Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Exclusion Criteria

• •Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.
• •Is breastfeeding or plans to breastfeed while on bictegravir (BIC) or emtricitabine (FTC) containing regimen. Mothers on BIC or FTC containing regimen, but not breastfeeding, can be enrolled in the study.
• •Had prior or expected to require blood exchange transfusion.
• •Is receiving or plans to receive any component of B/F/TAF or dolutegravir as part of their SOC ARV prophylaxis regimen.
• •Has a documented positive HIV-1 nucleic acid test.
• •Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.