In Clinical Infectious Diseases Angela Colbers, Stein Schalkwijk and David Burger give considerations on how to effectively evaluate aspects of clinical pharmacology required for safe and effective treatment to optimize pharmacotherapy during pregnancy and breastfeeding. They advocate for shortening the time period between registration of antiretroviral drugs and first pregnancy data becoming available.Recently, the FDA and EMA issued warnings on the use of dolutegravir and darunavir/cobicistat for treatment of pregnant women living with HIV. It took 3 to 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.
Importance of prospective studies in pregnant and breastfeeding women living with HIV.
Colbers A, Mirochnick M, Schalkwijk S, Penazzato M, Townsend C, Burger D.
Angela Colbers, Stein Schalkwijk and David Burger are members of theme Infectious diseases and global health.
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