ABSTRACT
OBJECTIVE: To assess the incidence of anti-tuberculosis (TB) drug induced hepatitis (AIH) in Sri Lankan patients, determine risk factors of AIH, and to address management options in AIH. DESIGN: A prospective study. SETTING: Chest Hospital, Welisara, Sri Lanka, from April 2001 to April 2002. PATIENTS: Seven hundred and eighty three patients with a confirmed diagnosis of TB and resident in the Colombo and Gampaha districts who presented to Chest Hospital, Welisara, Sri Lanka. METHODS: WHO recommended treatment was commenced in all cases. AIH was diagnosed when patients complained of decreased appetite with nausea or vomiting and elevated serum bilirubin (SB; >1.1 mg/dL) or elevated serum alanine transferase (ALT; > 3 times upper limit of normal). RESULTS: Of 783 enrolled patients, 74 (9.5%) developed AIH, the majority (58%) developing AIH within the first 2 weeks of the intensive phase of treatment. AIH was more common among patients over 60 years (p = 0.018), who developed pulmonary TB (p = 0.028), and in patients weighing 33-55 kg (p = 0.004). Age, weight and rifampicin overdosage were significant predictors of AIH. Of the 74 AIH patients, standard treatment was restarted in 60, treatment modified in six, two defaulted and six died. CONCLUSIONS: The incidence of AIH in Sri Lanka is 9.5% in treated patients. AIH was associated with age, low body weight and rifampicin overdosage.