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

Author:

Kawashima Makoto1,Imafuku Shinichi2,Fujio Kosuke3,Komazaki Hiroshi3

Affiliation:

1. Tokyo Women’s Medical University , Tokyo , Japan

2. Department of Dermatology, Fukuoka University Faculty of Medicine , Fukuoka , Japan

3. Department of Clinical Development, Maruho Co, Ltd , Kyoto , Japan

Abstract

Abstract Background Amenamevir 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. Methods In 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. Results In 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. Conclusions Patient-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.

Funder

Maruho Co, Ltd

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

Reference28 articles.

1. Herpes simplex virus: global infection prevalence and incidence estimates, 2016;James;Bull World Health Organ,2020

2. Treatment of common cutaneous herpes simplex virus infections;Emmert;Am Fam Physician,2000

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3. Recent advance in management of herpes simplex in Japan;The Journal of Dermatology;2023-02-13

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