Sofosbuvir-velpatasvir combo safe, effective for HCV patients with end-stage renal disease
The combination of sofosbuvir and velpatasvir is safe and effective for the treatment of hepatitis C virus (HCV) in patients with end-stage renal disease (ESRD) undergoing haemodialysis, a study has shown.
Fifty-nine HCV patients (mean age, 60 years; 59 percent male) undergoing haemodialysis or peritoneal dialysis of ESRD were given open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of participants reaching sustained virological response 12 weeks after the treatment was discontinued (SVR12). Discontinuation due to adverse events was the primary safety endpoint.
Almost all patients achieved SVR12 (95 percent; n=56). Most of the patients who achieved the primary efficacy endpoint had drug adherence rates of at least 90 percent. Those who fell short of SVR12 had adherence rates of <90 percent; one patient died of suicide after achieving viral suppression 79 days after treatment.
Adverse events were also fairly common, with 80 percent of the study population reporting at least one episode. Most were mild or moderate in severity.
The most common side effects were headache (17 percent), fatigue (14 percent), nausea (14 percent), vomiting (14 percent) and insomnia (10 percent). Eleven patients (19 percent) experienced serious adverse events, though none were deemed to be related to the study treatment. There were no discontinuations due to adverse events.
Aside from the suicide, one other death occurred due to metastatic lung cancer 111 days after completing the study.