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Early ART Initiation Improves Survival in Resource-Limited Settings

New findings from Haiti (described at IAS 2009) support starting ART when CD4 counts fall below 350 cells/mm³ — the same threshold that is recommended in resource-rich settings.

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.

— Gerald H. Friedland, MD

Published in Journal Watch HIV/AIDS Clinical Care August 31, 2009

Reader Remarks:

Review and add to remarks on this article

• cd4 count
  Satya Prasad Venkata, government hospital Anakapalli, 21 Sep 2009 12:05 PM EST
  Dear sir
  
  Regarding the initiation of ART to patients with CD4 below 350 we rightly agree with your. But why... [more]

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