Valacyclovir Decreases Plasma HIV-1 RNA in HSV-2 Seronegative Individuals: A Randomized Placebo-Controlled Crossover Trial

Clin Infect Dis. 2015 Jun 1;60(11):1708-14. doi: 10.1093/cid/civ172. Epub 2015 Mar 3.

Abstract

Background: Acyclovir (ACV), a highly specific anti-herpetic drug, acts as a DNA chain terminator for several human herpesviruses (HHVs), including HHV-2 (HSV-2), a common human immunodeficiency virus (HIV)-1 co-pathogen. Several trials demonstrated that HSV-2 suppressive therapy using ACV or its prodrug valacyclovir (valACV) reduced plasma HIV-1 viral load (VL) in HIV-1/HSV-2 coinfected persons, and this was proposed to be due to a decrease in generalized immune activation. Recently, however, we found that ACV directly suppresses HIV-1 ex vivo in tissues free of HSV-2 but endogenously coinfected with other HHVs. Here, we asked whether valACV suppresses VL in HIV-1 infected HSV-2-seronegative persons.

Methods: Eighteen HIV-1 infected HSV-2-seronegative individuals were randomly assigned in a double blind placebo-controlled, crossover trial. Eligible participants had CD4 cell counts of ≥500 cells/µL and were not taking antiretroviral therapy. Subjects in group A received 12 weeks of valACV 500 mg given twice daily by mouth followed by 2 weeks of a no treatment washout and then 12 weeks of placebo; subjects in group B received 12 weeks of placebo followed by 2 weeks of no treatment washout and then 12 weeks of valACV 500 mg twice daily.

Results: HIV-1 VL in plasma of patients treated with valACV 500 mg twice daily for 12 weeks was reduced on average by 0.37 log10 copies/mL.

Conclusions: These data indicate that the effects of valACV on HIV-1 replication are not related to the suppression of HSV-2-mediated inflammation and are consistent with a direct effect of ACV on HIV-1 replication.

Keywords: HIV-1; HSV-2; acyclovir; herpesvirus; reverse transcriptase inhibitor.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Acyclovir / administration & dosage
  • Acyclovir / analogs & derivatives*
  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Cross-Over Studies
  • Female
  • HIV Infections / virology*
  • HIV-1 / isolation & purification*
  • Humans
  • Male
  • Placebos / administration & dosage
  • Plasma / virology*
  • RNA, Viral / blood*
  • Valacyclovir
  • Valine / administration & dosage
  • Valine / analogs & derivatives*
  • Viral Load*
  • Virus Replication / drug effects
  • Young Adult

Substances

  • Anti-HIV Agents
  • Placebos
  • RNA, Viral
  • Valine
  • Valacyclovir
  • Acyclovir