When pre-exposure prophylaxis was offered to transgender women and men who have sex with men in public health clinics, uptake was high, results from trials conducted in Brazil and the United States indicate.
The consensus from the science on pre-exposure prophylaxis is clear: "It works when it's taken," said Chris Beyrer, MD, president of the International AIDS Society (IAS).
The two trials tested how likely people were to take the drugs and adhere to treatment in real-world settings. Results from both were presented at the 8th IAS Conference in Vancouver, British Columbia, Canada.
The Demo Project was launched in October 2012, shortly after the US Food and Drug Administration approved pre-exposure prophylaxis. It is the first multisite open-label study conducted in the United States, and assessed treatment delivery in sexually transmitted infection clinics in San Francisco and Miami and community health clinics in Washington, DC.
The Demo Project
Participants were recruited when they were at the clinics for unrelated reasons or they were self-referred. They were offered 48 weeks of open-label emtricitabine and tenofovir (Truvada, Gilead Sciences).
Of the 921 people eligible for the study, 557 (60%) agreed to participate.
During the study period, adherence to treatment was high, according to Albert Liu, MD, from the San Francisco Department of Health.
Drug testing with dried blood spots indicated that 65% of participants were taking at least four doses of the drug a week, which is linked to high levels of protection, Dr Liu explained. Of the other participants, 3% always had levels consistent with fewer than two doses a week and 32% had an inconsistent pattern.
The incidence of HIV was low in this high-risk group. Sexually transmitted infections were common in the cohort, but did not increase during prophylaxis use, which highlights the importance of screening and treatment, he pointed out.
"Despite the high rates of sexually transmitted infections, we only saw two individuals who became infected during follow-up," he reported. And both had low or undetectable levels of pre-exposure prophylaxis.
"Adherence was higher among those with higher-risk behaviors, which will likely increase the cost-effectiveness," he added.
Uptake was higher in this study than in previous studies. Dr Liu said he attributes this, in part, to the fact that most of the participants were also part of previous studies. But "pre-exposure prophylaxis acceptability and knowledge of validity is increasing," and larger numbers of people are getting referred by their peers, he explained.
Prophylaxis isn't for everyone, Dr Liu acknowledged. It has to be an individual decision, but "for people who are interested in the strategy, I think it's worth having a discussion with your provider."
The PrEP Brasil demonstration project tested the feasibility of providing once-daily oral prophylaxis at no cost to high-risk men who have sex with men and transgender women being treated in the Brazilian public health system.
The Brazilian Experience
This is the first demonstration project for these populations — which have been at the center of the AIDS epidemic in Brazil — in a middle-income country.
Of the 798 eligible participants who were approached from April 2014 and April 2015, 409 (51.25%) were enrolled. This uptake is high for such populations, said Beatriz Grinsztejn, MD, from the STD/AIDS Clinical Research Laboratory at Instituto Pesquisa Clinica Evandro Chagas in Rio de Janeiro.
Median age at enrollment was 29 years, and 83.9% of the cohort identified as homosexual, 8.8% identified as bisexual, and 5.9% identified as transgender.
Use was high in those who perceived themselves to be at high risk and in those who were already aware of prophylaxis, which demonstrates that it is most likely to be used by those most in need, said Dr Grinsztejn.
This highlights the need for improving HIV risk perception and prophylaxis awareness in Brazil's high-risk communities, she added. The project was advertised through social and other media.
Dr Beyrer, Dr Liu, and Dr Grinsztejn have disclosed no relevant financial relationships.
8th International AIDS Society (IAS) Conference. Presented July 20, 2015.
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Cite this: HIV Pre-exposure Prophylaxis Popular in High-Risk Patients - Medscape - Jul 23, 2015.