"Real life" use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study.

Authors:
Pierre Gantner
Pierre Gantner
Université Paris Descartes
Paris | France
Laurence Morand-Joubert
Laurence Morand-Joubert
Groupe Hospitalier Pitié-Salpêtrière
France
Pierre Frange
Pierre Frange
Unité d'Immunologie
Karine Lacombe
Karine Lacombe
INSERM UMR-S707
Toulouse | France
Claudine Duvivier
Claudine Duvivier
Pitié-Salpêtrière Hospital
France
Odile Launay
Odile Launay
Université Paris Descartes
France

PLoS One 2019 24;14(4):e0216010. Epub 2019 Apr 24.

INSERM IAME UMR-S 1137, Université Paris Diderot, Paris, France.

Introduction: Limited "real life" data on raltegravir (RAL) use during pregnancy are available. Thus, we aimed at describing effectiveness and safety of RAL-based combined antiretroviral therapy (cART) in this setting.

Methods: HIV-1-infected women receiving RAL during pregnancy between 2008 and 2014 in ten French centers were retrospectively analysed for: (1) proportion of women receiving RAL anytime during pregnancy who achieved a plasma HIV-RNA (pVL) < 50 copies/mL at delivery, and (2) description of demographics, immuno-virological parameters and safety in women and new-borns.

Results: We included 94 women (median age, 33 years) of which 85% originated from Sub-Saharan Africa and 16% did not have regular health insurance coverage. Sixteen women were cART-naïve (median HIV diagnosis at 30 weeks of gestation), whereas 78 were already on cART before pregnancy (40% with pVL < 50 copies/mL). RAL was initiated before pregnancy (n = 33), during the second trimester (n = 11) and the third trimester of pregnancy (n = 50). No RAL discontinuations due to adverse events were observed. Overall, at the time of delivery, pVL was < 50 copies/mL in 70% and < 400 copies/mL in 84% of women. Specifically, pVL at delivery was < 50 copies/mL in 82%, 55% and 56% of cases when RAL was started before pregnancy, during the second or third trimester of pregnancy, respectively. Median term was 38 weeks of gestation, no defect was reported and all new-borns were HIV non-infected at Month 6.

Conclusions: RAL appears safe and effective in this "real-life" study. No defect and no HIV transmission was reported in new-borns.

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Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0216010PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6481866PMC
April 2019
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