title: FV-100 versus valacyclovir for the prevention of post-herpetic neuralgia and the treatment of acute herpes zoster-associated pain: A randomized-controlled trial.
abstract: This prospective, parallel-group, randomized, double-blind, multicenter study compared the efficacy and safety of FV-100 with valacyclovir for reducing pain associated with acute herpes zoster (HZ). Patients, ≥50 years of age, diagnosed with HZ within 72 h of lesion appearance who had HZ-associated pain, were randomized 1:1:1 to a 7-day course of either FV-100 200 mg QD (n = 117), FV-100 400 mg QD (n = 116), or valacyclovir 1000 mg TID (n =117). Efficacy was evaluated on the basis of the burden of illness (BOI; Zoster Brief Pain Inventory scores); incidence and duration of clinically significant pain (CSP); pain scores; incidence and severity of post-herpetic neuralgia (PHN); and times to full lesion crusting and to lesion healing. Safety was evaluated on the basis of adverse event (AE)/SAE profiles, changes in laboratory and vital signs values, and results of electrocardiograms. The burden of illness scores for pain through 30 days were 114.5, 110.3, and 118.0 for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg, respectively. The incidences of PHN at 90 days for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg were 17.8%, 12.4%, and 20.2%, respectively. Adverse event and SAE profiles of the two FV-100 and the valacyclovir groups were similar and no untoward signals or trends were evident. These results demonstrate a potential for FV-100 as an antiviral for the treatment of shingles that could both reduce the pain burden of the acute episode and reduce the incidence of PHN compared with available treatments.
authors.affiliation: University of Texas Health Sciences Center, Houston, Texas.
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Tyring
authors.affiliation: Center for Clinical Studies, Webster, Texas.
authors.forename: Patricia
authors.initials: P
authors.lastname: Lee
authors.affiliation: Oakwell Clinical Research, LLC, San Antonio, Texas.
authors.forename: Gordon T
authors.initials: GT
authors.lastname: Hill
authors.affiliation: Bay Care Medical Group, Inc., Health Point Medical Group, Inc., Burnette and Silverfield MDS, Tampa, Florida.
authors.forename: Joel C
authors.initials: JC
authors.lastname: Silverfield
authors.affiliation: Arlington Center for Dermatology, Arlington Research Center, Arlington, Texas.
authors.forename: Angela Yen
authors.initials: AY
authors.lastname: Moore
authors.affiliation: ContraVir Pharmaceuticals, Inc., Edison, New Jersey.
authors.forename: Theresa
authors.initials: T
authors.lastname: Matkovits
authors.affiliation: ContraVir Pharmaceuticals, Inc., Edison, New Jersey.
authors.forename: John
authors.initials: J
authors.lastname: Sullivan-Bolyai
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017281:Cost of Illness; D004311:Double-Blind Method; D005260:Female; D006562:Herpes Zoster / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000517:prevention & control* / Q000821:virology; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management; D011446:Prospective Studies; D011741:Pyrimidine Nucleosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; C526677:FV-100; D011741:Pyrimidine Nucleosides; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir
keywords: antiviral agents; herpes simplex virus; herpes virus; reinfection