Both cabotegravir and oral FTC/TDF have high efficacy for PrEP among women in sub-Saharan Africa
Durham, N.C., Nov. 09, 2020 (GLOBE NEWSWIRE) — Researchers from the HIV Prevention Trials Network (HPTN) announced today data from the HPTN 084 clinical trial indicate that a pre-exposure prophylaxis (PrEP) regimen of long-acting
NIAID has accepted the DSMB’s recommendations and is releasing the results in the interest of public health. The study investigators will provide more detailed information about the study findings, including more comprehensive data, as soon as is feasible. The HPTN 084 study is jointly-funded through a unique partnership between NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study drugs are provided by ViiV Healthcare and Gilead Sciences, Inc.
“The results from HPTN 084 are incredibly important for women in Africa where lowering HIV incidence remains a priority,” said Dr. Sinead Delany-Moretlwe, HPTN 084
Overall, HPTN 084 enrolled 3,223 cisgender
“After years of evaluating HIV prevention strategies for women, I am thrilled that we have found CAB LA so effectively reduces HIV acquisition and provides women more choices in how to protect themselves,” said Dr. Mina Hosseinipour, HPTN 084 protocol co-chair, professor of medicine at the University of North Carolina (UNC) at Chapel Hill School of Medicine and scientific director of UNC Project-Malawi in Lilongwe, Malawi.
Earlier this year, the HPTN 083 clinical trial showed that a PrEP regimen containing CAB LA injected once every eight weeks was superior to daily oral FTC/TDF for HIV prevention among cisgender men and transgender women who have sex with men.
“The results from HPTN 084 along with the HPTN 083 results released earlier this year show how far we have come in the fight against HIV,” said Dr. Myron Cohen, HPTN co-principal investigator and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “A highly effective product like CAB LA that does not require a daily pill can be an important part of ending the epidemic globally.”
“The HPTN is thrilled by these outstanding results, a milestone for the prevention of HIV among women,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP and professor of epidemiology and medicine at Columbia University in New York. “These findings motivate continued evaluation of the safety of CAB LA in adolescents, a group at substantial risk for HIV infection. Defining the safety of CAB LA in adolescents will hopefully lead to faster access to CAB LA, once approved for use as PrEP.”
The HIV Prevention Trials Network (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 interventions. For more information, visit hptn.org.
Kevin Bokoch HIV Prevention Trials Network (HPTN) +1.440.376.1901 [email protected]