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Patients with Advanced HIV and Tuberculosis May Benefit from Starting Antiretroviral Therapy Early
A new study shows that starting antiretroviral therapy (ART) soon after beginning tuberculosis treatment can significantly reduce the onset of new AIDS-defining illness and death in those with advanced HIV. The research is published in the October 20, 2011 issue of the New England Journal of Medicine. MHRP scientists in Kenya participated in the research and were co-authors of the publication.
Researchers from the AIDS Clinical Trials Group (ACTG) enrolled 809 patients in the A5221 study entitled, “Timing of Antiretroviral Therapy for HIV-1 Infection and Tuberculosis.” The study, which took place at clinical research sites on four continents, compared two groups of patients with HIV and suspected tuberculosis. One group began ART within 2 weeks of starting tuberculosis treatment and the other received ART 8 to 12 weeks following the start of tuberculosis treatment.
Researchers found that among patients with advanced HIV, defined by CD4+ T-cell counts of less than 50, there was a marked decrease in new AIDS-defining illness and death for those who started ART earlier versus later (15.5% and 26.6% respectively). This benefit, however, was accompanied by a higher risk of developing tuberculosis-related immune reconstitution inflammatory syndrome (IRIS), although overall health outcomes were the same.
In patients whose CD4+ T-cell counts were greater than 50, findings indicate there was no significant difference between starting ART earlier versus later with respect to rates of new AIDS-defining illness or death. In this instance, briefly delaying the start of ART may simplify the management of a patient’s tuberculosis by reducing the risk of developing IRIS.
“These findings tell us that ART can be initiated soon after a patient has begun tuberculosis treatment, however, the immune status of a patient is an important factor to consider when deciding when to start ART,” said Dr. Fred Sawe, Deputy Director of Walter Reed Project and Principal Investigator of the study at the Kericho Clinical Research Site.
Tuberculosis is the leading cause of death in people living with HIV. However, many basic questions—such as when to start ART in patients who are suspected of having tuberculosis—have remained unanswered.
These findings extend and confirm the results of two additional HIV/tuberculosis studies carried out simultaneously and published in the same edition of the New England Journal of Medicine. The results will help guide policy on treatment of HIV-tuberculosis co-infection.
The U.S. Military HIV Research Program (MHRP) has two NIH ACTG Clinical Research Sites in Kericho and Eldoret, Kenya. Both Clinical Research Sites under the MHRP Clinical Trials Unit participated in this study.