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INCIDENCE AND PREDICTORS OF TUBERCULOSIS-ASSOCIATED IRIS IN PEOPLE WITH HIV TREATED FOR TUBERCULOSIS: FINDINGS FROM REFLATE TB2 RANDOMIZED TRIAL
HIV/AIDS
IRIS
Randomized controlled trial
Tuberculosis
Autor
Coelho, Lara E.
Chazallon, Corine
Laureillard, Didier
Escada, Rodrigo
N'takpe, Jean-Baptiste
Timana, Isabelle
Messou, Eugène
Eholie, Serge
Khosa, Celso
Chau, Giang D.
Cardoso, Sandra Wagner
Veloso, Valdiléa G.
Delaugerre, Constance
Molina, Jean-Michel
Grinsztejn, Beatriz
Marcy, Olivier
Castro, Nathalie De
Chazallon, Corine
Laureillard, Didier
Escada, Rodrigo
N'takpe, Jean-Baptiste
Timana, Isabelle
Messou, Eugène
Eholie, Serge
Khosa, Celso
Chau, Giang D.
Cardoso, Sandra Wagner
Veloso, Valdiléa G.
Delaugerre, Constance
Molina, Jean-Michel
Grinsztejn, Beatriz
Marcy, Olivier
Castro, Nathalie De
Afiliación
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France.
Nimes University Hospital. Department of Infectious and Tropical Diseases. Nimes, France / Research Unit 1058. Pathogenesis and Control Chronical Infections. INSERM. French Blood Center. University of Montpellier. Montpellier, France.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Rio de Janeiro, RJ, Brazil.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France / Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire / Université Félix Houphouët Boigny. UFR des Sciences Médicales. Département de Dermatologie et d'Infectiologie. Abidjan, Cote d'Ivoire.
Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire / Université Félix Houphouët Boigny. UFR des Sciences Médicales. Département de Dermatologie et d'Infectiologie. Abidjan, Cote d'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Pham Ngoc Thach Hospital. Ho Chi Minh City, Vietnam.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
APHP-Hôpital Saint-Louis. Virology Department. Paris, France / INSERM U944. Paris, France / Université Paris Cité. Paris, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France.
Nimes University Hospital. Department of Infectious and Tropical Diseases. Nimes, France / Research Unit 1058. Pathogenesis and Control Chronical Infections. INSERM. French Blood Center. University of Montpellier. Montpellier, France.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Rio de Janeiro, RJ, Brazil.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France / Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire / Université Félix Houphouët Boigny. UFR des Sciences Médicales. Département de Dermatologie et d'Infectiologie. Abidjan, Cote d'Ivoire.
Programme PACCI/ANRS Research Center. Abidjan, Côte-d'Ivoire / Université Félix Houphouët Boigny. UFR des Sciences Médicales. Département de Dermatologie et d'Infectiologie. Abidjan, Cote d'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Pham Ngoc Thach Hospital. Ho Chi Minh City, Vietnam.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
APHP-Hôpital Saint-Louis. Virology Department. Paris, France / INSERM U944. Paris, France / Université Paris Cité. Paris, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. STD and AIDS Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France.
National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. University of Bordeaux. Bordeaux, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Resumen en ingles
Background: After antiretroviral therapy (ART) initiation, people with HIV (PWH) treated for tuberculosis (TB) may develop TB-associated immune reconstitution inflammatory syndrome (TB-IRIS). Integrase inhibitors, by providing a faster HIV-RNA decline than efavirenz, might increase the risk for this complication. We sought to assess incidence and determinants of TB-IRIS in PWH with TB on raltegravir- or efavirenz-based ART. Methods: We conducted a secondary analysis of the Reflate TB 2 trial, which randomized ART-naive PWH on standard TB treatment, to receive raltegravir- or efavirenz-based ART. The primary objective was to evaluate the incidence of TB-IRIS. Incidence rate ratio comparing TB-IRIS incidence in each arm was calculated. Kaplan-Meier curves were used to compare TB-IRIS-free survival probabilities by ART arm. Cox regression models were fitted to analyze baseline characteristics associated with TB-IRIS. Results: Of 460 trial participants, 453 from Brazil, Côte d'Ivoire, Mozambique, and Vietnam were included in this analysis. Baseline characteristics were median age 35 years (interquartile range [IQR], 29-43), 40% female, 69% pulmonary TB only, median CD4, 102 (IQR, 38-239) cells/mm³, and median HIV RNA, 5.5 (IQR, 5.0-5.8) log copies/mL. Forty-eight participants developed TB-IRIS (incidence rate, 24.7/100 PY), 19 cases in the raltegravir arm and 29 in the efavirenz arm (incidence rate ratio 0.62, 95% confidence interval .35-1.10). Factors associated with TB-IRIS were: CD4 ≤ 100 cells/μL, HIV RNA ≥500 000 copies/mL, and extrapulmonary/disseminated TB. Conclusions: We did not demonstrate that raltegravir-based ART increased the incidence of TB-IRIS compared with efavirenz-based ART. Low CD4 counts, high HIV RNA, and extrapulmonary/disseminated TB at ART initiation were associated with TB-IRIS.
Palabras clave en ingles
Antiretroviral therapyHIV/AIDS
IRIS
Randomized controlled trial
Tuberculosis
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