Cabotegravir sodium

FRIDAY, Feb. 27, 2026 -- Monthly injections of long-acting cabotegravir-rilpivirine are superior to standard oral antiretroviral therapy (ART) in persons with human immunodeficiency virus ( HIV ) and medication adherence challenges, according to a study published online Feb. 18 in the New England Journal of Medicine . Aadia I. Rana, M.D., from the University of Alabama at Birmingham, and colleagues enrolled 453 persons with HIV who had inadequate adherence to ART (a persistent HIV-1 RNA level of >200 copies per milliliter or loss to follow-up) to 24 weeks of adherence support, conditional economic incentives, and standard care with oral ART as part of step 1. Then, in step 2, the 306 participants achieving an HIV-1 RNA level of ≤200 copies per milliliter were randomly assigned to continue standard care (154 participants) or switch to monthly injections of long-acting cabotegravir plus rilpivirine with or without oral lead-in therapy (152 participants). The researchers reported that step 2 randomization was stopped early on the basis of the superiority of cabotegravir-rilpivirine to standard care at a prespecified analysis. By week 48, the cumulative incidence of regimen failure was 22.8 percent in the cabotegravir-rilpivirine group and 41.2 percent in the standard-care group. For adverse events, the cumulative incidence was 43.5 percent in the cabotegravir-rilpivirine group versus 42.4 percent in the standard-care group. Two participants in each group developed resistance-associated mutations with confirmed virologic failure. "These findings have the potential to validate a long-acting approach for this additional group of patients and could make a significant difference to people living with HIV and our goal of ending the epidemic," Kimberly Smith, M.D., head of research & development at ViiV Healthcare, said in a statement. Several authors disclosed ties to ViiV Healthcare, the maker of cabotegravir-rilpivirine. Abstract/Full Text Editorial (subscription or payment may be required)

The IMPAACT 2017 study showed adolescents using Cabenuva largely preferred the injections to daily oral therapies. As GSK’s HIV unit ViiV Healthcare grapples with a new rival in the injectable HIV prevention and treatment field, the company is reinforcing the staying power of its long-acting treatment Cabenuva in adolescents.ViiV originally tested its long-acting injectable Cabenuva, made from ViiV’s cabotegravir and Johnson & Johnson’s Edurant (rilpivirine), as an every-two-month HIV treatment in children 12 years and older in its Mocha (More Options for Children and Adolescents) study, born from a collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). A Week 16 interim analysis of the study helped the company secure an expanded FDA approval covering the younger population of HIV patients in 2022, marking another milestone for what was then the only marketed long-acting HIV treatment regimen. Since then, Gilead Sciences’ twice-yearly lenacapavir has entered the scene as both a long-acting pre-exposure prophylaxis med and as a treatment for multidrug-resistant HIV.With Gilead looking to edge in further on the long-acting treatment market by testing lenacapavir in the broader HIV population, ViiV is sharpening the case for Cabenuva with 96-week data from its Mocha study, also referred to as IMPAACT 2017.  As ViiV announced at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Colorado this week, 94.4% of virologically suppressed adolescents with HIV who switched from a daily oral treatment to every-two-month Cabenuva maintained viral suppression at Week 96. The study enrolled adolescents between the ages of 12 and 18.More than 97% of the trial participants indicated they preferred long-acting injections over daily oral antiretrovirals at “all weeks evaluated,” ViiV said in a Feb. 24 press release, with 100% of the group expressing the preference for injections at Week 96 specifically. For many in the 144-person study, the treatment period was “the first time in their lives they did not have to take an oral HIV medicine every day,” co-lead investigator Aditya Gaur, M.D., said in a statement. Meanwhile, ViiV is looking to grow the reach of its long-acting treatment with its IMPAACT 2036 study in younger children between the ages of 2 and 12. The study is in very early stages, but the company recently secured the first pharmacokinetic and safety evidence that can help inform the remainder of the trial, ViiV said at CROI.  Elsewhere, ViiV hopes to reach new ultralong-acting heights with its investigational lotivibart, a broadly neutralizing antibody that it has paired with Cabenuva in studies. Newly presented 12-month data on the treatment regimen showed efficacy when dosed every four months, but the company hopes to eventually progress the trial to a twice-yearly dosing interval. Long-acting Cabenuva made up 55% of total HIV growth for GSK in 2025, raking in yearly sales of 1.4 billion pounds sterling ($1.9 billion).