- Emtricitabine/tenofovir alafenamide (F/TAF) performs comparably to emtricitabine/tenofovir disoproxil fumarate (F/TDF) as HIV preexposure prophylaxis (PrEP)
Why this matters
- F/TAF is approved for HIV treatment and has a better safety profile than F/TDF, but it is not known whether F/TAF is effective for PrEP.
- DISCOVER phase 3 randomized controlled trial at 94 sites in 11 countries in North America and Europe (n=5387 transgender women and cis men who have sex with men).
- Participants received daily blinded F/TAF or F/TDF.
- Funding: Gilead.
- Of all patients:
- 9% were black.
- 1% were transgender women.
- 23% had used PrEP previously.
- 41% had ≥3 receptive condomless anal sex partners in the previous 90 days.
- 90% completed at least 48 weeks of the study; median follow-up, 84 weeks.
- 1.3% discontinued F/TAF; 1.8% discontinued F/TDF.
- According to a company news release, HIV infection incidence was lower in the F/TAF group than in the F/TDF group (0.16/100 person-years vs 0.34/100 person-years).
- F/TAF is not yet approved for PrEP.
- "We can embrace that F/TAF is noninferior, but we don't know how good it is (due to lack of a placebo control)." Sharon Hillier, PhD, University of Pittsburgh, Pennsylvania.