EFFICACY AND SAFETY

FLAIR trial results

FLAIR was a Phase 3 trial comparing Monthly VOCABRIA + REKAMBYS to Triumeq (dolutegravir/abacavir/lamivudine)

Triumeq prescribing information found here
FLAIR: TRIAL DESIGN1–3
Visual representation of the FLAIR trial design

FLAIR established non-inferior efficacy of monthly VOCABRIA + REKAMBYS to daily oral therapy with ABC/DTG/3TC at 48 and 96 weeks1,2

  • Results at 48 weeks

    • FLAIR established non-inferior efficacy of monthly VOCABRIA + REKAMBYS to daily oral therapy with ABC/DTG/3TC**1
    • VOCABRIA + REKAMBYS demonstrated a low level of confirmed virologic failure (CVF, 1.4%)†±1,4
    • Monthly dosing was generally well tolerated, with a low rate of discontinuation (2.8%)4
    • 91% of trial patients preferred monthly dosing vs oral daily therapy with ABC/DTG/3TC1
      • An exploratory analysis of a single-item question regarding therapy preference at Week 48 in the intention-to-treat exposed population who received long-acting therapy indicated that 90.8% (257/283) preferred the long-acting regimen vs 0.7% (2/283) who preferred daily oral therapy (8.5%, 24/283, did not respond to the question)1,4,5
  • Results at 96 weeks

    • VOCABRIA + REKAMBYS continued to provide non-inferior efficacy to the daily oral ABC/DTG/3TC at Week 962
    • There were no new CVF cases recorded among participants on VOCABRIA + REKAMBYS from Week 48 to Week 962
    • There were few new AEs and discontinuations beyond Week 482

Colleague Testimonials

Hear what colleagues say about their experiences with long-acting therapy

*DTG + 2 NRTIs if HLA-B*5701 positive.1
**Primary endpoint trial-defined efficacy threshold of percentage of patients demonstrating a virologic outcome of HIV-1 RNA ≥50 copies/mL at Week 48 (FLAIR, 6% non-inferiority margin). Endpoints assessed at Week 96 were proportion of participants with HIV-1 RNA ≥50 copies/mL (primary) and <50 copies/mL and incidence of CVF (secondary).1,2,4
Two consecutive plasma HIV-1 RNA levels ≥200 copies per milliliter.1
±In the long-acting therapy group, 4 participants had CVF. In 1 of those participants (who had HIV-1 subtype AG), oral lead-in therapy was suspended owing to a false-positive pregnancy test; on re-initiation of oral therapy, criteria for CVF were met and the participant was withdrawn from the trial before long-acting therapy was initiated, with no resistance mutations detected.1

 

ABC=abacavir; DTG= dolutegravir; 3TC=lamivudine; ARV=antiretroviral; CVF=confirmed virologic failure; AE=adverse event.

References:

  1. Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. 2020; 382:1124-35. doi: 10.1056/NEJMoa1909512.
  2. Orkin C et al. Long-acting cabotegravir + rilpivirine for HIV treatment: FLAIR week 96 results. Conference on Retroviruses and Opportunistic Infections, Boston USA, March 8-11, 2020.
  3. Data on file. FLAIR Clinical Protocol. REF 57528. ViiV Healthcare group of companies.
  4. Orkin C et a. Long-acting cabotegravir + rilpivirine for HIV maintenance: FLAIR week 48 results. Conference on Retroviruses and Opportunistic Infections, Seattle USA, March 4-7, 2019.
  5. Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. (Supplementary data) N Engl J Med. 2020; 382:1124-35. doi: 10.1056/NEJMoa1909512.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

REKAMBYS (rilpivirine long acting injection), including the trademark is owned by the Janssen Pharmaceutical Companies and used under license by the ViiV Healthcare group of companies. All other trademarks are owned by the ViiV Healthcare group.

PM-GB-CBR-WCNT-210001v3 I April 2022

Report an adverse event

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.