Nebenwirkungen · Biktarvy
Biktarvy 30 mg/120 mg/15 mg film-coated tablets Biktarvy 50 mg/200 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-139322 · Präparat HOS-098314
Paediatric population The safety of Biktarvy was evaluated in 50 HIV-1 infected adolescents aged 12 to < 18 years and weighing ≥ 35 kg through Week 96 (48-week main phase and 48-week extension), in 50 children aged 6 to < 12 years and weighing ≥ 25 kg through Week 96 (48-week main phase and 48-week extension), and in 22 children ≥ 2 years of age and weighing ≥ 14 to < 25 kg through Week 24 in an open-label clinical study (GS-US-380-1474). In this study, no new adverse reactions have been observed in paediatric subjects aged 2 years and older living with HIV-1 as compared to adult subjects living with HIV-1. Bone mineral density data were not collected in this study. Reductions in BMD of the spine and of the TBLH ≥ 4% have been reported in paediatric patients receiving other tenofovir alafenamide containing products for 48 weeks (see section 4.4).
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Version 2026-01-28T17:05:00Z · SHA-256 8ec4738243d92aa421e74b71a9bad453e15421c1f952d3be4e88479f189e0fe4 · Passage 72d02f3eb9e467875603bb3d40fca92ee5ed5e27bd8fbf406ff15258a6ce94e0 · Zeichen 5379–6237 im Abschnitt