title: Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels during pregnancy and postpartum: a randomized trial.
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.
  
  
  BACKGROUND
  NCT00530777.
authors.affiliation: Department of Global Health, University of Washington, Seattle 98195-7236, USA. adrake2@uw.edu
authors.forename: Alison L
authors.initials: AL
authors.lastname: Drake
authors.forename: Alison C
authors.initials: AC
authors.lastname: Roxby
authors.forename: Francisca
authors.initials: F
authors.lastname: Ongecha-Owuor
authors.forename: James
authors.initials: J
authors.lastname: Kiarie
authors.forename: Grace
authors.initials: G
authors.lastname: John-Stewart
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Barbra A
authors.initials: BA
authors.lastname: Richardson
authors.forename: Jane
authors.initials: J
authors.lastname: Hitti
authors.forename: Julie
authors.initials: J
authors.lastname: Overbaugh
authors.forename: Sandra
authors.initials: S
authors.lastname: Emery
authors.forename: Carey
authors.initials: C
authors.lastname: Farquhar
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D007630:Kenya; D008895:Milk, Human / Q000821:virology*; D019829:Nevirapine / Q000008:administration & dosage; D010919:Placebos / Q000008:administration & dosage; D010949:Plasma / Q000821:virology*; D049590:Postpartum Period; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D012367:RNA, Viral / Q000032:analysis / Q000097:blood / Q000302:isolation & purification; D016896:Treatment Outcome; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D019562:Viral Load; D055815:Young Adult; D015215:Zidovudine / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D010919:Placebos; D012367:RNA, Viral; D015215:Zidovudine; D019829:Nevirapine; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir