Format

Send to

Choose Destination
See comment in PubMed Commons below
PLoS One. 2014 Mar 17;9(3):e91513. doi: 10.1371/journal.pone.0091513. eCollection 2014.

Daily oral emtricitabine/tenofovir preexposure prophylaxis and herpes simplex virus type 2 among men who have sex with men.

Author information

1
Gladstone Institute of Virology and Immunology, San Francisco, California, United States or America; University of California, Berkeley, California, United States of America.
2
University of California San Francisco, San Francisco, California, United States of America.
3
Gladstone Institute of Virology and Immunology, San Francisco, California, United States or America.
4
Asociación Civil Impacta Salud y Educación, Lima, Peru.
5
Fenway Institute, Fenway Health, Boston, Massachusetts, United States of America; Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
6
Bridge HIV, San Francisco Department of Public Health, San Francisco, California, United States of America.
7
Fundación Ecuatoriana Equidad, Guayaquil, Guayas, Ecuador.
8
Asociación Civil Selva Amazónica, Iquitos, Peru.
9
Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
10
Gladstone Institute of Virology and Immunology, San Francisco, California, United States or America; University of California San Francisco, San Francisco, California, United States of America.

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 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.

PMID:
24637511
PMCID:
PMC3956614
DOI:
10.1371/journal.pone.0091513
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments

    Supplemental Content

    Full text links

    Icon for Public Library of Science Icon for PubMed Central
    Loading ...
    Support Center