A double-blind, randomized, placebo-controlled trial of acyclovir in late pregnancy for the reduction of herpes simplex virus shedding and cesarean delivery.
OBJECTIVE
The purpose of this study was to assess the efficacy of acyclovir in the reduction of herpes simplex virus culture and polymerase chain reaction positivity and cesarean delivery.


METHODS
Women with recurrent genital herpes simplex virus were randomized to acyclovir 400 mg three times daily or placebo from 36 weeks of gestation until delivery. A subset of daily specimens for herpes simplex virus culture and DNA polymerase chain reaction was self-collected. Analyses used chi(2), Fisher exact, and Mann-Whitney U tests.


RESULTS
Lesions occurred at delivery among 11 of 78 women (14%) who received placebo and 4 of 84 women (5%) who received acyclovir (P =.08). Herpes simplex virus culture and polymerase chain reaction positivity near delivery occurred in 7% and 34% women in the placebo group and 0 and 2% in the acyclovir group (P =.03 and <.01, respectively). Cesarean delivery for herpes simplex virus occurred in 8 of the women (10%) in the placebo group and in 3 of the women (4%) in the acyclovir group (P =.17). Despite reductions in herpes simplex virus detection, 6% of the women who received acyclovir had herpes simplex virus detected by polymerase chain reaction on >20% of days. Neonatal outcomes were similar between groups.


CONCLUSIONS
Acyclovir significantly reduced, but did not eliminate, herpes simplex virus lesions and detection in late pregnancy.
Watts
D Heather
DH
Department of Obstetrics and Gynecology, University of Washington, Seattle, USA.
Brown
Zane A
ZA
Money
Deborah
D
Selke
Stacy
S
Huang
Meei Li
ML
Sacks
Stephen L
SL
Corey
Lawrence
L
D000212:Acyclovir / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D002585:Cesarean Section; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006558:Herpes Genitalis / Q000473:pathology / Q000821:virology*; D006801:Humans; D010919:Placebos; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000473:pathology; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D018139:Simplexvirus / Q000302:isolation & purification / Q000502:physiology*; D017201:Virus Shedding
D000998:Antiviral Agents; D010919:Placebos; D000212:Acyclovir