Safety Profile of Updated Weight-based Anti-Tuberculosis Therapy Compared with Conventional Dosing Regimens during the Intensive Phase of Pulmonary Tuberculosis Treatment: A Retrospective Cohort Study

Abstract

The World Health Organization updated weight-based ATT dosing to optimize drug exposure, but safety evidence in Indonesian populations is limited. This study compared ADR incidence, severity, and timing between new and conventional regimens during intensive-phase pulmonary tuberculosis treatment. In a retrospective cohort of 112 newly diagnosed pulmonary tuberculosis patients at Dr. Wahidin Sudirohusodo Hospital and affiliated hospitals, Makassar, Indonesia, conventional (n=56) and new weight-based dosing (n=56) ATT regimens were compared. ADRs were assessed from medical records and the national tuberculosis information system. Chi-square/Fisher–Freeman–Halton tests and multivariate logistic regression analyzed ADRs and predictors. Baseline characteristics were comparable (all p>0.05). Gastrointestinal disturbances were most common, and most reactions occurred within the first two weeks. No significant differences in overall incidence, severity, or timing were observed. The updated regimen was not associated with overall adverse drug reactions (OR=0.90, 95% CI: 0.37–2.20; p=0.820) after multivariable adjustment (aOR=0.96, 95% CI: 0.38–2.45; p=0.938). Safety was comparable to conventional regimen. Further prospective multicenter studies are needed.