The Impact of Viral Infections Directly on Antivirals

[摘要] To attain the goal of eliminating hepatitis C HCV by 2030, mass production of low-cost, generic Direct-Acting Antivirals (DAAs) will benecessary. The pharmaceutical companies Gilead and Bristol-Myers Squibb have awarded generic companies Voluntary Licences (VLs) tomass produce the DAAs sofosbuvir and daclatasvir at a cheap cost. To meet World Health Organization prequalification standards, genericmanufacturers must demonstrate bioequivalent pharmacokinetics for their DAAs when compared to the originator versions. The purpose ofthis study was to see if generic versions of sofosbuvir and daclatasvir exhibited bioequivalent pharmacokinetics to the original forms.Generic drug companies were approached for the results of bioequivalence tests with sofosbuvir and daclatasvir, two of the most commonlyused DAAs in underdeveloped countries. Five generic businesses provided data on Maximum Concentration (Cmax) and Area Under theCurve (AUC). The pre-specified ranges for the 90% confidence intervals for AUC and Cmax were 80%-125% and 69%-145%, respectively,of the original pharmacokinetic concentrations. For all five generic businesses, the pharmacokinetics of generic sofosbuvir and daclatasvirwere proven to be bioequivalent to the originator versions. This is an important step toward obtaining prequalification from thesecorporations for the manufacture of these pharmaceuticals.

[学科分类] 药理学