1. Pharmacokinetics, Safety and Efficacy of Ritonavir-Boosted Atazanavir (300/100 mg Once Daily) in HIV-1-Infected Pregnant Women
- Author
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P. Faucher, Patricia Bourse, Florence Damond, Gilles Peytavin, Sylvie Lariven, Sylvie Legac, Marc Dommergues, Françoise Meier, Roland Landman, Agnès Bourgeois-Moine, Roland Tubiana, Vincent Calvez, Minh Patrick Lê, Sophie Matheron, Diane Descamps, Houria Ichou, Emmanuel Mortier, Cathia Soulié, Dominique Duro, Laurent Mandelbrot, and Marc-Antoine Valantin
- Subjects
Adult ,Atazanavir Sulfate ,Human immunodeficiency virus (HIV) ,Pharmacology ,medicine.disease_cause ,Drug Administration Schedule ,Pharmacokinetics ,Pregnancy ,medicine ,Humans ,Pharmacology (medical) ,Protease inhibitor (pharmacology) ,Pregnancy Complications, Infectious ,Hyperbilirubinemia ,Ritonavir ,Transmission (medicine) ,business.industry ,Infant, Newborn ,HIV Protease Inhibitors ,Viral Load ,medicine.disease ,CD4 Lymphocyte Count ,Atazanavir ,Drug Combinations ,Cross-Sectional Studies ,Infectious Diseases ,HIV-1 ,Female ,Once daily ,business ,medicine.drug - Abstract
Background Atazanavir/ritonavir (ATV/r) is a boosted protease inhibitor recommended to minimize the risk of mother-to-child HIV-1 transmission (MTCT). We aimed to assess the pharmacokinetics, safety and efficacy of ATV/r in HIV-1-infected pregnant women and their neonates. Methods A multicentre, cross-sectional, non-interventional cohort of HIV-1-infected pregnant women receiving ATV/r (300/100 mg once daily) who delivered in three Paris hospitals from 2006 to 2013 was designed. We determined antiretroviral trough plasma concentrations using liquid chromatography–mass spectrometry at each of the three trimesters, delivery and post-partum. ATV concentrations at 24 h (C24h) were interpreted by the 150–850 ng/ml efficacy–tolerance thresholds. Safety data and newborn HIV status were recorded. A mother's virological failure was defined as two successive measurements of plasma HIV-1 RNA>50 copies/ml within the 2 months before delivery. Results 103 pregnant women were included, mostly from sub-Saharan Africa (88%). ATV C24h at each of the three trimesters and delivery remained similar to post-partum values. No dose adjustment was needed during pregnancy. The median plasma ratio of fetal/ maternal ATV level was 0.19 ( n=28). Only three patients showed two successive detectable viral loads but Conclusions In this population, an ATV/r-containing anti-retroviral regimen demonstrated good pharmacokinetics, virological efficacy and safety. No significant impact of pregnancy on ATV C24h was found. No dose adjustment was required.
- Published
- 2014