(HealthDay News) — Additional data supports daily pre-exposure prophylaxis (PrEP) for HIV-negative gay men at high risk for infection. The findings were reported online September 9 in The Lancet.
A team of researchers led by Sheena McCormack, of the Medical Research Council clinical trials unit at University College London, sought to investigate PrEP in the PROUD study. The randomized trial, which was conducted at 13 sexual health clinics in England, involved HIV-negative gay men who had had anal sex at least once without a condom within 90 days. The researchers randomly assigned 275 of the men to receive tenofovir disoproxil fumarate (245mg) and emtricitabine (200mg) immediately. Another 269 men received the treatment after a delay of one year. The researchers conducted a follow-up with the men every three months. The participants and the researchers were aware of their assigned treatment group.
Based on early findings suggesting that PrEP is highly effective, the trial steering committee recommended in October 2014 that all participants in the delayed-treatment group be offered the preventive treatment. Among the men who received treatment right away, three HIV infections occurred, compared to 20 in the delayed-treatment group. The researchers calculated that those in the immediate-treatment group had an 86% relative reduction in their risk for infection compared to the group that received delayed treatment. The prevalence of sexually transmitted infections, such as syphilis, gonorrhea, or chlamydia, was similar in both treatment groups.
“The PROUD results show that PrEP should be part of the range of services offered by any clinical program that focuses on sexual health,” write the authors of an accompanying editorial. “The time for cautionary speculation is over: HIV prevention services should be expanded worldwide by offering PrEP routinely to those who could benefit.”
The study was funded in part by Gilead Sciences, the manufacturer of tenofovir disoproxil fumarate and emtricitabine (Truvada).