Publication of HPTN 052 final results
DURHAM, N.C. – The HIV Prevention Trials Network (HPTN) announced today that the final results of the HPTN 052 study were published in the New England Journal of Medicine (NEJM). This pivotal study demonstrated that antiretroviral therapy (ART) for HIV infection provides durable and reliable protection against the sexual transmission of the virus from infected men and women to their HIV-uninfected sexual partners.
The final results showed a 93 percent reduction of HIV transmission when the HIV-infected person started ART when their immune system was relatively healthy. HIV transmission from HIV-infected study participants to their partners was not observed when viral replication in the treated individual was stably suppressed by ART.
"The HPTN 052 study confirms the urgent need to treat people for HIV infection as soon as it is diagnosed to protect their health and for public health," said Myron S. Cohen, M.D., principal investigator for HPTN 052 and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. "This study represents more than a decade of effort by a worldwide team of investigators, and the tremendous courage and generosity of more than 3,500 clinical trial participants."
HPTN 052 began in 2005 and enrolled 1,763 HIV-serodiscordant couples – where one person was HIV infected and the other was not – at 13 sites in nine countries (Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States, and Zimbabwe). The majority of the couples were heterosexual (97 percent). HIV-infected participants were assigned at random to start ART at the beginning of the study when their immune system was relatively healthy (called the "early" arm), or later in the study when they had immune system decline (called the "delayed" arm).
In 2011, interim study results demonstrated significant benefit of early ART, with a 96 percent reduction in HIV transmission from early ART compared to delayed ART. This finding was reported based on the recommendation of the study's data safety and monitoring board; presented at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy; and published in NEJM.
All HIV-infected participants in the study were then offered ART and the study was continued until May 2015 to understand the magnitude and durability of "treatment as prevention"; 87 percent of the HIV-infected participants remained in the study for its 10-year duration.
The HPTN 052 results have helped to galvanize a worldwide commitment to a universal "treatment as prevention" strategy for combatting the HIV/AIDS epidemic, with ART offered to all HIV-infected people, regardless of CD4 cell count.
About HPTN 052
HPTN 052 was a randomized, controlled trial designed to evaluate the effectiveness of antiretroviral therapy (ART) to prevent the sexual transmission of HIV in serodiscordant couples. The trial was conducted by the HIV Prevention Trials Network (HPTN) and funded by the U.S., National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). Additional support was provided by the NIAID-funded AIDS Clinical Trials Group. The antiretroviral drugs used in the study were made available by Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline; and Merck & Co., 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.hptn.org.