Bone Data
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.

Less impact on BMD

Significantly less impact on BMD1-6

Change seen in both arms continued through Week 96

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

Lumbar spine
Hip

24% to 30% of patients in this substudy had osteopenia or osteoporosis at baseline.

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 patients in both treatment arms at Week 48, and in 4% of DESCOVY patients and 16% of FTC/TDF patients 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 patients and 2% of FTC/TDF patients at Week 96
  • Analysis of these parameters was conducted in a subset of the study population (n=375)
  • Median age for the substudy was 37 years, with patients ranging from 19 to 74 years of age
  • BMD was assessed at baseline, Week 48, and Week 96 by dual-energy X-ray absorptiometry (DXA) scans
  • DESCOVY FOR PrEP® had less impact on BMD compared with FTC/TDF. Increases in BMD observed in DISCOVER patients may be consistent with innate bone development
DISCOVER Trial Baseline Characteristics

DESCOVY® had less long-term impact on BMD over 96 weeks in patients <25 years of age1,4,5,7,9,10

Males can continue to develop bone mass up to age 33, highlighting the need to consider BMD in this group

Lumbar spine
Hip

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

DISCOVER Trial Baseline Characteristics

Patients may be staying on a PrEP regimen for extended periods of time. Consider BMD when prescribing a PrEP medication.7,8

BMD=bone mineral density; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; SEM=standard error of the mean; y=years.