Adverse drug reactions to the nine-month all-oral and 18-month regimens for multidrug-resistant tuberculosis in Indonesia

Background The treatment of multidrug-resistant (MDR) tuberculosis (TB) requires the long-term administration of multiple second-line drugs in combination therapy. Objective We investigated the ADRs to a 9-month all-oral regimen (i.e., pyrazinamide, ethambutol, high-dose isoniazid, levofloxacin, bedaquiline, and clofazimine) and a longer 18-months regimen (i.e., levofloxacin, bedaquiline, linezolid, clofazimine, and cycloserine) for MDR-TB during the first 4 months of treatment. Method The patients in this cohort study were recruited from three referral hospitals in Indonesia. The inclusion criteria were patients aged ≥18 years diagnosed with MDR-TB who received either the 9-month all-oral or 18-months regimens. We used the causality assessment categories from the WHO–Uppsala Monitoring Center. Results A total of 60 patients were included in this study. The ADRs included nausea and/or vomiting (48.3%), arthralgia (38.3%), prolonged QTcF interval (30.0%), among others. One case of prolonged QT interval in a grade 3 ADR was observed, in which the 18-month regimen was modified during the first 4 months of treatment. Conclusion In the first 4 months of treatment, the predominant ADRs were nausea and/or vomiting, arthralgia, and prolonged QT interval. This study showed that active patient monitoring is needed.