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.