July 20, 2015

Two landmark studies provide evidence to recommend earlier initiation of antiretroviral therapy

Written by Leanne Gray, Communications Specialist, FHI 360

Myron Cohen presents results of HPTN 052 at a press conference on Monday, July 20, 2015 in Vancouver. Photo: Leanne Gray/FHI 360

Myron Cohen presents results of HPTN 052 at a press conference on Monday, July 20, 2015 in Vancouver. Photo: Leanne Gray/FHI 360

Final results from two research studies presented at IAS 2015 today demonstrated clear scientific evidence on the benefits of early initiation of antiretroviral therapy (ART). Building on early results of HPTN 052 released in May 2011 that then showed a 96% reduction in HIV transmission, the study results presented today provide conclusive evidence that ART should be provided to all HIV-positive people as soon as they are diagnosed for the benefit of both themselves and their sexual partners.

Jens Lundgren of the University of Copenhagen presented the initial results of the Strategic Timing of AntiRetroviral Treatment (START) study, a randomized trial looking at whether starting ART in people with CD4+ cell counts above 500 cells/mm3, rather than waiting for CD4+ cell counts to drop below 350 cells/mm3, reduces the occurrence of serious morbidity and mortality. START was recently unblinded by the international Data & Safety Monitoring Board (DSMB) 18 months early due to data that showed very clear benefits of immediate treatment versus delayed treatment. Previous studies and guidance from WHO suggested that ART should not be given to patients unless they had symptomatic HIV and/or whose CD4+ counts were below 350 cells/mm3. The interim results from START show that ART is safe and effective for all HIV-infected persons regardless of CD4+ count.

The HPTN 052 team, led by Myron Cohen of the University of North Carolina at Chapel Hill, provided final results of their study that recently wrapped up on May 3, 2015. The study determined conclusively that ART treatment is effective and durable at reducing HIV transmission among discordant couples. Over the 10 years of the trial, HPTN 052 observed 1,763 couples and, after the early data release in 2011, provided ART for all HIV-infected partners who wanted it. By the end of the trial, 98% of participants were on ART, including those randomized into both the immediate-initiation arm and the delayed-initiation arm, and data collected from all participants demonstrated a 93% reduction in sexual HIV transmission between partners. No linked HIV transmission was found in couples whose HIV-positive partner remained on ART for the duration of the study.

The two studies together provide conclusive evidence of the benefits of ART beyond the suppression of the virus in HIV-infected individuals.

“IAS 2015 will be remembered as the definitive moment when the world agreed earlier initiation of treatment is the best way to preserve the health of people living with HIV, and one of the best tools we have to slow HIV transmission to others,” said Julio Montaner, IAS 2015 Local CoChair and Director of the British Columbia Centre for Excellence in HIV/AIDS. “The new data presented today will inform HIV treatment guidelines worldwide, and inspire governments, funders and health systems to act to save millions more lives.”

Gottfried Hirnschall, Director of the HIV Department at the World Health Organization (WHO), said, “The data speak a very clear language.” WHO will be releasing updated ARV guidelines later this year, likely in September, and Hirnschall made clear to IAS delegates that early initiation of ART will be recommended for all HIV-infected individuals, regardless of CD4+ count as a part of these guidelines.

Hirnschall stressed that though these results are exciting, we need to focus our attention on getting people tested for HIV in order to put them on ART – it is estimated that only 50% of people living with HIV actually know their status. WHO released updated guidelines for HIV testing services at the conference this year.