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https://www.arca.fiocruz.br/handle/icict/60911
INTEGRASE INHIBITOR-BASED ANTIRETROVIRAL TREATMENT DOES NOT INCREASE THE RISK OF TB-IRIS IN PEOPLE WITH HIV TREATED FOR TUBERCULOSIS: FINDINGS FROM THE REFLATE TB2 RANDOMIZED TRIAL
Alternative title
O tratamento anti-retroviral baseado em inibidor da integrase não aumenta o risco de TB-IRIS em pessoas com HIV tratadas para tuberculose: resultados do estudo randomizado refletido TB2Author
Affilliation
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
Nimes University Hospital. Department of Infectious and Tropical Diseases. Nimes, France / University of Montpellier. Research Unit 1058. Pathogenesis and Control Chronical Infections. INSERM. French Blood Center. Montpellier, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France / Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire.
Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire / Université Félix Houphouët Boigny. Département de Dermatologie et d’Infectiologie. UFR des Sciences Médicales. Abidjan, Cote D'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Pham Ngoc Thach Hospital. Ho Chi Minh City, Vietnam.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis. Virology Department. Paris, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
Nimes University Hospital. Department of Infectious and Tropical Diseases. Nimes, France / University of Montpellier. Research Unit 1058. Pathogenesis and Control Chronical Infections. INSERM. French Blood Center. Montpellier, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France / Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire.
Programme PACCI/ANRS Research Center. Abidjan, Cote D'Ivoire / Centre de Prise en Charge de Recherche et de Formation. CePReF-Aconda-VS. Abidjan, Cote D'Ivoire / Université Félix Houphouët Boigny. Département de Dermatologie et d’Infectiologie. UFR des Sciences Médicales. Abidjan, Cote D'Ivoire.
Instituto Nacional de Saúde. Marracuene, Mozambique.
Pham Ngoc Thach Hospital. Ho Chi Minh City, Vietnam.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis. Virology Department. Paris, France.
INSERM U944. Paris, France / Université Paris Cité. Paris, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France.
University of Bordeaux. National Institute for Health and Medical Research. Research Institute for Sustainable Development. Bordeaux Population Health Centre. Bordeaux, France / AP-HP-Hôpital Saint-Louis Lariboisière. Infectious Diseases Department. Paris, France.
Abstract
Background: Antiretroviral therapy (ART) initiation in people living with HIV (PWHIV) treated for tuberculosis (TB) may be complicated due to the occurrence of tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS). Integrase inhibitors (INSTIs), by providing a faster HIV-RNA decline than efavirenz, could increase the risk for this complication. We sought to assess incidence and determinants of TB-IRIS in PWHIV with TB on raltegravir or efavirenz-based ART. Methods: We conducted a secondary analysis of the ANRS 12300 Reflate TB 2 multicenter, phase 3 trial, that randomized ART-naive PWHIV on standard TB treatment, to receive raltegravir or efavirenz-based ART. TB-IRIS was defined according to the International Network for the Study of HIV-associated IRIS (INSHI) criteria. Incidence rates (IR) were estimated by 100 persons-year (PY), stratified Kaplan-Meier curves (log-rank test) and cox regression models were used to assess determinants of TB-IRIS. Results: Of 460 trial participants, 453 participants from Brazil, Côte d’Ivoire, Mozambique and Vietnam were included in this analysis. Median age 35 years (IQR: 29-43), 40% female, 69% pulmonary TB only, median CD4 102 (IQR 38-239) cells/µL and median HIV RNA 5.5 (IQR 5.0-5.8) log10 copies/mL. Overall, 48 participants developed TB-IRIS (IR = 24.2/100 PY), 19 cases in the raltegravir arm and 29 in the efavirenz arm (log-rank test: p=0.123) (Figure). Factors associated with TB-IRIS were: CD4 count =100 cells/µL, HIV RNA =500,000 copies/mL, extra-pulmonary/disseminated TB (Table). Conclusions: INSTI-based ART did not increase TB-IRIS risk. Low CD4 counts, high HIV RNA and extrapulmonary/disseminated TB were risk factors for TB-IRIS.
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