The US FDA Approves the Label Update of Gilead’s Biktarvy for Pregnant Adults with HIV
Shots:
- The US FDA approved label update with additional safety & efficacy data of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets) for pregnant adults with HIV-1 (PWH) having suppressed viral loads, based on P-Ib (Study 5310) trial
- The P-Ib study assessed the PK, safety & efficacy of Biktarvy (QD from 2nd/3rd trimester through postpartum) in PWH adults (n=32) with suppressed viral loads & without known resistance to the drug components
- The data showed low plasma exposure during pregnancy, sustained viral suppression by wk.18 postpartum & median CD4+ cell count of 558 cells/μL at baseline with 159 cells/μL median change by wk.12 postpartum. All 29 newborns were HIV-1 -ve at birth & 4-8wks. after birth
Ref: Gilead | Image: Gilead
Related News:- Gilead’s Biktarvy Receives EC’s Marketing Authorization for the Treatment of HIV in Pediatric Patients
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
