Biktarvy Label Update Adds Data on Safety, Efficacy in Pregnant HIV Patients

The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy^® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) to include additional data regarding pregnant patients with HIV-1 who are virologically-suppressed (HIV-1 RNA <50 copies per mL).

The update was based on data from an open-label clinical trial (ClinicalTrials.gov Identifier: NCT03960645) that included 33 virologically-suppressed pregnant adults with HIV-1 and no known substitutions associated with resistance to the individual components of Biktarvy. Study participants received Biktarvy once daily from the second or third trimester through postpartum. At baseline, the median CD4+ cell count was 558 cells/μL.

Findings showed viral suppression was maintained during pregnancy, at delivery, and through week 18 postpartum in the 32 participants who completed the study. The median change in CD4+ cell count from baseline to week 12 postpartum was 159 cells/μL. Twenty-nine neonates who received testing at birth and/or at 4 to 8 weeks after birth were reported to have negative/undetectable HIV-1 PCR results. 

In pregnant patients, viral load should be monitored closely as lower exposures of Biktarvy were observed during pregnancy compared with the postpartum period. According to the prescribing information, the exposure changes during pregnancy are not considered clinically significant in virologically suppressed pregnant individuals.

The overall safety profile of Biktarvy was consistent with that seen in previous studies; no new safety or tolerability concerns were observed with Biktarvy during pregnancy and postpartum.

“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant [people living with HIV-1], an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.

Biktarvy is a 3-drug combination of bictegravir, an HIV-1 integrase strand transfer inhibitor, and emtricitabine and tenofovir alafenamide, both HIV-1 nucleoside analog reverse transcriptase inhibitors. It is supplied as a tablet in 2 dosage strengths: 30mg/120mg/15mg and 50mg/200mg/25mg. The recommended dosage for pregnant individuals is one 50mg/200mg/25mg tablet once daily.