Tenofovir gel for prevention of herpes simplex virus type 2 acquisition: Findings from the VOICE trial

for the VOICE Study Team

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Genital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study. Methods. We measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis. The TFV level in plasma at the first quarterly visit was used as a measure of gel use. Results. Of 566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study HSV-2 serologic data available. Over a follow-up period of 501 person-years, 92 incident cases of HSV-2 acquisition occurred: 77 were in women with no TFV detected in plasma, and 15 occurred in women with TFV detected in plasma (incidence, 20.6 cases/100 personyears [95% confidence interval [CI], 16.2-25.7] vs 11.9 cases/100 person-years [95% CI, 6.6-19.6], respectively). TFV detection in plasma was associated with a trend toward a reduced risk of HSV-2 seroconversion, with an unadjusted hazard ratio (HR) of 0.59 (95% CI,.34-1.02; P =.060) and a HR adjusted for site, age, having ≥2 male sex partners in the past 3 months, use of hormonal contraception, having anal sex in the past 3 months, and HIV status of 0.60 (95% CI,.33-1.08; P =.086). Conclusions. Detection of TFV in plasma among TFV gel users was associated with a trend toward a reduced risk of HSV-2 acquisition, after controlling for sexual behavior and HIV-1 acquisition.

Original languageEnglish (US)
Pages (from-to)1940-1947
Number of pages8
JournalJournal of Infectious Diseases
Volume219
Issue number12
DOIs
StatePublished - Jun 1 2019

Keywords

  • Genital herpes
  • HIV-1
  • Herpes simplex virus
  • Preexposure prophylaxis
  • Tenofovir

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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