Evaluation of Hepatotoxicity of Anti-Tuberculosis Regimens: A Prospective Study in Tribal Population of Central India

Background: The magnitude of tuberculosis (TB) and associated risk factors for development of toxicity to anti-TB drugs in vulnerable tribal groups are useful indicators for understanding extent of TB transmission, effectiveness of TB therapy. Such studies help to gather information, helps in planning control and preventive strategies for TB in this special population. The study was carried out to evaluate incidence of hepatotoxicity, association between risk factors, anti-TB regimen and hepatotoxicity in selected vulnerable population. Materials and Methods: Prospective study in tribes (Gond, Halba, Kawar) of a district in central India diagnosed with pulmonary/ extrapulmonary/Multi drug resistant TB. These patients were on anti- TB regimen, monitored clinically and biochemically for hepatotoxicity at the end of 1, 3 and 6 months of anti-tubercular therapy. A specific criterion was set for diagnosing hepatotoxicity. Results: Incidence of hepatotoxicity was 9.23%. Raised serum transaminase, bilirubin level and symptoms of hepatotoxicity like nausea, anorexia, vomiting, malaise, jaundice, were observed. The onset of hepatotoxicity ranged from 25-180 days (median 65 days). Of various risk factors analyzed, high alcohol intake was associated with hepatotoxicity (odds ratio = 9.3, 95% confidence interval 1.8–47, p=0.003). Age, gender, extent of tuberculosis disease, malnutrition was not significantly associated with anti-tuberculosis treatment hepatotoxicity. Relative risk of developing hepatotoxicity in alcoholic addicted males was 14.117. Conclusion: Withdrawal of alcohol habit in selected tribes on antiTuberculosis regimen will cause a drop in developing hepatotoxicity by 93%. Mass education regarding same would curtail hepatotoxicity making therapy safe.