Pharmacokinetics, safety and efficacy of ritonavir-boosted atazanavir (300/100 mg once daily) in HIV-1-infected pregnant women

被引：11

作者：

Le, Minh P. ^{[1
]}

Mandelbrot, Laurent ^{[2
,3
]}

Descamps, Diane ^{[4
,5
]}

Soulie, Cathia ^{[6
,7
,8
]}

Ichou, Houria ^{[9
]}

Bourgeois-Moine, Agnes ^{[10
]}

Damond, Florence ^{[5
]}

Lariven, Sylvie ^{[11
]}

Valantin, Marc-Antoine ^{[12
]}

Landman, Roland ^{[4
,11
]}

Faucher, Philippe ^{[10
]}

Tubiana, Roland ^{[12
]}

Duro, Dominique ^{[2
,3
]}

Meier, Francoise ^{[3
]}

Legac, Sylvie ^{[11
]}

Bourse, Patricia ^{[12
]}

Mortier, Emmanuel ^{[13
]}

Dommergues, Marc ^{[14
]}

Calvez, Vincent ^{[6
,7
,8
]}

Matheron, Sophie ^{[4
,11
]}

Peytavin, Gilles ^{[1
,4
]}

机构：

[1] Hop Univ Paris Nord Val Seine, Hop Bichat Claude Bernard, APHP, Clin Pharmacotoxicol Dept, Paris, France

[2] Paris Diderot Univ, Paris, France

[3] Hop Univ Paris Nord Val Seine, Louis Mourier Hosp, APHP, Dept Obstet & Gynecol,DHU Risks Pregnancy, Colombes, France

[4] Univ Paris Diderot, Sorbonne Paris Cite, INSERM, IAME,UMR 1137, Paris, France

[5] Hop Univ Paris Nord Val Seine, Hop Bichat Claude Bernard, APHP, Dept Virol, Paris, France

[6] Hop La Pitie Salpetriere, APHP, Dept Virol, Paris, France

[7] Univ Paris 06, Sorbonne Univ, UMR S 1136, Pierre Louis Inst Epidemiol & Publ Hlth, Paris, France

[8] Pierre Louis Inst Epidemiol & Publ Hlth, INSERM, UMR S 1136, Paris, France

[9] Hop Univ Paris Nord Val Seine, Louis Mourier Hosp, APHP, Dept Virol, Colombes, France

[10] Hop Univ Paris Nord Val Seine, Hop Bichat Claude Bernard, APHP, Dept Obstet & Gynecol, Paris, France

[11] Hop Univ Paris Nord Val Seine, Hop Bichat Claude Bernard, APHP, Dept Infect Dis, Paris, France

[12] Hop La Pitie Salpetriere, APHP, Dept Infect Dis, Paris, France

[13] Hop Univ Paris Nord Val Seine, Louis Mourier Hosp, APHP, Dept Internal Med, Colombes, France

[14] Hop La Pitie Salpetriere, APHP, Dept Obstet & Gynecol, Paris, France

来源：

ANTIVIRAL THERAPY | 2015年 / 20卷 / 05期

关键词：

PROTEASE INHIBITORS; PLACENTAL-TRANSFER; INFECTION; LOPINAVIR; DELIVERY; EXPOSURE; PLASMA;

D O I：

10.3851/IMP2936

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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 <400 copies/ml. Among 82 available newborn data, 16 were born preterm. Three in utero deaths occurred. Tolerance was good with one case of maternal grade 3 hyperbilirubinaemia, no cases in neonates at delivery and no clinically relevant adverse event. No case of MTCT was reported. Conclusions: In this population, an ATV/r-containing antiretroviral regimen demonstrated good pharmacokinetics, virological efficacy and safety. No significant impact of pregnancy on ATV C24h was found. No dose adjustment was required.

引用

页码：507 / 513

页数：7

共 19 条

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