No impact of oral tenofovir disoproxil fumarate on herpes simplex virus shedding in HIV-infected adults.

OBJECTIVE: to determine the impact of oral tenofovir as part of combination antiretroviral therapy on asymptomatic herpes simplex virus (HSV) shedding.
DESIGN: observational study of a cohort of HSV, HIV-1 co-infected adults.
METHODS: HSV infection was diagnosed using type-specific serology (HerpeSelect ELISA, Focus Technologies). Asymptomatic HSV, HIV-1 co-infected individuals achieving HIV viral load below 50 copies/ml on antiretroviral therapy self-collected oral, genital and anal swabs daily for 28 days. Refrigerated specimens were dropped off weekly for HSV-1 and HSV-2 testing by polymerase chain reaction (PCR). Shedding rate was calculated as the proportion of days on which HSV PCR was positive.
RESULTS: : Forty co-infected patients were enrolled, of whom 30 were HSV-2 seropositive. Tenofovir was part of the antiretroviral regimen in 22 of 40 (55%) participants overall and 17 of 30 (57%) of HSV-2 infected participants. The median (interquartile range) HSV-2 shedding rate among HSV-2 seropositive participants was low, at 7.1% (0, 14.3) of specimen collection days, and did not differ between tenofovir users and nonusers (P = 0.36). There was no difference in the number of HSV-2 shedders in the tenofovir and nontenofovir groups (59 vs. 46%; P = 0.49). Rates of shedding for HSV-1 alone (P = 0.59), and for either HSV-1 or HSV-2 (P = 0.38), were also similar between tenofovir users and nonusers.
CONCLUSION: although topical tenofovir 1% gel was associated with a significant decrease in HSV-2 acquisition among high-risk women in the recent CAPRISA 004 trial, in these preliminary data we did not observe an impact of oral tenofovir on HSV-2 or HSV-1 shedding rates among HIV, HSV co-infected asymptomatic adults. 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.