TY - JOUR
T1 - Pharmacokinetic interaction between nevirapine and ethinyl estradiol/norethindrone when administered concurrently to HIV-infected women
AU - Mildvan, Donna
AU - Yarrish, Robert
AU - Marshak, Ann
AU - Hutman, Herbert W.
AU - McDonough, Marita
AU - Lamson, Michael
AU - Robinson, Patrick
PY - 2002
Y1 - 2002
N2 - Objective: To determine the effects of nevirapine (NVP), a nonnucleoside reverse-transcriptase inhibitor of HIV-1 and P450 inducer, on the pharmacokinetics (PK) of ethinyl estradiol (EE)/norethindrone (NET), a widely used oral contraceptive, and to assess the effects of EE/NET on the steady-state PK of NVP. Methods: Ten HIV-1-infected women underwent intensive PK sampling after single-dose administration of EE/NET (days 0-1). Oral NVP 200 mg once daily (days 2-15), followed by 200 mg twice daily (days 16-29), was added to background potent antiretroviral therapy. On day 30, intensive PK sampling was performed after concurrent administration of NVP 200 mg and a single dose of EE/NET. Results: Concomitant administration of NVP at steady state with EE/NET resulted in a significant (29%) median reduction in the area under the plasma concentration time curve (AUC∞) and a significant reduction in mean residence time (MRT) and half-life (t1/2) of EE. There was a significant (18%) median reduction in the AUC∞ for NET that was not associated with a detectable change in NET Cmax, MRT, or t1/2. Conclusion: Oral contraceptives should not be the primary method of birth control in women of child-bearing potential who are treated with NVP.
AB - Objective: To determine the effects of nevirapine (NVP), a nonnucleoside reverse-transcriptase inhibitor of HIV-1 and P450 inducer, on the pharmacokinetics (PK) of ethinyl estradiol (EE)/norethindrone (NET), a widely used oral contraceptive, and to assess the effects of EE/NET on the steady-state PK of NVP. Methods: Ten HIV-1-infected women underwent intensive PK sampling after single-dose administration of EE/NET (days 0-1). Oral NVP 200 mg once daily (days 2-15), followed by 200 mg twice daily (days 16-29), was added to background potent antiretroviral therapy. On day 30, intensive PK sampling was performed after concurrent administration of NVP 200 mg and a single dose of EE/NET. Results: Concomitant administration of NVP at steady state with EE/NET resulted in a significant (29%) median reduction in the area under the plasma concentration time curve (AUC∞) and a significant reduction in mean residence time (MRT) and half-life (t1/2) of EE. There was a significant (18%) median reduction in the AUC∞ for NET that was not associated with a detectable change in NET Cmax, MRT, or t1/2. Conclusion: Oral contraceptives should not be the primary method of birth control in women of child-bearing potential who are treated with NVP.
KW - Ethinyl estradiol
KW - Human immunodeficiency virus
KW - Nevirapine
KW - Norethindrone
KW - Oral contraceptives
KW - Pharmacokinetic interaction
UR - http://www.scopus.com/inward/record.url?scp=0036238929&partnerID=8YFLogxK
U2 - 10.1097/00042560-200204150-00007
DO - 10.1097/00042560-200204150-00007
M3 - Article
C2 - 11981363
AN - SCOPUS:0036238929
SN - 1525-4135
VL - 29
SP - 471
EP - 477
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 5
ER -