Eight weeks of Merck’s Zepatier (grazoprevir/elbasvir) boasted a near-perfect hepatitis C virus (HCV) cure rate among a group of European men who have sex with men (MSM) in a recent study, the National AIDS Treatment Advocacy Project (NATAP) reports. These men had a very high reinfection rate, with 5 percent of them testing positive for a new hep C infection within 12 weeks of finishing Zepatier treatment.
Researchers conducted a single-arm open-label trial, known as the Dutch Acute HCV in HIV Study-2 (DAHHS-2), of eight weeks of Zepatier among 86 people from the Netherlands and Belgium who had acute, or recently contracted, hep C. They presented their findings at the International AIDS Conference in Amsterdam (AIDS 2018).
Eighty of those enrolled in the study began Zepatier treatment within 26 weeks of their estimated date of HCV infection. All of them had genotype 1a or 4 of HCV and all were MSM. Seventy-three men were coinfected with HIV, and all of these men were on antiretroviral treatment for that virus. Nineteen (24 percent) of the acute HCV infections represented reinfections among men previously cured of that virus. The men had an average age of 47 years old.
The participants tolerated Zepatier well; none experienced serious adverse health events.
Data on the HCV cure status of one participant are pending. As for the remaining 79 men, 78 achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). By comparison, 96 percent of those members of the C-EDGE trial, who were chronically infected with HCV, all coinfected with HIV and all treated with 12 weeks of Zepatier, were cured. Consequently, the study authors concluded that eight weeks of Zepatier treatment among those acutely infected with HCV is noninferior to, or as effective as, 12 weeks of such treatment among those chronically infected with the virus.
Four of the men who were cured of hep C in the DAHHS-2 study were reinfected with that virus by the time they had their 12-week post-treatment follow-up visit.