- Treatment with sofosbuvir/velpatasvir for 12 weeks is safe, well tolerated, and effective in patients with hepatitis C virus (HCV) infection and end-stage renal disease (ESRD) undergoing dialysis.
Why this matters
- Although off-label use of sofosbuvir-containing regimens occurs regularly in HCV-infected patients undergoing dialysis for ESRD, these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population.
- 59 patients with HCV infection and ESRD undergoing dialysis received sofosbuvir/velpatasvir (400 mg/100 mg) once-daily for 12 weeks, including 46 (78%) treatment-naive and 13 (22%) treatment-experienced patients.
- Primary efficacy outcome: proportion of patients achieving sustained virologic response 12 weeks after discontinuation of therapy (SVR12).
- Primary safety outcome: proportion of patients who discontinued study drug due to adverse events.
- Funding: Gilead Sciences, Inc.
- Overall, 56 of 59 patients achieved SVR 12 (95%; 95% CI, 86-99%).
- 2 of 3 patients who did not achieve SVR 12 had virologic relapse at post-treatment week 4 (including 1 who prematurely discontinued therapy) and 1 patient died from suicide after achieving SVR post-treatment week 4.
- Headache (17%), fatigue (14%), nausea (14%) and vomiting (14%) were the most common adverse events reported during the treatment period.
- Serious adverse events were reported in 11 patients (19%), and none were related to sofosbuvir/velpatasvir.
- Small sample size.
- Results have limited generalisability.