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New START Data Fill in When to Start ART, Now the Question Is How

May 27, 2015

New data from a trial looking at the individual health benefits of starting those living with HIV on antiretroviral therapy (ART) at CD4 cell counts above 350 were released today. The data, from a trial known as START, are further evidence in support of the expansion of ART access worldwide. The data from START should also start the clock on even more substantial engagement with the types of ART programs that are most likely to help people make informed choices to begin and remain on life-saving treatment.

It's now been nearly four years since the release of trial data showing that people living with HIV who started ART at CD4 cell counts between 350 and 500 were significantly less likely to transmit HIV to their sexual partners, compared with people who started according to national guidelines. That trial -- known as HPTN 052 -- may be the single most important factor behind today's push to use ART to end the epidemic.

In case you've been pre-occupied with other parts of the AIDS response like, for example, the war on drug users in Russia or the imperiled VMMC programs in Africa, see UNAIDS' 90-90-90 campaign for the frontline example of the ART-to-end-AIDS message. AVAC and other allies have been working with UNAIDS, PEPFAR and governments to try to ensure that this message is accurately conveyed and understood as encompassing prevention beyond ART -- including saturation-level coverage of VMMC, targeted PrEP, harm reduction and male and female condoms. For more on this work -- and why prevention is "on the line" see our most recent Report.

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In the wake of early data from HPTN 052, people living with HIV and their allies were quick to point out that the strongest evidence this trial provided was about the prevention benefit of starting ART "early" (i.e., before national guidelines). HPTN 052 did find that earlier initiation had clinical benefits for the individual, including delaying the time to AIDS events, death and tuberculosis. But for many advocates and activists, these data were not definitive and that a real answer would have to come from the START trial, which was a randomized investigation of exactly this question: does immediate initiation of ART improve individual health for people living with HIV?

Today the answer came in, early, and with resounding clarity: Yes.

The START trial, which enrolled 4,685 people at 215 sites in 35 countries (twenty-seven percent of the participants are women, and approximately half are gay men) looked at rates of AIDS, and serious AIDS-defining illness or death in people with CD4 cell counts above 500 who started ART on enrollment in START, versus those participants who also had CD4 cell counts above 500 and delayed treatment until the initiation criteria dictated by the clinical guidelines in their countries.

At a scheduled interim review of the data, the trial's Data and Safety Monitoring Board (DSMB) found compelling evidence that the benefits of starting antiretroviral treatment immediately at CD4 cell counts above 500 cells/mm3 outweigh the risks. This conclusion was based on the fact that, over an average follow-up period of three years, the risk of AIDS, other serious illnesses or death was reduced by 53 percent among those in the "early" treatment group versus those who started treatment according to national guidelines.

START effectively validates the direction that the WHO's Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection had begun to take -- initiation regardless of CD4 cell count in many populations, including pregnant women, children under the age of five, and people in serodiscordant couples. And it may settle some concerns about whether earlier initiation was good for the person living with HIV -- or just for his or her sexual partners and/or potential children.

But it's critical to recognize that figuring out when to start is only part of the puzzle. The question of how to start is equally critical and isn't going to be settled by any randomized trial. The how concerns the environment in which individuals are offered treatment, the services that are part of that offer -- peer support, community-based refills, non-biased provider care, among others -- and the ways that the decision to start is framed. Even with clinical and public health benefits, ART may not be for everyone as soon as they are diagnosed. Issues with disclosure exist everywhere and are compounded in places where laws criminalizing HIV are on the books.

At a time when funding for civil society organizations is dropping everywhere -- and when some PEPFAR country programs are placing funding for community engagement as "near- or non-core" (pieces of USG jargon that set priority for PEPFAR funding) -- and when UNAIDS has yet to step forward with staunch, straightforward condemnation of rights-violating legislation and hate speech by politicians, this "How?" question is far from resolved.

That's why START has to be welcomed for what it is -- a clear answer to a critical question. And also understood for what it is not -- an answer to the urgent challenge of how best to truly seek to end the epidemic with comprehensive prevention programs that include, but are not restricted to, delivering ART so that everyone who wants it can start it, stay on it, achieve virologic suppression and, more importantly, a life lived with health, dignity and joy.

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This article was provided by AVAC: Global Advocacy for HIV Prevention. Visit AVAC's website to find out more about their activities and publications.
 

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