Bone Data

Less impact on BMD1-8

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 weeks1,6

A separate substudy of the analysis of BMD from baseline to ≥144 weeks (DESCOVY®)

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

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

a Due 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 age1,2,4,7,8

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.2,5 Consider BMD when prescribing a PrEP medication.

SEE RENAL DATA FROM THE DISCOVER TRIAL

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