There were no clinically relevant drug interactions found between NGM/EE and VEL in healthy subjects. The investigators concluded that no dose adjustment for either drug is necessary when co-administering the two drugs.
Norgestimate/ethinyl estradiol vs velpatasvir
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Study Design
In an open-label, fixed sequence, phase I study, healthy HCV-uninfected females (n=13) received norgestimate/ethinyl estradiol (NGM/EE, Ortho Tri-Cyclen LoŽ) alone in cycle 1, followed by coadministration of NGM/EE and velpatasvir (VEL; formerly known as GS-5816) 150 mg daily for 7 days (Days 8-14) in cycle 2.
Study Results
When patients were given NGM/EE together with VEL 150 mg daily for 7 days, GS-5816 had no significant effect on PK parameters of norelgestromin (NGMN), norgestrel (NG; metabolite of NGMN), and EE. The geometric mean ratios (GMRs; VEL + NGM/EE / NGM/EE) [90% CIs] of NGMN were: 0.97 [0.90, 1.04] for Cmax, 0.89 [0.85, 0.94] for AUC, and 0.92 [0.86, 0.98] for Cmin.GMRs (VEL + NGM/EE / NGM/EE) [90% CIs] of NGM were: 0.96 [0.80, 1.17] for Cmax, 0.91 [0.73, 1.14] for AUC, and 0.92 [0.74, 1.15] for CminGMRs (VEL + NGM/EE / NGM/EE) [90% CIs] of EE were: 1.42 [1.28, 1.58] for Cmax, 1.06 [0.98, 1.14] for AUC, and 0.84 [0.77, 0.92] for Cmin
References
E Mogalian, Brainard DM, J McNally, et al. Lack of clinically relevant pharmacokinetic drug-drug interaction between norgestimate/ethyinyl estradiol and pangenotypic hcv ns5a inhibitor gs-5816 in hcv-uninfected female subjects. The American Association For The Study Of Liver Diseases 65th Annual Meeting. Boston, MA. ; 2014.
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