Incidence, Clinical Features, Associated Factors and Outcomes of Intensive Phase Antituberculosis Drug Induced Liver Injury Among Patients With Tuberculosis at a Tertiary Care Hospital in Nepal: A Descriptive Cross-Sectional Study.

Background And Aims: Tuberculosis (TB) remains a significant global health concern, especially in Nepal, where the incidence of anti-TB drug-induced liver injury (DILI) is substantial. The main aim of this study is to investigate the incidence, clinical characteristics, outcomes, and contributing factors related to intensive phase anti-TB DILI among TB patients.

Methods: This prospective cross-sectional study enrolled 78 TB patients. Patients received a weight-based fixed-dose Antitubercular therapy (ATT). Liver function tests (LFTs) were performed at baseline and periodically during treatment to monitor for anti-TB DILI. Patients with DILI received immediate ATT discontinuation, supportive care, and reintroduction of ATT upon LFT normalization. Outcomes were tracked up to 60 days post-DILI. Data were analyzed using SPSS v21. Statistical significance was set at  < 0.05.

Results: The mean age of the patients was 49.87 years (SD = 18.61), and 57.7% were male. Anti-TB DILI was observed in 15.4% of patients during the intensive treatment phase, with moderate severity in 50% of these cases. Half of the patients with DILI presented with nausea, vomiting, and anorexia. Notably, 91.7% of DILI patients showed improvement upon treatment discontinuation. The recurrence rate of anti-TB DILI after ATT re-initiation was 8.3%. Anti-TB DILI developed at a median of 11 days (range: 7-60 days) after ATT initiation, with liver enzyme normalization after discontinuation of ATT averaging 10.9 ± 6.45 days. The mortality rate among DILI patients was 8.3% (1 out of 12 patients). Hepatotoxic drugs, low BMI, and low serum albumin were identified as independent predictors of anti-TB DILI.

Conclusion: Anti-TB DILI occurred in a significant proportion of TB patients, with moderate severity being most common. Early detection and management, including treatment discontinuation, led to high recovery rates, though mortality remained notable. Low BMI, low serum albumin, and hepatotoxic drugs were key independent risk factors, emphasizing the need for careful monitoring and tailored management during ATT.