(117) Time Trends of HIV Treatment in Girls and Women of Childbearing Age in Germany

Publication Number: 1112

Background: In Germany, approximately 9,000 girls and women of childbearing age (WCBA) are living with diagnosed HIV. Since 2015 German guidelines recommend antiretroviral treatment (ART) directly after diagnosis to prevent disease progression and transmission. Integrase inhibitors (INI) were introduced in 2008. In 2018, an increased risk of neural tube defects was observed for the INI dolutegravir compared to efavirenz and official warnings have been issued June 2018 not to use dolutegravir in WCBA

Objectives: To describe time trends of ART use in WCBA in Germany with special focus on dolutegravir.

Methods: Using data from the German Pharmacoepidemiological Research Database (GePaRD), we conducted year wise cross-sectional analyses. For each year, we calculated age-specific prescription prevalences of ART classes and individual substances by dividing the number of females aged 13-49 years who had ≥1 dispensing of the respective class/substance by the mid-year population of the respective year. Age-standardized prescription prevalences were calculated using the age distribution of the German female population on December 31, 2020. ART was classified in non-nucleoside reverse transcriptase inhibitors (NNRTI), nucleoside reverse transcriptase inhibitors (NRTI), protease inhibitors (PI), INI and other.
The study was financed by the German Federal Institute for Drugs and Medical Devices (BfArM).

Results: The age-standardized prescription prevalence of NRTI increased from 2004 to 2020 (0.26 to 0.61/1,000). For NNRTI and PI the age-standardized prescription prevalence remained stable during the study period. Since the introduction of INI in 2008, the age-standardized prescription prevalence has increased, especially since the approval of dolutegravir in 2014 (0.11/1,000 in 2014 to 0.25/1,000 in 2019). From 2019 to 2020, no further increase was observed. For all classes and also for dolutegravir, the prescription prevalence was higher in women ≥35 years than in younger women. For dolutegravir, there was no change between 2018 and 2020 in women ≥40 years but a decrease in younger women, predominantly between 20 to 24 years (0.04/1,000 to 0.02/1,000) and 35 to 39 years (0.15/1,000 to 0.11/1,000).

Conclusions: The prescription prevalence of HIV treatment and particularly of NRTI and INI has considerably increased in Germany among WCBA. The warnings on dolutegravir seem effective in younger age groups, i.e. where pregnancies most commonly occur. The observed differences in prescription prevalence between age groups have to be considered in the design and interpretation of studies comparing potential risks of use during pregnancy between ART classes and individual substances.