Noninferiority (12% margin) of an FTC/TAF backbone regimen* to an FTC/TDF backbone regimen* based on HIV-1 RNA <50 copies/mL at Week 48
Selected secondary endpoints1
Serum creatinine, treatment-emergent proteinuria, and lumbar spine and hip BMD at Week 48
|Median age, years (range)||33 (18-74)||35 (18-76)|
|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 (%)||77||78|
|Median CD4+ cell count, cells/µL (range)||404 (283-550)||406 (291-542)|
|CD4+ cell count ≥200 cells/µL (%)||87||87|
|Median eGFRCG, mL/min||117||114|
|Dipstick proteinuria (any grade) (%)||10||10|
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.
†Studies were combined for a prespecified pooled efficacy and safety analysis.
‡Administered as an STR.
BMD, bone mineral density; COBI, cobicistat; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); EVG, elvitegravir; STR, single-tablet regimen.
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