Janssen Pharmaceuticals has issued a new alert against using darunavir/cobicistat during pregnancy. This new contraindication is based on significantly reduced plasma levels of darunavir and cobicistat during the second and third trimesters of pregnancy.
Darunavir can still be used during pregnancy, but only when boosted by ritonavir
The new results are from a pharmacokinetic study presented earlier this year in six HIV positive pregnant women and a more recent US Food and Drug Administration (FDA) update.
In summary, the mean exposure (AUC) of darunavir boosted with cobicistat was 56% and 50% lower during the second and third trimesters of pregnancy, respectively, compared with 6 to 12 weeks postpartum. Mean darunavir Cmin concentrations were around 90% lower during the second and third trimesters, compared to postpartum.
Exposure of cobicistat was 63% and 49% lower during the second and third trimeters, respectively, as compared to postpartum.
Although another recent FDA update to the darunavir/cobicistat in February 2018 cautioned about low darunavir exposure during the third trimester, the new alert goes further in making pregnancy a contraindication.
No HIV transmissions to the baby were reported in these studies, but it is unclear whether transmissions have been reported in other settings.
The coformulation of darunavir/cobicisat is marketed as Rezolsta in the EU and Prezcobix in the US.
The single pill fixed dose combination of darunavir/cobicistat/emtricitabine/TAF is marketed as Symtuza.
[link url="http://i-base.info/htb/34337"]I-Base material[/link]
[link url="http://i-base.info/htb/34341"]Dear Doctor letter[/link]
[link url="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=94"]FDA update (June 2018)[/link]
[link url="http://i-base.info/htb/33410"]FDA update (February 2018)[/link]