Incidence of Drug-Induced Liver Injury in Patients Taking Antituberculosis Therapy

Abstract

Background: Tuberculosis remains a major global health challenge, particularly in high-burden countries where treatment-related complications can compromise outcomes. Drug-induced liver injury (DILI) is the most common and clinically significant adverse effect associated with first-line antituberculosis therapy, potentially leading to treatment interruption, morbidity, and prolonged disease transmission. Objective: To determine the incidence of drug-induced liver injury among patients receiving first-line antituberculosis therapy and to compare baseline clinical and biochemical characteristics between patients who developed DILI and those who did not. Methods: A prospective observational cohort study was conducted at the Department of Pulmonology, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from July to December 2023. Adult patients with newly diagnosed pulmonary or extrapulmonary tuberculosis initiating standard four-drug antituberculosis therapy were enrolled consecutively. Baseline demographic, clinical, and biochemical data were recorded, and participants were monitored during the intensive treatment phase for development of DILI according to standard biochemical criteria. Statistical analysis was performed using SPSS version 26, with comparisons conducted using independent sample t-tests and chi-square tests. Results: Among 173 patients, 18 developed drug-induced liver injury, yielding an incidence of 10.4% (95% CI: 6.3–15.9). The mean time to onset was 9.61 ± 3.11 days, with 50% of cases occurring between days 11 and 14 of therapy. Higher baseline alanine aminotransferase levels were observed among patients who developed DILI (p=0.035), while most affected patients recovered with appropriate management (83.3%). Conclusion: Drug-induced liver injury occurred in approximately one in ten patients receiving antituberculosis therapy and typically developed early during treatment. Baseline liver function abnormalities may help identify patients requiring closer monitoring during the intensive phase of therapy.