Expanded Analysis of HPTN 052 Study Results Reveal Additional Benefits of Early HIV Treatment

Study results released today by the HIV Prevention Trials Network (HPTN) show additional benefits of early antiretroviral therapy (ART) in HIV clinical outcomes. Expanded analysis of HPTN 052 study data, presented today at the XIX International AIDS Conference in Washington, D.C., demonstrated that early versus delayed ART showed a trend toward delaying the time to both AIDS and non-AIDS primary events and significantly delayed the time to AIDS events, death and tuberculosis. The overall incidence of clinical events was significantly lower in participants treated in the early therapy arm. The new findings show that immediate ART significantly decreased the incidence of clinical events likely due to reversal of immune suppression.

Commenting on the findings, Myron Cohen, M.D., Co-Principal Investigator of HPTN, and the HPTN 052 Protocol Chair said, "These new findings provide further confirmation of the health benefits of early antiretroviral therapy. The combined prevention and treatment benefits of antiretroviral therapy make broader testing and treatment urgent and imperative."

HPTN 052 is a landmark study which has received worldwide attention for demonstrating that early ART reduces HIV transmission by 96%, in serodiscordant couples and has been used to revise World Health Organization (WHO) and U.S. treatment guidelines.

HPTN 052 is an ongoing randomized clinical trial. A total of 1763 HIV serodiscordant couples were enrolled in HPTN 052 between April 2005 and May 2010.The study is being conducted at 13 sites in Africa, Asia, and North and South America. The majority of couples (97%) are heterosexual. All participants receive couples risk-reduction counseling, free condoms, and testing and treatment for sexually transmitted infections. Primary HIV care is also provided to the HIV-infected partner. Following the public announcement of results in May 2011, all HIV infected participants in the study were offered ART. All participants will continue to be followed until the planned study end in April 2015 to assess the durability of the prevention and clinical benefits.

HPTN 052 is funded by the Division of AIDS (DAIDS)/U.S. National Institute of Allergy and Infectious Diseases (NIAID)/U.S. National Institutes of Health (NIH). HPTN 052 is conducted in collaboration with the AIDS Clinical Trials Group (ACTG). Study drugs are donated by Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; Gilead Sciences, Inc.; GlaxoSmithKline/ViiV Healthcare; and Merck & Co., Inc.

To learn more about the HIV Prevention Trials Network, visit www.hptn.org.