CROI 2019—Monthly CAB+RPV noninferior to DTG/ABC/3TC in FLAIR


  • Jim Kling
  • Conference Reports
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Takeaway

  • Long-acting (LA) cabotegravir and rilpivirine (CAB+RPV) maintenance therapy, injected monthly, was noninferior to continuing 3-drug antiretroviral therapy (ART) out to 48 weeks in FLAIR.

Why this matters

  • If approved, the combination would be the first long-acting therapy for HIV.

Study design

  • Open-label FLAIR study of 629 antiretroviral therapy (ART)-naive patients who underwent induction therapy with oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for 20 weeks.
  • Subjects with HIV-1 RNA
  • Those who switched to CAB+RPV LA received 4 weeks of oral cabotegravir+rilpivirine to assess tolerability before receiving the injection.
  • Funding: Janssen; GlaxoSmithKline; ViiV.

Key results

  • At 48 weeks, 2.1% of patients in the CAB+RPV LA group had HIV RNA ≥50 copies/mL compared with 2.5% in the DTG/ABC/3TC group (noninferior).
  • At 48 weeks, 93.6% of patients in the CAB+RPV LA group had HIV RNA
  • 4 CAB+RPV LA patients and 3 DTG/ABC/3TC patients experienced virologic failure.
  • Injection site reaction rate: 82% of the CAB+RPV LA group (99% grade 1/2; median duration, 3 days).
  • 99% of patients who completed CAB+RPV LA to 48 weeks were more satisfied with that regimen than with oral DTG/ABC/3TC.

Limitations

  • CAB+RPV LA therapy is not yet approved.