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Immediate ART decreased progression to AIDS, mortality in patients coinfected with HIV, TB

Issue: March 2011

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BOSTON – Compared with early antiretroviral therapy, immediate antiretroviral therapy lowered rates for AIDS and mortality among patients with CD4 cell counts less than or equal to 50 cells/mm³, according to findings from the AIDS Clinical Trials Group 5221.

“We should not wait until the end of TB treatment to start ART,” Diane Havlir, MD, professor of medicine at the University of California, said during a press conference. “However, the question is, when should we start ART during TB treatment?”

In the open-label, randomized trial, Havlir and colleagues set out to determine the optimal timing of ART initiation for HIV/TB co-infection in patients from 26 sites across four continents. The researchers hypothesized that immediate ART (initiated 2 weeks after start of TB treatment) would reduce AIDS and death by 48 weeks when compared to early ART (initiated 8 weeks to 12 weeks after start of TB treatment).

Patients with CD4+ cell counts less than 250/mm³ treated for confirmed or suspected TB were randomly assigned to either immediate ART (n=405) or early ART (n=401). Randomization was stratified by CD4 cell count less than 50/mm vs. greater than or equal to 50/mm, according to Havlir.

Although both ART regimens were safe and did not negatively affect treatment response, TB immune reconstitution inflammatory syndrome (IRIS) was higher with immediate ART vs. early ART (11% vs. 5%; P=.009). Yet, no deaths were associated with IRIS, according to Havlir.

At 1 year, the proportion of AIDS cases or deaths that occurred in patients with CD4 cell counts less than 50/mm was 27% in the early treatment arm vs. 16% in the immediate treatment arm.

“These results call for the rapid initiation of ART at 2 weeks in TB patients with low CD4 cell counts in order to reduce AIDS and death,” Havlir told Infectious Disease News. “This practice will require coordination of HIV and TB programs, hospital and outpatient programs and the adaption of ART counseling programs to enable immediate ART initiation in persons with TB.” – by Ashley DeNyse

For more information:

• Havlir D. #38. Presented at:18th Conference on Retroviruses and Opportunistic Infections; Feb. 27-March 3, 2011; Boston.

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