New York, May 12, 2011 – Today the sponsors of a randomized clinical trial known as HPTN 052, which is evaluating combination antiretroviral therapy for HIV prevention, announced that randomization would halt due to overwhelming evidence of benefit.
“We now have evidence from a randomized trial confirming what has been seen in observational settings: ARV treatment is prevention,” said AVAC Executive Director Mitchell Warren. “These data must serve as a clarion call to funders, policy makers, civil society and implementers. HPTN 052 shows a prevention benefit that must be translated into programmatic reality. If deployed effectively, efficiently and ethically, early initiation of treatment will be fundamental to turning the tide of the epidemic.”
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-positive partner significantly reduced the risk of transmitting HIV to their HIV-negative 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,” 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.”
“Today’s result should be viewed in light of other recent findings from trials using ARVs for prevention,” said Warren. “The recent results from the iPrEx trial showed that PrEP is effective in gay men and transgender women, while the CAPRISA 004 microbicide trial showed that 1% tenofovir gel is effective at reducing HIV risk for women.”
“Together, these results allow us to imagine a world in which men and women seek HIV testing with the knowledge and confidence that they will receive a range of highly effective options for staying healthy and protecting themselves and their partners—whatever the test result,“ Warren added. “The results of the study require us to rethink how we structure the delivery and funding of HIV services overall.”
“The financial, human and technical resources needed to translate the HPTN 052 trial finding into a public health breakthrough on a national or global level will not come overnight. And ARVs alone will not solve the epidemic,” said Warren. “Existing prevention tools including male and female condoms, syringe exchange, male circumcision, behavior change programming, prevention of vertical transmission, and HIV testing, remain critical as do structural interventions, stigma reduction initiatives and comprehensive care and treatment programs. We also still need to maintain and build on the momentum of other recent positive results from vaccine, microbicide and PrEP research.”
“Realizing this vision will require substantial resources,” said Warren. “The upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account,” Warren said. “We need to start critical discussions and come to quick decisions about where and how to deploy treatment as prevention in the short-term. Government and international normative agencies now have a critical mass of data to publish guidelines for appropriate implementation of treatment as prevention in concert with other prevention methods.”
“Now is the best time to invest in an expanded response to the AIDS epidemic. AVAC stands with the global community of advocates for HIV prevention, treatment, research and implementation to expect and demand an extraordinary response to this unprecedented epidemic,” Warren added.
Contact:
Mitchell Warren, +1 914-661-1536, mitchell@avac.org
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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.