HealthDay News — The investigational drug pritelivir reduced the rate of viral shedding in patients with genital herpes simplex virus-2 (HSV-2) infection, according to researchers.
“Pritelivir reduced the rates of genital HSV shedding and days with lesions in a dose-dependent manner in otherwise healthy men and women with genital herpes,” Ann Wald, MD, MPH, from the University of Washington in Seattle, and colleagues, reported in New England Journal of Medicine.
They assessed the efficacy and safety of pritelivir in a small, double-blind, placebo-controlled study involving156 individuals with genital HSV-2 infection. Participants were randomly assigned to receive oral pritelivir at doses of 5, 25, or 75 mg daily or 400 mg weekly or placebo for 28 days.
Daily swabs were obtained from the genital area for HSV-2 testing, and a diary was maintained to record genital signs and symptoms. The primary endpoint was the proportion of days with viral shedding in treatment versus placebo. comparison with placebo in the proportion of days in which viral shedding was seen. Information on the number of days in which lesions occurred was also collected.
A daily dose of 75 mg of the pritelivir reduced the relative risk of viral shedding 87%, whereas a weekly dose of 400 mg weekly reduced viral shedding 68%, the researchers found. Currently approved HSV-2 drugs decrease lesions, but not shedding — an important factor in the spread of disease, they noted.
In the placebo group, patients experienced genital lesions on 9% of days compared with 1.2% in both the 75-mg and 400-mg groups (relative risk, 0.13 for both). All groups had similar rates of adverse events.
Several authors disclosed financial ties to pharmaceutical companies, including AiCuris, which manufactures pritelivir and funded the study.