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.
Related news items
Four Veni grants for young RIMLS researchers22 July 2019
Four young researchers, affiliated to the RIMLS, have each received a Veni grant of 250,000 Euro from NWO. Our researchers received this prestigious grant for their remarkable and original talent and their ability to carry out innovative research.read more
4,8 million euros for prevention of tuberculosis among people with diabetes in Africa16 July 2019
Reinout van Crevel and Lindsey te Brake have received European funding of 4.8 million euros to lead an international consortium to screen thousands of people with diabetes in Uganda and Tanzania for TB, and investigate the effect and costs of 3 months preventive treatment for TB.read more
Handbook of biomarkers and precision medicine a new publication by Alain van Gool12 July 2019
Alain van Gool published a new handbook on biomarkers and applications in (pre)clinical drug development for precision medicine.read more
The real impact of menstrual complaints on work and school productivity8 July 2019
Menstrual period symptoms may be linked to nearly nine days of lost productivity every year, through presenteeism, suggests the largest study of its kind, published in the journal BMJ Open. But the real impact on women and society is underestimated and poorly appreciated, say the researchers.read more