Gilead Sciences’ Epclusa (sofosbuvir/velpatasvir) is safe and highly effective for the treatment of hepatitis C virus (HCV) among those on dialysis.
Presenting their findings at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco, researchers enrolled 59 people with HCV in a study of 12 weeks of Epclusa treatment. The participants were enrolled at 21 sites in Canada, the United Kingdom, Spain, Israel, Australia and New Zealand.
The median age of participants was 62 years old. Fifty-nine percent were male, 53 percent were white, 32 percent had been treated for hep C before and 29 percent had cirrhosis. Forty-two percent had genotype 1 of HCV, 11 percent had genotype 2 and 27 percent had genotype 3. Ninety-two percent were on dialysis, for an average of 7.3 years.
None of the participants stopped treatment because of adverse health events. One person stopped treatment on day 74 because of poor adherence to the daily regimen, having taken only 48 percent of the prescribed pills according to a pill count.
Ninety-five percent of the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Two people (3 percent) experienced virologic relapse, including one who adhered poorly to the Epclusa regimen. One person did not achieve a cure because of death by suicide after four weeks of treatment.
The most frequent adverse health events were headache, fatigue, nausea and vomiting. Nineteen percent of the participants experienced serious adverse health events, none of which was assessed as related to Epclusa treatment.
To read the conference abstract, click here.