TB IRIS and Use Of Diagnostics

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Tuberculosis Immune Reconstitution Inflammatory Syndrome in A5221 STRIDE: Timing, Severity and Implications for HIV-TB programs

Luetkemeyer, Anne F. MD; Kendall, Michelle A. M.S.; Nyirenda, Mulinda MMED, FCP (SA); Wu, Xingye M.S.; Ive, Prudence FCP (SA); Benson, Constance A. MD; Andersen, Janet W. Sc.D; Swindells, Susan M.B.B.S; Sanne, Ian M. M.B.B.S, FCP; Havlir, Diane V. MD; Kumwenda, Johnstone FRCP

Published Ahead-of-Print
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Abstract

Rationale and Objectives: Earlier initiation of antiretroviral therapy (ART) in HIV-tuberculosis(TB) is associated with increased immune reconstitution inflammatory syndrome (IRIS). The severity, frequency and complications of TB IRIS were evaluated in A5221, a randomized trial of earlier ART (within 2 weeks after TB treatment initiation) vs. later ART (8-12 weeks after TB treatment) in HIV-infected patients starting TB treatment.
Methods and Measurements: In 806 participants, TB IRIS was defined using published clinical criteria. Cases were classified as severe(hospitalization/death), moderate(corticosteroid use/invasive procedure), or mild(no hospitalization/procedures/steroids). Fisher's Exact, Wilcoxon, and log rank tests were used for comparisons.
Main Results: TB IRIS occurred in 61 (7.6%) patients: 10.4% in earlier vs. 4.7% later ART, 11.5% with CD4+ < 50 vs. 5.4% CD4+ >= 50 cells/mm3. The CD4+/ART arm interaction was significant, p=0.014, with 44.3% of TB IRIS occurring with CD4+ < 50 and earlier ART. TB IRIS occurred sooner with earlier vs. later ART initiation, at a median of 29 vs. 82 days after TB treatment initiation (p<0.001). IRIS manifestations included lymphadenopathy(59.0%), constitutional symptoms(54.1%), and radiographic changes(41.0%); CNS TB IRIS was uncommon (6.6%). TB IRIS was mild in 27.9%, moderate in 41.0%, and severe in 31.1%. No TB IRIS-associated deaths occurred. IRIS management required >= 1 invasive procedures in 34.4%, hospitalization in 31.1% and corticosteroids in 54.1%.
Conclusions: TB IRIS was more frequent with earlier ART initiation and CD4+ <50 cells/mm3. As ART is implemented earlier in HIV-TB co-infection, programs will require the diagnostic capabilities, clinical resources and training necessary to manage TB IRIS.
(C) 2013 by Lippincott Williams & Wilkins

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