Antiretroviral Regimen and Pregnancy Outcomes of Women Living with HIV in a US Cohort.

Women who are pregnant and living with HIV have traditionally been excluded from clinical trials regarding new pharmacotherapy. Immediate initiation of antiretroviral therapy (ART) is recommended for women who are pregnant and living with HIV. Integrase inhibitors (INSTIs) are first-line recommended agents as they lead to more rapid HIV viral load reduction. We conducted a retrospective study of women who are pregnant and living with HIV who received prenatal care at the University of Washington. Mothers were categorized by ART class: INSTI, protease inhibitors (PI), and non-nucleoside reverse transcriptase inhibitors (NNRTI). Chi-square and t-tests were used for the analysis of baseline characteristics, and generalized estimating equations were used to adjust for HIV viral suppression between groups. There were a total of 234 mother-infant pairs whose pregnancies progressed beyond 20 weeks. The study demonstrated that women on INSTI regimens were more likely to have a shorter time to viral load suppression than women on NNRTI regimens. Additionally, seven congenital anomalies were identified in this cohort, none of which were neural tube defects. There was no perinatal transmission of HIV to any of the infants. This small cohort of women provides high-quality data regarding the safety and efficacy of INSTI use for both mothers and infants in resource-rich settings.

[1]  J. Stringer,et al.  Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, rando , 2021, The Lancet.

[2]  V. Veloso,et al.  Dolutegravir and pregnancy outcomes in women on antiretroviral therapy in Brazil: a retrospective national cohort study. , 2021, The lancet. HIV.

[3]  R. Tubiana,et al.  Risk of birth defects and perinatal outcomes in HIV-infected women exposed to integrase strand inhibitors during pregnancy. , 2020, AIDS.

[4]  Marta Illán Ramos Effectiveness and safety of integrase inhibitors in HIV-infected pregnant women followed up in the Madrid Cohort , 2020, Medicina Clínica (English Edition).

[5]  L. Myer,et al.  Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial. , 2020, The lancet. HIV.

[6]  M. Hughes,et al.  Mother-to-Child HIV Transmission with in utero Dolutegravir vs. Efavirenz in Botswana. , 2020, Journal of acquired immune deficiency syndromes.

[7]  R. Walensky,et al.  Where Were the Women? Gender Parity in Clinical Trials. , 2019, The New England journal of medicine.

[8]  A. Vos,et al.  Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV. , 2019, The New England journal of medicine.

[9]  D. Havlir,et al.  Global HIV Treatment - Turning Headwinds to Tailwinds. , 2019, The New England journal of medicine.

[10]  S. Lockman,et al.  Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana. , 2019, The New England journal of medicine.

[11]  M. Cortina-Borja,et al.  Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018 , 2019, Journal of acquired immune deficiency syndromes.

[12]  R. Finnell,et al.  Overview on neural tube defects: From development to physical characteristics , 2018, Birth defects research.

[13]  O. Ogbuagu,et al.  Integrase inhibitor-based regimens result in more rapid virologic suppression rates among treatment-naïve human immunodeficiency virus–infected patients compared to non-nucleoside and protease inhibitor–based regimens in a real-world clinical setting , 2018, Medicine.

[14]  M. Lampe,et al.  Reconsidering the Number of Women With HIV Infection Who Give Birth Annually in the United States , 2018, Public health reports.

[15]  A. Turner,et al.  Use of Antiretroviral Therapy During Pregnancy and Adverse Birth Outcomes Among Women Living With HIV-1 in Low- and Middle-Income Countries: A Systematic Review , 2018, Journal of acquired immune deficiency syndromes.

[16]  R. Shapiro,et al.  Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception. , 2018, The New England journal of medicine.

[17]  S. Rasmussen,et al.  Protecting Mothers and Babies - A Delicate Balancing Act. , 2018, The New England journal of medicine.

[18]  A. V. van Herwaarden,et al.  Pharmacokinetics of HIV-Integrase Inhibitors During Pregnancy: Mechanisms, Clinical Implications and Knowledge Gaps , 2018, Clinical Pharmacokinetics.

[19]  Paige L. Williams,et al.  Birth Outcomes for Pregnant Women with HIV Using Tenofovir–Emtricitabine , 2018, The New England journal of medicine.

[20]  Paige L. Williams,et al.  What is the risk of major congenital abnormalities among women on antiretroviral therapy? , 2018, AIDS.

[21]  R. Schinazi,et al.  Pharmacokinetics and Placental Transfer of Elvitegravir, Dolutegravir, and Other Antiretrovirals during Pregnancy , 2017, Antimicrobial Agents and Chemotherapy.

[22]  M. Vitoria,et al.  Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015-2025 , 2016, PloS one.

[23]  S. Khoo,et al.  Early experience of dolutegravir pharmacokinetics in pregnancy: high maternal levels and significant foetal exposure with twice-daily dosing , 2016, AIDS.

[24]  E. Livingston,et al.  Integrase inhibitors in late pregnancy and rapid HIV viral load reduction. , 2016, American journal of obstetrics and gynecology.

[25]  L. Mandelbrot,et al.  Bidirectional Transfer of Raltegravir in an Ex Vivo Human Cotyledon Perfusion Model , 2016, Antimicrobial Agents and Chemotherapy.

[26]  Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. , 2008, MMWR. Morbidity and mortality weekly report.