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. 2023 Feb 7;18(2):e0269765.
doi: 10.1371/journal.pone.0269765. eCollection 2023.

Impact of adverse drug reactions on the outcomes of tuberculosis treatment

Flávia M Sant Anna  1   2 , Mariana Araújo-Pereira  3   4   5 , Carolina A S Schmaltz  2 , María B Arriaga  3   4   5 , Bruno B Andrade  3   4   5   6   7 , Valeria C Rolla  1   2
Affiliations

Impact of adverse drug reactions on the outcomes of tuberculosis treatment

Flávia M Sant Anna et al. PLoS One. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Study design and probability of presenting adverse drug reactions during the antitubercular treatment.
(A) Study design. (B) Event free curve (Kaplan-Meier) of tuberculosis patients during antitubercular treatment. Mean time (in state, restricted max time = 365) in days of event occurrence: 140.7. Abbreviation: ADR: adverse drug reaction; ATT: anti-TB treatment; CI: confidence interval; TB: tuberculosis.
Fig 2
Fig 2. Association between clinical characteristics and tuberculosis treatment outcomes among tuberculosis patients.
The logistic binary regression model (backward stepwise regression) was performed to evaluate the independent associations between clinical characteristics, including adverse drug reaction occurrence, of tuberculosis patients and variables showed in the univariate analyses (Table 1) and unfavorable treatment outcome. Only variables remaining in the final model are shown. Abbreviation: ADR: adverse drug reaction; CI: confidence interval; TB: tuberculosis.
See this image and copyright information in PMC

References

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