Risks of hepatotoxicities during the intensive phase of tuberculosis treatment: A hospital-based case control study

Objective: To identify factors associated with hepatotoxicity during the intensive phase of treatment in tuberculosis (TB) patients. Methods: A case-control study was conducted of TB patients treated with first-line anti-TB drugs from 2013 to 2020. Cases were defined as patients who developed hepatotoxicity, while controls were those without hepatotoxicity, at a 1:2 ratio. Controls were randomly selected from the same hospitals as the cases. The primary outcome was the occurrence of hepatotoxicity during the intensive treatment phase, with data retrospectively collected from medical records. Descriptive statistics and multiple logistic regression with backward elimination were used for analysis. Results: Among 3021 tuberculosis patients who received first-line anti-tuberculosis regimen, 50 had abnormal liver function and 14 developed hepatotoxictiy. In addition, 2957 patients had normal liver function and 128 served as controls for this analysis. Multiple logistic regression analysis revealed that female patients had about twice the risk of hepatotoxicity compared to males (adjusted OR 2.25, 95% CI 1.11-4.59), and patients with HIV coinfection were nearly 10 times more likely to develop hepatotoxicity than those without HIV (adjusted OR 9.74, 95% CI 3.12-30.41). Conclusions: Female sex and HIV coinfection were found to be significant risk factors for hepatotoxicity during the intensive phase of TB treatment. Enhanced monitoring and preventive strategies are recommended for these high-risk groups to reduce the risk of hepatotoxicity.