Safety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093

Abstract

Background-Concomitant use of antiretrovirals (ARV) and hormonal contraceptives may change the metabolism of each and the resulting safety profiles. We evaluated the safety and tolerability of depot medroxyprogesterone acetate (DMPA) among women on ARV.Study Design-HIV-infected women on selected ARV regimens or no ARV were administered DMPA 150 mg intramuscularly and evaluated for 12 weeks for adverse events, changes in CD4+ count and HIV RNA levels, and ovulation.Results-Seventy evaluable subjects were included, 16 on nucleoside only or no ARV, 21 on nelfinavir-containing regimens, 17 on efavirenz-containing regimens, and 16 on nevirapinecontaining regimens. Nine grade 3 or 4 adverse events occurred in 7 subjects; none were judged related to DMPA. The most common findings possibly related to DMPA were abnormal vaginal bleeding (9, 12.7%), headache (3, 4.2%), abdominal pain, mood changes, insomnia, anorexia, and fatigue, each occurring in 2 (2.9%) subjects. No significant changes in CD4+ count or HIV RNA levels occurred with DMPA. No evidence of ovulation was detected, and no pregnancies occurred. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conclusions-The clinical profile associated with DMPA administration in HIV-infected women, most on ARV, appears similar to that seen in HIV-uninfected women. DMPA prevented ovulation and did not affect CD4+ counts or HIV RNA levels. In concert with previously published DMPA/ ARV interaction data, these data suggest that DMPA can be used safely by HIV-infected women on the ARV studied. Conflicts of interest

Influence of Culture on Contraceptive Utilization Among HIV-Positive Women in Brazil, Kenya, and South Africa

“…Discontinuation for side-effects, particularly those associated with bleeding and weight changes, was also common to Kenya and South Africa sites and similar to that reported among populations in the United States and Zambia [26,69]. However, HIV likely factored into intolerance of oligo/amenorrhea and weight loss due to fears of deteriorating health and imminent AIDS, particularly in Kenya and South Africa where ART availability is relatively recent.…”

Contraceptive Efficacy of Oral and Transdermal Hormones When Co-Administered With Protease Inhibitors in HIV-1-Infected Women: Pharmacokinetic Results of ACTG Trial A5188

“…Cohn et al 29 found no significant changes in medroxyprogesterone acetate levels among 54 HIV-infected women using ARV regimens that included nevirapine, efavirenz, or the PI nelfinavir compared with those in 16 controls using other ARV regimens or on no ARVs. DMPA was well tolerated, no women had evidence of ovulation during the 12-week study, and minor adverse effects observed were similar to those seen in HIV-uninfected women, 30 Although this study demonstrated the safety and efficacy of a PI-based regimen (eg, nelfinavir) with injectable progestins, it did not evaluate ARV regimens that included RTV.…”

Effectiveness of hormonal contraception in HIV-infected women using antiretroviral therapy

“…The literature regarding EFV is more mixed. Studies have found no effect of EFV on progesterone levels when using DMPA [8,10,16], but significantly lower progesterone levels among implant users [17–19,15], along with contraceptive failure rates up to 15% among levonorgestrel implant users [20–22]. Evidence regarding EFV and OCs is very limited, suggesting lower progesterone levels but not necessarily increased ovulation on EFV [13,23,24].…”