Takeaway
- Prophylactic prednisone within 4 weeks of antiretroviral therapy (ART) initiation was associated with a 30% lower incidence of tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) vs placebo in patients with HIV, tuberculosis and very low CD4 counts.
- Prednisone was well tolerated and did not increase risk for severe infection or death.
Why this matters
- TB-IRIS is a common complication of combining ART and antituberculosis treatment, and no prevention strategy exists until now.
Study design
- Randomised, double-blind, placebo-controlled trial of 240 HIV-infected patients (CD4 count, ≤100 cells/µL) who had started tuberculosis treatment in <30 days before initiating ART.
- Patients were randomly assigned to receive either prednisone or placebo.
- Funding: European and Developing Countries Clinical Trials Partnership; others.
Key results
- Patients in the prednisone vs placebo group had significantly lower:
- incidence of TB-IRIS (32.5% vs 46.7%; relative risk [RR], 0.70; P=.03).
- use of open-label glucocorticoid (13.3% vs 28.3%; RR, 0.47; 95% CI, 0.27-0.81).
- In the prednisone vs placebo groups, no significant difference was observed in:
- number of deaths (5 vs 4; P=1.00) or
- incidence of severe infection (11 vs 18; P=.23).
- 1 Kaposi’s sarcoma incidence occurred in the placebo group.
Limitations
- Results may not be generalisable to inpatients.
References
References
