Darunavir (Prezista) is an antiretroviral medication used to treat and prevent HIV/AIDS. Cobicistat can be co-administered with darunavir as a booster to increase darunavir levels. Darunavir and cobicistat are available in combination in fixed-dose products Rezolsta▼ (darunavir and cobicistat) and Symtuza▼(darunavir, cobicistat, emtricitabine, tenofovir alafenamide).
Researchers pooled new pharmacokinetic data of 6 women enrolled in phase 3b study which showed lower mean exposure levels of darunavir boosted with cobicistat (darunavir/cobicistat) during the second trimester (56% lower) and third trimester (50% lower) of pregnancy, compared with 6–12 weeks postpartum. Mean darunavir Cmin concentrations were around 90% lower during the second and third trimesters of pregnancy than during 6–12 weeks postpartum. Exposure of cobicistat was 63% lower and 49% lower during the second trimester and third trimesters of pregnancy than during 6–12 weeks postpartum.
Low darunavir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the child. Thus, therapy with darunavir/cobicistat should not be initiated during pregnancy and darunavir/ritonavir may be considered as an alternative.
Mother-to-child transmission did not occur in any of the 6 infants born to the 6 mothers who delivered during the study and completed the study. So far, the advice is precautionary, and we are unaware of any clinical pattern to suggest that patient safety has been affected.
Healthcare professionals are asked to report all suspected adverse reactions associated with black triangle drugs such as Rezolsta▼ and Symtuza▼ on a Yellow Card. Also, any cases of material-to-child transmission of HIV due to low treatment efficacy should be reported on a Yellow Card.
