Obstet Gynecol. 2006 Jul;108(1):141-7.
Valacyclovir prophylaxis to prevent recurrent herpes at delivery: a randomized
clinical trial.
Sheffield JS, Hill JB, Hollier LM, Laibl VR, Roberts SW, Sanchez PJ, Wendel GD.
Department of Obstetrics and Gynecology, University of Texas Southwestern
Medical Center at Dallas, Dallas, Texas 75390-9032, USA. Jeanne.Sheffield@utsouthwestern.edu
Objectives:
To measure the efficacy of valacyclovir suppression in
late pregnancy to reduce the incidence of recurrent genital
herpes in labor and subsequent cesarean delivery.
Methods:
A total of 350 pregnant women with a history of genital
herpes were assigned randomly to oral valacyclovir 500 mg
twice a day or an identical placebo from 36 weeks of
gestation until delivery. In labor, vulvovaginal herpes
simplex virus (HSV) culture and polymerase chain reaction (PCR)
specimens were collected. Vaginal delivery was permitted if
no clinical recurrence or prodromal symptoms were present.
Neonatal HSV cultures and laboratory tests were obtained,
and infants were followed up for 1 month after delivery.
Data were analyzed using chi2 and Student t tests.
Results:
One hundred seventy women treated with valacyclovir and
168 women treated with placebo were evaluated. Eighty-two
percent of the women had recurrent genital herpes; 12% had
first episode, nonprimary genital herpes; and 6% had first
episode, primary genital herpes. At delivery, 28 women (8%)
had recurrent genital herpes requiring cesarean delivery: 4%
in the valacyclovir group and 13% in the placebo group (P =
.009). Herpes simplex virus was detected by culture in 2% of
the valacyclovir group and 9% [corrected] of the placebo
group (P =.02). No infants were diagnosed with neonatal HSV,
and there were no significant differences in neonatal
complications. There were no significant differences in
maternal or obstetric complications in either group.
Conclusion:
Valacyclovir suppression after 36 weeks of gestation
significantly reduces HSV shedding and recurrent genital
herpes requiring cesarean delivery.
