DURBAN, South Africa and DURHAM, N.C. - Investigators from the HIV Prevention Trials Network (HPTN) today announced key results from the HPTN 073 Study at the International AIDS Conference (AIDS 2016) in Durban, South Africa. The study, which assessed uptake and adherence of oral pre-exposure prophylaxis (PrEP) for the prevention of HIV infection among Black men who have sex with men (BMSM) in the U.S., demonstrated consistency between self-report and biological markers of adherence. The new findings confirm the prior study report at CROI 2016 that showed high uptake and self-report of adherence of oral PrEP by participants in this study.
"The new report from HPTN 073 supports the primary research finding of high acceptability and uptake of oral PrEP among BMSM when combined with coordinated counseling," said Darrell P. Wheeler, Ph.D., M.P.H., 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. "The PrEP drug levels in the blood suggest about 60 percent of participants took four or more doses per week, which was previously demonstrated to protect MSM from HIV infection."
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. PrEP was accepted by 178 (79 percent) study participants. Among those continuing PrEP at week 26, 62 percent self-reported high adherence. Drug concentrations consistent with taking pills at least four times a week were also observed in approximately the same proportion of participants.
"In an environment of new modes of PrEP administration such as intravenous infusions and intramuscular injections, oral PrEP for BMSM is an effective strategy available now for those at risk and offer an option for those not able or willing to use other methods to be identified in the future," said Sheldon D. Fields, Ph.D., R.N., HPTN 073 protocol co-chair. "The findings from HPTN 073 demonstrate that when given the opportunity, BMSM are eager to engage in promoting their own health and well-being."
"The HPTN is committed to studying combination prevention strategies for populations at high-risk for HIV infection," said Wafaa El-Sadr M.D., M.P.H., HPTN co-principal investigator and professor of epidemiology and medicine at Columbia University. "Focusing on BMSM, a population at substantial risk for HIV in the U.S., is critically important. The C4 counselling approach offers great promise in helping to achieve high uptake and adherence with not only oral PrEP but other PrEP interventions in the future."
HPTN 073 was sponsored by the U.S. National Institute of Allergy and Infectious Diseases, of 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. NIH funds HPTN. For more information, visit http://www.