Abstract
IntroductionLimited “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.MethodsHIV-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.ResultsWe 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.ConclusionsRAL appears safe and effective in this “real-life” study. No defect and no HIV transmission was reported in new-borns.
Highlights
Limited “real life” data on raltegravir (RAL) use during pregnancy are available
Current mother-to-child transmission (MTCT) rates globally fall below 5% [1], this risk reaching almost zero for women on successful combined antiretroviral therapy (cART) before pregnancy and maintaining success until delivery [2]
No antiretroviral drug can be considered totally safe during pregnancy, and several severe adverse events have been reported in new-borns exposed to cART in utero, such as heart defects with zidovudine (ZDV) exposure [4], neonatal adrenal dysfunction with lopinavir/ritonavir exposure [5], discrepant results between preclinical and clinical studies about neurologic defects with efavirenz [4, 6, 7], which is considered as safe as other cART [8], risk of cancer during childhood with didanosine exposure [9] and alteration of DNA repair and telomere maintenance genes with ZDV/tenofovir exposure [10]
Summary
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. We conducted a comprehensive retrospective chart review of all HIV-1-infected pregnant women, followed in ten selected clinical centers across France, who received a RAL (400 mg twice daily)-based cART for at least 15 days anytime during pregnancy, regardless of pregnancy outcome, between 2009 and end of 2014 (Coferal-IMEA048 cohort study). The precise timing and the reason for initiation of RAL were reported, as well as pregnancy outcome, neonates’ clinical characteristics and their HIV status at 6 months of age. Secondary endpoints included delivery mode, the HIV status of new-borns from birth until month 6 of age, and safety parameters of the infant and the mother. Maternal safety parameters included clinical and biological tolerance of RAL-based cART
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
