BOSTON and DURHAM, N.C. - Investigators from the HIV Prevention Trials Network (HPTN) today announced key results from the HPTN 073 Study at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts. The study showed high uptake of pre-exposure prophylaxis (PrEP) for prevention of HIV infection among Black men who have sex with men (BMSM) in the U.S. with the use of a novel coordinated counseling and care approach resulting in findings suggestive of a lower rate of HIV infection.
"Black men who have sex with men are at alarming risk for HIV infection. While comprising less than 0.4 percent of the U.S. population, they accounted for more than 20 percent of all new infections in 2013," said Darrell P. Wheeler, PhD, MPH, HPTN 073 protocol chair and vice provost for public engagement and dean of the School of Social Welfare at the State University of New York (SUNY) at Albany. "It is heartening that use of coordinated counseling intervention with the offer of emtricitabine/tenofovir for PrEP resulted in high uptake of PrEP and offers the possibility for its use in future efforts."
A total of 226 HIV-uninfected BMSM were enrolled in three U.S. cities (Washington, D.C., Los Angeles and Chapel Hill, N.C.). All participants were offered once daily oral emtricitabine and tenofovir (FTC/TDF, the two drugs contained in Truvada) combined with client-centered care coordination (C4), a theory-based counseling approach to promote and support PrEP use, which combined service referral, linkage and follow-up strategies to assist participants in addressing unmet psychosocial needs.
Each participant was offered PrEP and followed for a total of 12 months with HIV testing every three months. A total of 209 participants (92%) completed the 12 months of follow-up. PrEP was accepted by 178 (79%) of study participants; 68% indicated they were continuing PrEP at 26 weeks. Those agreeing to take PrEP utilized a median of six C4 sessions compared to a median of four sessions by men not accepting PrEP. Among the 178 men who ever accepted PrEP in this study, five HIV infections occurred (incidence=2.9 95%CI:0.9-6.8); two of these men reported they had discontinued PrEP 50 and 272 days prior to first testing positive for HIV. Among the 48 men who never accepted PrEP, three became HIV infected (incidence=7.7 95%CI: 1.6-22.5). The study was not designed to evaluate the efficacy of FTC/TDF PrEP for HIV prevention.
"HPTN 073 is one of the first studies to evaluate PrEP in a U.S. BMSM population and supports the principles, priorities and actions of the National HIV/AIDS Strategy," said Sheldon D. Fields, PhD, RN, HPTN 073 protocol co-chair and dean and professor of the Mervyn M. Dymally School of Nursing at Charles R. Drew University of Medicine and Science in Los Angeles. "These findings help address a vital U.S. public health gap in HIV prevention and demonstrate that when given the opportunity, BMSM are eager to engage in promoting their own health and well-being."
"The HPTN is committed to using integrated strategies that enable populations at high risk for HIV infection to garner the benefits from prevention tools that we know work," said Wafaa El-Sadr MD, MPH, HPTN principal investigator and professor of epidemiology and medicine at Columbia University. "Further research is needed to confront the high risk for new HIV infections among BMSM in the US."
HPTN 073 was sponsored by the U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute on Drug Abuse, and the U.S. National Institutes of Health. Study drug was provided by Gilead Sciences, Inc.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions.