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IMPACT OF ADVERSE DRUG REACTIONS ON THE OUTCOMES OF TUBERCULOSIS TREATMENT
Adverse drug reactions (ADR)
Cohort study
HIV
Anti-tuberculosis treatment (ATT)
Author
Affilliation
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Postgraduate Program Clinical Research in Infectious Diseases. Rio de Janeiro, RJ, Brazil / Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Clinical Research Laboratory on Mycobacteria, (LAPCLIN-TB). Rio de Janeiro, RJ, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Clinical Research Laboratory on Mycobacteria, (LAPCLIN-TB). Rio de Janeiro, RJ, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil / Escola Bahiana de Medicina e Saúde Pública. Curso de Medicina. Salvador, BA, Brazil / Universidade Salvador. Laureate Universities. Curso de Medicina. Salvador, BA, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Postgraduate Program Clinical Research in Infectious Diseases. Rio de Janeiro, RJ, Brazil / Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Clinical Research Laboratory on Mycobacteria, (LAPCLIN-TB). Rio de Janeiro, RJ, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Clinical Research Laboratory on Mycobacteria, (LAPCLIN-TB). Rio de Janeiro, RJ, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil.
Federal University of Bahia. School of Medicine. Salvador, BA, Brazil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Laboratory of Inflammation and Biomarkers. Salvador, BA, Brazil / Escola Bahiana de Medicina e Saúde Pública. Curso de Medicina. Salvador, BA, Brazil / Universidade Salvador. Laureate Universities. Curso de Medicina. Salvador, BA, Brazil.
Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Postgraduate Program Clinical Research in Infectious Diseases. Rio de Janeiro, RJ, Brazil / Oswaldo Cruz Foundation. National Institute of Infectious Diseases Evandro Chagas. Clinical Research Laboratory on Mycobacteria, (LAPCLIN-TB). Rio de Janeiro, RJ, Brazil.
Abstract
Background: Adverse drug reactions (ADR) challenge successful anti-tuberculosis treatment (ATT). The aim of this study was to evaluate the impact of ATT-associated ADR and related factors on ATT outcomes. Methods: A prospective cohort study of persons with tuberculosis (TB) at a referral center in Rio de Janeiro, Brazil, from 2010 to 2016. Baseline information: race, sex, schooling, economic status, tobacco, drugs and alcohol abuse, HIV-infection status and comorbidities were captured during TB screening and diagnosis. Laboratory exams were performed to confirm TB diagnosis and monitor ADRs, favorable (cure and treatment completion) and unfavorable (death, loss to follow up and failure) outcomes were prospectively captured. The Kaplan-Meier curve was used to estimate the probability of ADR-free time. A logistic regression analysis (backward elimination) was performed to identify independent associations with unfavorable outcomes. Results: 550 patients were enrolled, 35.1% were people living with HIV (PLHIV) and ADR occurred in 78.6% of all participants. Smoking (OR: 2.32; 95% CI:1.34-3.99) and illicit-drug use (OR:2.02; 95% CI:1.15-3.55) were independent risk factors for unfavorable outcomes. In PLHIV, alcohol abuse and previous ART use were associated with unfavorable outcomes. In contrast, ADR increased the odds of favorable outcomes in the overall population. PLHIV more frequently experienced grade 3/4-ADR (18.36%), especially "liver and biliary system disorders". Lower CD4 counts (<100 cells/uL) were associated with hepatotoxicity (p = 0.03). ART-naïve participants presented a higher incidence of ADR in comparison with ART-experienced patients. Conclusion: Substance use was associated with unfavorable outcomes, highlighting the need for better strategies to reduce this habit. In contrast, ADRs were associated with favorable outcomes. Attention to the occurrence of ADR in PLHIV is essential, especially regarding hepatotoxicity in those with high immunosuppression.
Keywords
TuberculosisAdverse drug reactions (ADR)
Cohort study
HIV
Anti-tuberculosis treatment (ATT)
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