Gilead Sciences’ Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is quite effective at curing hepatitis C virus (HCV) among those who have been treated for the virus before, including those with and without HIV coinfection, MD Magazine reports.
Presenting their findings at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco (The Liver Meeting), researchers analyzed data from the RESOLVE trial, a Phase IIb study of the safety and efficacy of 12 weeks of Vosevi treatment. The study included those with both early and advanced liver disease and those with or without HIV or hepatitis B virus (HBV) coinfection. Participants had not been cured by a previous round of hepatitis C virus (HCV) treatment.
The analysis included 77 people; 83 percent were male, and 86 percent were Black. The study group had an average age of 60 years old. Seventy-five percent had genotype 1a of HCV, 22 percent had HIV and 3 percent had both HIV and HBV.
Fifty-one percent had a history of injection drug use. Forty percent had compensated cirrhosis (the milder form of the advanced liver disease) and 35 percent had moderate or less severe fibrosis.
Twenty-nine percent of the participants did not complete their previous HCV treatment.
Seventy (91 percent) of the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Eighteen (81 percent) of the 22 participants who did not complete their previous HCV treatment were cured. Two people were still awaiting results of their SVR12 testing when the analysis was conducted while two others had stopped treatment early because of illness.
Three participants (4 percent) stopped Vosevi treatment early because of adverse health events. Two participants (3 percent) were lost to follow-up, one person died of hepatocellular carcinoma (HCC, the most common form of liver cancer) and one person experienced virologic relapse.
Adverse health events reported by at least 5 percent of participants included fatigue, headache, diarrhea, abdominal pain and constipation. Three people experienced Grade 4 adverse health events, which were all deemed unrelated to Vosevi treatment.
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