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Trials Offer Evidence-based Blueprint for HIV Treatment and Prevention

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A trio of major clinical trials -- SMART, START, and HPTN 052 -- provide definitive evidence supporting prompt antiretroviral treatment for all people diagnosed with HIV, both to improve their own health and to reduce the risk of transmission to others, according to a recent commentary published in the December 3 edition of the New England Journal of Medicine. Further, results from the IPERGAY study, published in the same issue, add to the growing body of evidence supporting pre-exposure prophylaxis (PrEP) for HIV prevention.

Anthony Fauci and Hilary Marston of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), which supported the 3 studies, recalled that after the advent of effective combination antiretroviral therapy (ART) providers and people with HIV worried about the toxic effects of treatment, and "wondered whether long-term treatment was worse than the virus itself for some patients." Cost, inconvenience, and the risk of drug resistance were also concerns.

The SMART (Strategies for Management of Antiretroviral Therapy) trial, published in NEJM in November 2006, was the first to definitively show that treatment interruption -- deferring or stopping ART while CD4 T-cell counts remained above 350 cells/mm3 and starting when they fell below 250 -- was associated with an increased risk of disease progression or death compared with continuous treatment.

After SMART put the idea of treatment interruption to rest, the debate continued regarding the best time to initiate therapy, especially for people with high CD4 counts and no clinical signs of HIV/AIDS. The START (Strategic Timing of Antiretroviral Treatment) trial, presented this summer at the International AIDS Society (IAS) Conference in Vancouver and published in the August 27, 2015, edition of NEJM, showed that people who start ART soon after HIV diagnosis have a significantly lower risk of both AIDS-related and non-AIDS illness and death compared to those who wait for their T-cells to fall.

HPTN 052, first presented at the 2011 IAS Conference in Rome and published in the July 18, 2011, edition of NEJM, showed that prompt ART after diagnosis regardless of CD4 count reduced the risk of HIV transmission among heterosexual couples by 96%.

Taken together, these 3 studies provide strong support for early treatment for everyone living with HIV, as recommended by U.S. DHHS treatment guidelines since 2012, and by the European AIDS Clinical Society (EACS) and the World Health Organization this year.

"Clinicians and patients can now be assured that ART’s benefits outweigh the risks for the infected person, regardless of CD4+ T-cell count," Fauci and Marston concluded. "Public health officials can confidently support early treatment, recognizing the spillover public health benefits for HIV prevention."

Below is an edited excerpt from a NIAID press releasesummarizing the commentary.

NIH Scientists Draw Evidence-Based Blueprint for HIV Treatment and Prevention

Trifecta of Key Studies Provides Compelling Data

December 1, 2015 -- For many years, clinicians debated the best time to start antiretroviral therapy (ART) for HIV infection, with some worrying that the risks of treatment in terms of drug toxicities could outweigh the benefits of controlling the virus.

In a new commentary, scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, argue that the results of three large clinical trials definitively prove that the benefits of starting ART early in infection outweigh any theoretical risk.

Together, the findings from the NIH-funded SMART study reported in 2006, HPTN 052 study in 2011, and START study this year conclusively demonstrate that starting ART promptly after HIV diagnosis protects the health of the infected individual while preventing HIV transmission to uninfected sexual partners, the authors write.

NIAID Director Anthony S. Fauci, MD, and colleague Hilary D. Marston, MD, MPH, also note that the results of the IPERGAY study, published concurrently with their commentary online by the New England Journal of Medicine, represent important new data on HIV prevention. The study, conducted in France and Canada, focused on the use of ART for HIV prevention, a practice known as pre-exposure prophylaxis (PrEP).

The IPERGAY researchers found that men who have sex with men and transgender women at high risk for HIV infection who took PrEP around the time of sexual activity were 86 percent less likely to acquire HIV than similar individuals who took a placebo.

According to Drs. Fauci and Marston, this finding is further evidence of the power of PrEP to prevent HIV infection in high-risk populations. The combination of PrEP and prompt initiation of ART for infected individuals offers a promising blueprint to bring about an end to the HIV/AIDS pandemic, the authors write.

Now, the scientists conclude, realizing the promise of early ART and PrEP depends on whether sufficient global political will can be mustered to provide sufficient human and financial resources to scale up HIV testing and treatment throughout the world.

12/15/15

Reference

AS Fauci and HD Marston. Ending the HIV-AIDS Pandemic -- Follow the Science. New England Journal of Medicine. 373(23):2197-2199. December 3, 2015.

Other Source

National Institute of Allergy and Infectious Diseases. NIH Scientists Draw Evidence-Based Blueprint for HIV Treatment and Prevention. Press release. December 1, 2015.