Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 as defined by FDA snapshot algorithm with a prespecified noninferiority margin of 12%
Selected secondary endpoints1
Serum creatinine, proteinuria, and spine and hip BMD at Week 48
|Median age, years||33||35|
|Black or African descent (%)||26||25|
|Hispanic/Latino ethnicity (%)||19||19|
|Median HIV-1 RNA, log10 copies/mL (range)||4.58 (4.04-4.95)||4.58 (4.15-4.96)|
|HIV-1 RNA >100,000 copies/mL (%)||23||22|
|Median CD4+ cell count, cells/µL (range)||404 (283-550)||406 (291-542)|
|CD4+ cell count <200 cells/µL (%)||13||13|
|Dipstick proteinuria (any grade) (%)||10||10|
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.
*Studies were combined for a prespecified pooled safety and efficacy analysis.
†Administered as an STR.
BMD, bone mineral density; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); QD, once daily.
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