Drug intelligence / Profile preview

filibuvir + oral contraceptives

Development stage
Discontinued
Lead developer
Pfizer
Modality
Small Molecules
Administration
Oral
01

Overview

Filibuvir (PF-00868554) is an investigational small molecule that acts as a non-nucleoside inhibitor of the Hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase. The combination of filibuvir and oral contraceptives was specifically studied by Pfizer in Phase 1 clinical trials to assess potential drug-drug interactions (DDI). These studies aimed to determine if filibuvir, which is metabolized by and can influence cytochrome P450 enzymes, would affect the pharmacokinetics of ethinyl estradiol and norethindrone, the active hormonal components in many oral contraceptive products. The clinical data indicated that filibuvir did not have a significant impact on the systemic exposure of these hormones, suggesting that no dose adjustments would be necessary for women using oral contraceptives while being treated for HCV with filibuvir. However, the development of filibuvir was discontinued in 2011 following Phase 2 trials for Hepatitis C.

Other names
filibuvir + oral contraceptivesPF-00868554 + ethinyl estradiol + norethindronePF-00868554 + Ortho-Novum
02

Targets

NS5B (Hepatitis C virus non-structural protein 5B (NS5B) RNA-dependent RNA polymerase)

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