ROME — Researchers from the University of North Carolina at Chapel Hill School of Medicine are presenting detailed data from the landmark HIV Prevention Trials Network (HPTN) 052 study today at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. The HPTN 052 study found that early treatment of HIV-infected people with combination antiretroviral therapy (cART) led to a 96 percent reduction in transmission of the the virus to their uninfected partners.
Today’s presentation of the HPTN 052 results will include new data indicating that the protective benefit of early cART treatment may be even stronger than initially reported. “This study represents the culmination of many years of work, and we are thrilled by its success and by the opportunity to share these data with our colleagues and the public,” said Dr. Myron Cohen, J. Herbert Bate Distinguished Professor of Medicine at UNC and principal investigator of the study.
HPTN 052, which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, was designed to evaluate whether early versus delayed use of cART by HIV-infected individuals would reduce transmission of HIV to their uninfected partners and benefit the HIV-infected individuals as well. During the course of the study, 39 participants who had been HIV-uninfected at the start of the study became infected with HIV. Of those, 29 were linked transmissions, where the virus from the originally-infected partner was confirmed by genetic analysis to be the source of infection in the newly infected sexual partner. Of these 29 linked infections, only one infection occurred in the early cART arm. Based on the latest analyses, this one transmission most likely occurred close to the time the couple enrolled in the study and before HIV viral replication could have been suppressed by cART in the infected participant.
The new analyses also provide more insight as to how early initiation of cART benefits the HIV-infected person. Individuals who were put on early cART maintained higher absolute CD4 counts than those in the delayed arm, who received treatment when their CD4 counts fell below 250 cells/mm≥ or an AIDS-related event occurred. Early cART was also associated with a 41% reduction in HIV-related illnesses or death, a direct benefit for the HIV-infected partner. The reliable suppression of HIV among HIV-infected people in the early treatment arm suggests potential impact on adherence when the infected individual is informed that their cART may also benefit their partner.
Results of HPTN 052 are already being considered in policy recommendations. At a joint press conference held today by the HPTN, the World Health Organization (WHO), the National Institutes of Health (NIH) and the International AIDS Society, the WHO will introduce progress in developing guidance for couples where one partner is HIV-infected and the other is not (serodiscordant). According to the WHO, in African countries with the highest HIV rates, close to half of the HIV-infected adults in stable relationships have an HIV-uninfected partner, and more than half of new adult infections occur within such couples.
“HPTN 052 is the first randomized clinical trial to indicate definitively that an HIV-infected individual can reduce sexual transmission of HIV to an uninfected partner by beginning antiretroviral therapy sooner,” said Cohen, who also directs the Institute of Global Health & Infectious Diseases at UNC. “We could not be more pleased that the WHO is considering these findings in its work on guidance for serodiscordant couples.”
The initial trial results will be published today (July 18) in The New England Journal of Medicine. In addition to Cohen, the other UNC authors on the study are Mina Hosseinipour, MD, Irving Hoffman, PA, and Joseph Eron, MD.
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