A new drug regimen requiring injections every eight weeks has shown to be more effective in preventing HIV infection than one in which a pill must be taken daily, researchers from the HIV Prevention Trials Network (HPTN) announced today at the 23rd International AIDS Conference.
Emory University was a key participant in the study, enrolling seven percent of the more than 4,500 participants worldwide.
The HPTN 083 clinical trial showed that a pre-exposure prophylaxis (PrEP) regimen of long-acting cabotegravir (CAB LA) injected once every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men. HPTN 083 is a randomized, controlled, double-blind study comparing the safety and efficacy of a regimen including CAB LA to daily TDF/FTC at 43 sites around the world.
"This groundbreaking study has the potential to change the landscape of HIV prevention," says Carlos del Rio, MD, executive associate dean, Emory University School of Medicine at Grady Health System. Del Rio is a member of the study team and the principal investigator at the Ponce de Leon Center, one of the largest, most comprehensive facilities dedicated to the treatment of advanced HIV/AIDS in the United States.
"More options for HIV prevention mean that we have taken an important step toward ending this deadly epidemic," says del Rio.
Colleen Kelley, MD, MPH, associate professor at Emory University School of Medicine, served as the principal investigator at Emory's Hope Clinic, which was the third-highest enrolling site in the United States.
"We know that some people either don't want to take pills or have trouble remembering to take a pill every day," says Kelley. "Giving people options that work for them is critical in combatting HIV."
Emory enrolled volunteers in the study at The Hope Clinic (86 participants); and the Ponce de Leon Center (35 participants) in Atlanta as well as at their partner site the U.S. Centers for Disease Control and Prevention's Silom Community Clinic in Bangkok, Thailand (203 participants).
An independent Data and Safety Monitoring Board (DSMB) that reviewed interim study data in May found that the PrEP regimen including CAB LA injected once every eight weeks safely and effectively prevented HIV acquisition in the study population. Consequently, the DSMB recommended stopping the blinded comparison, offering CAB to all study participants, and disseminating the results. The final analysis of these data demonstrates the superiority of CAB compared to TDF/FTC for PrEP in the HPTN 083 study population.
For more on the study results see the release from The HIV Prevention Trials Network.
Separately, an ongoing study, HPTN 084, is comparing the safety and efficacy of CAB LA to oral TDF/FTC for PrEP among cisgender women in sub-Saharan Africa. This study began approximately a year after the launch of HPTN 083 and was also reviewed in May by the DSMB, which recommended that the study continue as planned. Emory is also participating in that study, enrolling participants in Kisumu, Kenya.
The HPTN 083 study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and jointly funded by NIAID and ViiV Healthcare. Study product is provided by ViiV Healthcare and Gilead Sciences, Inc.
About the HIV Prevention Trials Network
The HPTN is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. NIAID, NIMH, Office of The Director, and NIDA, all part of NIH, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations that bear a disproportionate burden of infection. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – 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
