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The standard of care for HIV treatment in most resource-limited countries is to provide antiretroviral therapy (ART) to patients when their CD4 counts drop below 200 cells/mm3 or they receive a diagnosis of clinical AIDS. Backed by observational data, experts have advocated for starting ART earlier in these settings — at CD4 counts of 350 cells/mm3, as is currently recommended in developed countries. New data from a randomized controlled trial in Haiti support this approach.
The CIPRA HT 001 trial — described by Daniel Fitzgerald at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention [Abstract WESY201] — was an open-label clinical trial conducted among 816 asymptomatic HIV-infected men and women who, at enrollment, had CD4 counts between 200 and 350 cells/mm3. They were randomized to either initiate ART immediately or wait until they had a CD4 count below 200 cells/mm3 or a diagnosis of clinical AIDS. For all participants, ART consisted of AZT + 3TC + efavirenz.
During its May 28, 2009, review, the Data and Safety Monitoring Board (DSMB) found a significant survival benefit to starting ART at CD4 counts between 200 and 350 cells/mm3. At the time of the review, almost four times as many patients had died in the deferred-treatment arm as in the early-treatment group (23 vs. 6). In addition, the deferred-treatment group was twice as likely to develop tuberculosis (TB). These differences led the DSMB to end the trial early and recommend immediate ART for the deferred-therapy group.
These findings have important implications for both clinical practice and public-health policy, particularly in resource-limited settings where both HIV infection and TB are common. The WHO should reconsider its recommended ART starting point of 200 CD4 cells/mm3 and align the timing of ART initiation to be the same in both developed and developing countries. This would further broaden global access to — and availability of — life-prolonging ART.