular filtration (eGFR) rate below 30 ml/min) or end-stage renal disease (ESRD) based on concerns raised during premarket animal testing over hepatobiliary and cardiovascular toxicity in this population. We report the first published data on use of sofosbuvir-based regimens in patients with severe renal insufficiency and ESRD, focusing on clinical efficacy and safety. Six patients were treated with full dose sofosbuvir; three received sofosbuvir and simeprevir, two received sofosbuvir and ribavirin, and one received sofosbuvir, ribavirin, and interferon. Three of the patients had cirrhosis. On-treatment viral suppression was 100% and sustained virological response (SVR) rate at 12 weeks was 67%. One patient had to discontinue antiviral therapy early due to side effects. No hepatobiliary or cardiovascular toxicity was reported.

Keywords::

• Hepatitis C
• sofosbuvir
• chronic kidney disease
• end-stage renal disease

Declaration of interest: Funding received: NIH K24 DK078772 (RTC), ASN Foundation for Kidney Research Fellows Award (M.E.S.). M.E.S. discloses receiving research grant from Gilead Sciences. L.S.F. discloses royalties from Elsevier, UpToDate, McGraw-Hill, and Wiley. K.E.C. discloses prior history on advisory boards for Gilead Sciences. R.T.C. discloses research grants from Gilead Sciences, Bristol Myers Squibb, Abbvie Pharmaceuticals, Janssen, and Merck.