INDICATION & LIMITATION OF USE

DESCOVY® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use: DESCOVY FOR PrEP® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Please see below for Important Safety Information for DESCOVY.

Less impact on markers of renal function across populations

DESCOVY® had less long-term impact on markers of renal function vs FTC/TDF1,2

Median change in eGFRCG through Week 96

There was a 4.1 mL/min difference between DESCOVY FOR PrEP® (+3.7 mL/min) and FTC/TDF (-0.4 mL/min) in eGFRCG at Week 96.2

The long-term clinical significance of changes in eGFR is not known.

Lower serum creatinine levels were also seen with DESCOVY FOR PrEP through Week 96

  • Median serum creatinine decrease 0.02 mg/dL with DESCOVY FOR PrEP vs a 0.01 mg/dL decrease with FTC/TDF from baseline at Week 96
  • DESCOVY FOR PrEP can be used in people with impaired renal function of CrCl ≥30 mL/min

eGFR remained steady over 144 weeks with DESCOVY®2,3

Analysis of eGFR from baseline to ≥144 weeks (DESCOVY)

Median change in eGFR

Graph displaying DESCOVY® (emtricitabine/tenofovir alafenamide) median change in eGFR through week 144. See BOXED WARNING.

The long-term clinical significance of changes in eGFR is not known.

DESCOVY® had less long-term impact on eGFR in participants ≥50 years of age2,4

Results were seen in participants of an age group that may already be experiencing age-associated declines

Median change in eGFRCG in participants ≥50 years of age through Week 96

There was a 4.4 mL/min difference between DESCOVY FOR PrEP® (+1.2 mL/min) and FTC/TDF (-3.2 mL/min) in eGFRCG at Week 96.4

The long-term clinical significance of changes in eGFR is not known.

DESCOVY FOR PrEP® can be used in people with impaired renal function of CrCl ≥30 mL/min.2

BMD=bone mineral density; CrCl=creatinine clearance; eGFRCG=estimated glomerular filtration rate (Cockcroft-Gault); FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; Q1, Q3=first quartile, third quartile.

You may also be interested in: