Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV‐Uninfected female subjects
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Study Design
In this study the drug-drug interaction potential of ledipasvir (LDV) with norgestimate and ethinyl estradiol was assessed. Norgestimate was administered as 0.18/0.215/0.25 mg QD with ethinyl estradiol 25 mcg QD, while LDV was given as 90mg QD (n=15). Changes in pharmacokinetic parameters of ethinyl estradiol and norgestimate metabolites, norelgestromin and norgestrel were analyzed.
Study Results
Using geometric mean ratios (GMR) and 90% confidence intervals (CI), the Cmax, AUC and Cmin for ethinyl estradiol were 1.40 (1.18-1.66), 1.20 (1.04-1.39) and 0.98 (0.79-1.22), respectively. Those for norelgestromin were 1.02 (0.89-1.16), 1.03 (0.90-1.18) and 1.09 (0.91-1.31), while those for norgestrel were 1.03 (0.87-1.23), 0.99 (0.82-1.20) and 1.00 (0.81-1.23), respectively. There was no effect on the AUC of SOF or LDV (GMRs were not reported).
Study Conclusions
The manufacturer states that no clinically significant interaction is expected when an oral contraceptive containing ethinyl estradiol 25 mcg and norgestimate 0.18/0.215/0.25 mg is co-administered with LDV or SOF. Drug-drug interactions with other oral contraceptives have not been reported.
References
German P, Moorehead L, Pang P, Vimal M, Mathias A. Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in hcv‐uninfected female subjects. Journal Of Clinical Pharmacology. 2014; 11: 1290-1298.
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