Abstract
Background: Bedqauiline (BDQ) is a relatively new agent for multidrug
(MDR) and extremely drug resistant (XDR) TB. It is important to look for
cardiac safety and the bizarre adverse reactions after initiation of the
drugs from the real world studies. Methods: An observational study was
conducted on the institutionalized MDR and XDR patients under the
conditional access program of BDQ in India. Daily ECG, adverse events
and change in laboratory values for first two weeks were recorded with
mortality and serious adverse events till first three months of
initiation of BDQ containing regimen. Results: Among the total of 49
patients, nausea (n=33) was the most reported side effect. Though a mean
rise of QTcF (12%) was noted after 14 days, individually, both
prolongations (QTcF >440 ms) and shortening (from baseline
values) of QTcF were noted in 95.92% (n=47) and 89.8% (n=44) patients.
Three distinct QT patterns noted in ECG were, a) initial rise then fall
(n=8), b) initial fall then rise (n=9) and c) rise followed by further
rise (32). There was no serious adverse event leading to drug withdrawal
or mortality in the first three months. Conclusions: Prolongation of
QTcF occurs in alarming numbers during first two weeks of BDQ therapy as
well as shortened QT. However, BDQ was otherwise tolerated well by the
real world MDR & XDR-TB patients in short term. Intensive ECG and
clinical monitoring is recommended to detect possible serious
implications of such ECG changes in the long term.