CROI 2019—F/TAF noninferior to F/TDF for HIV PrEP in DISCOVER


  • Jim Kling
  • Conference Reports
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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). 

Limitations

  • F/TAF is not yet approved for PrEP.

Expert comment

  • "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.

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