Change from baseline in eGFRCG at Week 24
Selected secondary endpoints1,2
Change from baseline in eGFRCG at Week 48
Efficacy (HIV-1 RNA <50 copies/mL), safety, and tolerability observed at Week 24 and Week 48
|Median age, years||58|
|Age ≥65 years, n (%)||63 (26)|
|Black or African descent (%)||18|
|Hispanic/Latino ethnicity (%)||13|
|Median CD4 count, cells/µL||632|
|Pre-switch TDF use (%)||65|
|Median eGFR mL/min||56|
|eGFR <50 mL/min (n)||80|
|eGFR ≥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
DESCOVY® is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients 12 years and older.
Limitations of Use:
DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.
*Administered in combination with EVG and COBI as an STR.
eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); TDF, tenofovir disoproxil fumarate; UACR, urine albumin to creatinine ratio; UPCR, urine protein to creatinine ratio.
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