scholarly journals Drug–Drug Interactions with Antiretroviral Drugs in Pregnant Women Living with HIV: Are They Different from Non-Pregnant Individuals?

2020 ◽  
Vol 59 (10) ◽  
pp. 1217-1236
Author(s):  
Vera E. Bukkems ◽  
Angela Colbers ◽  
Catia Marzolini ◽  
Jose Molto ◽  
David M. Burger
Keyword(s):  
Drug Interactions ◽  
Pregnant Women ◽  
Antiretroviral Drugs ◽  
Women Living With Hiv ◽  
Living With Hiv

scholarly journals Importance of Prospective Studies in Pregnant and Breastfeeding Women Living With Human Immunodeficiency Virus

2019 ◽  
Vol 69 (7) ◽  
pp. 1254-1258 ◽  
Author(s):  
Angela Colbers ◽  
Mark Mirochnick ◽  
Stein Schalkwijk ◽  
Martina Penazzato ◽  
Claire Townsend ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Pregnant Women ◽  
Clinical Care ◽  
Antiretroviral Drugs ◽  
New Drugs ◽  
European Medicines Agency ◽  
Controlled Clinical Trial ◽  
Women Living With Hiv ◽  
Immunodeficiency Virus ◽  
Living With Hiv

Abstract Recently, the US Food and Drug Administration and European Medicines Agency issued warnings on the use of dolutegravir and darunavir/cobicistat for treatment of pregnant women living with human immunodeficiency virus (HIV). It took 3–5 years to identify the risks associated with the use of these antiretroviral drugs, during which time pregnant women were exposed to these drugs in clinical care, outside of controlled clinical trial settings. Across all antiretroviral drugs, the interval between registration of new drugs and first data on pharmacokinetics and safety in pregnancy becoming available is around 6 years. In this viewpoint, we provide considerations for clinical pharmacology research to provide safe and effective treatment of pregnant and breastfeeding women living with HIV and their children. These recommendations will lead to timelier availability of safety and pharmacokinetic information needed to develop safe treatment strategies for pregnant and breastfeeding women living with HIV, and are applicable to other chronic disease areas requiring medication during pregnancy.

scholarly journals Pharmacokinetics and Drug‐Drug Interactions of Isoniazid and Efavirenz in Pregnant Women Living With HIV in High TB Incidence Settings: Importance of Genotyping

2020 ◽  
Author(s):  
Kamunkhwala Gausi ◽  
Lubbe Wiesner ◽  
Jennifer Norman ◽  
Carole L. Wallis ◽  
Carolyne Onyango‐Makumbi ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Pregnant Women ◽  
Women Living With Hiv ◽  
Living With Hiv

Pharmacokinetics, Placental and Breast Milk Transfer of Antiretroviral Drugs in Pregnant and Lactating Women Living with HIV

2019 ◽  
Vol 25 (5) ◽  
pp. 556-576 ◽  
Author(s):  
E.M. Hodel ◽  
C. Marzolini ◽  
C. Waitt ◽  
N. Rakhmanina
Keyword(s):  
Breast Milk ◽  
Protease Inhibitors ◽  
Drug Class ◽  
Drug Transporters ◽  
Maternal Plasma ◽  
Antiretroviral Drugs ◽  
Physiological Changes ◽  
Women Living With Hiv ◽  
Living With Hiv ◽  
In Pregnancy

Background:Remarkable progress has been achieved in the identification of HIV infection in pregnant women and in the prevention of vertical HIV transmission through maternal antiretroviral treatment (ART) and neonatal antiretroviral drug (ARV) prophylaxis in the last two decades. Millions of women globally are receiving combination ART throughout pregnancy and breastfeeding, periods associated with significant biological and physiological changes affecting the pharmacokinetics (PK) and pharmacodynamics (PD) of ARVs. The objective of this review was to summarize currently available knowledge on the PK of ARVs during pregnancy and transport of maternal ARVs through the placenta and into the breast milk. We also summarized main safety considerations for in utero and breast milk ARVs exposures in infants.Methods:We conducted a review of the pharmacological profiles of ARVs in pregnancy and during breastfeeding obtained from published clinical studies. Selected maternal PK studies used a relatively rich sampling approach at each ante- and postnatal sampling time point. For placental and breast milk transport of ARVs, we selected the studies that provided ratios of maternal to the cord (M:C) plasma and breast milk to maternal plasma (M:P) concentrations, respectively.Results:We provide an overview of the physiological changes during pregnancy and their effect on the PK parameters of ARVs by drug class in pregnancy, which were gathered from 45 published studies. The PK changes during pregnancy affect the dosing of several protease inhibitors during pregnancy and limit the use of several ARVs, including three single tablet regimens with integrase inhibitors or protease inhibitors co-formulated with cobicistat due to suboptimal exposures. We further analysed the currently available data on the mechanism of the transport of ARVs from maternal plasma across the placenta and into the breast milk and summarized the effect of pregnancy on placental and of breastfeeding on mammal gland drug transporters, as well as physicochemical properties, C:M and M:P ratios of individual ARVs by drug class. Finally, we discussed the major safety issues of fetal and infant exposure to maternal ARVs.Conclusions:Available pharmacological data provide evidence that physiological changes during pregnancy affect maternal, and consequently, fetal ARV exposure. Limited available data suggest that the expression of drug transporters may vary throughout pregnancy and breastfeeding thereby possibly impacting the amount of ARV crossing the placenta and secreted into the breast milk. The drug transporter’s role in the fetal/child exposure to maternal ARVs needs to be better understood. Our analysis underscores the need for more pharmacological studies with innovative study design, sparse PK sampling, improved study data reporting and PK modelling in pregnant and breastfeeding women living with HIV to optimize their treatment choices and maternal and child health outcomes.

Social Vulnerability among Foreign-Born Pregnant Women and Maternal Virologic Control of HIV

2020 ◽  
Author(s):  
Ashish Premkumar ◽  
Lynn M. Yee ◽  
Lia Benes ◽  
Emily S. Miller
Keyword(s):  
Antiretroviral Therapy ◽  
Pregnant Women ◽  
Median Time ◽  
Social Vulnerability ◽  
Viral Suppression ◽  
Foreign Born ◽  
Women Living With Hiv ◽  
Virologic Control ◽  
Clinical Records ◽  
Living With Hiv

Objective The aim of this study was to assess whether social vulnerability among foreign-born pregnant women living with HIV is associated with maternal viremia during pregnancy. Study Design This retrospective cohort study included all foreign-born pregnant women living with HIV who received prenatal care in a multidisciplinary prenatal clinic between 2009 and 2018. A licensed clinical social worker evaluated all women and kept detailed clinical records on immigration status and social support. Social vulnerability was defined as both living in the United States for less than 5 years and reporting no family or friends for support. The primary outcome was evidence of viral non-suppression after achievement of initial suppression. Secondary outcomes were the proportion of women who required > 12 weeks after starting antiretroviral therapy to achieve viral suppression, median time to first viral suppression (in weeks) after initiation of antiretroviral therapy, and the proportion who missed ≥ 5 doses of antiretroviral therapy. Bivariable analyses were performed. Results A total of 111 foreign-born women were eligible for analysis, of whom 25 (23%) were classified as socially vulnerable. Social and clinical characteristics of women diverged by social vulnerability categorization but no differences reached statistical significance. On bivariable analysis, socially-vulnerable women were at increased risk for needing > 12 weeks to achieve viral suppression (relative risk: 1.78, 95% confidence interval: 1.18–2.67), though there was no association with missing ≥ 5 doses of antiretroviral therapy or median time to viral suppression after initiation of antiretroviral therapy. Conclusion Among foreign-born, pregnant women living with HIV, markers of virologic control during pregnancy were noted to be worse among socially-vulnerable women. Insofar as maternal viremia is the predominant driver of perinatal transmission, closer clinical surveillance and support may be indicated in this population. Key Points

scholarly journals Prevalence of Drug–Drug Interactions with Hormonal Contraceptives and Antiretrovirals in Women Living with HIV

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S662-S662
Author(s):  
Milena M McLaughlin ◽  
Ashley Jensen ◽  
Susan Cohn ◽  
Kristin Darin
Keyword(s):  
Drug Interactions ◽  
Hormonal Contraceptives ◽  
Women Living With Hiv ◽  
Living With Hiv

scholarly journals Quality of Life of Pregnant Women Living with HIV/AIDS

2016 ◽  
Vol 38 (05) ◽  
pp. 246-252 ◽  
Author(s):  
Mariângela Silveira ◽  
Cristina Müller ◽  
Marysabel Silveira
Keyword(s):  
Quality Of Life ◽  
Pregnant Women ◽  
Women Living With Hiv ◽  
Living With Hiv ◽  
Hiv Aids
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