Cabenuva achieves superior viral suppression versus daily oral therapy in Phase IIIb CROWN study

ViiV Healthcare has reported positive Phase IIIb results showing that long acting Cabenuva, a combination of cabotegravir and rilpivirine, achieved superior rates of viral suppression compared with daily oral antiretroviral therapy in people living with HIV who had detectable virus when entering the study.

The CROWN trial is the first large international Phase IIIb study to assess direct initiation of long acting cabotegravir plus rilpivirine in treatment experienced adults and adolescents with unsuppressed HIV.

At six months, the study met its primary endpoint, with Cabenuva producing higher rates of viral suppression than standard oral antiretroviral therapy.

The findings build on previous results from the LATITUDE study.

LATITUDE showed that long acting cabotegravir and rilpivirine was superior to daily oral therapy in maintaining viral suppression among people with HIV who had first achieved suppression on oral treatment but had a history of adherence difficulties.

CROWN was designed to address a different clinical question by assessing whether people who still had detectable HIV at study entry could begin the long acting regimen directly.

Participants were required to have no evidence of resistance to integrase inhibitors or non nucleoside reverse transcriptase inhibitors.

The international, randomised, open label study enrolled approximately 326 adults and adolescents across 85 sites in eight countries.

Participants had previously received daily oral antiretroviral therapy but continued to have detectable virus.

Cabotegravir plus rilpivirine was administered as a long acting regimen six times a year.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said people who struggle to achieve or maintain viral suppression with daily oral treatment can face significant barriers to optimising their care.

She said the CROWN results add to the growing evidence supporting long acting cabotegravir and rilpivirine and provide further insight into its potential use in treatment experienced populations.

Cabenuva is already approved in the U.S. and other markets for adults and adolescents with HIV 1 who are virologically suppressed on a stable antiretroviral regimen and have no history of treatment failure or known or suspected resistance to cabotegravir or rilpivirine.

In the European Union and Japan, the regimen is marketed as Vocabria plus Rekambys.

Use of long acting cabotegravir and rilpivirine in people who have detectable viremia at treatment initiation remains investigational and has not yet been approved by regulatory authorities.

ViiV Healthcare plans to share the CROWN findings with health authorities as part of future regulatory discussions.

Full results from the study are also expected to be presented at an upcoming scientific meeting.

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Related Topics and Keywords

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