DRUG-RESISTANT TUBERCULOSIS TREATMENT WITH BEDAQUILINE AND DELAMANID. WHAT ADVERSE EVENTS ARE TO BE EXPECTED?

Abstract

The aim. To determine if treatment regimens including new antituberculous drugs bedaquiline (BDQ) and delamanid (DLM) are clinically safe. Methods. A retrospective analysis of 32 drug-resistant tuberculosis (DR-TB) patients who were treated with BDQ and/or DLM in Lithuanian University of Health Sciences Kauno klinikos affiliated hospital Romaniai Hospital of Tuberculosis Department of Resistant TB was performed. The features of patients and possible adverse events (AEs) of new antituberculous drugs were evaluated. Results. The majority of patients were relatively young men (mode – 50 years). 59.38% of patients were excessive alcohol users. 56.3% of patients which were treated with these new antituberculous drugs had extensively drug-resistant TB. Bilateral involvement was the most common radiological finding (68.75%). Half of the patients had at least 1 of the possible AEs. The most common possible AEs were QTc interval prolongation, skin rash, nausea/vomiting, while peripheral neuropathy, diarrhea and palpitations were rarer. One patient had to stop treatment because of clinically significant changes in electrocardiogram. 3 (9.38%) cases of AEs were undoubtedly caused by new antituberculous drugs (BDQ and DLM).
There was no statistically significant relation between age, sex, alcohol consumption and possible AEs (p>0.05). There was no statistically significant relation between age, sex and QTc interval prolongation (p>0.05) either. However, in our study QTc interval prolongation occurred only in men. Conclusion. After a careful consideration of the research results it was concluded that treatment with these new antituberculous drugs is sufficiently safe. However, in order to assess how various factors impact the manifestation of AEs, studies with larger sample size should be performed.