Glecaprevir/Pibrentasvir versus Omeprazole
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Study Design
This was an open label study conducted in (n=12) healthy adult subjects to assess the potential for CYP mediated drug-drug interactions after administration of a CYP probe substrate and the direct acting antiviral combination of ABT-493/ABT-530. On days 1 and 11 of the study subjects were administered single oral dose of 20mg of omeprazole. Subsequently subjects were administered ABT-493 300mg and of ABT-530 120mg daily from days 4-13 of the study. Pharmacokinetic analysis using repeated-measures was performed on days 1 and 11 for the CYP substrates and on day 10 for ABT-493/ABT-530. Safety of the study medications was monitored throughout the study period.
Study Results
Based on central value ratios and 90% confidence intervals, the AUC was similar (≤16%) (0.70-0.90) and the Cmax was lower with a (39%) (0.43-0.75) decrease suggesting the lower exposure of omeprazole may be due to absorption and therefore not CYP mediated induction. Pharmacokinetic parameters for ABT-493/ABT-530 were not reported although exposures were similar to other studies in healthy subjects.
This combination was generally well tolerated and no serious adverse events were reported.
Study Conclusions
Per the authors, ABT-493/ABT-did not appear to inhibit CYP2C19, of which omeprazole is a substrate. Therefore, significant drug-drug interactions are not expected. No dosage adjustment is recommended when the two are co-administered in therapy
References
Kosloski MP, Dutta S, Pugatch D, Li H, Mensa F, Kort J. Abt-493 and abt-530 combination demonstrated minimal potential for cyp-mediated drug-drug interactions. abstract thu-229. Ilc: International Liver Congress. Barcelona, Spain. 2016; April 2016.
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