Study: Begin Antiretroviral Therapy Early With All HIV Patients

Starting antiretroviral therapy sooner rather than later in HIV-positive patients could reduce the risk of death or development of a serious illness by more than 50%, according to new findings from an international clinical trial sponsored by the National Institutes of Health. 

Although the Strategic Timing of AntiRetroviral Treatment (START) study is expected to continue well into 2016, an independent data safety and monitoring board recommended these results be released early because the benefits of earlier treatment were so clear.
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“START provides definitive evidence that benefits outweigh any potential harm from using antiretroviral treatment in all HIV+ persons, irrespective of the degree of harm that the HIV infection may have caused on the person’s immune system,” says study investigator Jens Lundgren, MD, of the University of Copenhagen in Denmark. “Therefore, the study indicates that all HIV+ persons should be offered this treatment.”

Initiated in March 2011, the START study was conducted at 215 sites in 35 countries. The trial enrolled 4,685 HIV-infected men and women ages 18 and older who had never taken antiretroviral therapy and had an apparent “normal” immune function when entering the study—their CD4+ cell count was 500 cells/mm³ or higher.

About half of study participants were randomized to begin antiretroviral treatment immediately, while the other half were randomized to defer treatment until their CD4+ cell count fell to 350 cells/mm³.

Researchers monitored the study participants for an average of 3 years, measuring a combination of outcomes that included serious AIDS events (such as AIDS-related cancer), serious non-AIDS events (such as cancer, cardiovascular disease, and renal and liver disease), and mortality rates.

An independent data safety and monitoring board conducted an interim data analysis this March, which identified 86 cases of AIDS, serious non-AIDS events, and deaths among participants whose antiretroviral therapy was deferred, compared with 41 such cases among participants who received immediate antiretroviral treatment.

The risk of death or developing a serious illness was 53% lower in the early treatment group, compared with the deferred treatment group. These findings were consistent across geographic regions, and the benefits of early treatment were similar for participants from low-, middle-, and high-income countries.

The data support US treatment guidelines for HIV, which recommend that all individuals with HIV receive antiretroviral therapy regardless of their CD4+ count. Current guidelines from the World Health Organization state that HIV-infected individuals should begin antiretroviral therapy when their CD4+ count falls to 500 cells/mm³ or less.

“START provides the evidence base for recommending antiretroviral therapy to all HIV+ persons irrespective of their immunological status,” Lundgren says. “Guideline committees around the world will now have to consider whether this evidence base is sufficiently compelling for them to adopt their guidelines along these lines.”

The full analysis of findings from the START study will be presented this July at the International AIDS Society conference in Vancouver, Canada, and soon will also be published in a peer-reviewed medical journal. There is a long list of additional analyses and publications underway from the START study.

“The START study will continue at least until the end of 2016,” Lundgren says. “We need to understand what happens to the health status of the participants in the longer run when we are recommending that participants that have not yet started antiretroviral therapy should do so now because of the findings.”

—Colleen Mullarkey

Reference

National Institutes of Health. (27 May 2015). Starting antiretroviral treatment early improves outcomes for HIV-infected individuals. Available at: www.nih.gov/news/health/may2015/niaid-27.htm.