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

Prior treatment

• 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.

Other illness

• Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.
• Has a documented positive HIV-1 nucleic acid test.

Lab values

• Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

• Mother exclusion criteria:
• 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.
  • Neonate exclusion criteria:

• Mother inclusion criteria:
• Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment.
• Have confirmed HIV-1 infection based on positive test results obtained from medical records.
  • Neonate inclusion criteria:
• Be born at term (≥ 37.0 weeks gestational age).
• Be able to take oral medication.
• Be ≤ 120 hours of life at enrollment.
• Have a birth weight ≥ 2.5 kg.
• Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission.