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Pharmacokinetics and Pharmacodynamics of Depot Medroxyprogesterone Acetate (DMPA) in African women receiving treatment for HIV and TB: Potential concern for standard dosing frequency.

BACKGROUND: Effective contraception is critical to young women with HIV-associated tuberculosis (TB), as unintended pregnancy is associated with increased perinatal morbidity and mortality. The effects of co-administration of efavirenz and rifampicin on the pharmacokinetics of depot medroxyprogesterone acetate (DMPA) are unknown. We hypothesized that clearance of medroxyprogesterone acetate (MPA) would increase when given with rifampicin and efavirenz, thus increasing risk of ovulation.

METHODS: This pharmacokinetics study assessed DMPA among HIV/TB co-infected women on an efavirenz-based antiretroviral treatment (ART) and rifampicin-based TB treatment. Plasma MPA concentrations and progesterone were measured pre-dose (MPA only), 2, 4, 6, 8, 10 and 12 weeks after a single DMPA 150 mg intramuscular injection. The primary outcome measure, MPA concentration (<0.1 ng/mL) at week 12, was assessed using exact 95% Clopper-Pearson confidence intervals. MPA PK parameters were calculated using non-compartmental analysis.

RESULTS: Among 42 PK-evaluable women from five African countries, median age was 32 years and median CD4 was 414 cells/mm3. Five women [11.9% (95% CI 4.0-25.6%)] had MPA <0.1 ng/mL at week 12; of these, one had MPA <0.1 ng/mL at week 10. The median clearance of MPA was 19,681 L/week compared to 12,118 L/week for historical controls. There were no adverse events related to DMPA and progesterone concentrations were <1 ng/mL for all women for the study duration.

CONCLUSIONS: DMPA, when given with rifampicin and efavirenz, was safe. MPA clearance was higher than in women with HIV not on ART, leading to sub-therapeutic concentrations of MPA in 12% of women, suggesting that more frequent dosing might be needed.

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