Pharmacokinetic interaction between bedaquiline and clofazimine in patients with drug-resistant tuberculosis
METHODS: We assessed the effect of co-administered CFZ on BDQ bioavailability, or on clearance of BDQ and its N-monodesmethyl metabolite (M2), in patients with DR-TB using a population PK model developed from data of patients with DR-TB. This was a secondary analysis of a study designed to explore drug-drug interactions between BDQ and antiretrovirals.
RESULTS: Of 46 participants, 30 were on concomitant CFZ when intensive PK sampling of BDQ was done. CFZ did not have a statistically significant effect on BDQ bioavailability (−9.1%, 90%CI −22.8 to +7.1; P = 0.19) or on BDQ and M2 clearance (+12.2%, 90%CI −13.7 to +38; P = 0.32).
CONCLUSION: We did not find a statistically significant PK drug-drug interaction between BDQ and CFZ, but cannot exclude a potentially clinically relevant interaction due to the wide confidence intervals of the estimated interaction effects.
Document Type: Research Article
Affiliations: 1: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa 2: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden 3: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden, Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands
Publication date: January 1, 2018
This article was made available online on November 16, 2017 as a Fast Track article with title: "Pharmacokinetic interaction between bedaquiline and clofazimine in patients with drug-resistant tuberculosis".
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