Cabotegravir + Rilpivirine Shows Superior Viral Suppression at Six Months in People With Detectable HIV-1
GSK announced that ViiV Healthcare, its majority-owned global specialist HIV company, with Shionogi as a shareholder, reported positive topline results from the Phase 3b CROWN study.
The 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 at study entry.
Key Highlights
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CROWN Phase 3b met its primary endpoint.
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CAB + RPV LA achieved superior viral suppression at six months compared with standard oral ART.
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The study included people with HIV-1 who had detectable virus when entering the study.
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Approximately 326 participants were enrolled across 8 countries and 85 study sites.
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CROWN builds on findings from the LATITUDE study.
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The regimen was administered six times per year in the CROWN study.
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Use of CAB + RPV LA in people with detectable viremia remains investigational and is not currently approved by regulatory authorities.
What the CROWN Study Evaluated
CROWN is an international, randomized, open-label Phase 3b study evaluating whether people living with HIV-1 who have detectable virus despite a history of daily oral ART can directly initiate CAB + RPV LA and achieve viral suppression.
The study enrolled approximately:
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326 participants
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Adults and adolescents
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8 countries
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85 study sites
Participants received the long-acting regimen six times per year.
Primary Objective
The study was designed to assess whether direct initiation of CAB + RPV LA could achieve effective viral suppression in people who entered the study with detectable HIV-1.
Building on the LATITUDE Study
The CROWN findings build on the LATITUDE study, which showed that CAB + RPV LA was superior to daily oral therapy in maintaining viral suppression among people with HIV who had:
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Previously achieved viral suppression on oral ART
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A history of challenges with treatment adherence
CROWN addresses a different evidence gap by evaluating direct initiation of CAB + RPV LA in people who still had detectable virus at study entry.
Participants had no evidence of resistance to:
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INSTIs — integrase inhibitors
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NNRTIs — non-nucleoside reverse transcriptase inhibitors
Important Regulatory Note
CAB + RPV LA is currently approved in the U.S. and other markets as Cabenuva and in the EU and Japan as Vocabria + Rekambys for specific populations who are already virologically suppressed on a stable antiretroviral regimen.
However, use of CAB + RPV LA in people with detectable viremia is investigational and has not been approved by regulatory authorities.
Full CROWN study results are planned for presentation at an upcoming scientific meeting.
How Cabotegravir + Rilpivirine Works
The complete long-acting regimen combines two antiretroviral medicines:
Cabotegravir
Cabotegravir is an integrase strand transfer inhibitor (INSTI) developed by ViiV Healthcare.
INSTIs work by preventing HIV viral DNA from integrating into the genetic material of human immune cells, a critical step in the HIV replication cycle.
Rilpivirine
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Johnson & Johnson.
It works by interfering with the viral reverse transcriptase enzyme, helping prevent HIV from multiplying.
Current Cabenuva Indication
Cabenuva is approved as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older who weigh at least 35 kg, when replacing their current antiretroviral regimen in individuals who:
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Are virologically suppressed (HIV-1 RNA <50 copies/mL)
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Are on a stable antiretroviral regimen
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Have no history of treatment failure
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Have no known or suspected resistance to cabotegravir or rilpivirine
Leadership Perspective
“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.”
— Jean van Wyk, MBChB, MFPM, Chief Medical Officer, ViiV Healthcare
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in 2009, with GSK and Shionogi as current shareholders.
The company focuses on developing innovative medicines for HIV treatment and prevention, while supporting communities affected by HIV.
About GSK
GSK is a global biopharma company focused on bringing together science, technology, and talent to get ahead of disease and improve health outcomes.
