A randomized, placebo-controlled comparison of oral valacyclovir and acyclovir in immunocompetent patients with recurrent genital herpes infections. The Valaciclovir International Study Group.
OBJECTIVE
To compare valacyclovir hydrochloride with acyclovir in the treatment of recurrent genital herpes infection.


METHODS
A multicenter, double-blind, placebo-controlled, randomized, parallel-design study.


METHODS
University clinics (dermatology, gynecology, and infectious diseases) and private practices.


METHODS
One thousand two hundred patients with recurrent genital herpes simplex infections.


METHODS
Patients self-initiated oral therapy with 1000 mg of valacyclovir hydrochloride twice daily, 200 mg of acyclovir 5 times daily, or placebo for 5 days.


METHODS
Resolution of all signs and symptoms of recurrent genital herpes infection.


RESULTS
Both drugs were significantly more effective than placebo in speeding resolution of herpetic episodes (median duration, 4.8, 4.8, and 5.9 days, respectively); the hazards ratios for valacyclovir and acyclovir vs placebo were 1.66 (95% confidence interval [CI], 1.38-2.01) and 1.71 (95% CI, 1.41-2.06) (both P < .001). Similarly, valacyclovir and acyclovir significantly hastened lesion healing (hazards ratios vs placebo were 1.88 [95% CI, 1.53-2.32] and 1.90 [95% CI, 1.55-2.34], respectively; P < .001). Pain duration was shorter in valacyclovir- and acyclovir-treated patients (median, 2 vs 3 days). Viral shedding stopped 2.55 times faster in patients treated with valacyclovir and 2.24 times faster in patients treated with acyclovir than in patients treated with placebo. Aborted episodes, in which lesions did not progress beyond the macule or papule stage, tended to occur in more patients treated with valacyclovir (25.9%) or acyclovir (24.8%) than in patients treated with placebo (19.8%). Valacyclovir and acyclovir did not differ significantly with regard to their respective effects on any of the above efficacy parameters. The nature, severity, and frequency of adverse events did not differ among the 3 treatment groups.


CONCLUSIONS
Twice-daily valacyclovir was as effective and well tolerated in the treatment of recurrent genital herpes simplex virus infection as 5-times-daily acyclovir. Therefore, valacyclovir could prove a useful alternative to acyclovir when convenience of dosing or compliance issues are the prime considerations in treatment.
Tyring
S K
SK
Department of Dermatology, University of Texas Medical Branch, Galveston, USA. Tyring@flash.net
Douglas
J M
JM
Corey
L
L
Spruance
S L
SL
Esmann
J
J
D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D006558:Herpes Genitalis / Q000188:drug therapy*; D006801:Humans; D007121:Immunocompetence; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D010919:Placebos; D011355:Prodrugs / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D012008:Recurrence; D012074:Remission Induction; D012648:Self Care; D013997:Time Factors; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D017201:Virus Shedding / Q000187:drug effects; D014945:Wound Healing
D000998:Antiviral Agents; D010919:Placebos; D011355:Prodrugs; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir