Early ART proves more beneficial than deferred treatment

Results from the ongoing START trial suggest early initiation of ART significantly reduces the progression to AIDS and other serious illnesses.

Taken together with previous research demonstrating that ART lowers the risk for sexual transmission of HIV in serodiscordant couples, these findings appear to support guidelines in the United States recommending treatment for asymptomatic HIV patients regardless of CD4 count.

“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others. These findings have global implications for the treatment of HIV.”

Anthony S. Fauci

Funded by the NIAID, the Strategic Timing of AntiRetroviral Treatment (START) study, which began in March 2011, is a large-scale randomized clinical trial conducted by the International Network for Strategic Initiatives in Global HIV Trials at more than 200 sites in 35 countries. Investigators have enrolled 4,685 treatment-naive men and women with HIV, aged 18 years and older. All participants had normal CD4 counts, above 500 cells/mm³. Approximately half the study population was randomly assigned to early treatment; the other half had treatment deferred until their CD4 counts declined to 350 cells/mm³. Participants were followed for an average of 3 years.

The primary outcome of the study included a composite endpoint of AIDS progression, serious non-AIDS diagnoses — including cardiovascular disease and cancer — and all-cause mortality.

As of March, there were 41 instances of AIDS, serious non-AIDS diagnoses or death among those in the early treatment group, compared with 86 instances in the deferred group. Interim analysis indicated that the likelihood of developing serious illness or death was reduced by 53% in the early treatment group vs. the deferred group. In addition, serious AIDS-related and non-AIDS–related illnesses were both lower in the early treatment group.

According to the NIH, the results were consistent across geographic regions, and the health benefits of early ART were similar among participants from low-, middle- and high-income countries.

Jens Lundgren

“This is an important milestone in HIV research,” Jens Lundgren, MD, chief physician and director of the Copenhagen HIV Program in Denmark and one of the co-chairs of the START trial, said in the release. “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.”

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