In 2013, according to the World Health Organization (WHO), an estimated 2.1 million people worldwide contracted HIV (Human Immunodeficiency Virus), an incurable viral infection that wreaks havoc on the immune system and can eventually lead to AIDS (Acquired immunodeficiency syndrome), along with many other opportunistic infections and cancers.
And while there are several potentially groundbreaking treatments and even cures for the hardy retrovirus in the pipeline, the question of how best to ensure those newly suffering from it can remain healthy is perhaps a much more timely one. To that end, the National Institutes of Health (NIH) has released the preliminary results from a large-scale randomized clinical trial of nearly 5,000 HIV-infected men and women in 35 countries. The study found that HIV-sufferers who are provided early antiretroviral treatment (ART) are unequivocally better for it, being less likely to develop AIDS and other serious complications than those who are treated once their immune system degrades below a certain point. The presence of HIV in their bodies is similarly lowered as well as their risk of passing on the virus to uninfected others. “These findings have global implications for the treatment of HIV,” said director of the National Institute of Allergy and Infectious Diseases (NIAID) Dr. Anthony S. Fauci in a statement released by the NIH.
The first of its kind and six years in the making, the Strategic Timing of Antiretroviral Treatment (START) study expended considerable effort in pooling together recently diagnosed and relatively healthy HIV-infected subjects who hadn’t yet received ART therapy, recruiting them from 215 individual sites across the world. They then randomly assigned participants to either receive ART therapy immediately or to be given treatment once their CD4+ T-cell levels, a long-established guidepost of immune system health, had dropped below 350 cells per millimeter. As the authors note, the latter group’s treatment plan is close in line to current HIV treatment guidelines established by the WHO, which recommends that ART therapy begin once a person has CD4 levels below 500 cells per millimeter. Current U.S. treatment guidelines recommend that all HIV-infected individuals, even if they’re asymptotic, begin treatment as early as possible, but the recommendation hadn’t been empirically supported by evidence up until now.
Though the full study isn’t due for release until the end of 2016, its investigators were so encouraged by their early analysis they felt it was necessary to disclose their results ahead of time. “This is an important milestone in HIV research,” said University of Copenhagen professor and START co-chair Dr. Jens Lundgren. “We now have strong evidence that early treatment is beneficial to the HIV-positive person. These results support treating everyone irrespective of CD4+ T-cell count.”
Specifically, they found that the early treatment group was half as likely to develop AIDS or other serious health conditions related to HIV than the standard treatment group over a three-year period (41 such events to 86 respectively). Similarly, the risk of serious illness or death was reduced by 53 percent among the early treatment group compared to the latter. Especially gratifying was that these findings held steady among participants from poorer countries, where HIV has most devastated its victims. In light of the dramatic differences found, the authors will offer treatment to all START participants regardless of their CD4 count, and they will continue to be followed up with until 2016.
While START’s results are no doubt very encouraging for the future of HIV treatment, not to be lost in the shuffle is the somber fact that many people with HIV aren’t receiving the life-saving therapies they need, whether early or not. The WHO estimates that only one-third globally of people living with HIV currently take any ART medication, a gap largely explained by the equally depressing reality that 19 million of the currently 35 million people with HIV are unaware of it. In order to ensure that HIV can be stamped out in our lifetimes, it will take a multinational effort to find and aid these missing persons.
Source: Neaton J, Babiker A, Emery S, et al. Strategic Timing of Antiretroviral Treatment (START) 2016.