Prescription behavior of HIV therapeutics in women of childbearing age and during pregnancy in Germany
- Prescription of HIV therapeutics in women of childbearing age and during pregnancy in Germany
At the end of 2019, there were approximately 80,000 persons with a diagnosed infection with the human immunodeficiency virus (HIV) in Germany, including about 9,000 girls and women of childbearing age. Guidelines specify that also during pregnancy, HIV infection should be treated with antiretroviral therapy to prevent progression of infection and transmission of HIV to the child (vertical HIV transmission). In addition to the efficacy of the therapy (i.e., inhibition of viral replication), the safety for the mother and especially the child must also be considered. The critical time window for the development of malformations due to the use of drugs during pregnancy is between the third and eighth week after conception, i.e., at a time when many women are not aware of their pregnancy yet. Therefore, whenever possible, high-safety and effective HIV therapeutics should be prescribed to all HIV-infected girls and women of childbearing age due to potentially occurring pregnancies.
However, there are not sufficient data on the safety and efficacy of all active substances during pregnancy. Based on available data, some substances should not be used during pregnancy because they raise the risk for malformations (e.g., dolutegravir for neural tube defects). Other substances are less effective during pregnancy and the risk of mother-to-child transmission increases accordingly (e.g., with darunavir/cobicistat and elvitegravir/cobicistat). Corresponding warnings from the Federal Institute for Drugs and Medical Devices (BfArM) on the use of these drugs during pregnancy have been published in the form of Dear Doctor Letters (German: Rote-Hand-Briefe).
The main objective of this project, which is funded by BfArM, is to investigate how these recommendations and warnings translate into actual health care practice in Germany. The following questions will be investigated based on the health insurance data of the pharmacoepidemiological research database GePaRD:
• How frequently are the individual HIV therapeutics used in girls and women of childbearing age? Did the utilization change due to the warnings?
• How frequently does pregnancy occur while receiving anti-retroviral HIV therapy?
• Which patterns of prescribing HIV therapeutics during pregnancy can be observed?
- Begin: January 2022
End: December 2022
- Federal Institute for Drugs and Medical Devices