Product labels for cobicistat with atazanavir or darunavir, and for elvitegravir/cobicistat/emtricitabine/tenofovir (alafenamide or disoproxil fumarate) were recently updated to state that these products are not recommended for initiation during pregnancy, and an alternative regimen is recommended for those who become pregnant during therapy with these products. Herein, we present the rationale for these recommendations, which are based on studies in pregnant women evaluating the pharmacokinetics and antiviral activity of darunavir/cobicistat or elvitegravir/cobicistat-containing antiretroviral regimens. In these studies, mean steady-state minimum concentrations in the second and third trimester versus postpartum of cobicistat, darunavir, and elvitegravir were reduced by 61–83%, 89–92%, and 82–86%, respectively. In the absence of data with atazanavir/cobicistat, we leveraged the available data with darunavir/cobicistat and elvitegravir/cobicistat to make recommendations for atazanavir/cobicistat. Darunavir/ritonavir and atazanavir/ritonavir remain viable treatment options for pregnant women.
aFood and Drug Administration, Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products
bFood and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Clinical Pharmacology IV, Silver Spring, Maryland, USA.
Correspondence to Sarita D. Boyd, 10903 New Hampshire Avenue, Building 22, Room 6315, Silver Spring, MD 20993, USA. Tel: +1 301 796 4713; e-mail: Sarita.email@example.com
Received 20 November, 2018
Revised 9 January, 2019
Accepted 10 January, 2019