Full-Dose Sofosbuvir-Based Anti-HCV Regimens for Patients on Hemodialysis

Sofosbuvir 400 mg was safe and effective in 12 HCV-infected patients on hemodialysis.

Currently, two regimens for the treatment of hepatitis C virus (HCV) infection seem safe and effective in patients requiring hemodialysis: grazoprevir/elbasvir and paritaprevir/ritonavir/ombitasvir/dasabuvir. Although, sofosbuvir is a cornerstone of many HCV treatment regimens, its use is not typically recommended in patients with severe renal impairment (glomerular filtration rates <30 mL/min).

In a multicenter, prospective, observational study, investigators assessed the safety and efficacy of sofosbuvir 400 mg daily or 3 times a week with daclatasvir, ledipasvir, ribavirin, or simeprevir in HCV-infected patients on hemodialysis. Drug plasma concentrations of sofosbuvir were determined 4 hours before and after hemodialysis and 1.5 hours after last drug intake at the end of hemodialysis.

Of 12 patients enrolled, 11 had genotype 1 infection, 2 were coinfected with HIV, 10 had cirrhosis, and 6 were treatment-experienced. Seven patients received sofosbuvir daily and 5 received it three times weekly. In pharmacokinetic analysis, plasma concentrations of sofosbuvir and its inactive ingredient sofosbuvir-007 did not accumulate with either dosage regimen between hemodialysis sessions or during HCV treatment. Hemodialysis did not eliminate any of the other anti-HCV drugs included in the treatment regimens. Sustained virologic response at 12 weeks posttherapy was achieved in all patients except for two patients who relapsed (both received sofosbuvir three times weekly). No serious adverse events occurred.