Bictegravir, Emtricitabine, and Tenofovir Alafenamide

CD4 count, HIV RNA plasma levels; serum creatinine, urine glucose, urine protein (prior to initiation and as clinically indicated during therapy); serum phosphorus in patients with chronic kidney disease; hepatic function tests, bone density (patients with a history of bone fracture or have risk factors for bone loss); testing for HBV is recommended prior to the initiation of antiretroviral therapy. If used as therapy replacement in virologically suppressed patients meeting criteria, additional HIV-1 RNA and regimen tolerability monitoring is recommended to assess potential virologic failure or rebound. Patients with HIV and HBV coinfection should be monitored for several months following therapy discontinuation.

The Health and Human Services (HHS) Perinatal HIV Guidelines note data are insufficient to make recommendations for use of tenofovir alafenamide in pregnant females. Information related to the use of bictegravir in pregnancy is not available.

In general, females who become pregnant on a stable antiretroviral therapy regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated (HHS [perinatal] 2017).