May 12, 2011
Earlier today, the HPTN 052 trial team announced that this trial of treatment as prevention in HIV-serodiscordant couples would cease randomization due to data indicating an overwhelming benefit. The major finding was that initiating immediate ARV treatment in the HIV-positive partner within a couple where one partner was HIV-positive and the other was HIV-negative, significantly reduced HIV transmission. This update contains links to AVAC’s statement, information about a May 13 global teleconference to discuss the results, and other resources to help advocates understand this exciting development.
HPTN 052 is a large, multi-site, randomized trial designed to determine whether antiretrovirals, medicines currently licensed to treat HIV infection, can prevent the sexual transmission of HIV among couples in which one partner is HIV-infected and the other is not (serodiscordant couples). Nearly 1,800 of these HIV-serodiscordant couples from four continents are participating in the trial. At the time of enrollment, the HIV-positive partners had CD4 cell counts between 350 and 550 cells/cubic millimeter and so were not eligible for ARVs based on most national guidelines. Couples who enrolled were randomly assigned to one of two groups. In one group, HIV-positive partners received antiretroviral therapy immediately. In the other group, HIV-positive partners deferred initiation of ARV treatment until they had the clinical or laboratory findings indicating ARV eligibility based on national guidelines.
In a scheduled review of interim data, the trial’s independent Data Safety and Monitoring Board (DSMB) found clear evidence that providing immediate antiretroviral therapy to the HIV-infected partner significantly reduced the risk of transmitting HIV to their uninfected partner. The trial team has used viral genetic analysis to establish which new infections were linked to the HIV-positive partner. They reported that there was one such “linked” HIV infection in the immediate treatment group versus 27 infections in the group that began treatment according to national guidelines.
Based on this indication of a clear benefit, the DSMB recommended that the trial halt randomization. The trial team announced today that it would do so, and begin offering immediate treatment to all HIV-positive partners. All couples will continue to be followed until the protocol-defined end of the trial.
“We congratulate the trial sponsors, scientific collaborators and partners who conducted this landmark global trial. We especially want to thank the nearly 1,800 HIV-serodiscordant couples from four continents whose commitment as trial volunteers made this effort possible,” AVAC’s Mitchell Warren said. “As the global community reflects on the prevention and treatment implications of this trial, we must also consider current and future trials working with serodiscordant couples, and civil society voices must contribute to the way forward.” Click here to read AVAC’s full statement on HPTN 052.
We hope that you can join us tomorrow’s call, and we will post a recording and a call summary shortly afterwards. Also, if you have any questions that you would like to pose to the HPTN 052 team, please email us at email@example.com.