Increased exposure of norethindrone in HIV+ women treated with ritonavir-boosted atazanavir therapy

摘要: Abstract Objective Pharmacokinetics of norethindrone in combination oral contraceptive regimen are well described among HIV+ women treated with ritonavir-boosted protease inhibitor therapies; however, such characterization is lacking using progestin-only contraception. Our objective to characterize pharmacokinetics atazanavir treatment during regimens. Study design An open-label, prospective, nonrandomized trial the receiving ( n =10; group) and other antiretroviral therapy known not alter levels =17; control was conducted. Following informed consent, were instructed take a single daily fixed dose 0.35 mg 300 mg/100 atazanavir/ritonavir for 22 days. On day 22, serial blood samples collected by venous catheter at 0, 1, 2, 3, 4, 6, 8, 12, 24, 48 72 h. Whole processed collect serum stored −20°C until later analysis radioimmunoassay. Pharmacokinetic parameters estimated noncompartmental method. Results In group, compared an increase area under curve 0–24 (16.69 h*ng/mL vs. 25.20 h*ng/mL; p Conclusion(s) findings suggest that contraceptives, unlike benefit from drug–drug interaction achieve higher exposure. Further studies needed establish whether pharmacokinetic leads favorable clinical outcomes. Implications Norethindrone-based exhibit greater drug exposure when co-administered thus may warrant category 3 designation World Health Organization. Prospective confirm results