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HCV treatment with Epclusa safe in patients undergoing dialysis for ESRD

Although not currently licensed for patients undergoing dialysis for severe renal impairment, researchers found that treatment with Epclusa for hepatitis C was safe and effective in patients with end-stage renal disease.

“Chronic HCV infection has a significant negative impact on morbidity and mortality in patients undergoing dialysis,” Sergio M. Borgia, MD, FRCPC, from Brampton Civic Hospital in Ontario, Canada, and colleagues wrote. “HCV-infected patients with [chronic kidney disease (CKD)] have an accelerated rate of loss of kidney function, risk of progression to end-stage renal disease (ESRD), and increased risk of all-cause mortality when undergoing dialysis.”

Borgia and colleagues enrolled 59 patients with HCV and ESRD to undergo 12 weeks of treatment with Epclusa (sofosbuvir/velpatasvir, Gilead Sciences). Most were treatment-naive (78%), 92% were undergoing hemodialysis for a mean duration of 7 years (range, 0-40 years), and 8% were undergoing peritoneal dialysis.

Fifty-six patients achieved SVR (95% CI, 86-99), of whom 53 had study drug adherence rates of 90% or higher. Two patients experienced virologic relapse posttreatment and one patient was discontinued from the study after 11 weeks due to nonadherence.

Most patients experienced a mild to moderate adverse event (80%) such as fatigue, headache, nausea, vomiting and insomnia. The researchers noted no adverse events associated with renal dysfunction among the patients and that the incidence of grade 3 and grade 4 laboratory abnormalities was consistent with patients undergoing dialysis for ESRD.

“Over the last few years, several HCV treatments have been approved for use in patients with HCV infection and CKD, and each regimen has limitations,” the researchers wrote. “The data collected in this study provide information to support the use of sofosbuvir/velpatasvir in HCV-infected patients with ESRD.” – by Talitha Bennett

Disclosure: Borgia and his institution have received honoraria from AbbVie, Gilead Sciences and Merck. Please see the full study for all other authors’ relevant financial disclosures.