ViiV Healthcare’s Cabenuva achieved superior viral suppression versus daily oral ART at six months in the Phase IIIb CROWN study of people with HIV-1 viremia.
Written By: Kirti Kumbhar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
ViiV Healthcare has announced that its Phase IIIb CROWN study met its primary endpoint, showing that long-acting Cabenuva (cabotegravir plus rilpivirine; CAB + RPV LA) achieved superior viral suppression compared with standard-of-care daily oral antiretroviral therapy (ART) at six months in adults and adolescents living with HIV-1 who had detectable virus at study entry.
The international randomized study evaluated direct initiation of CAB + RPV LA in people with a history of oral ART who remained viremic at study entry. The findings address an evidence gap for a population in which direct initiation of the long-acting regimen remains investigational.
CROWN Evaluates Long-Acting Therapy in People with Viremia
CROWN (NCT06694805) is an international, randomized, open-label Phase IIIb study evaluating whether people with HIV-1 and detectable virus after a history of daily oral ART can directly initiate CAB + RPV LA and achieve viral suppression.
The study enrolled approximately 326 adults and adolescents across eight countries and 85 study sites. Participants had detectable HIV-1 at study entry and no evidence of resistance to integrase strand transfer inhibitors (INSTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Viral suppression at six months was the primary endpoint. ViiV Healthcare reported that CAB + RPV LA achieved superior viral suppression compared with standard-of-care oral ART.
However, the company has not yet disclosed the numerical suppression rates, treatment-effect estimates, or statistical values for the primary endpoint. Full results are expected to be presented at an upcoming scientific meeting.
CROWN Builds on Evidence From LATITUDE
The findings add to evidence from the Phase III LATITUDE study (NCT03635788), but the two trials evaluated different treatment-experienced populations.
LATITUDE evaluated people who had achieved viral suppression with oral ART but had a history of adherence challenges. CROWN, in contrast, evaluated people who entered the study with detectable virus and were assessed for direct initiation of CAB + RPV LA.
This distinction is important because the clinical setting in CROWN differs from that of patients who are already virologically suppressed. The study therefore extends investigation of long-acting CAB + RPV LA into a population with ongoing viremia.
Cabotegravir and Rilpivirine Target Different Steps in HIV Replication
Cabenuva combines two antiretroviral agents with complementary mechanisms of action.
Cabotegravir is an integrase strand transfer inhibitor that prevents HIV viral DNA from integrating into the genetic material of host immune cells, a critical step in the viral replication cycle.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that inhibits the viral reverse transcriptase enzyme and interferes with HIV replication.
Use in People with Viremia Remains Investigational
The CROWN findings do not represent an approved expansion of the current Cabenuva indication.
In the United States, Cabenuva is indicated as a complete regimen for adults and adolescents aged 12 years and older weighing at least 35 kg who are virologically suppressed, defined as HIV-1 RNA below 50 copies/mL, on a stable antiretroviral regimen. The approved population also requires no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine.
In the European Union and Japan, the corresponding long-acting regimen is marketed as Vocabria plus Rekambys.
Importantly, direct initiation of CAB + RPV LA in people with detectable viremia, as evaluated in CROWN, remains investigational and has not been approved by regulatory authorities. ViiV Healthcare said the CROWN findings will be shared with health authorities for regulatory review.
Full CROWN Dataset Is Still Awaited
The topline result establishes that CROWN met its primary endpoint and demonstrated superiority at six months, but the currently available announcement does not provide the magnitude of the treatment effect or the complete safety dataset.
Detailed results on viral suppression rates, statistical analyses, adverse events, treatment discontinuations and other clinical outcomes will be needed to assess the full clinical significance of the findings.
For now, the CROWN announcement provides evidence that long-acting CAB + RPV LA can achieve superior six-month viral suppression compared with daily oral ART in the studied population. However, its use in people with detectable viremia remains investigational pending detailed results and regulatory review.
ViiV Healthcare said the full CROWN findings will be presented at an upcoming scientific meeting.
Reference
ViiV Healthcare. 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. 6 October 2026
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 (CROWN), ClinicalTrials.gov ID NCT06694805
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.