Interação farmacocinetica entre o acetato de medroxiprogesterona de deposito e a terapia anti-retroviral

AUTOR(ES)
DATA DE PUBLICAÇÃO

2007

RESUMO

Primary Objective: To evaluate the interaction between antiretroviral therapy and hormonal contraceptives. Secondary Objectives: 1- To review the knowledge about hormonal contraceptive use by HIV-infected women under antiretroviral therapy; 2- To compare pharmacokinetic (PK) profile of depot-medroxyprogesterone acetate (DMPA) in HIV-infected women treated with zidovudine (AZT), lamivudine (3TC) and efavirenz (EFV) with PK profile of DMPA in HIV-infected women not-treated with antiretroviral therapy. Methods: This was an open-label, prospective, non-randomized PK study of two groups of HIV-infected reproductive-age women (users of an ARV regimen containing AZT, 3TC and EFV, and non-users of ARV therapy). We conducted this study at the Department of Obstetrics and Gynecology, School of Medicine, Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil. Fifteen users of AZT/3TC and EFV and 15 non-users of ARVs were selected for PK analysis. We administered 150 mg of DMPA intramuscularly and we followed participants at 2-week visit intervals (± 3 days) through 12 weeks. We obtained blood samples for determination of plasma concentration of MPA by liquid chromatography?mass spectrometry (LC?MS) before administration of DMPA (admission) and blood samples for the determination of MPA by LC?MS and for the determination of serum concentration of progesterone by microparticle enzyme immunoassay (MEIA) at each subsequent visit. Results: Medline papers and recommendations about contraceptive use from World Health Organization (WHO) and from Ministry of Health in Brazil were used to make a review paper. This paper was accepted for publication in Revista Brasileira de Ginecologia e Obstetrícia (RBGO). The PK study became a paper sent to Fertility &Sterility with the following results: Most women in both groups were aged 30-39 years, married or living with a partner. BMI (kg/m2) was similar for both groups. HIV-1 viral load was below the detection limit in 11/15 and 2/16 of the women in the ARV and non-ARV groups, respectively. The CD4+ counts (cells/mm3) were similar. The area under the plasma concentration-time curve (AUC), maximum concentration (Cmax), the time to maximum concentration (Tmax), half-life (t1/2) and clearance were also similar in users and non-users of ARV therapy. Bleeding patterns were similar in both groups. Only one woman (in the non-ARV group) had a repeatedly elevated serum progesterone compatible with ovulation. Conclusions: 1- There is not enough information to offer evidence-based recommendations for the use of hormonal contraceptives among HIV-infected women under ARV therapy; 2- The selected ARVs do not interfere with PK profile of DMPA

ASSUNTO(S)

aids (doença) terapia anti-retroviral de alta atividade contraceptivos farmacocinetica hiv (virus)

ACESSO AO ARTIGO

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