Valacyclovir Suppressive Therapy Reduces Plasma and Breast Milk HIV-1 RNA Levels During Pregnancy and Postpartum: A Randomized Trial.

Publication Type:

Journal Article

Source:

The Journal of infectious diseases, Volume 205, Issue 3, p.366-75 (2012)

Keywords:

2012, Acyclovir, Adolescent, Adult, Anti-HIV Agents, Center-Authored Paper, Double-Blind Method, Female, HIV Infections, HIV-1, Human Biology Division, Humans, Infectious Disease Transmission, Vertical, January 2012, Milk, Human, Nevirapine, Placebos, PLASMA, Postpartum Period, PREGNANCY, Pregnancy Complications, Infectious, Treatment Outcome, Vaccine and Infectious Disease Division, Valine, Viral, Viral Load, Young Adult, Zidovudine

Abstract:

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.