Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial

Abstract

A randomized cross-over trial of herpes simplex virus type 2 (HSV-2)-suppressive therapy (valacyclovir, 500 mg twice daily, or placebo for 8 weeks, a 2-week washout period, then the alternative therapy for 8 weeks) was conducted among 20 Peruvian women coinfected with HSV-2 and human immunodeficiency virus type 1 (HIV-1) who were not on antiretroviral therapy. Plasma samples (obtained weekly) and endocervical swab specimens (obtained thrice weekly) were collected for HIV-1 RNA polymerase chain reaction. Plasma HIV-1 level was significantly lower during the valacyclovir arm, compared with the placebo arm (-0.26 log10 copies/mL, a 45% decrease [P < .001]), as was cervical HIV-1 level (-0.35 log10 copies/swab, a 55% decrease [P < .001]). Suppressive HSV-2 therapy has the potential to reduce HIV-1 infectiousness and slow HIV-1 disease progression.

Trial registration: ClinicalTrials.gov NCT00465205.

Conflict of interest statement

Potential conflicts of interest: C.C. has received research grant support from the GlaxoSmithKline (GSK) and has served on an advisory board for GSK. J.S. has received grant support from GSK. A.W. has received grant support GSK, Antigenics, 3M, Roche, and Vical; she is a consultant for Novartis, PowderMed, and MediGene and is a speaker for Merck Vaccines. The University of Washington Virology Division Laboratories have received grant funding from GSK and Novartis to perform herpes simplex virus serologic assays and polymerase chain reaction assays for studies funded by these companies. L.C. directs these laboratories. He receives no salary support from these grants.

Figures

Figure 1

HIV-1 concentrations in plasma (A) and cervical (B) samples, for each study participant, stratified by treatment arm (blue = placebo, green = valacyclovir). Circles represent the mean and brackets indicate 1 SD. Undetectable levels were imputed at the midpoint between zero and the lower limit of quantification.

Figure 1

HIV-1 concentrations in plasma (A) and cervical (B) samples, for each study participant, stratified by treatment arm (blue = placebo, green = valacyclovir). Circles represent the mean and brackets indicate 1 SD. Undetectable levels were imputed at the midpoint between zero and the lower limit of quantification.