PHARMACOKINETIC STUDY OF BEDAQUILINE AMONG INDIAN MDR-TB PATIENTS IN
CLINICAL SETTINGS
Abstract
Bedaquiline, a novel drug was approved for the treatment of multi-drug
resistance tuberculosis (MDR-TB) by the US FDA in 2012. It is majorly
caused because of the transmission of multi-resistant strain from a
diseased person to a healthy individual and by genetic factors. Safety,
efficacy, and bactericidal activity of Bedaquiline were reported in
various studies, but the pharmacokinetic analysis of Bedaquiline in
clinical settings was unclear. This study serves as evidence for the
physicians regarding the pharmacokinetic data and managing drug therapy
and for better patient outcome in routine clinical practice. This study
is conducted in a total of 58 patients with newly diagnosed,
smear-positive, MDR-TB patients who received Bedaquiline as per RNTCP
guidelines. Plasma samples were collected after the Bedaquiline
administration. The patient samples were analyzed. The pharmacokinetic
data were drawn by using software kinetic-2000, version 5.03.The
observed Cmax was 2523.08 ng/mL, Tmax was reached at 4 hrs, AUC(0-24)
was 21727.1 ng *hr/mL, AUMC (0-24) was 222953.8 ng *hr2/mL. Whereas the
half-life of the drug was found at 7 .02 hrs and mean residence time
(MRT) was found to be 10.25 hrs respectively. The data was even on the
14th day of therapy. The Cmax is shown to be 5937.1ng/mL reaching the
Cmax at about 5 hours. While the AUC(0-24) was found to be 65780 ng
*hr/mL. Conclusively, pharmacokinetic parameters were evaluated and
found to be within the desired limits with minimal changes. This method
can be further used for the quantification of Bedaquiline in routine
clinical practice.