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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome after early initiation of antiretroviral therapy in a randomized clinical trial
AIDS, Volume 27, No. 16, Year 2013
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Description
OBJECTIVE: To analyze cases of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) in the CAMbodian Early versus Late Introduction of Antiretrovirals (CAMELIA) randomized trial designed to compare early (2 weeks) versus late (8 weeks) antiretroviral therapy (ART) initiation after tuberculosis treatment onset in Cambodia (NCT00226434). METHODS: ART-naive adults with CD4 cell count of 200 cells/μl or less, newly diagnosed tuberculosis, and at least one follow-up visit after ART initiation were included in this analysis. Each case of suspected TB-IRIS was systematically validated by two physicians not involved in patients' management. Factors associated with occurrence of TB-IRIS were identified using the Cox proportional hazard model. RESULTS: Among 597 patients, 26% experienced TB-IRIS with an incidence rate of 37.9 cases per 100 person-years [95% confidence interval (CI) 32.4-44.4]. Main clinical manifestations included new or worsening lymphadenopathy (77.4%) and fever (68.4%). Chest radiograph revealed new or worsening abnormalities in 53.4%. Symptoms resolved in 95.5% of patients. Six deaths were directly related to TB-IRIS. Initiating ART early increased the risk of TB-IRIS by 2.61 (95% CI 1.84-3.70). Extrapulmonary or disseminated tuberculosis, CD4 cell count of 100 cells/μl or less, and HIV RNA concentration more than 6 log10 copies/ml were also significantly associated with higher risk of TB-IRIS. CONCLUSION: Shortening the delay between tuberculosis treatment onset and ART initiation to 2 weeks was associated with an increased risk of developing TB-IRIS. However, TB-IRIS was generally easily manageable. Given the marked reported survival advantage of early ART initiation after tuberculosis treatment onset, these data indicate that fear of TB-IRIS should not be an impediment to early ART in adults with advanced immunodeficiency in resource-limited, high burden settings. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Laureillard, Didier
Unknown Affiliation
Marcy, Olivier
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Cambodia, Phnom Penh
Cambodian Health Committee
Madec, Yoann
France, Paris
Institut Pasteur, Paris
Chan, Sarin
Cambodia, Phnom Penh
Cambodian Health Committee
Borand, Laurence
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Dim, Bunnet
Switzerland, Geneva
Medecins Sans Frontieres
Nerrienet, Eric
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Delfraissy, Jean François
France, Le Kremlin-bicetre
Hopital de Bicetre
Goldfeld, Anne E.
Cambodia, Phnom Penh
Cambodian Health Committee
United States, Boston
Harvard Medical School
Blanc, François Xavier
France, Le Kremlin-bicetre
Hopital de Bicetre
Statistics
Citations: 71
Authors: 10
Affiliations: 6
Identifiers
Doi:
10.1097/01.aids.0000432456.14099.c7
ISSN:
14735571
Research Areas
Environmental
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study