Single-Dose, Patient-Initiated Amenamevir Therapy for Recurrent Genital Herpes: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study.

Abstract

BackgroundAmenamevir is a helicase-primase inhibitor with novel mechanisms of antiherpetic action. A patient-initiated single-dose regimen showed clinical efficacy for genital herpes in a phase 2 study.MethodsIn this phase 3 study, adult immunocompetent patients with recurrent genital herpes and able to accurately recognize prodromal symptoms were randomly assigned to administer amenamevir 1200 mg or placebo as a patient-initiated therapy within 6 hours after onset of prodromal symptoms. The primary efficacy endpoint was time to healing of all genital herpes lesions.ResultsIn the modified intention-to-treat population, which excluded patients with aborted lesions (amenamevir, n = 89; placebo, n = 97), the median time to all lesion healing was 4.0 days for amenamevir versus 5.1 days for placebo (hazard ratio, 1.60 [95% confidence interval, 1.19–2.15]; P = .0018), indicating superiority of amenamevir. All treatment-emergent adverse events in both groups were mild in severity.ConclusionsPatient-initiated single-dose amenamevir reduced the time to all lesion healing of recurrent genital herpes versus placebo, with no safety concerns, suggesting it could be an effective treatment option for patients with recurrent genital herpes. Clinical Trials Registration. JapicCTI-194955.