title: ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study.
abstract: 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.
  
  
  BACKGROUND
  NCT00486200.
authors.affiliation: Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Tyring
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Neddie
authors.initials: N
authors.lastname: Zadeikis
authors.forename: Shobha
authors.initials: S
authors.lastname: Dhadda
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Takenouchi
authors.forename: Ramona
authors.initials: R
authors.lastname: Rorig
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006558:Herpes Genitalis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010069:Oxadiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: C568714:ASP2151; D000998:Antiviral Agents; D010069:Oxadiazoles; D010919:Placebos; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir