General Obstetrics and Gynecology: Obstetrics
Valacyclovir therapy to reduce recurrent genital herpes in pregnant women

https://doi.org/10.1016/j.ajog.2005.11.051Get rights and content

Objective

The purpose of this study was to estimate the efficacy of valacyclovir suppressive therapy in pregnant women with recurrent genital herpes.

Study design

At 36 weeks' gestation, herpes simplex virus (HSV)-2 seropositive women were randomized to receive oral valacyclovir 500 mg or placebo twice daily until delivery. Genital tract and neonatal specimens were collected weekly for HSV culture and qualitative polymerase chain reaction (PCR) assay to detect viral DNA from the time of randomization to delivery. Both maternal and neonatal toxicity measures were obtained.

Results

The 112 enrolled women (57 valacyclovir, 55 placebo) had similar HSV recurrence risks, including mean number of active HSV recurrences before randomization during the index pregnancy (1.1 ± 1.9 vs 1.5 ± 2.1, P = .308) and days between randomization and delivery (20.3 ± 10.2 vs 22.0 ± 8.9, P = .344). The number of women with clinical HSV recurrences between the time of randomization and delivery was significantly lower in the valacyclovir versus placebo group (10.5% vs 27.3%; P = .023, RR 0.4, 95% CI 0.2-0.9). Shedding of HSV within 7 days of delivery was similar in the valacyclovir and placebo group (10.4% vs 12.0%, P = .804; RR 0.9, 95% CI 0.3-2.7), as was the number of women with clinical HSV lesions at delivery (5.3% vs 14.6%, P = .121; RR 0.4, 95% CI 0.1-1.3). No neonates had symptomatic congenital HSV infection before discharge or up to 2 weeks' postpartum, and no clinical or laboratory safety concerns were identified.

Conclusion

Administration of valacyclovir beginning at 36 weeks' gestation to women with a history of recurrent genital HSV reduced the number of women with subsequent clinical HSV recurrences.

Section snippets

Material and methods

This was a randomized double-masked, placebo-controlled clinical trial of gravid women with documented recurrent HSV-2 infection conducted between March 1998 and May 2001. The primary site for the investigation was the Center for Research in Women's Health at the University of Alabama at Birmingham (UAB) and a secondary site was the University of South Alabama (USA) in Mobile, AL. One hundred and two women were enrolled at UAB and 10 at USA. The Institutional Review Boards of both institutions

Results

A summary of screening, enrollment, and randomization of women to valacyclovir and placebo groups is provided in the Figure. A total of 112 women were randomized, including 57 in the valacyclovir group and 55 in the placebo group. Demographic characteristics of the 2 groups are depicted in Table I. No significant differences were observed between the 2 groups for maternal age, ethnicity, marital status, nulliparity, or gestational age at enrollment. There was also no significant difference

Comment

In this study, daily valacyclovir suppression initiated at 36 weeks' gestation and continued through delivery in women with a documented history of recurrent HSV infection significantly reduced the number of women with subsequent clinical HSV recurrences after treatment initiation. However, suppression did not decrease the number of women with viral shedding near delivery, active HSV lesions at delivery, or the number requiring cesarean delivery for active HSV lesions. Although not

Acknowledgment

The authors acknowledge Dr Susan Baker at the University of South Alabama, Mobile, AL, for her contributions to this study.

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  • Cited by (70)

    • No. 208-Guidelines for the Management of Herpes Simplex Virus in Pregnancy

      2017, Journal of Obstetrics and Gynaecology Canada
      Citation Excerpt :

      Valacyclovir is the valine ester of acyclovir and is broken down to acyclovir in the blood stream, so safety data on acyclovir may be extrapolated to valacyclovir. A recent study has demonstrated the cost effectiveness of acyclovir suppression in pregnant women.35 Use of acyclovir in pregnancy has not been associated with any consistent pregnancy complications or fetal/neonatal adverse effects, other than transient neutropenia in data from the Acyclovir Pregnancy Registry.23,36,37

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    Supported by a research grant from GlaxoSmithKline, Research Triangle Park, North Carolina.

    Dr Deeter is currently at Amgen, Inc, Thousand Oaks, CA.

    Presented at the 2003 Society of Maternal-Fetal Medicine Annual Meeting, San Francisco, CA, February 2003.

    Reprints not available from the authors.

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