Adverse Reactions

INDICATION

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 safety profile1

Adverse reactions (all grades) reported in ≥2% of patients were similar through primary analysis*

DESCOVY®(n=2694)

TRUVADA®(n=2693)

Diarrhea

5%

6%

Nausea

4%

5%

Headache

2%

2%

Fatigue

2%

3%

Abdominal pain

2%

3%

Mean changes from baseline in fasted lipid values at Week 48:

  • Increase in total-cholesterol-to-HDL ratio was similar with DESCOVY FOR PrEP vs TRUVADA (+0.2 mg/dL vs +0.1 mg/dL, respectively)
  • No increases in LDL or HDL were observed with DESCOVY FOR PrEP (0 mg/dL and -2 mg/dL, respectively) vs decreases with TRUVADA (-7 mg/dL and -5 mg/dL, respectively)
Discontinuation Rates

*Primary analysis: when 100% of patients reached Week 48 and ≥50% reached Week 96.

HDL=high-density lipoprotein; LDL=low-density lipoprotein.