ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo-
and valacyclovir-controlled, dose-finding study.
Author(s): Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R.
Affiliation(s): Department of Dermatology, University of Texas Health Science Center, Houston,
TX, USA.
Publication date & source: 2012, J Infect Dis. , 205(7):1100-10
BACKGROUND: Current therapies for genital herpes have only partial efficacy.
Helicase-primase inhibitors are novel, potent inhibitors of herpes simplex virus
replication.
METHODS: This randomized trial assessed the safety and efficacy of ASP2151 for
episodic therapy of recurrent genital herpes. Participants self-initiated with
ASP2151 (100, 200, or 400 mg daily for 3 days), ASP2151 (1200 mg as a single
dose), placebo for 3 days, or valacyclovir (500 mg twice daily for 3 days). The
primary efficacy endpoint, time to lesion healing excluding aborted lesions, was
analyzed using a proportional hazards model. Statistical significance was
determined by P = .01.
RESULTS: Of 695 adults enrolled, 437 experienced a recurrence and received study
drug. Median time for lesion healing excluding aborted lesions was 139.8 hours
with placebo, 119.6 hours with ASP2151 (100 mg; hazard ratio [HR], 1.40; P =
.065), 106.2 with ASP2151 (200 mg; HR, 1.40; P = .081), 115.9 with ASP2151 (400
mg; HR, 1.25; P = .25), 102.1 with ASP2151 (1200 mg; HR, 1.72; P = .007), and
113.9 with valacyclovir (500 mg twice daily; HR, 1.42; P = .077), indicating
improvement in all treatment groups except ASP2151 (400 mg). Incidence of
treatment-emergent adverse events was similar across groups.
CONCLUSIONS: Three-day or single-day courses of ASP2151 appear to be effective
and safe options for treatment of episodes of recurrent genital herpes.
CLINICAL TRIALS REGISTRATION: NCT00486200.
|