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.
Seroconversions and adherence are strongly correlated
Seroconversions from baseline to ≥96 weeks1,2
Suspected baseline infections: 1 (DESCOVY) and 4 (FTC/TDF)
Seroconversions at other timepoints2-4
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Primary endpoint analysis: 7 (DESCOVY) vs 15 (FTC/TDF)
- Primary analysis: when 100% of participants reached Week 48 and ≥50% reached Week 96
- Baseline to ≥144 weeks analysis: 3 additional seroconversions occurred in the DESCOVY arm (n=2070)
- Median intracellular drug levels were substantially lower in participants infected with HIV-1 at the time of diagnosis vs uninfected, matched control participants. Values for 1 participant in the DESCOVY arm are not available
Efficacy is strongly correlated with adherence.
*Seroconversion was observed in 1 person in the FTC/TDF arm with missing DBS sample at the visit of HIV-1 diagnosis; a DBS sample collected 7 weeks prior to the diagnosis showed TFV-DP levels indicating high adherence at that time.
High adherence rates of DESCOVY FOR PrEP® were observed among a randomly selected subset through the primary endpoint in the DISCOVER Trial2,4,5,†
†Primary endpoint: When 100% of participants reached Week 48 and ≥50% reached Week 96.
DBS adherence analysis:
- A subset of DISCOVER Trial participants (n=total number of participants) were randomly selected
- Adherence was evaluated by quantifying tenofovir diphosphate concentration in DBS at each post-baseline visit
- High adherence was defined as ≥900 fmol/punch, which correlates to approximately ≥4 pills a week
Counsel individuals to strictly adhere to the one tablet, once-daily dosing schedule, as efficacy is strongly correlated with adherence.
No seroconversions in individuals with high adherence in the DESCOVY arm.3,5,‡
‡High adherence was defined as ≥900 fmol/punch, which correlates to approximately ≥4 pills a week.5
DBS=dried blood spot; fmol=femtomole; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; TFV-DP=tenofovir-diphosphate.
