FDA approves Delstrigo and Pifeltro for HIV

  • Merck & Co., Inc., Kenilworth, NJ, USA
  • Merck & Co., Inc., Kenilworth, NJ, USA
  • 30 Aug 2018

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • Delstrigo (once-daily, fixed-dose doravirine [100 mg], lamivudine [3TC 300 mg], tenofovir disoproxil fumarate [TDF 300 mg]) and Pifeltro (doravirine 100 mg), a non-nucleoside reverse transcriptase inhibitor (NNRTI), have been approved for the first-line treatment of HIV.
  • Target approval date was October 2018; the manufacturer anticipates the products will be stocked through wholesalers within 1 month.

Why this matters

  • Consult Delstrigo and Pifeltro prescribing information for contraindications, drug interactions, and warnings.
  • Breastfeeding is not recommended with either drug.
  • Registering pregnant patients is encouraged (at 1-800-258-4263).

Key points

  • In DRIVE-AHEAD trial (n=728), 84% Delstrigo vs 81% efavirenz [EFV]/emtricitabine [FTC]/TDF patients achieved viral suppression through week 48 (treatment difference, 3.5%; 95% CI, −2.0% to 9.0%), demonstrating noninferiority.
    • Of 21% of patients with high baseline viral loads, 77% of Delstrigo vs 72% of EFV/FTC/TDF patients achieved viral suppression.
  • In DRIVE-FORWARD (n=766), 84% of Pifeltro vs 80% of darunavir (800 mg) + ritonavir (100 mg, DRV+r) both combined with FTC/TDF or abacavir/3TC, patients achieved viral suppression, demonstrating noninferior efficacy through week 48 (treatment difference, 3.9%; 95% CI, −1.6% to 9.4%).
    • Of 20% of patients with high baseline viral loads, 77% of Pifeltro vs 74% of DRV-r patients achieved viral suppression.
  • No grade >2 adverse reactions observed.

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