Daily Oral Emtricitabine/Tenofovir Preexposure Prophylaxis and Herpes Simplex Virus Type 2 among Men Who Have Sex with Men

Sep 27, 2026

Uploaded by James

The study evaluates whether daily oral emtricitabine/tenofovir (FTC/TDF) preexposure prophylaxis influences herpes simplex virus type 2 (HSV-2) acquisition and ulcer development in men who have sex with men (MSM) in the iPrEx trial. HSV-2 serum testing occurred at baseline and every six months. Among HSV-2–seronegative participants, Cox models compared FTC/TDF with placebo and accounted for drug exposure; ulcer outcomes were assessed in prevalent or incident HSV-2 infection.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusions

Introduction

Daily Oral Emtricitabine/Tenofovir Preexposure Prophylaxis and Herpes Simplex Virus Type 2 among Men Who Have Sex with Men Julia L. Marcus 1,2, David V. Glidden3, Vanessa McMahan 1, Javier R. Lama4, Kenneth H. Mayer5,6, Albert Y. Liu7, Orlando Montoya-Herrera8, Martin Casapia9, Brenda Hoagland10, Robert M. Grant 1,3* 1 Gladstone Institute of Virology and Immunology, San Francisco, California, United States or America, 2 University of California, Berkeley, California, United States of America, 3University of California San Francisco, San Francisco, California, United States of America, 4Asociaci´on Civil Impacta Salud y Educaci´on, Lima, Peru, 5Fenway Institute, Fenway Health, Boston, Massachusetts, United States of America, 6Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America, 7Bridge HIV, San Francisco Department of Public Health, San Francisco, California, United States of America, 8 Fundaci´on Ecuatoriana Equidad, Guayaquil, Guayas, Ecuador, 9Asociaci´ ´on Civil Selva Amazonica, Iquitos, Peru, 10 Instituto de Pesquisa Cl´ınica Evandro Chagas, Funda˜ao Oswaldo Cruz, Rio de Janeiro, Brazil | Abstract
Background: In addition to protecting against HIV acquisition, antiretroviral preexposure prophylaxis (PrEP) using topical 1% tenofovir gel reduced Herpes simplex virus type 2 (HSV-2) acquisition by 51% among women in the CAPRISA 004 study. We examined the effect of daily oral emtricitabine/tenofovir (FTC/TDF) PrEP on HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial.
Methods: HSV-2 serum testing was performed at screening and every six months. Among HSV-2-seronegative individuals, we used Cox regression models to estimate hazard ratios (HRs) of HSV-2 seroincidence associated with randomization to FTC/TDF. We used multiple imputation and Cox regression to estimate HRs for HSV-2 seroincidence accounting for drug exposure. We assessed ulcer occurrence among participants with prevalent or incident HSV-2 infection.
Results: Of the 2,499 participants, 1383 (55.3%) tested HSV-2-seronegative at baseline, 892 (35.7%) tested positive, 223 (8.9%) had indeterminate tests, and one test was not done. Of the 1,347 HSV-2-seronegative participants with follow-up, 125 (9.3%) had incident HSV-2 infection (5.9 per 100 person-years) . Compared with participants receiving placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF (HR 1.1, 95% CI: 0.8–1.5; P= 0.64) or among participants receiving FTC/TDF with a concentration of tenofovir diphosphate .16 per million viable cells (HR 1.0, 95% CI: 0.3–3.5; P= 0.95) . Among participants with HSV-2 infection, the proportion with $ 1 moderate or severe ulcer adverse event was twice as high in the placebo [vs. active](vs. active) arm (5.9% vs. 2.9%, P= 0.02), but there were no differences in the proportions with $ 1 clinical examination during which perianal or groin ulcers were identified.
Conclusions: Tenofovir in daily oral FTC/TDF PrEP may reduce the occurrence of ulcers in individuals with HSV-2 infection but does not protect against HSV-2 incidence among MSM. | | --- | | Citation: Marcus JL, Glidden DV, McMahan V, Lama JR, Mayer KH, et al. (2014) Daily Oral Emtricitabine/Tenofovir Preexposure Prophylaxis and Herpes Simplex
Virus Type 2 among Men Who Have Sex with Men. PLoS ONE 9(3): e91513 . doi:10.1371/journal.pone.0091513
Editor: D. William Cameron, University of Ottawa, Canada
Received October 25, 2013; Accepted February 8, 2014; Published March 17, 2014
Copyright: 􀀂 2014 Marcus et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was supported by the Division of Acquired Immunodeficiency Syndrome, National Institute of Allergy and Infectious Dis

FAQs

What is the main research question of this study?

Whether daily oral FTC/TDF PrEP affects HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial.

How was HSV-2 infection measured during the trial?

HSV-2 serum testing was performed at screening and then every six months, allowing classification of participants as HSV-2–seronegative or positive over time.

What did the study find about HSV-2 incidence with FTC/TDF?

Compared with placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF, including when considering tenofovir diphosphate concentration.

What did the study find regarding ulcers in participants with HSV-2 infection?

Among participants with HSV-2 infection, moderate or severe ulcer adverse events were more frequent in the placebo arm than in the active arm, while perianal or groin ulcer findings on clinical examination did not differ.

Sep 27, 2026

Uploaded by James