Co-administration of DCV-TRIO (DCV 30 mg, ASV 200 mg, BCV 75 mg) twice daily with an oral contraceptive containing high dose NEA and EE did not affect the PK of NEA to a clinically meaningful extent.
Daclatasvir/asunaprevir/beclabuvir vs ethinyl estradiol/norethindrone acetate
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Study Design
In an open-label, 2-cycle study, healthy female subjects (n=22; age 18-40 years) received low dose of norethindrone with ethinyl estradiol (NE 1000ug/EE 20ug) for a single cycle (Days 1-21). Subjects then received high dose of NE/EE (1500/30 ug) for 11 days (Days 29-49), followed by coadministration of high dose of NE/EE and DCV-TRIO, a fixed-dose regimen of asunaprevir (ASV) 200 mg, daclatasvir (DCV) 30 mg, and beclabuvir (BCV) 75 mg twice daily, for 11 days (Days 39-49) in cycle 2. Note that during Days 39 to 49, additional BCV 75 mg twice daily was administered in order to achieve BCV exposures comparable to those seen in HCV-infected individuals.
Study Results
GMRs (DCV-TRIO + high-dose NEA/EE / low-dose NEA/EE) [90% CIs] of NEA were 1.19 [1.06, 1.33] for Cmax and 1.40 [1.25, 1.58] for AUC.After dose normalization, GMRs (DCV-TRIO + NEA/EE / NEA/EE) [90% CIs] of NEAwere 0.79 [0.71, 0.88] for Cmax and 0.94 [0.83, 1.05] for AUC.
References
R Adamczyk, S Lubin, M Hesney, et al. Effect of daclatasvir with asunaprevir and beclabuvir on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norethindrone acetate in women. 16th International Workshop On Clinical Pharmacology Of Hiv ; Hepatitis Therapy. Washington, DC. ; 2015.
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