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.

Demonstrated long-term safety profile

Nearly all individuals stayed on DESCOVY® in the DISCOVER Trial1,2

1%

of participants discontinued
DESCOVY FOR PrEP®
(n=2694)

VS

2%

of participants discontinued
FTC/TDF
(n=2693)

Adverse events reported in ≥2% of participants

DESCOVY(n=2694)

FTC/TDF(n=2693)

Diarrhea

5%

6%

Nausea

4%

5%

Headache

2%

2%

Fatigue

2%

3%

Abdominal pain or discomfort

2%

2%

The DESCOVY FOR PrEP safety profile at 144 weeks was similar to data through 96 weeks.3

Mean change in lipid values through Week 962,4-6

  • Total-cholesterol-to-HDL ratio was similar for DESCOVY and FTC/TDF
  • Decreases from baseline were seen in LDL-C, HDL-C, and total cholesterol levels in both arms
  • The DESCOVY arm had increases in triglycerides vs decreases in the FTC/TDF arm; however, both were still within the target level

Mean levels of fasting lipids were mostly stable for those who were on DESCOVY over 144 weeks.3

Participants were excluded from the study if they took lipid-modifying medications at study entry or initiated the medications during the study. Only participants with both baseline and postbaseline fasting values were included in the above data.2

DDI=drug-drug interaction; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; HDL-C=high-density lipoprotein cholesterol; LDL-C=low-density lipoprotein cholesterol.