Monthly IV cabotegravir/rilpivirine represents potential treatment strategy in ART-naive HIV patients

  • Orkin C & al.
  • N Engl J Med
  • 4 Mar 2020

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • Monthly, long-acting (LA) intravenous (IV) cabotegravir plus rilpivirine regimen is noninferior to continuous, daily oral dolutegravir-abacavir-lamivudine (CAR) for maintaining viral suppression in antiretroviral therapy (ART)-naive adults over 48 weeks.
  • See related study, editorial

Why this matters

  • Long-acting IV treatment represents an alternative treatment strategy for HIV-infected patients to achieve viral suppression.
  • Findings show that patients prefer a long-acting regimen over prior oral therapy.

Key results

  • 566 participants (283/group); median, 34 years.
  • At week 48, 2.1% (6) of LA vs 2.5% (7) of CAR group had HIV-1 RNA ≥50 copies/mL.
    • Adjusted difference: −0.4 (95% CI, −2.8 to 2.1) percentage points.
  • At week 48, 93.6% (265) of LA vs 93.3% (264) of CAR group achieved HIV-1 RNA
    • Adjusted difference: 0.4 (95% CI, −3.7 to 4.5) percentage points.
  • Virologic failures occurred in 4 patients in the LA group and 3 in CAR.
  • 3 in each group had resistance mutations. 
  • 86% of LA participants had >1 injection site reaction (82% cited pain); 4 withdrew.
  • 61.31% LA vs 56.03% CAR reported high treatment satisfaction (HIV Treatment Satisfaction Questionnaire).
    • Adjusted difference: 0.44 (95% CI, −0.48 to 1.37).

Study design

  • Randomized, open-label, phase 3 noninferiority study comparing switch to LA IV cabotegravir plus rilpivirine monthly vs daily oral CAR in ART-naive HIV-positive adults.
  • Funding: ViiV Healthcare, Janssen.

Limitations

  • Selection bias.
  • Limited generalizability.