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European Journal of Clinical Pharmacology : Volume 73

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Effect of carbamazepine on dolutegravir pharmacokinetics and dosing recommendation

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European Journal of Clinical Pharmacology : Volume 72, Issue 2, February 2016

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Effect of carbamazepine on dolutegravir pharmacokinetics and dosing recommendation

Content Provider	Springer Nature Link
Author	Song, Ivy Weller, Steve Patel, Juhin Borland, Julie Wynne, Brian Choukour, Mike Jerva, Fred Piscitelli, Stephen
Copyright Year	2016
Abstract	Dolutegravir (DTG) is primarily metabolized by UGT1A1 with CYP3A as a minor route. Carbamazepine (CBZ) is a potent inducer of these enzymes; thus, the effect of oral extended-release CBZ on DTG pharmacokinetics (PK) was evaluated to provide dose recommendation when co-administered.This was a single-center, open-label, fixed-sequence, crossover study in healthy adults. Subjects received three treatments: DTG 50 mg every 24 h (q24h) × 5 days in period 1, followed by CBZ 100 mg every 12 h (q12h) × 3 days, then 200 mg q12h × 3 days, then 300 mg q12h × 10 days in period 2, and DTG 50 mg q24h + CBZ 300 mg q12h × 5 days in period 3. No washout intervals occurred. Each dose was administered with a moderate-fat meal. Serial PK samples for DTG were collected on day 5 of periods 1 and 3. Plasma DTG PK parameters were determined with non-compartmental analysis. Geometric least-squares mean ratios (GMRs) and 90 % confidence intervals (CIs) were generated by the mixed-effect model for within-subject treatment comparisons. Safety assessments were performed throughout the study.Sixteen subjects enrolled; 14 completed the study. CBZ significantly reduced DTG exposure: GMRs (90 % CI) for DTG + CBZ versus DTG alone were 0.51 (0.48–0.549), 0.67 (0.61–0.73), and 0.27 (0.24–0.31) for area under the curve from time zero to the end of the dosing interval (AUC(0-τ)), maximum observed plasma concentration (Cmax), and plasma concentration at the end of the dosing interval (Cτ), respectively. DTG alone and co-administered with CBZ was well tolerated.Integrase strand transfer inhibitor-naive subjects taking CBZ should receive DTG 50 mg twice daily versus once daily, as is recommended with other potent UGT1A/CYP3A inducers.ClinicalTrials.gov: NCT01967771
Starting Page	665
Ending Page	670
Page Count	6
File Format	PDF
ISSN	00316970
Journal	European Journal of Clinical Pharmacology
Volume Number	72
Issue Number	6
e-ISSN	14321041
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2016-02-22
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Carbamazepine Dolutegravir Drug interaction Healthy subjects Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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