- 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.
- 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.
- 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.
- CAB+RPV LA therapy is not yet approved.