As competition in both the HIV treatment and prevention fields continues to mount, GSK’s ViiV Healthcare is looking to expand the reach of its long-acting Cabenuva, homing in on the combination treatment’s potential to help people whose infection isn’t adequately kept in check by antiretrovirals.
At six months in the phase 3b Crown trial, Cabenuva—which weds ViiV’s cabotegravir with Johnson & Johnson’s rilpivirine—hit superior viral suppression rates versus standard-of-care oral antiretroviral therapy (ART) in adults and adolescents with HIV-1 who had detectable levels of the virus when they started the study. The results helped the trial meet its primary endpoint, ViiV said on Tuesday.
ViiV now plans to share a detailed look at the data at an upcoming medical meeting, and it will also confer with regulators on the results for the HIV treatment, which reeled in 1.4 billion pounds sterling (around $1.9 billion at the time) in 2025 sales, accounting for 55% of GSK’s total HIV growth last year.
ViiV’s Crown study enrolled 326 people across eight countries, with the goal to see whether those with detectable HIV-1 virus, despite historic daily oral ART use, could directly initiate Cabenuva to achieve viral suppression.
The GSK unit framed the study as filling a “remaining evidence gap” in Cabenuva’s profile by evaluating that direct initiation of the drug in patients who, apart from starting the study with viremia, also showed no signs of resistance to integrase inhibitors or non-nucleoside reverse transcriptase inhibitors—the drug classes that make up Cabenuva’s constituent parts.
"People living with HIV who experience challenges achieving or maintaining viral suppression with daily oral therapy continue to face significant barriers to optimizing care,” said Jean van Wyk, M.D., ViiV’s medical chief, in a statement.
“The Crown study was designed to address this important evidence gap,” added van Wyk. “These findings add to the growing body of data around long-acting treatment with cabotegravir plus rilpivirine, and provide important insights into the potential role of this approach for treatment-experienced people living with HIV."
ViiV noted that Crown builds upon its prior Latitude study, which pointed to Cabenuva’s superiority over daily oral therapy at maintaining viral suppression in people who had met that goal on an oral ART but had a history of adherence challenges.
Injected Cabenuva can be dosed just six times throughout the year, or at every two months, offering a long-acting alternative to oral treatments that must be taken each day.
As it stands, Cabenuva’s present approval covers treatment of HIV-1 infection in adults and teens who’ve achieved virological suppression a stable antiretroviral regimen with no history of treatment failure. Overseas in the European Union and Japan, GSK markets the medicine as Vocabria + Rekambys.
First approved in 2021, Cabenuva isn’t alone in the field. Gilead Science's lenacapavir—branded as Sunleca—is its archrival in the long-acting HIV treatment space. Maintenance doses of the drug are given just once every six months. Lenacapavir also scored a landmark long-acting pre-exposure prophylaxis (PrEP) approval last summer, adopting the Yeztugo commercial moniker in that HIV niche.
For their part, GSK and ViiV moved to further reinforce Cabenuva’s position earlier this year when they unveiled data from the Mocha study, also coded IMPAACT 2017.
Those data found that 94.4% of virologically suppressed adolescents with HIV who switched from a daily oral treatment to every-two-month Cabenuva kept viral suppression in check at the 96-week mark. Meanwhile, ViiV touted results showing that more than 97% of the study participants pointed to a preference for long-acting injections over a daily oral antiretroviral at “all weeks evaluated.”