Change from baseline in eGFRCG at Week 24
Selected secondary endpoints2
Change from baseline in eGFRCG at Week 48
Efficacy (HIV-1 RNA <50 copies/mL), safety, and tolerability observed at Weeks 24 and 48
|Switched to FTC/TAF + EVG/COBI†
|Median age, years (range)||58 (24-82)|
|Age ≥65 year, n (%)||63 (26)|
|Black or African descent (%)||18|
|Hispanic/Latino ethnicity (%)||13|
|Median CD4+ cell count, cells/µL (range)||632 (126-1813)|
|Pre-switch TDF use (%)||65|
|Median eGFRCG mL/min||56|
|eGFRCG <50 mL/min, n||80|
|eGFRCG ≥50 mL/min, n||162|
|Dipstick proteinuria (Grade 1 or 2) (%)||33|
|Significant proteinuria (UPCR >200 mg/g) (%)||42|
|Significant albuminuria (UACR ≥30 mg/g) (%)||49|
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years and older who have no antiretroviral (ARV) treatment history with HIV-1 RNA ≤100,000 copies/mL; or to replace a stable ARV regimen in patients who are virologically-suppressed (HIV-1 RNA <50 copies/mL) for ≥6 months with no history of treatment failure and no known resistance to any component of ODEFSEY.
*Administered in combination with EVG and COBI as an STR.
†Administered as an STR.
UACR, urine albumin to creatinine ratio; UPCR, urine protein to creatinine ratio.
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