Liverpool HEP Interactions

Interaction Checker

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No Interaction Expected

Sofosbuvir/Velpatasvir

Norethisterone (Norethindrone)/mestranol (COC)

Summary:

Coadministration has not been studied but based on metabolism and clearance a clinically significant interaction is unlikely and contraceptive efficacy is unlikely to be affected. Norethisterone is metabolized by CYP3A4. Mestranol is rapidly and almost completely converted to ethinylestradiol by CYP2C9. Ethinylestradiol is mainly metabolized by hydroxylation with CYP3A4 and CYP2C9 as the major contributing enzymes. These pathways are not affected by sofosbuvir/velpatasvir. Coadministration of a triphasic oral contraceptive containing ethinylestradiol (0.025 mg) and another progestogen, norgestimate (0.180/0.215/0.25 mg), with sofosbuvir (400 mg once daily) or velpatasvir (100 mg once daily) was studied. There were no clinically relevant changes in the concentrations of ethinylestradiol, norelgestromin or norgestrel.

Description:

No dose adjustment of oral contraceptives is required. Coadministration of norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg) and sofosbuvir (400 mg once daily) had no effect on ethinyl estradiol Cmax, AUC or Cmin. There was no change in norelgestromin Cmax, AUC or Cmin; norgestrel Cmax was unaltered, but AUC and Cmin both increased by 20%. Coadministration of norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg) and velpatasvir (100 mg once daily) increased ethinyl estradiol Cmax by 40%, had no effect on AUC, and decreased Cmin by 17%. There was no change in the Cmax, AUC or Cmin of norelgestromin or norgestrel.

Epclusa Summary of Product Characteristics, Gilead Sciences Ltd, March 2021.

Based on drug interaction studies conducted with sofosbuvir and velpatasvir, no clinically significant drug interactions have been observed with ethinyl estradiol/norgestimate. Coadministration of a once daily triphasic oral contraceptive containing ethinyl estradiol (0.025 mg) and norgestimate (0.180/0.215/0.25 mg) with sofosbuvir (400 mg once daily) or velpatasvir (100 mg once daily) was studied. When administered with velpatasvir, ethinyl estradiol Cmax and AUC increased by 39% and 4%, but Cmin decreased by 17% (n=12); Cmax, AUC and Cmin of norelgestromin decreased by 3%, 10% and 8% and those of norgestrel decreased by 4%, 9% and 8%, respectively (n=13). When administered with sofosbuvir, ethinyl estradiol Cmax and AUC increased by 15% and 9%, but Cmin decreased by 1% (n=15); Cmax, AUC and Cmin of norelgestromin increased by 7%, 6% and 7% and those of norgestrel increased by 18%, 19% and 23%, respectively (n=15).

Epclusa Prescribing Information, Gilead Science Inc., June 2021.

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