GSK’s ViiV Healthcare has said its long-acting HIV treatment Cabenuva delivered superior viral suppression to standard daily oral therapy at six months in people with HIV-1 who entered a Phase IIIb study with detectable virus.
The company said the CROWN study met its primary endpoint, providing new evidence for cabotegravir plus rilpivirine (CAB + RPV LA) in adults and adolescents living with HIV-1 who had not yet achieved viral suppression despite oral antiretroviral therapy (ART).
The findings extend evidence from the LATITUDE study, which showed CAB + RPV LA was superior to daily oral therapy at maintaining viral suppression among people who had previously achieved suppression but faced challenges adhering to oral treatment.
CROWN was designed to address a different treatment gap: whether patients with detectable virus could start CAB + RPV LA directly, provided they had no evidence of resistance to integrase inhibitors (INSTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Jean van Wyk, Chief Medical Officer at ViiV Healthcare, said: “People living with HIV who experience challenges achieving or maintaining viral suppression with daily oral therapy continue to face significant barriers to optimising care.
"The CROWN study was designed to address this important evidence gap. 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."
The international, randomised, open-label CROWN study enrolled about 326 adults and adolescents across 85 sites in eight countries. Participants had detectable HIV-1 despite a history of daily oral ART and were evaluated for their ability to achieve viral suppression after initiating CAB + RPV LA, administered six times a year.
ViiV said use of CAB + RPV LA in people with detectable viremia remains investigational and has not been approved by regulatory authorities.
Cabenuva is currently approved in the US and other markets, while CAB + RPV LA is marketed as Vocabria + Rekambys in the EU and Japan.
Current approvals cover adults and adolescents with HIV-1 who are already virologically suppressed on a stable antiretroviral regimen, have no history of treatment failure, and have no known or suspected resistance to cabotegravir or rilpivirine.
