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Once Daily Valacyclovir Reduces Transmission of Genital Herpes
  L. COREY1, S. TYRING2, S. SACKS3, T. WARREN4, K. BEUTNER5, R PATEL6, A WALD1, G MERTZ7, J PAAVONEN8, VALACYCLOVIR STUDY GROUP. 1Univ. of Washington, Seattle, WA, 2Univ. of Texas, Galveston, TX, 3Viridae Clin. Sci. and Univ. of British Columbia, Vancouver, Canada, 4Westover Heights Clin., Portland, OR, 5Univ. of California, San Francisco, CA, 6Southampton Univ. Hosp., Southampton, UK, 7Univ. of New Mexico, Albuquerque, NM, 8Univ. of Helsinki, Helsinki, Finland
This study was reported at the ICAAC meeting in September 2002.
Background: Transmission of genital herpes to a sexual partner is a major concern to patients. Daily valacyclovir (VAL) suppresses genital herpes (GH) clinical recurrences and HSV shedding. We investigated the efficacy of VAL suppressive therapy in the source partner for reducing GH transmission to the susceptible partner in heterosexual, monogamous, HSV-2 discordant couples.
Methods: In a randomized double-blind study, HSV-2 seropositive source partners with a history of <10 episodes/year received VAL 500mg once daily or placebo (P) for 8 months. HSV-2 seronegative susceptible partners were monitored monthly for acquisition of GH. The primary endpoint was the proportion of susceptible partners with a first episode of symptomatic GH (confirmed by HSV culture, PCR or seroconversion). Couples were offered condoms and counseled on safer sexual behavior at all visits. A all endpoints were ratified under blind.
Results: 741 source partners received P, 743 VAL. 488 susceptible partners were women and 996 were men. 17 (2.3%) subjects in the P, vs 4 (0.5%) in the VAL group acquired symptomatic GH p=0.006, relative risk (RR, 95% CI): 0.23 (0.1, 0.7), a reduction of 77%. Overall acquisition of genital HSV-2 infection (laboratory-confirmed symptoms or seroconversion) was 3.8% in P vs.1.9% in VAL p=0.039, RR (95%CI): 0.50 (0.3, 0.9), a reduction of 50%. Adverse events were similar between treatment groups.
Conclusions: Once daily VAL suppressive therapy reduces the transmission of genital herpes among heterosexual HSV-2 discordant couples. This is the first randomized controlled trial of an antiviral demonstrating a reduction in sexual transmission of an infection.
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