Prevalence of liver function test derangements in adult tuberculosis patients initiated on a daily fixed combination regimen: a prospective study from Kerala, India

Anti-tuberculosis drug-induced hepatotoxicity is a major challenge in tuberculosis (TB) management, particularly in high-burden countries like India. Early liver function test (LFT) derangements during daily fixed-dose combination (FDC) therapy may reflect subclinical hepatocellular stress and guide timely intervention; however, evidence from Indian programmatic settings remains limited. To determine the prevalence, severity, demographic associations, biochemical trends, and clinical outcomes of early (two-week) LFT abnormalities in adult TB patients initiating daily FDC therapy under the National Tuberculosis Elimination Programme (NTEP). A prospective observational study was conducted among adults with newly diagnosed TB at a tertiary center in Kerala (January-June 2025). Baseline and two-week LFTs were compared using paired t-tests. Associations with demographic and clinical variables were assessed using Chi-square tests. LFT derangement was defined as per the WHO/NTEP criteria. Among 146 participants, 41 (28.1%) developed LFT derangements at two weeks (95% CI: 20.9-36.4%). No significant associations were observed with age (χ²=0.05, p=0.977), sex (χ²=0.11, p=0.898), TB type (χ²=0.00, p=1.000), or weight band (p>0.05). Mean alanine aminotransferase (ALT) increased from 26.6 to 58.1 IU/L (mean difference +31.5 IU/L; 95% CI: 25.8-37.2; p