Effect of On-Demand Oral Pre-exposure Prophylaxis With Tenofovir/Emtricitabine on Herpes Simplex Virus-1/2 Incidence Among Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Trial

Abstract

We evaluated the impact of on-demand oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for pre-exposure prophylaxis (PrEP) on herpes simplex virus (HSV)-1/2 incidence among men who have sex with men (MSM) enrolled in the ANRS IPERGAY trial. Serum samples were tested at baseline and at the last visit for HSV-1/2 antibodies. Overall HSV-1 incidence was 11.7 per 100 person-years; 16.2 and 7.8 per 100 person-years in the TDF/FTC and placebo arm, respectively (P = .19). Overall HSV-2 incidence was 7.6 per 100 person-years; 8.1 and 7.0 per 100 person-years in the TDF/FTC and placebo arm, respectively (P = .75). On-demand oral PrEP with TDF/FTC failed to reduce HSV-1/2 incidence in this population.

Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection

“…The current first line therapies for chronic HBV infection also includes TDF and TAF, which have proven to be well-tolerated and also highly effective in preventing liver fibrosis progression [ 62 , 63 , 64 ]. Further, tenofovir has been proposed to reduce the risk of herpes simplex virus 1 and 2 (HSV-1, HSV-2) infections, although studies have shown conflicting results [ 65 , 66 , 67 , 68 ].…”

Interest in Hypothetical Preexposure Prophylaxis Against Herpes Simplex Virus: A Cross-Sectional Survey

“…We observed considerable interest in HSV PrEP among gbMSM, suggesting that further study is warranted. Assuming HSV-2 incidence is 7.6/100 person-years, 9 a placebo-controlled trial would require 635 gbMSM per arm to detect a relative risk of 0.5 with α = 0.05 and 80% power. Future studies should address patient preferences (acceptable levels of prevention efficacy, costs, feasibility of combining with HIV PrEP, interest in HSV prevention as a strategy for HIV prevention), willingness to participate in clinical trials, and seroprevalence in candidate study populations.…”

“… 7 Preexposure prophylaxis (PrEP) is a successful strategy for preventing new HIV infections and may warrant study in clinical trials for HSV prevention if acceptable to populations at risk. Given the high prevalence 8 and incidence 9 of HSV-1 and HSV-2 among gay, bisexual, and other men who have sex with men (gbMSM), this population may be particularly motivated to take HSV PrEP, were it to become available. We quantified interest in hypothetical HSV PrEP among gbMSM attending sexual health clinics in 2 Canadian cities.…”

Current Drugs to Treat Infections with Herpes Simplex Viruses-1 and -2

“…Studies were originally designed to assess daily oral emtricitabine plus tenofovir (FTC/TDF) as a means to protect HIV-negative partners from acquiring that virus from HIV-positive partners [ 85 ]. As a side effect, it was shown that the same nucleoside/nucleotide analog regimen used to combat HIV-1 seroconversion could also reduce the risk of acquiring HSV-2 to 2.1 incidents per 100 person-years [ 86 ]; however, one study found that emtricitabine alone did not wholly lessen the chance of contracting HSV-2 [ 82 ]. Depending on the amount and means of drug delivery among other existing variables, FTC/TDF has been found to be effective at reducing the presence and severity of genital ulcers, a common HSV symptom [ 82 ].…”