On World AIDS Day, the Evidence for Prevention With Anti-Retroviral Therapy Is Powerful

Thirty years ago, fear of AIDS was at its height. The year 1985 brought the first commercial blood test to detect HIV, the military began testing recruits for the virus, and the first international AIDS conference convened in Atlanta. The actor Rock Hudson shocked the world when he announced he had the disease and died shortly later.

A young Indiana boy named Ryan White, who had contracted AIDS from contaminated blood products, forever changed the discussion after he was denied admission to his middle school. Instead of staying quiet, White and his mother went public to highlight AIDS stigma and the need for more research.

It would take another 11 years—and another 254,860 deaths in the United States alone—before the first anti-retroviral therapy (ART), fueled by a powerful protease inhibitor, would slow the tidal wave. In the first year after approval of ART, the number of known deaths from AIDS in the United States was cut in half, from 34,947 to 17,403.

When ART arrived, the idea that it might someday be used to end the pandemic was unthinkable, but that is the concept behind World AIDS Day 2015: Getting to Zero, End AIDS by 2030. It’s also the message from the nation’s longtime warrior against AIDS, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, who writes today in the New England Journal of Medicine with Hilary D. Marston, MD, MPH, the agency’s policy advisor for global health.

In “Ending the HIV-AIDS Pandemic—Follow the Science,” Fauci and Marston make the case that there is sufficient evidence to support widespread use of ART for prevention of AIDS, not just treatment. They review results from 3 key trials, which have taken place from 2006 through 2015, that answered 3 distinct questions:

(1) Do the long-term benefits of ART outweigh the risks, particularly on the cardiovascular system?

(2) Can suppression of the virus prevent it from being transmitted to others, especially an intimate partner?

(3) How early should we treat patients?

The first question, the authors write, was answered with the SMART trial (Strategies for Management of Antiretroviral Therapy, published in 2006. That study compared outcomes of HIV patients treated conservatively and aggressively and found that grade 4 toxic effects did not differ signficantly between the 2 groups. “The virus was worse than the drugs,” they write.

The HIV Prevention Trials Network (HPTN) study of 2011 answered the second question. Investigators studied couples in which one partner was HIV positive and the other was not. Half the group received ART therapy, known as PrEP, and the other half deferred therapy until changes in T-cell counts reached certain levels, or AIDS-related illnesses developed. “The study documented a 96% reduction in HIV transmission in the immediate-therapy group as compared with the deferred-therapy group,” Fauci and Marston write, noting, “treatment as prevention could dramatically reduce the incidence of HIV infection.”

The final piece came this summer with results of START (Strategic Timing of Antiretroviral Treatment), which found that the treatment arm that started right away on ART, when viral levels were still quite low, was 57% less likely to develop serious illiness—AIDS-related or otherwise, the authors noted.

Fauci has long advocated a preventive approach to AIDS. In a 2014 interview with The American Journal of Managed Care, he discussed the challenge of researching vaccines, saying that treatment will never reach every person who needs it, and that human behavior is such that stopping the disease from taking hold is essential. While the current article in NEJM does not discuss it, a challenge today is the cost of HIV medication, as many therapies are in the specialty pharmacy tier with high out-of-pocket costs for patients.

“Taken together, these studies provide an evidence-based blueprint for effective treatment and prevention of HIV infection and will serve as critical tools in the fight to end the HIV-AIDS pandemic,” Fauci and Marston write. “However, in order to realize that promise, the political will must be mobilized to match the scientific evidence and provide the financial and human resources necessary to dramatically scale up HIV testing and treatment around the world. The science has spoken. There can now be no excuse for inaction.”

Reference

Fauci AS, Marston HD. Ending the HIV-AIDS pandemic—follow the science. N Engl J Med. 2015;373(23):2197-2199.