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DAILY ORAL EMTRICITABINE/TENOFOVIR PREEXPOSURE PROPHYLAXIS AND HERPES SIMPLEX VIRUS TYPE 2 AMONG MEN WHO HAVE SEX WITH MEN
Author
Affilliation
Gladstone Institute of Virology and Immunology. San Francisco, CA, United States of America / University of California. Berkeley, CA, United States of America
University of California San Francisco. San Francisco, CA, United States of America
Gladstone Institute of Virology and Immunology. San Francisco, CA, United States of America
Asociación Civil Impacta Salud y Educación. Lima, Peru
Fenway Institute. Fenway Health. Boston, MA, United States of America / Beth Israel Deaconess Medical Center. Boston, MA, United States of America
Bridge HIV. San Francisco Department of Public Health. San Francisco, CA, United States of America
Fundación Ecuatoriana Equidad. Guayaquil, Ecuador
Asociación Civil Selva Amazónica. Iquitos, Peru
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasi
Gladstone Institute of Virology and Immunology. San Francisco, CA, United States of America / University of California San Francisco. San Francisco, CA, United States of America
University of California San Francisco. San Francisco, CA, United States of America
Gladstone Institute of Virology and Immunology. San Francisco, CA, United States of America
Asociación Civil Impacta Salud y Educación. Lima, Peru
Fenway Institute. Fenway Health. Boston, MA, United States of America / Beth Israel Deaconess Medical Center. Boston, MA, United States of America
Bridge HIV. San Francisco Department of Public Health. San Francisco, CA, United States of America
Fundación Ecuatoriana Equidad. Guayaquil, Ecuador
Asociación Civil Selva Amazónica. Iquitos, Peru
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasi
Gladstone Institute of Virology and Immunology. San Francisco, CA, United States of America / University of California San Francisco. San Francisco, CA, United States of America
Abstract
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.
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