Drug-Induced Liver Injury in Newly Diagnosed Patients with Tuberculosis on Anti-Tuberculous Therapy: A Prospective Cohort Study
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Abstract
Objective: This study aimed to determine the cumulative incidence and clinical risk factors of Drug-induced liver injury (DILI) in patients on anti-tuberculous therapy (ATT).
Material & Methods: A single-arm prospective cohort study was conducted at Hayatabad Medical Complex, Peshawar, evaluating 222 newly diagnosed tuberculosis (TB) patients initiated on first-line ATT. Patients with abnormal baseline liver function tests (LFTs), pregnancy, alcohol use, or concurrent hepatotoxic medication use were excluded. Enrolled participants underwent clinical and biochemical follow-up at the end of the second, fourth, and eighth weeks, or at any time in case they developed symptoms of DILI. Drug-induced liver injury was diagnosed using the standardized American Thoracic Society (ATS) criteria. Associations between the risk factors and DILI were evaluated using Mann-Whitney U and Chi-square / Fisher's exact tests and multivariable logistic regression analysis.
Results: The cumulative incidence of DILI was 14% (n=31), with 90.3% (n=28) of cases occurring within the first four weeks of starting therapy. Symptomatic presentation occurred in 61.3% (n=19) of cases, with nausea (78.9%) and anorexia (63.2%) being the most frequent clinical manifestations. Age (AOR: 1.04, 95% CI: 1.01 – 1.07, p = 0.005), chronic liver disease (AOR: 3.82, 95% CI: 1.10 – 13.24, p = 0.034), and obesity (AOR: 2.48, 95% CI: 1.05 – 5.88, p = 0.039) were identified as independent predictors of DILI.
Conclusion: The cumulative incidence of ATT-induced DILI was 14%, with most cases presenting within the first month of treatment. Increasing age, chronic liver disease, and obesity were significant risk factors for DILI.
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