GSK's Long-Acting HIV-1 Therapy Cabenuva Demonstrates Superior Efficacy Over Daily Oral ART in Phase III LATITUDE Trial

February 21,GSKUnder its umbrellaViiV HealthcareAnnounce a codenamed LATITThe interim analysis results of UDE's Phase III trial showed that, in antiretroviral therapy (ART) Poor compliance in HIV-infected individuals, with daily oralARTIn comparison, its long-acting injectable ART therapyCabenuva（Cabotegravir+Rilpivirine) demonstrated superior efficacy in maintaining viral load suppression.

The study screened subjects who were intolerant to daily oral ART and subjects with evidence of viremia according to regulations, to ensure that the HIV in their blood was not resistant to the study drug and that they met other health and safety standards. Once enrolled, the subjects would receive a triple oral ART regimen recommended by the guidelines (includingDolutegravirAndBictegravir-based regimen) to achieve viral suppression. Afterward, they were randomly assignedEvery four weeks to receive the long-acting injection Cabenuva or continue daily oral ART treatment.

Last week, the DSMB conducted a planned interim review. After considering all study endpoints, they concluded that there is evidence indicating the superiority of the long-acting antiretroviral therapy Cabenuva over standard daily oral ART. The DSMB recommended offering the long-acting injection to all eligible participants.Cabenuva。

Cabenuva(Cabotegravir + Rilpivirine)It's GSKA long-acting injectable developed, whereinCabotegravir, an HIV-1 integrase inhibitor developed by GSK, and Rilpivirine...Johnson & JohnsonAn HIV-1 reverse transcriptase inhibitor developed by ViiV Healthcare. In February 2021, Cabenuva was approved by the FDA for the treatment of HIV-1 infection.Administered once every month or every two months, as an alternative therapy to the existing ARV regimen, for patients in a stable phase of virological suppression (HIV-1 RNA <50 copies/mL), with no history of treatment failure, and toCabotegravirPatients with type 1 HIV infection who have no known or suspected resistance to either drug.

However, patients must first take cabotegravir tablets and rilpivirine tablets for one month (oral lead-in period) before receiving Cabenuva treatment. In March 2022, the FDA updated the Cabenuva prescribing information, allowing patients to receive Cabenuva treatment without the oral lead-in period.

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