Clinical profile of antitubercular drugs induced liver injury in patients receiving treatment under the national tuberculosis elimination program in a tertiary care centre

Background and aims: Tuberculosis, including India, remains a significant infectious disease worldwide. The mainstay of drugs in treating tuberculosis includes isoniazid, rifampicin, pyrazinamide, and ethambutol. Antitubercular drug-induced (ATD) liver injury is a leading cause of drug-induced liver injury and acute liver failure in India and much of the developing world. This paper aims to study the clinical profile of patients developing antitubercular drug-induced liver injury while receiving treatment under the National Tuberculosis Elimination Programme (NTEP) in a tertiary care centre. Methods: A hospital-based, observational study was conducted on 389 patients admitted to the Department of Medicine, Gauhati Medical College and Hospital (GMCH), Guwahati, Assam. All patients underwent pretreatment clinical and laboratory evaluation, including haemoglobin level, serum albumin, Liver Function Test (LFT), ultrasonography (USG) of the abdomen, hepatitis B, C, and HIV status. LFTs were repeated weekly in the first month, then at the end of the second and third weeks. Collected data were analyzed by applying the chi-square test. Results: 53(13.62%) out of 389 patients developed hepatotoxicity with a male-to-female ratio of 1.8:1, the highest number of patients aged 40-49 years. 66.04% of patients were symptomatic. 88.23% of patients developed an initial rise of bilirubin in 2nd week, and 90.56% developed elevated Alanine Transaminase (ALT) in 2nd week. Conclusion: A significant number of patients develop hepatotoxicity during treatment with antitubercular drugs. Most patients developed LFT derangements in the first two weeks of treatment and were symptomatic; all recovered completely by the next six to eight weeks, and there was no mortality. Keywords: Antitubercular drugs; hepatotoxicity; serum bilirubin; alanine transaminase.