Treatment of hepatitis C virus (HCV) infection with sofosbuvir/velpatasvir for 12 weeks was safe and effective in patients undergoing dialysis for end-stage renal disease (ESRD), according to a multicenter, open-label study published in the Journal of Hepatology.
Sofosbuvir/velpatasvir is a combination direct-acting antiviral that is approved for patients with HCV. Although there are a lack of dosing recommendations for sofosbuvir-containing regimens for patients who were infected with HCV and undergoing dialysis, these regimens are still often used to treat these patients. Therefore, researchers evaluated the safety and efficacy of sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks in 59 patients with HCV infection and ESRD who were undergoing hemodialysis or peritoneal dialysis. Overall, they found that 56 (95%) of 59 patients achieved a sustained virologic response 12 weeks after discontinuation of treatment. Three patients did not achieve this response because 2 patients had virologic relapse at posttreatment week 4 (and 1 prematurely discontinued study treatment) and 1 died from suicide after achieving sustained virologic response through posttreatment week 4. Headache (17%), fatigue (14%), nausea (14%), and vomiting (14%) were the most commonly reported adverse events. Although all were found to be unrelated to sofosbuvir/velpatasvir, serious adverse events were reported in 11 patients (19%).
“In conclusion, the single-tablet, pangenotypic regimen of sofosbuvir/velpatasvir for 12 weeks is a safe, well tolerated, and highly effective treatment option for HCV-infected patients undergoing dialysis for ESRD,” stated the authors. They added that, “The results from this study also support the applicability of this data in patients with severe renal impairment and the use of sofosbuvir/velpatasvir in this population with no additional safety risks.”
Borgia SM, Dearden J, Yoshida EM, et al. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis [published online June 10, 2019]. J Hepatol. doi:10.1016/j.jhep.2019.05.028