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Reduction in the Once-daily valacyclovir to reduce the
risk of transmission of genital herpes.
New England Journal of Medicine 2004;350:11-20.
Corey L, Wald A, Patel R, Sacks SL, Tyring SK, Warren T, Douglas JM
Jr, Paavonen J, Morrow RA, Beutner KR, Stratchounsky LS, Mertz G, Keene
ON, Watson HA, Tait D, Vargas-Cortes M; Valacyclovir HSV Transmission
Study Group.
Abstract
BACKGROUND: Nucleoside analogues against herpes simplex virus (HSV) have been
shown to suppress shedding of HSV type 2 (HSV-2) on genital mucosal surfaces
and may prevent sexual transmission of HSV. METHODS: We followed 1484 immunocompetent,
heterosexual, monogamous couples: one with clinically symptomatic genital
HSV-2 and one susceptible to HSV-2. The partners with HSV-2 infection were
randomly assigned to receive either 500 mg of valacyclovir once daily or
placebo for eight months. The susceptible partner was evaluated monthly for
clinical signs and symptoms of genital herpes. Source partners were followed
for recurrences of genital herpes; 89 were enrolled in a substudy of HSV-2
mucosal shedding. Both partners were counseled on safer sex and were offered
condoms at each visit. The predefined primary end point was the reduction
in transmission of symptomatic genital herpes. RESULTS: Clinically symptomatic
HSV-2 infection developed in 4 of 743 susceptible partners who were given
valacyclovir, as compared with 16 of 741 who were given placebo (hazard ratio,
0.25; 95 percent confidence interval, 0.08 to 0.75; P=0.008). Overall, acquisition
of HSV-2 was observed in 14 of the susceptible partners who received valacyclovir
(1.9 percent), as compared with 27 (3.6 percent) who received placebo (hazard
ratio, 0.52; 95 percent confidence interval, 0.27 to 0.99; P=0.04). HSV DNA
was detected in samples of genital secretions on 2.9 percent of the days
among the HSV-2-infected (source) partners who received valacyclovir, as
compared with 10.8 percent of the days among those who received placebo (P<0.001).
The mean rates of recurrence were 0.11 per month and 0.40 per month, respectively
(P<0.001). CONCLUSIONS: Once-daily suppressive therapy with valacyclovir
significantly reduces the risk of transmission of genital herpes among heterosexual,
HSV-2-discordant couples. Copyright 2004 Massachusetts Medical Society
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