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.
DESCOVY (n=2670)
FTC/TDF (n=2665)
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
DESCOVY (n=2070)
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
Baseline
demographics
DESCOVY
(n=2694)
FTC/TDF
(n=2693)
Median age, years (IQR)
Sex/gender
Cis male
TGW
Race
White
Blackba
Asian
Ethnicity
Hispanic or Latino
Baseline
demographics
DESCOVY
(n=2694)
FTC/TDF
(n=2693)
Baseline HIV risk factors
≥2 condomless anal sex
partners, past 12 weeks
Rectal gonorrhea,
past 24 weeks
Rectal chlamydia,
past 24 weeks
Syphilis, past 24 weeks
Recreational drug use,
past 12 weeks
Binge drinkingcb
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).
Consider proven HIV prevention data from the largest clinical trial of PrEP.
bIncludes mixed Black race.
c≥6 drinks ≥1 occasion, at least monthly.
CI=confidence interval; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; IQR=interquartile range; IRR=incidence rate ratio; MSM=men who have sex with men; PY=person-years; Q12W=every 12 weeks; TGW=transgender women (who have sex with men).
