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Title
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
Presenter
Lara Esteves Coelho
Authors
L.E. Coelho1, C. Chazallon2, D. Laureillard3,4, R. Escada1, J.-B. Ntakpe2,5, I. Timana6, S.W. Cardoso1, E. Messou5,7, S. Eholie5,7,8, C. Khosa6, G. Do Chau9, V.G. Veloso1, X. Anglaret2, C. Deaugerre10,11,12, J.-M. Molina10,11,13, B. Grinsztejn1, O. Marcy2, N. De Castro2,13
Institutions
1National Institute of Infectious Diseases Evandro Chagas, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil, 2University of Bordeaux, National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, Bordeaux, France, 3Nimes University Hospital, Department of Infectious and Tropical Diseases, Nimes, France, 4University of Montpellier, Research Unit 1058, Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, Montpellier, France, 5Programme PACCI/ANRS Research Center, Abidjan, Cote D'Ivoire, 6Instituto Nacional de Saúde, Marracuene, Mozambique, 7Centre de Prise en Charge de Recherche et de Formation, CePReF-Aconda-VS, Abidjan, Cote D'Ivoire, 8Université Félix Houphouët Boigny, Département de Dermatologie et d’Infectiologie, UFR des Sciences Médicales, Abidjan, Cote D'Ivoire, 9Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam, 10INSERM U944, Paris, France, 11Université Paris Cité, Paris, France, 12AP-HP-Hôpital Saint-Louis, Virology Department, Paris, France, 13AP-HP-Hôpital Saint-Louis Lariboisière, Infectious Diseases Department, Paris, France

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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