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Randomized Controlled Trial
. 2023 Oct 1;37(12):1837-1842.
doi: 10.1097/QAD.0000000000003521. Epub 2023 Feb 16.

Virologic response to antiretroviral therapy in people with HIV and tuberculosis in high tuberculosis burden countries

Nathalie De Castro  1   2 , Corine Chazallon  1 , Carlos Brites  3 , Eugène Messou  4   5   6 , Celso Khosa  7 , Didier Laureillard  8   9 , Giang D Chau  10 , José H Pilotto  11 , Serge Eholié  4   6 , Constance Delaugerre  12   13   14 , Jean-Michel Molina  2   13   14 , Linda Wittkop  15   16   17 , Beatriz Grinsztejn  18 , Olivier Marcy  1
Affiliations
Randomized Controlled Trial

Virologic response to antiretroviral therapy in people with HIV and tuberculosis in high tuberculosis burden countries

Nathalie De Castro et al. AIDS. .

Abstract

Objective: We sought to compare virologic outcomes on antiretroviral therapy (ART) between people with HIV (PWH) also treated for tuberculosis in the different countries who participated to two randomized trials.

Design: Pooled analysis of two randomized clinical trials.

Methods: In the phase II Reflate TB and phase III Reflate TB2 trials conducted in Brazil, Côte d'Ivoire, Mozambique and Vietnam, ART-naïve PWH treated for tuberculosis were randomized to receive raltegravir or efavirenz. We assessed country differences in baseline characteristic using Wilcoxon tests and chi-square, or Fisher's exact test. We used logistic regression to analyze determinants of virologic success, defined as week-48 plasma HIV-1 RNA <50 copies/ml.

Results: Of 550 participants (140 from Brazil, 170 from Côte d'Ivoire, 129 from Mozambique and 111 from Vietnam) with median baseline HIV-1 RNA of 5.4 log 10 copies/ml, 362 (65.8%) achieved virologic success at week 48. Virologic success rates were: 105/140 (75.0%) in Brazil, 99/170 (58.2%) in Côte d'Ivoire, 84/129 (65.1%) in Mozambique and 74/111 (66.7%) in Vietnam ( P = 0.0233). Baseline HIV-1 RNA, but not the country, was independently associated with virologic success: baseline HIV-1 RNA ≥500 000 copies/ml (reference), HIV RNA <100 000 copies/ml odds ratio 3.12 [95% confidence interval (CI) 1.94; 5.01] and HIV-1 RNA 100 000-499 999 copies/ml odds ratio: 1.80 (95% CI 1.19; 2.73). Overall, 177/277 (63.9%) patients treated with raltegravir and 185/273 (67.9%) patients treated with efavirenz had a plasma HIV-1 RNA <50 copies/ml at week 48.

Conclusions: Virologic response to antiretroviral therapy in PWH with TB varied across countries but was mainly driven by levels of pretreatment HIV-1 RNA.

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References

    1. Dooley KE, Kaplan R, Mwelase N, Grinsztejn B, Ticona E, Lacerda M, et al. Dolutegravir-based antiretroviral therapy for patients coinfected with tuberculosis and human immunodeficiency virus: a multicenter, noncomparative, open-label randomized Trial . Clin Infect Dis 2020; 70:549–556.
    1. De Castro N, Marcy O, Chazallon C, Messou E, Eholié S, N’takpe J, et al. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, noninferiority, randomised, phase 3 trial . Lancet Infect Dis 2021; 21:813–822.
    1. Grinsztejn B, De Castro N, Arnold V, Veloso VG, Morgado M, Pilotto JH, et al. Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, noncomparative, open-label, randomised trial . Lancet Infect Dis 2014; 14:459–467.
    1. Taburet A-M, Sauvageon H, Grinsztejn B, Assuied A, Veloso V, Pilotto JH, et al. Pharmacokinetics of raltegravir in HIV-infected patients on rifampicin-based antitubercular therapy . Clin Infect Dis 2015; 61:1328–1335.
    1. Marcy O, De Castro N, Chazallon C, Messou E, Eholie S, Bhatt N et al. Adherence and factors associated with virologic success in HIV-1 infected adults with tuberculosis receiving raltegravir or efavirenz in the ANRS 12300 Reflate TB2 trial. In: 23rd International AIDS Conference, Virtual, 6–10 July 2020. Abstract OAB0303.

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