An Analysis of Risk Factors for Anti-tuberculosis Drug-induced Liver Injury at Pattaya Bhattamakhun (Banglamung) Hospital

Abstract

BACKGROUND: Tuberculosis is a disease with a high incidence and mortality rate. The standard regimen for the treatment of tuberculosis includes Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol, which are known to have significant adverse drug reactions, including antituberculosis drug-induced liver injury (ATDILI). Therefore, identifying the risk factors for ATDILI is crucial for treatment planning and monitoring.

OBJECTIVES: This study was conducted to investigate the estimated risk factors for drug-induced liver injury from the use of antituberculosis drugs (ATDILI).

METHODS: This was a retrospective case-control study, which collected data from the medical records of patients diagnosed with tuberculosis who received follow-up treatment at the TB Clinic of Pattaya Bhattamakhun Hospital from January 1, 2021, to December 31, 2023. The study group consisted of tuberculosis patients who experienced ATDILI after receiving a standard antituberculosis regimen, while the control group included tuberculosis patients who did not experience ATDILI. Groups were matched at a ratio of 1:3, with control subjects selected using a similar age and gender to the study group. The study results were analyzed using both Univariable and Multivariable analysis through a logistic regression model to identify the association of risk factors, expressed in terms of odds ratios and 95% confidence intervals.

RESULTS: From a group of 66 individuals with ATDILI and a control group of 198 individuals, both groups had 60.6% male participants, with average ages of 49.8 and 49.5 years in the study and control groups, respectively. The average duration of ATDILI occurred 19.7 days after the initiation of anti-tuberculosis drugs. Univariable analysis revealed that those with HIV infection had a 2.6 times higher risk (95%CI 1.35-4.93, p<0.05). Individuals receiving Ethambutol at doses greater than 20 mg/kg/day had a 2.5 times higher risk (95%CI 1.07-5.72, p<0.05), and those with less than 3.5mg/dl of serum albumin had a 1.9 times higher risk (95%CI 1.09-3.37, p<0.05). According to Multivariable analysis, individuals with HIV infection had a 2.5 times higher risk (95%CI 1.19-5.14, p<0.05), and those receiving Ethambutol at doses greater than 20 mg/kg/day had a 2.4 times higher risk (95%CI 1.02-5.71, p<0.05).

CONCLUSIONS: Two statistically significant risk factors for the development of ATDILI were identified: HIV infection and receiving Ethambutol in excess of the recommended dosage. Therefore, it is essential to plan treatment and closely monitor the risk of ATDILI in patients with these risk factors.

Thaiclinicaltrials.org number, TCTR20250222006