Abstract
ObjectiveHerpes simplex virus type 2 (HSV-2) suppression has been shown to reduce HIV-1 disease progression in non-pregnant women and men, but effects on pregnant and postpartum women have not been described.MethodsWe analyzed data from a cohort of Kenyan women participating in a randomized clinical trial of HSV-2 suppression. Pregnant HIV-1-seropositive, HSV-2-seropositive women who were not eligible for antiretroviral therapy (WHO stage 1–2, CD4>250 cells/µl) were randomized to either 500 mg valacyclovir or placebo twice daily from 34 weeks gestation through 12 months postpartum. Women received zidovudine and single-dose nevirapine for prevention of mother-to-child HIV-1 transmission. HIV-1 progression markers, including CD4 count and plasma HIV-1 RNA levels, were measured serially. Multivariate linear regression was used to compare progression markers between study arms.ResultsOf 148 women randomized, 136 (92%) completed 12 months of postpartum follow-up. While adjusted mean CD4 count at 12 months (565 cells/µl placebo arm, 638 cells/µl valacyclovir arm) increased from antenatal levels in both arms, the mean CD4 count increase was 73 cells/µl higher in the valacyclovir arm than placebo arm (p = 0.03). Mean increase in CD4 count was 154 cells/µl in the valacyclovir arm, almost double the increase of 78 cells/µl in the placebo arm. At 12 months, adjusted HIV-1 RNA levels in the placebo arm increased by 0.66 log10 copies/ml from baseline, and increased by only 0.21 log10 copies/ml in the valacyclovir arm (0.40 log10 copies/ml difference, p = 0.001).ConclusionWomen randomized to valacyclovir suppressive therapy during pregnancy and postpartum had greater increases in CD4 counts and smaller increases in plasma HIV-1 RNA levels than women in the placebo arm. Valacyclovir suppression during pregnancy and breastfeeding may improve outcomes and delay antiretroviral therapy for HIV-1/HSV-2 co-infected women.
Highlights
Addressing herpes simplex virus type 2 (HSV-2) co-infection may be a pathway to improving health of HIV-1 infected mothers
Study Outcomes The primary outcomes of this nested study were CD4 counts and log10 plasma HIV-1 RNA levels compared between participants in the two study arms
Our study of daily valacyclovir during late pregnancy and postpartum showed a significant increase in CD4 counts among women in the valacyclovir arm at 12 months postpartum
Summary
Addressing herpes simplex virus type 2 (HSV-2) co-infection may be a pathway to improving health of HIV-1 infected mothers.More than 80% of HIV-1-seropositive women in sub-Saharan Africa are co-infected with HSV-2 [1]. Trials of herpes virus suppression in HIV-1/ HSV-2 co-infected persons have consistently shown reductions in HIV-1 plasma RNA levels, but these trials have excluded pregnant women [4,5,6,7,8,9,10,11]. Recent randomized clinical trials of acyclovir for herpes suppression in co-infected persons have demonstrated 16–25% reductions in HIV-1 disease progression endpoints over 2 years of follow-up [12,13]. Progression endpoints for both studies included CD4 thresholds and evidence of clinical disease progression including non-traumatic death and/or ART initiation
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
