Nearly all individuals remained HIV negative with DESCOVY® over 144 weeks in the DISCOVER Trial1-3
DISCOVER is the largest PrEP clinical trial, with over 5300 participants1,4,5
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
At primary analysis
(DESCOVY vs FTC/TDF)
- HIV incidence rate of 0.16/100 PY vs 0.34/100 PY (IRR=0.47; CI: 0.19-1.15)
- Primary endpoint for the DISCOVER Trial (HIV incidence per 100 PY) was analyzed when 100% of participants reached Week 48 and ≥50% reached Week 96
Analysis from baseline through 96 weeks (DESCOVY vs FTC/TDF)
- HIV incidence rate of 0.16/100 PY vs 0.30/100 PY (IRR=0.54; CI: 0.23-1.26)
- Conducted when 100% of participants reached Week 96
- 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 incidence rate with DESCOVY FOR PrEP was similar over 144 weeks2,3,6
Analysis from baseline to ≥144 weeks (DESCOVY)
- HIV incidence rate of 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
DESCOVY FOR PrEP was studied over 144 weeks in the DISCOVER Trial1-3,6
At entry and Q12W, participants were offered1:
- Adherence counseling
- Prevention services (risk-reduction counseling, condoms)
Primary endpoint analysis (n=5335)1:
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)2
-
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)1-3,6
-
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 HIV1
b a Includes mixed Black race.
c b ≥6 drinks on ≥1 occasion, at least monthly.
FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; 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).