Abnormal baseline liver function and incidence of antituberculosis therapy-induced hepatotoxicity in patients notified under the national tuberculosis program

Abstract Background: Data from programmatic settings in India examining the role of baseline abnormal liver function and antituberculosis therapy (ATT)-induced hepatotoxicity is limited. This study aimed to estimate the incidence and identify risk factors of ATT-induced hepatotoxicity. Methodology: The prospective cohort study conducted in Puducherry, India, from May 2022 to April 2023, included adult drug-sensitive TB patients initiated on 6-month standard ATT regimen. Patients were followed up during the intensive phase of treatment with liver function tests (LFTs) to monitor hepatotoxicity. Results: Of 386 patients, 24 (6.2%, 95% confidence interval [CI]: 4.2%–9.1%) developed ATT-induced hepatotoxicity. Risk factors for hepatotoxicity included abnormal baseline LFT (risk ratio [RR]: 4.1), hazardous alcohol use (RR: 3.4), diabetes mellitus (RR: 2.7), and severe anemia (RR: 3.4). Among the 24 patients who developed hepatotoxicity, 4 (16.7%) expired, and 4 (16.7%) required changes in treatment regimen indicating the impact of hepatotoxicity on treatment outcomes. Conclusion: Approximately one in 16 patients developed ATT-induced hepatotoxicity during the intensive phase of treatment. Abnormal liver function at baseline emerged as an important risk factor, emphasizing the role of baseline LFT assessment and targeted monitoring of high-risk patients for early detection and management of hepatotoxicity.