GSK plc (LSE/NYSE: GSK) and ViiV Healthcare, the global specialist HIV company majority-owned by GSK with Shionogi as a shareholder, have announced headline findings from the phase IIIb CROWN study confirming that long-acting Cabenuva(cabotegravir + rilpivirine [CAB + RPV LA]) achieved superior rates of viral suppression at six months compared with daily standard-of-care oral antiretroviral therapy (ART). The milestone trial evaluated adults and adolescents living with HIV-1 who had detectable viremia upon study entry despite a documented history of daily oral treatment.
CROWN is the first large-scale, international, randomized, open-label trial specifically designed to address a critical therapeutic gap: evaluating direct initiation of long-acting CAB + RPV LA, administered six times per year (every two months), in patients with active, detectable viral loads and no baseline resistance to integrase strand transfer inhibitors (INSTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs). The trial recruited approximately 326 adult and adolescent participants across 85 clinical sites in eight countries.
Dr. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, stated:
“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 results expand upon ViiV’s landmark LATITUDE trial, which showed the superiority of long-acting CAB + RPV over daily oral regimens in maintaining viral suppression among patients with adherence barriers who had already attained undetectable viral loads prior to switching. By proving efficacy in patients presenting with viremia at initiation, the CROWN data establish a precedent for long-acting injectable regimens as an active intervention for unsuppressed populations.
Cabenuva is currently approved in the United States and global markets and as Vocabria + Rekambys in the European Union and Japan exclusively for virologically suppressed individuals (HIV-1 RNA <50 copies/mL) on stable regimens with no history of treatment failure or viral resistance. The direct use of CAB + RPV LA in viremic individuals remains investigational, and full study results will be presented at an upcoming scientific conference and submitted to global regulatory agencies for label expansion review.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
