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A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
Status:Active, no longer recruiting
Phase of Trial:
Phase II/III
Latest Information Update:21 Oct 2021
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18 Oct 2021
According to a Gilead Sciences media release, based results from cohort 3 of this study, the U.S FDA has approved supplemental New Drug Application (sNDA) of low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.
18 Oct 2021
Results presented in the Gilead Sciences Media Release.
20 Aug 2021
Results characterizing the efficacy and safety of B/F/TAF in FWH, including young, elderly, and ART-naive participants, data from 5 clinical trials ((NCT02652624, NCT02607930, NCT02607956, NCT02881320, NCT03405935) were analyzed published in the JAIDS
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