Studiensammlung

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is approved by the US FDA and EMA for treatment of HIV-1 infection (treatment-naïve and virologically suppressed without resistance)

B/F/TAF safety, efficacy, and lack of emergent resistance have been demonstrated in controlled clinical trials

• Treatment-naïve adults: 2 Phase 3 studies of 634 participants through 96 weeks3-6
• Suppressed switch adults: 4 Phase 3 studies of 1090 participants through 48 weeks7-10
• Suppressed switch in adolescents and children: 1 Phase 2/3 study of 100 participants through 48 weeks11

Study GS-US-380-4030 is a phase 3, randomized, double-blindedstudy of HIV-1 RNA suppressed participants switching 1:1 to dolutegravir (DTG) + F/TAF or B/F/TAF for 48 weeks Proviral DNA genotyping (archive assays) can detect previously undocumented drug resistance in suppressed patients but can be insensitive.

Here, we present baseline resistance analyses and early blinded outcome data from the Week 12 Independent Data Monitoring Committee (IDMC)

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