Application of Exposure-Response Analyses to Establish the Pharmacodynamic Similarity of a Once-Daily Regimen to an Approved Twice-Daily Dosing Regimen for ... View Full Text


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Article Info

DATE

2017-07-06

AUTHORS

Akshanth R. Polepally, Haoyu Wang, Patrick J. Marroum, Mukul Minocha, Balakrishna Hosmane, Amit Khatri, Sven Mensing, Thomas J. Podsadecki, Daniel E. Cohen, Walid M. Awni, Rajeev M. Menon

ABSTRACT

The triple direct-acting antiviral (3-DAA) regimen (two co-formulated tablets of ombitasvir/paritaprevir/ritonavir once daily and one tablet of dasabuvir twice daily) for patients with hepatitis C virus (HCV) genotype 1 infection has been reformulated for once-daily administration containing all three active DAAs (3QD regimen). Two bioequivalence studies compared the 3-DAA and 3QD regimens. In study 1, fed, single-, and multiple-dose crossover comparisons revealed exposures for drug components that were slightly outside the bioequivalence criteria, i.e., 21 to 29% lower dasabuvir Ctrough, paritaprevir Cmax, and ritonavir Cmax. In study 2, fed and fasted single-dose crossover comparisons demonstrated a large impact of food on exposures, confirming the product’s labeling requirement for administration only with food, and revealed a lack of bioequivalence under fasting conditions. Exposure-response analyses using efficacy data from phase 2/3 studies of the 3-DAA regimen demonstrated that the lower dasabuvir Ctrough for the 3QD regimen (under fed condition) would have minimal impact on sustained virologic response at week 12 post-treatment (SVR12). Thus, the pharmacodynamic similarity between the regimens was established and the analyses provided the basis for regulatory approval of the 3QD regimen to treat patients with chronic HCV genotype 1 infection. More... »

PAGES

1523-1535

Identifiers

URI

http://scigraph.springernature.com/pub.10.1208/s12248-017-0115-3

DOI

http://dx.doi.org/10.1208/s12248-017-0115-3

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1090365356

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28685397


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