ViiV Healthcare: Cabenuva long-acting regimen meets primary endpoint vs daily oral ART in viremic patients (CROWN)
- CROWN met its primary endpoint: CAB + RPV LA achieved superior viral suppression at six months versus standard-of-care oral ART in adults and adolescents with detectable virus at entry.
- The randomised, open-label phase IIIb study enrolled ~326 participants across eight countries and 85 sites.
- CAB + RPV LA was administered six times a year in the investigational regimen; use in people with detectable viremia is investigational and not approved.
- Findings build on the LATITUDE study; full results will be shared with health authorities and presented at an upcoming scientific meeting.
Primary result
The phase IIIb CROWN study met its primary endpoint, demonstrating that at six months long-acting Cabenuva (cabotegravir + rilpivirine [CAB + RPV LA]) achieved superior rates of viral suppression compared with standard-of-care daily oral antiretroviral therapy in adults and adolescents living with HIV-1 who had detectable virus when they entered the study.
Study design and population
CROWN was an international, randomised, open-label study evaluating direct initiation of CAB + RPV LA in people with detectable viremia despite a history of daily oral ART. The study enrolled approximately 326 participants, including adults and adolescents, across eight countries at 85 study sites. The investigational regimen was administered six times a year.
Context and regulatory path
Results build on the LATITUDE study, which showed CAB + RPV LA was superior to daily oral therapy in maintaining suppression among people previously suppressed on oral ART with adherence challenges. Use of CAB + RPV LA in people with detectable viremia is investigational and has not been approved by regulatory authorities. Data will be shared with health authorities for regulatory review and full results are planned for presentation at an upcoming scientific meeting.
Source: GSK