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 BMD

Significantly less impact on BMD1-4

24% to 29% of participants in this substudy had osteopenia or osteoporosis at baseline

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96 by DXA scans

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

  • BMD declines of ≥5% at the lumbar spine were experienced by 4% of participants in both treatment arms at Week 48, and in 4% of DESCOVY participants and 16% of FTC/TDF participants at Week 96. BMD declines of ≥7% at the total hip were experienced by 1% in both treatment arms at Week 48, and in 0% of DESCOVY participants and 1% of FTC/TDF participants at Week 96
  • Analysis of these parameters was conducted in a subset of the study population (n=383)
  • Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age

Changes in BMD were consistent over 144 weeks2,3,7

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY®, n=191)

Mean % change in lumbar spine and hip BMD at Weeks 48, 96, and 144 by DXA scans

Two graphs showing lumbar spine and hip bone mineral density safety data of DESCOVY® (emtricitabine/tenofovir alafenamide) through week 144. See BOXED WARNING. Two graphs showing lumbar spine and hip bone mineral density safety data of DESCOVY® (emtricitabine/tenofovir alafenamide) through week 144. See BOXED WARNING.

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

  • Analysis of these parameters was conducted in a subset of the study population (n=191)
  • Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age

aDue to timing of the analysis and participant visits, 1 additional participant was included in the 144-week analysis.

DESCOVY® had less long-term impact on BMD in participants <25 years of age3,4

Males can continue to develop bone mass up to about age 30, highlighting the need to consider BMD loss in this group

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96

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

People may be staying on a PrEP medication for extended periods of time.5,6 Consider BMD when prescribing a PrEP medication.

BMD=bone mineral density; CI=confidence interval; DXA=dual-energy X-ray absorptiometry; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; SEM=standard error of the mean.