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Timing of ART initiation key in HIV/TB coinfection

Issue: March 2011

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BOSTON – Delaying initiation of antiretroviral therapy would more than halve the incidence for immune reconstitution syndrome in HIV/TB patients who are not severely immuno-suppressed, according to findings from the open-label, randomized, controlled SAPiT trial.

“The current WHO guidelines recommend initiation of ART as early as possible in all TB patients — our data suggest a short delay of about 8 to 12 weeks and may be preferable in patients with higher CD4 counts in some settings,” Salim Abdool Karim, MD, PhD, of the University of KwaZulu-Natal and Columbia University, said during a presentation here.

Early ART was initiated within 4 weeks of initiation of TB treatment in 214 patients while 215 patients received late ART within the first 4 weeks of the continuation phase of TB treatment. All patients were TB smear positive as well as HIV-positive with CD4 counts less than 500 cells/mm³.

Median CD4+ cell count and viral load at baseline was 150 cells/mm³ and 161,000 copies/mL, respectively. The incidence for AIDS or death was 6.9 and 7.8 per 100 person-years for the early and late therapy groups, respectively (95%CI, 0.44-1.79).

In patients with CD4+ counts less than 50 cells/mm³, the incidence for AIDS or death was 8.5 in the early therapy group compared with 26.3 per 100 person-years in the late therapy group (95%CI, 0.07-1.13). Further, the incidence for immune reconstitution inflammatory syndrome (IRIS) was 46.8 in the early therapy group vs. 9.9 in the late therapy group (P=.01).

Of those with CD4+ counts greater than or equal to 50 cells/mm³, the incidence for AIDS or death was 6.6 and 4.4 per 100 person-years for the early and late therapy groups, respectively (P=.34). Patients assigned the early therapy group had a higher incidence for IRIS (15.8 vs. 7.2 per 100 person-years; P=.02), and more antiretroviral therapy switches associated with adverse events: seven in the early therapy group vs. one in the late therapy group (P=.04).

“The SAPiT study provides clear quantified risks and benefits to define the optimal time to initiate ART in HIV/TB coinfected patients,” Karim said. “Physician’s can use this information to determine the optimal timing for ART initiation in HIV/TB patients.” – by Ashley DeNyse

For more information:

• Karim S. #39LB. Presented at: 18th Conference on Retroviruses and Opportunistic Infections; Feb. 27-March 3, 2011; Boston.

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