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START sub-study shows more bone loss with earlier HIV treatment
Liz Highleyman, 2015-10-27 17:50:00

Participants who started antiretroviral therapy (ART) soon after HIV diagnosis in the large START trial showed a greater decrease in bone density at the hip and spine compared to those who deferred treatment, researchers reported at a joint session of the 15th European AIDS Conference and the 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV last week in Barcelona. There was no significant difference in the likelihood of fractures, however, and two other START sub-studies saw no differences in lung function or neuropsychological performance between people randomised to immediate or deferred ART.

Starting antiretroviral treatment before the development of serious immune system damage greatly reduces the risk of HIV disease progression and death, but early treatment can potentially also have drawbacks including longer exposure to toxic drugs. The INSIGHT START (Strategic Timing of Antiretroviral Treatment) trial was designed to address the long-standing controversy over the optimal timing of HIV treatment, especially for people who still have high CD4 counts.

START enrolled 4685 adults living with HIV in 35 countries who entered the trial with a CD4 count above 500 cells/mm3. They were randomly assigned to either start treatment at study entry or delay therapy until their CD4 count fell below 350 cells/mm3 or they developed AIDS-related symptoms.

Overall, nearly three-quarters were men and the group was quite young (average age 36 years). They had good immune function at baseline, with a median CD4 count of 651 cells/mm3. Over the course of follow-up, the CD4 count of people in the deferred group was 194 cells/mm3 lower, on average, than that of the immediate group.

The START Data Safety and Monitoring Board stopped the randomised portion of the trial ahead of schedule in May 2015 after it determined that there was already enough evidence to show a benefit of immediate treatment. At that point the average follow-up time was three years.

The primary START results, presented this summer at the International AIDS Society Conference in Vancouver and published in the August 27 New England Journal of Medicine, showed that participants randomised to start ART soon after HIV diagnosis had a significantly lower risk of illness and death than those who waited. The immediate treatment group not only had a 72% lower risk of AIDS-related infections and malignancies compared to the deferred group, but also were 39% less likely to experience serious non-AIDS events (heart, liver and kidney events and non-AIDS cancers) or death.

The START design included several sub-studies looking at the effects of early versus deferred therapy on specific outcomes known or suspected to be associated with HIV infection or its treatment, including bone density, lung function and neurocognitive function.