ViiV Healthcare, the HIV company majority owned by GSK, with Shionogi as a shareholder, reported that the Phase IIIb CROWN study of long-acting cabotegravir + rilpivirine (CAB + RPV LA; Cabenuva) met its primary endpoint, acheiving superior viral suppression at six months versus standard-of-care oral antiretroviral therapy (ART) in adults and adolescents with HIV-1 who had detectable virus at study entry.
The result extends the evidence base for CAB + RPV LA into a population not covered by its current approvals, which are limited to virologically suppressed adults and adolescents with no history of treatment failure and no known resistance to either component. CROWN is an international, randomized, open-label study that enrolled approximately 326 adults and adolescents across eight countries and 85 sites; participants had detectable virus at entry and no evidence of resistance to integrase strand transfer inhibitors (INSTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs), and the regimen was administered six times a year. The announcement provides no numerical efficacy data and no safety findings.
Cabotegravir inhibits HIV-1 replication by blocking viral DNA integration into host T-cell DNA, while rilpivirine interferes with reverse transcriptase; together they target two distinct steps in the HIV replication cycle. Rilpivirine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and the combination was co-developed through a collaboration between the two companies.
The CROWN findings build on the Phase III LATITUDE study, which showed CAB + RPV LA was superior to daily oral therapy in people with adherence challenges who first achieved viral suppression on oral treatment. Final 48-week data reported in February 2026 showed switching to the long-acting regimen reduced the risk of virological failure by nearly half. CROWN goes a step further by evaluating initiation of CAB + RPV LA in people who remain viremic at baseline.