Wirkstoffe & Arzneimittelsicherheit

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 14–15

HOS-139320 · Präparat HOS-098314

14 Changes in serum creatinine Bictegravir has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine, however these changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate. Increases in serum creatinine occurred by Week 4 of treatment and remained stable through Week 144. In Studies GS-US-380-1489 and GS-US-380-1490, median (Q1, Q3) serum creatinine increased by 0.11 (0.03, 0.19) mg/dL (9.7 [2.7, 16.8] µmol/L), 0.11 (0.04, 0.19) mg/dL (9.7 [3.5, 16.8] µmol/L), and 0.12 (0.06, 0.21) mg/dL (10.6 [5.3, 18.6] μmol/L) from baseline to Week 144 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively. There were no discontinuations due to renal adverse reactions through Week 144 in patients administered Biktarvy in clinical studies.

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