Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels
during pregnancy and postpartum: a randomized trial.
Author(s): Drake AL, Roxby AC, Ongecha-Owuor F, Kiarie J, John-Stewart G, Wald A, Richardson
BA, Hitti J, Overbaugh J, Emery S, Farquhar C.
Affiliation(s): Department of Global Health, University of Washington, Seattle 98195-7236, USA.
adrake2@uw.edu
Publication date & source: 2012, J Infect Dis. , 205(3):366-75
BACKGROUND: The effect of herpes simplex virus type 2 (HSV-2) suppression on
human immunodeficiency virus type 1 (HIV-1) RNA in the context of prevention of
mother-to-child transmission (PMTCT) interventions is unknown.
METHODS: Between April 2008 and August 2010, we conducted a randomized,
double-blind trial of twice daily 500 mg valacyclovir or placebo beginning at 34
weeks gestation in 148 HIV-1/HSV-2 coinfected pregnant Kenyan women ineligible
for highly active antiretroviral therapy (CD4 > 250 cells/mm(3)). Women received
zidovudine and single dose nevirapine for PMTCT and were followed until 12 months
postpartum.
RESULTS: Mean baseline plasma HIV-1 RNA was 3.88 log(10) copies/mL. Mean plasma
HIV-1 was lower during pregnancy (-.56 log(10) copies/mL; 95% confidence interval
[CI], -.77 to -.34) and after 6 weeks postpartum (-.51 log(10) copies/mL; 95% CI,
-.73 to -.30) in the valacyclovir arm than the placebo arm. Valacyclovir reduced
breast milk HIV-1 RNA detection at 6 and 14 weeks postpartum compared with
placebo (30% lower, P = .04; 46% lower, P = .01, respectively), but not after 14
weeks. Cervical HIV-1 RNA detection was similar between arms (P = .91).
CONCLUSIONS: Valacyclovir significantly decreased early breast milk and plasma
HIV-1 RNA among women receiving PMTCT.
CLINICAL TRIALS REGISTRATION: NCT00530777.
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