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Bioequivalent pharmacokinetics for generic and originator hepatitis C direct-acting antivirals

Author List
Andrew Hill
Loai Tahat
Mohammed K Mohammed
Rabab F Tayyem
Giten Khwairakpam
Sanjay Nath
James Freeman
Ismahane Benbitour
Sherine Helmy

Abstract

Mass production of low-cost, generic direct-acting antivirals (DAAs) will be required to achieve targets of eliminating hepatitis C (HCV) by 2030. The pharmaceutical companies Gilead and Bristol-Myers Squibb have granted voluntary licences (VLs) to generic companies to mass produce the DAAs sofosbuvir and daclatasvir at low cost. However, generic manufacturers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originator versions, to fulfil World Health Organization standards for prequalification. The aim of this study was to determine whether generic forms of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originator versions.

Article Category

Hepatitis C (HCV)

Article Type

Short communication

Posted Date

29-03-2018

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