HSV-2 acquisition among HIV-1 infected adults treated with tenofovir as part of combination antiretroviral therapy: Results from the ACTG A5175 PEARLS study.

Objective: Tenofovir has in vitro activity against HSV-2 and reduced HSV-2 acquisition as pre-exposure prophylaxis. Whether tenofovir-containing antiretroviral therapy (ART) reduces HSV-2 acquisition is unknown.

Design: Secondary analysis of ACTG A5175, a randomized, open-label study of three ART regimens among 1,571 participants.

Methods: HSV-2 serostatus was assessed at baseline, exit and prior to ART change.

Results: Of 365 HSV-2 seronegative persons, 68 acquired HSV-2 with 24 on tenofovir-containing ART and 44 on ART without tenofovir (HSV-2 incidence 6.42 and 6.63/100 person-years, respectively; Hazard Ratio 0.89; 95% Confidence Interval 0.55-1.44).

Conclusions: HSV-2 acquisition was not reduced in HIV-infected, HSV-2 uninfected persons on tenofovir-containing ART.