Background: Incidence of Antitubercular Therapy (ATT)-induced hepatotoxicity is
higher in India when compared to Western countries. As the occurrence of ATT-induced hepatotoxicity
is unpredictable, serial intensive monitoring of hepatic function is now being recommended by
the American Thoracic Society in individuals at high risk. This study was done to evaluate the risk
factors for the development of ATT induced hepatotoxicity in India.
Methodology: In this prospective, observational study, patient characteristics of microbiologically/
radiologically/ histopathologically confirmed tuberculosis were prospectively compiled. Serial
liver function tests were done once a month in all patients. Patients who developed ATT-induced
hepatotoxicity were considered as the study group and those who did not develop the event as a
control group. The primary outcome measure was to estimate the hazard ratios associated with risk
factors for the development of ATT induced hepatotoxicity. Cox Regression Analysis was done using
Results: A total of 200 patients were enrolled in the study, of them, 14% developed ATT-induced
hepatotoxicity and 86% did not develop the event. The baseline liver function tests in the study
group and control group were within normal limits. Female gender, alcoholism, HIV co-infection
and age >35 yrs were identified to have a higher risk for development of ATT-induced hepatotoxicity,
while cases with pulmonary tuberculosis were found to be at lower risk of developing event.
Conclusion: Intensive liver function monitoring needs to be done in patients with these risk factors,
female gender, alcoholism, HIV co-infection, extra-pulmonary tuberculosis and age >35 yrs.