A PROSPECTIVE EVALUATION OF PREDICTIVE RISK FACTORS, SEVERITY OF LIVER INJURY AND COURSE OF ANTI –TUBERCULAR TREATMENT INDUCED HEPATOTOXICITY

Abstract

Background: Hepatotoxicity is an established complication of Anti-tubercular treatment. However, there is limited information on the incidence, possible predictive risk factors and course of anti- tubercular treatment induced hepatotoxicity.

Objective: The study was planned to evaluate incidence, possible predictive risk factors and course of anti-tubercular treatment induced hepatotoxicity (ATTIH ) .

Methodology: The present prospective study was conducted with Newly diagnosed pulmonary and extra-pulmonary tuberculosis patients admitted from may 2014 to may 2016.A sample size of 150 patients were put on ATT ranging from 6 months to 12 months depending on type of Tuberculosis. Their pretreatment clinical, biochemical and radiological parameters were recorded. These parameters were compared between cases and controls by appropriate statistical methods. Patients with abnormal base line LFT’S, Treatment defaulters, failure, MDR cases and patients with NASH, cirrhosis ,acute viral hepatitis &/or renal or cardiac disease were excluded from this study.

Results: Out of 150 patients 22 patients (14.7%) developed ATTIH. Among 22 patients 15 (68.2%) were females and 7 (31.8%) were males. Higher incidence of ATTIH was seen in patients with low BMI of 18.99kg/m²(45.16%), pretreatment low serum albumin <2.5gm( 65.21%), Corrected calcium < 7.9gm/dl( 58.8%), Serum cholesterol < 200mg/dl (59.1%), Extra pulmonary TB(69.3%), concomitant paracetamol intake(77.7%). Age and consanguinity were statistically insignificant. In this study 18 patients (81.81%) developed ATTIH within 2 weeks of starting ATT with average of 9 days and severity of liver injury ranged from mild with ALT ( 51-250IU/L) in 12(54.5%), intermediate (251-500IU/L) in 7 ( 31.8%) and severe (ALT >500IU/L) in 3(13.6%). Normalization of LFTs after ATTIH was seen within first 2 weeks in 11(50%) patients with average of 11 days. ATTIH was associated with prolongation of expected treatment duration in 16 (72.7%) patients. Recurrence of ATTIH was not seen in any patient on reintroduction of treatment. Among 22 patients, 19(86.36%) were cured, 2(9.1%) expired and 1 patient lost follow up.

Conclusion: Early identification of predictive risk factors, modification of treatment with close monitoring and hospitalization are required for reducing morbidity, mortality and treatment completion in ATTIH.