Drug Interactions between atazanavir / cobicistat and Zovia 1/35E

GENERALLY AVOID: Coadministration with atazanavir may increase the plasma concentrations of ethinyl estradiol and norethindrone and possibly other contraceptive hormones. The mechanism is atazanavir inhibition of CYP450 3A4 and UGT1A1, the enzymes responsible for the metabolic clearance of contraceptive hormones. In 19 study subjects, atazanavir (400 mg once a day for 14 days) increased the mean steady-state peak plasma concentration (Cmax), area under the concentration-time curve (AUC) and trough plasma concentration (Cmin) of ethinyl estradiol (Ortho-Novum 7/7/7) by 15%, 48% and 91%, respectively, compared to administration of the oral contraceptive alone. The Cmax, AUC and Cmin of norethindrone were increased by 67%, 110% and 262%, respectively. Decreased HDL or increased insulin resistance may be associated with elevated plasma concentrations of norethindrone.

MANAGEMENT: The manufacturer recommends alternate methods of nonhormonal contraception during atazanavir or atazanavir-ritonavir therapy.

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GENERALLY AVOID: Coadministration with atazanavir may increase the plasma concentrations of ethinyl estradiol and norethindrone and possibly other contraceptive hormones. The mechanism is atazanavir inhibition of CYP450 3A4 and UGT1A1, the enzymes responsible for the metabolic clearance of contraceptive hormones. In 19 study subjects, atazanavir (400 mg once a day for 14 days) increased the mean steady-state peak plasma concentration (Cmax), area under the concentration-time curve (AUC) and trough plasma concentration (Cmin) of ethinyl estradiol (Ortho-Novum 7/7/7) by 15%, 48% and 91%, respectively, compared to administration of the oral contraceptive alone. The Cmax, AUC and Cmin of norethindrone were increased by 67%, 110% and 262%, respectively. Decreased HDL or increased insulin resistance may be associated with elevated plasma concentrations of norethindrone.

MANAGEMENT: The manufacturer recommends alternate methods of nonhormonal contraception during atazanavir or atazanavir-ritonavir therapy.

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ADDITIONAL CONTRACEPTION RECOMMENDED: Coadministration with cobicistat and elvitegravir may alter the plasma concentrations of contraceptive hormones. The exact mechanism of interaction has not been described. In 13 study subjects, administration of ethinyl estradiol 0.025 mg and norgestimate 0.18 to 0.25 mg once daily in combination with elvitegravir 150 mg plus cobicistat 150 mg once daily decreased the mean ethinyl estradiol peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by 6%, 25% and 44%, respectively. In contrast, norgestimate Cmax, AUC and Cmin increased by 2.08-, 2.26- and 2.67-fold, respectively. Clinical effects of increased progestogen levels are not fully known, but may include increased risk of insulin resistance, dyslipidemia, acne, and venous thrombosis.

MANAGEMENT: The potential risks and benefits of using norgestimate-containing contraceptives in combination with cobicistat and elvitegravir should be considered, particularly in women who have risk factors for insulin resistance, dyslipidemia, acne, and venous thrombosis. Coadministration of cobicistat and elvitegravir with other hormonal contraceptives (e.g., contraceptive patch, contraceptive vaginal ring, or injectable contraceptives), oral contraceptives containing progestogens other than norgestimate, or less than 25 mcg of ethinyl estradiol has not been studied and is not recommended. Some authorities recommend that hormonal contraceptives containing at least 30 mcg of ethinyl estradiol with norgestimate should be used in combination with the multi-ingredient antiretroviral formulations containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. However, the long term effects of increased progesterone exposure are not known. Alternative, nonhormonal methods of contraception may be considered.

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ADDITIONAL CONTRACEPTION RECOMMENDED: Coadministration with cobicistat and elvitegravir may alter the plasma concentrations of contraceptive hormones. The exact mechanism of interaction has not been described. In 13 study subjects, administration of ethinyl estradiol 0.025 mg and norgestimate 0.18 to 0.25 mg once daily in combination with elvitegravir 150 mg plus cobicistat 150 mg once daily decreased the mean ethinyl estradiol peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by 6%, 25% and 44%, respectively. In contrast, norgestimate Cmax, AUC and Cmin increased by 2.08-, 2.26- and 2.67-fold, respectively. Clinical effects of increased progestogen levels are not fully known, but may include increased risk of insulin resistance, dyslipidemia, acne, and venous thrombosis.

MANAGEMENT: The potential risks and benefits of using norgestimate-containing contraceptives in combination with cobicistat and elvitegravir should be considered, particularly in women who have risk factors for insulin resistance, dyslipidemia, acne, and venous thrombosis. Coadministration of cobicistat and elvitegravir with other hormonal contraceptives (e.g., contraceptive patch, contraceptive vaginal ring, or injectable contraceptives), oral contraceptives containing progestogens other than norgestimate, or less than 25 mcg of ethinyl estradiol has not been studied and is not recommended. Some authorities recommend that hormonal contraceptives containing at least 30 mcg of ethinyl estradiol with norgestimate should be used in combination with the multi-ingredient antiretroviral formulations containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. However, the long term effects of increased progesterone exposure are not known. Alternative, nonhormonal methods of contraception may be considered.

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