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PRIMARY PROPHYLAXIS TO PREVENT TUBERCULOSIS INFECTION IN PRISON INMATES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
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Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil / Universidade Estadual de Mato Grosso do Sul. Dourados, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil / Universidade Estadual de Mato Grosso do Sul. Dourados, MS, Brasil.
Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil.
Secretaria Municipal de Saúde. Dourados, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Stanford University. Stanford, CA, USA.
Stanford University. Stanford, CA, USA.
Fundação Oswaldo Cruz. Campo Grande, MS, Brasil / Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil / Universidade Estadual de Mato Grosso do Sul. Dourados, MS, Brasil.
Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil.
Secretaria Municipal de Saúde. Dourados, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Universidade Federal da Grande Dourados. Dourados, MS, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Stanford University. Stanford, CA, USA.
Stanford University. Stanford, CA, USA.
Fundação Oswaldo Cruz. Campo Grande, MS, Brasil / Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil.
Abstract
In many low- and middle-income countries, tuberculosis (TB) incidence in prisons is high, exposing incarcerated populations to an elevated risk of TB infection. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high TB burden prison to determine whether isoniazid given twice weekly (900 mg) for 12 months prevents TB infection. The primary outcome was QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL) at 6 months; secondary outcomes included alternative QFT thresholds (≥ 0.7, ≥ 2.0, and ≥ 4.0 IU/mL). In total, 467 participants were randomly assigned to intervention (N = 258) or control (N = 209). In an interim analysis of participants who had completed 6 months of follow-up (N = 170), QFT conversion occurred in 20.8% (19/91) and 21.5% (17/79) of participants in intervention and control arms (efficacy: 2.9%, P = 0.91), respectively. The trial was then stopped according to the trial protocol, and the remaining participants prematurely discontinued. In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%, P < 0.01). In conclusion, 900 mg of isoniazid, administered twice a week, did not effectively prevent QFT conversion at a cutoff point ≥ 0.35 IU/mL in a trial of QFT-negative inmates. Higher QFT cutoffs are associated with sustained conversion and greater protection. Future clinical trials that evaluate protection for latent infection should use the highest cutoff than that recommended by the manufacturer.
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