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ViiV HEALTHCARE'S LONG-ACTING HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) MEETS PRIMARY ENDPOINT OF SUPERIOR VIRAL SUPPRESSION VS. DAILY ORAL THERAPY IN PEOPLE WITH VIREMIA
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CROWN is the first large, phase IIIb international trial to evaluate the investigational use of long-acting Cabenuva versus daily oral therapy in people with a history of antiretroviral treatment and unsuppressed HIV
Results build on LATITUDE study and robust body of evidence supporting investigational use of long-acting cabotegravir + rilpivirine treatment in delivering viral suppression across treatment-experienced populations, including people with viremia at initiation
Data to be shared with health authorities for regulatory review
London, 6 October - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced 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 oral antiretroviral therapy (ART) in adults and adolescents living with HIV-1 who had detectable virus when they entered the study.
Findings build on the LATITUDE study, which demonstrated that CAB + RPV LA was superior to daily oral therapy in maintaining viral suppression among people with HIV who had achieved viral suppression on oral ART but had a history of adherence challenges.CROWN addresses a remaining evidence gap by evaluating direct initiation of the regimen in people who still had detectable virus at study entry and had no evidence of resistance to INSTIs (integrase inhibitors) or NNRTIs (non-nucleoside reverse transcriptase inhibitors). Use of CAB + RPV LA in people with detectable viremia is investigational and has not been approved by regulatory authorities.
CROWN is an international, randomised, open-label study designed to evaluate whether people living with HIV-1 who have detectable virus despite a history of daily oral ART can directly initiate CAB + RPV LA, administered six times a year, and achieve viral suppression. The study enrolled approximately 326 participants, including adults and adolescents, across eight countries at 85 study sites.
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