Impact of Adverse Drug Reactions in the outcomes of Tuberculosis Treatment

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 treatment outcomes. A prospective cohort study of persons with tuberculosis at a referral center in Rio de Janeiro, Brazil, from 2010 to 2016. 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 probability ADR-free time. A logistic regression model was performed to identify independent associations with unfavorable outcomes. 550 patients were enrolled and 35.1% were people living with HIV (PLHIV). ADR occurred in 78.6% of participants and was associated with favorable outcomes. Smokers (OR:2.32;95%CI:1.34-3.99) and illicit drug users (OR:2.02;95%CI:1.15-3.55) exhibited higher risk of unfavorable outcome. PLHIV more frequently experienced grade 3/4-ADR, specially “liver and biliary system disorders”. Lower CD4 counts were associated with hepatotoxicity (p=0.03). Male sex, low schooling, smoking and illicit-drug use are independent risk factors for unfavorable outcomes, as well alcohol abuse and previous ART in PLHIV. ADR increases the odds of favorable outcomes, although it is more severe in PLHIV and related to a higher risk of hepatotoxicity.