Background: Raltegravir (RAL) is used in association with other antiretrovirals (ARV) in pregnant women as a formal tritherapy or an additional ARV as intensification in late presenters or in low level viremia. Because of physiological changes during pregnancy, RAL plasma concentration 12 hours post-dose (C12h) at different trimester of pregnancy is important to evaluate. Secondary objectives are assessment of efficacy and safety of RAL containing regimen during pregnancyMethods: single center, observational, descriptive study. The main inclusion criteria were pregnant women treated with RAL 400mg BID containing regimen with available demographic, immuno-virological and therapeutic data. ARV maternal plasma and cord blood concentrations were performed using UPLC-MS/MS. All results were expressed as median [IQR25-75%] and Mann-Whitney test was usedResults: among the 23 women enrolled (31 yrs, 19 African), 11 of them received RAL as intensification of ongoing ARV treatment. Their characteristics were: duration of HIV infection 8.3 yrs (4.0-12.1); Plasma HIV-RNA (pVL) before ARV 32,365 c/mL (3,792-200,500), before RAL 544 c/mL (156-13,232) and before pregnancy 184 c/mL (35-17,650); Nadir CD4 224/mm3 (42-352) and CD4 before pregnancy 434/mm3 (280-529), duration of ARV 7.1 yrs (1.1-11.7); duration of RAL 8.1 months (2.6-67.1). All patients received RAL+PI/r+NRTIs except one (RAL+ABC/3TC). PI/r were: DRV/r (17), LPV/r (4) and SQV/r (1). RAL C12h at 2nd and 3rd trimesters was 84ng/mL (32-215, n=20) and 58ng/mL (20-185, n=47) (p=0.52), respectively. Cord blood/maternal plasma concentrations ratio (RCB/MP) was 1.03 (0.50-1.43, n=4). The mode of delivery was available in 16 women (10 caesarians). At delivery, 18 of 23 patients had pVL<50c/mL and all pVL<400c/mL. Among the 5 women with detectable pVL, 2 was non adherent and 3 late presenters. Neonate characteristics were: gestational age 38.7 weeks (38.1-40.1; n=20), Hb 16,4 g/dL (15,1-17.9; n=9), bilirubinemia 30 µmol/L (21-36; n=7). No neonate was HIV infected. No adverse event was observed in mothers and neonates during the follow-upConclusions: RAL plasma concentrations are not modified during pregnancy and are similar with historical data in non pregnant population. Besides, RAL containing regimen seems to be efficient and safe for mother and her children, probably due to a favorable placental transfer (RCB/MP >1.0)
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