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

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.

• Authors: Julia L Marcus, David V Glidden, Vanessa McMahan, Javier R Lama, Kenneth H Mayer, Albert Y Liu, Orlando Montoya-Herrera, Martin Casapia, Brenda Hoagland, Robert M Grant
• Journal: PloS one (PLoS One) Vol. 9 Issue 3 Pg. e91513 ( 2014) ISSN: 1932-6203 [Electronic] United States
• PMID: 24637511 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Organophosphonates
• Deoxycytidine
• Tenofovir
• Emtricitabine
• Adenine

Topics

• Adenine (administration & dosage, analogs & derivatives)
• Adolescent
• Adult
• Aged
• Antiviral Agents (administration & dosage)
• Chemoprevention
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Emtricitabine
• Herpes Simplex (epidemiology, prevention & control, virology)
• Herpesvirus 2, Human (classification, drug effects)
• Homosexuality, Male
• Humans
• Incidence
• Male
• Middle Aged
• Organophosphonates (administration & dosage)
• Prevalence
• Risk Factors
• Tenofovir
• Young Adult