Adverse Reactions and Discontinuations
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.

Demonstrated long-term safety profile through Week 961,2

Few discontinuations due to adverse events

1%

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

VS

2%

of patients discontinued
FTC/TDF
(n=2693)

Adverse reactions (all grades) reported in ≥2% of patients were similar in both study arms

DESCOVY®(n=2694)

FTC/TDF(n=2693)

Diarrhea

5%

6%

Nausea

4%

5%

Headache

2%

2%

Fatigue

2%

3%

Abdominal pain

2%

3%

Mean change in lipid values2-4,a

DESCOVY

FTC/TDF

Total cholesterol (fasted) target level: <200 mg/dL

Baseline (mg/dL)

175

176

Week 96 change

-2

-13

HDL cholesterol (fasted) target level: ≥60 mg/dL

Baseline (mg/dL)

51

51

Week 96 change

-2

-4

LDL cholesterol (fasted) target level: <100 mg/dL

Baseline (mg/dL)

103

103

Week 96 change

-1

-8

Triglycerides (fasted) target level: <150 mg/dL

Baseline (mg/dL)

108

111

Week 96 change

+6

-7

Total-cholesterol-to-HDL ratio target level: <4.5

Baseline (mg/dL)

3.7

3.7

Week 96 change

+0.1

0.0

Mean change in lipid values2-4,a

DESCOVY

FTC/TDF

Lipid value

Target level

Baseline (mg/dL)

Week 96 change

Baseline (mg/dL)

Week 96 change

Total cholesterol (fasted)

<200 mg/dL

175

-2

176

-13

HDL cholesterol (fasted)

≥60 mg/dL

51

-2

51

-4

LDL cholesterol (fasted)

<100 mg/dL

103

-1

103

-8

Triglycerides (fasted)

<150 mg/dL

108

+6

111

-7

Total-cholesterol-to-HDL ratio

<4.5

3.7

+0.1

3.7

0.0

  • 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

aPatients were excluded from the study if they took lipid-modifying medications at study entry or initiated the medications during the study.

Only patients with both baseline and postbaseline fasting values were included in the above data.

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