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.
Highlights
In May and June 2018, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued warnings on the use of the antiretroviral agents dolutegravir and darunavir/cobicistat for treatment of pregnant women living with human immunodeficiency virus (HIV)
There is a need for information, gathered under rigorous scientific conditions, on antiretroviral pharmacokinetics, efficacy, and safety during pregnancy and lactation [22]
In July 2018, the World Health Organization (WHO) Paediatric Antiretroviral Working Group launched a toolkit for research and development of paediatric antiretroviral drugs and formulations, which aims to guide industry on approaches for accelerating the development of antiretrovirals for children and pregnant and lactating women [23]
Summary
Angela Colbers,, Mark Mirochnick, Stein Schalkwijk, Martina Penazzato, Claire Townsend, and David Burger. 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). 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. In May and June 2018, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued warnings on the use of the antiretroviral agents dolutegravir and darunavir/cobicistat for treatment of pregnant women living with human immunodeficiency virus (HIV). Once new drugs are approved in adults, their use rapidly expands to include pregnant and breastfeeding women, exposing more mothers and infants to these potential risks than would have occurred in the context of a clinical trial
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 callMore From: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Disclaimer: 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.
