Pam Harrison

June 20, 2014

When gay and bisexual men are offered pre-exposure prophylaxis (PrEP) as part of a comprehensive prevention program, uptake is high, results from the PrEP Demonstration Project show.

"We now have strong evidence from several clinical trials that oral PrEP with emtricitabine/tenofovir [Truvada, Gilead Sciences] is safe and effective for HIV prevention," said Albert Liu, MD, MPH, from Bridge HIV at the San Francisco Department of Public Health. "However, despite this, PrEP uptake appears to be slow."

He explained that he and his colleagues started the demo project to figure out how to increase PrEP uptake in high-risk HIV-negative individuals.

Dr. Liu presented the results at the 9th International Conference on HIV Treatment and Prevention Adherence in Miami.

The project was implemented at 2 sexually transmitted infection clinics — one in San Francisco and the other in Miami — and at a community health center in Washington, DC. Enrolment at each of the 3 sites was rapid because communities made an effort to raise awareness and word of mouth was good.

"But I also think that offering PrEP as part of a comprehensive prevention program in these clinics [worked because it] provided a setting where people could access treatment in the context of their overall sexual healthcare," Dr. Liu explained.

During the enrolment period, self-referrals to the project rose from about 30% in the first 3 months to over 50% in the last 3 months. In fact, some sites had a waiting list of several months for men who wanted to be involved.

Demo Project

Potential participants were approached in the clinic while they were receiving services for an unrelated matter or were self-referred to the program.

Of the 921 individuals potentially eligible for the project, 364 declined, leaving 557 participants — an overall uptake of about 60%.

Participants were provided with open-label emtricitabine/tenofovir during the 48-week study period.

Four weeks after enrolment, a random sample of 136 participants underwent dried blood spot testing. Levels of tenofovir diphosphate indicated that adherence to prophylactic antiretroviral therapy was high.

In fact, most participants (77%) had a level consistent with taking at least 4 doses of PrEP per week.

Longitudinal Analyses

At multiple time points during the study period, 90 participants were also tested for tenofovir diphosphate concentrations.

In this group, "most participants had drug concentrations consistent with taking 4 or more doses per week at all visits tested, so there does not seem to be a lot of drop off," Dr. Liu reported. Previous studies have suggested that taking at least 4 doses per week of PrEP is associated with substantial levels of protection against HIV infection.

"Our preliminary data on adherence to PrEP are encouraging," Dr. Liu told Medscape Medical News.

"Almost all the men who were tested had drug detected in their system, and the majority were taking the drug consistently, which likely was affording them substantial levels of protection from HIV," he explained. "Still, these are early results, so it will be important to continue to follow this cohort."

Dr. Liu noted that efforts are needed to increase awareness of PrEP in the transgender community, another group heavily impacted by HIV.

These results demonstrate that when PrEP is offered to men who have sex with men in destigmatized environments, uptake is strong and adherence is robust enough to achieve its preventive benefit, said José Zuniga, PhD, MPH, who is president and chief executive officer of the International Association of Physicians in AIDS Care (IAPAC).

"That the results were replicated in a primary care setting — a community health center — is welcome news, particularly given that millions of Americans access healthcare services through this country's 7000-plus community health centers," he added.

"This PrEP scale-up model should be replicated nationwide, with additional emphasis placed on reaching key affected populations, including transgender individuals," Dr. Zuniga concluded.

The study was funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health. Dr. Liu and Dr. Zuniga have disclosed no relevant financial relationships.

9th International Conference on HIV Treatment and Prevention Adherence: Abstract 377. Presented June 9, 2014.


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