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.
Proven HIV prevention: 99.7% remained HIV negative with DESCOVY®1
DISCOVER is the largest PrEP clinical trial, with over 5300 participants1-5
Data from a randomized, active-controlled, double-blind study of adult HIV-seronegative MSM and TGW (N=5387) using once-daily DESCOVY FOR PrEP® (n=2694) vs FTC/TDF (n=2693).
DESCOVY FOR PrEP was noninferior to FTC/TDF through 96 weeks1,2
HIV incidence rate (DESCOVY vs FTC/TDF)
Primary endpoint analysis*: 0.16/100 PY vs 0.34/100 PY (IRR=0.47; CI: 0.19-1.15)
Baseline through 96-week analysis†: 0.16/100 PY vs 0.30/100 PY (IRR=0.54; CI: 0.23-1.26)
Study outcomes were similar across subgroups of age, race, gender identity, and baseline FTC/TDF use.
OF PARTICIPANTS REMAINED HIV NEGATIVE
AT PRIMARY ANALYSIS AND THROUGH 96 WEEKS
HIV prevention remained consistent over 144 weeks4,5
Analysis from baseline to over 144 weeks
- HIV incidence rate: 0.14/100 PY
- HIV incidence rate was calculated once participants, who were using DESCOVY at baseline in the 96-week randomized, double-blinded phase, had completed at least 48 weeks in the open-label extension phase
OF PARTICIPANTS REMAINED
HIV NEGATIVE OVER 144 WEEKS
*When 100% of participants reached Week 48 and >50% reached Week 96.
†When 100% of participants reached Week 96.
DESCOVY FOR PrEP was studied over 144 weeks in the DISCOVER Trial1-5
At entry and Q12W, participants were offered:
- Adherence counseling
- Prevention services (risk-reduction counseling, condoms)
Primary endpoint analysis (n=5335):
HIV incidence/100 PY when 100% of participants reached Week 48 and ≥50% reached Week 96. Secondary analysis was conducted when 100% of participants reached Week 96.
Analysis from baseline through 96 weeks (DESCOVY vs FTC/TDF):
Includes participants from both study arms in the 1:1 randomized, active-controlled, double-blind phase, from baseline through 96 weeks
- Participants received either DESCOVY or FTC/TDF once daily
Analysis from baseline to ≥144 weeks (DESCOVY):
Includes participants who initiated DESCOVY at baseline, through 96 weeks in the double-blind phase, and voluntarily continued on DESCOVY during the unblinded, open-label extension phase for another 48 weeks or more
- Participants received DESCOVY once daily
- Data for participants who switched from FTC/TDF, after 96 weeks in the blinded phase, to DESCOVY in the open-label extension phase are not shown
Participants selected for inclusion had significant risk of acquiring HIV2,6
Median age, years (IQR)
Hispanic or Latino
Baseline HIV risk factors
≥2 condomless anal sex
partners, past 12 weeks
past 24 weeks
past 24 weeks
Syphilis, past 24 weeks
Recreational drug use,
past 12 weeks
Taking FTC/TDF at baseline
baIncludes mixed Black race.
cb≥6 drinks on ≥1 occasion, at least monthly.
FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; IQR=interquartile range; TGW=transgender women (who have sex with men).