Open Access“Real life” use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study
Author(s) -
Pierre Gantner,
Babacar Sylla,
Laurence MorandJoubert,
Pierre Frange,
Karine Lacombe,
Marie-Aude Khuong,
Claudine Duvivier,
Odile Launay,
Marina Karmochkine,
Cédric Arvieux,
Amélie Ménard,
Lionel Piroth,
Ana Canestri,
Dominique Trias,
Gilles Peytavin,
Roland Landman,
Jade Ghosn
Publication year - 2019
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0216010
Subject(s) - pregnancy , medicine , raltegravir , cart , gestation , cohort , obstetrics , adverse effect , viral load , human immunodeficiency virus (hiv) , antiretroviral therapy , immunology , biology , mechanical engineering , genetics , engineering
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.