The proportion of patients with HIV-1 RNA <50 copies/mL at Week 48
Selected secondary endpoints1,2
Changes in serum creatinine and lumbar spine and hip BMD
|Remained on baseline
|Median age, years||41||40|
|Native Hawaiian (%)||1||<1|
|Native American (%)||1||<1|
|Hispanic/Latino ethnicity (%)||26||17|
|HIV-1 RNA <50 copies/mL (n)||943||466|
|Median CD4 count, cells/µL||675||662|
|Proteinuria by urine dipstick (any grade) (%)||9||10|
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 10%
Selected secondary endpoints3
Percentage change from baseline in hip and lumbar spine BMD, change from baseline in serum creatinine, and change from baseline in CD4 cell count
|Remained on baseline
|Median CD4 count, cells/µL (range)||663 (505-853)||624 (477-819)|
|Boosted PIs (%)||||47||45|
|DRV + RTV (%)||25||25|
|ATV + RTV (%)||16||15|
|LPV + RTV (%)||5||5|
|Other agents (%)||||53||55|
Data are median (IQR) unless stated otherwise.
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.
†Administered as an STR.
‡Third agents included: EVG + COBI (as an STR), EFV (as an STR), ATV + COBI, or ATV + RTV.1,2
§Patients remained on the following third agents: ATV + RTV, DRV + RTV, LPV + RTV, EFV, NVP, RPV, DTG, RAL, or MVC.3,4
||Adults on boosted PIs (ATV, DRV, and LPV, all boosted with RTV) who were randomly assigned to switch treatment received a fixed combination of 200 mg FTC with 10 mg TAF; those on other third agents received 200 mg FTC with 25 mg TAF. In the United States, only 1 dose of DESCOVY (FTC 200 mg/TAF 25 mg) is approved for use with any third agent. Adults who maintained FTC/TDF-based regimens received 200 mg FTC with 300 mg TDF for all regimens.3,5
¶EFV and RPV were allowed when administered as individual agents, but not as part of a single-tablet regimen.
ATV, atazanavir; COBI, cobicistat; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); EVG, elvitegravir; FTC, emtricitabine; IQR, interquartile range; QD, once daily; RTV, ritonavir; STR, single-tablet regimen.
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