HIV Incidence Rate

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)

99.7 %

FTC/TDF (n=2665)

99.4%

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)

99.5%

OF PARTICIPANTS
REMAINED HIV NEGATIVE

OVER 144 WEEKS

SEROCONVERSIONS

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).