February 27, 2026 — A study published online on February 18 in the New England Journal of Medicine demonstrates that long-acting monthly injectable cabotegravir–rilpivirine is superior to standard oral antiretroviral therapy (ART) for people living with human immunodeficiency virus (HIV) who face challenges with medication adherence.
Dr. Aadia I. Rana and her research team from the University of Alabama at Birmingham enrolled 453 people living with HIV who had poor antiretroviral therapy adherence, defined as persistent HIV-1 ribonucleic acid (RNA) levels >200 copies/mL or loss to follow-up. In the first phase of the study, all participants received 24 weeks of medication adherence support, conditional financial incentives, and standard oral antiretroviral therapy.
In the second phase, 306 participants whose HIV-1 RNA levels decreased to ≤200 copies/mL were randomized: 154 continued standard therapy, and 152 switched to monthly long-acting injectable cabotegravir plus rilpivirine (with an optional oral lead-in period).
The randomized portion of the second phase was terminated early, as prespecified analyses confirmed that the cabotegravir–rilpivirine regimen was significantly superior to standard therapy. By week 48, the cumulative incidence of treatment failure was 22.8% in the cabotegravir–rilpivirine group, compared with 41.2% in the standard therapy group.
For adverse events, the cumulative incidence was 43.5% in the cabotegravir–rilpivirine group and 42.4% in the standard therapy group. Two participants in each arm developed resistance-associated mutations after being diagnosed with virological failure.
Dr. Kimberly Smith, Head of Research and Development at ViiV Healthcare, stated in a release: “These findings promise to validate the value of long-acting regimens for this new patient population, and will be highly significant for the care and treatment of people living with HIV, as well as our goal to end the HIV epidemic.”
Multiple authors of the study reported financial relationships with ViiV Healthcare, the manufacturer of cabotegravir–rilpivirine.
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