Nebenwirkungen · Symtuza
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets Symtuza 675 mg/150 mg/200 mg/10 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 22
HOS-138533 · Präparat HOS-098200
In the Phase 3 trial of Symtuza in treatment-naïve patients, increases in serum creatinine and decreases in eGFRCG occurred at the first on-treatment assessment (Week 2) and remained stable through 96 weeks. At Week 48 changes from baseline were smaller with D/C/F/TAF than D/C+F/TDF. The median change in eGFRCG was -5.5 mL/min with D/C/F/TAF and -12.0 mL/min with D/C+F/TDF (p < 0.001). Using Cyst C as filtration marker, the median changes in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI CystC) formula were respectively 4.0 mL/min/1.73 m2 and 1.6 mL/min/1.73 m2 (p < 0.001). At Week 96, the median change in eGFRCG was -5.2 mL/min with D/C/F/TAF. Using Cyst C as filtration marker, the median change in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI Cyst C) formula (N = 22) was +4.4 mL/min/1.73 m2 with D/C/F/TAF.
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