ViiV Announces Promising Efficacy Data for Long-Acting Cabenuva in HIV Patients With Adherence Challenges to Daily ART

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Interim findings from the LATITUDE Phase III trial show long-acting Cabenuva (cabotegravir + rilpivirine) produced superior efficacy in maintaining viral load suppression in patients with HIV compared with daily oral antiretroviral treatment (ART) in patients with adherence challenges to an ART regimen.¹ The long-acting injectable ART combines the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), to lower HIV concentrations in the blood.²

“The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” Kimberly Smith, MD, MPH, head of R&D at ViiV Healthcare, in a press release. “There are many reasons why people may find it challenging to stay on daily oral treatment and the LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed, which benefits their overall health. Optimizing therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”¹

Cabenuva has been approved as a complete HIV-1 treatment regimen in adults. The medication replaces the current ART regimen of patients who have achieved virological suppression (HIV-1 RNA <50 c/ml) with a stable ART regimen, and who have no history of treatment failure with no known or suspected resistance to either cabotegravir or rilpivirine.

In clinical studies, cabotegravir has been found to affect the HIV replication cycle by inhibiting HIV integrase via attaching to the integrase active site and blocking the strand transfer step of retroviral DNA integration. Rilpivirine, a diarylpyrimidine NNRTI of HIV-1, has been found to inhibit viral replication via non-competitive inhibition of HIV-1 reverse transcriptase.²

The ongoing LATITUDE trial is part of the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) trials network funded by the National Institutes of Health. ACTG research efforts are exploring how to improve management of HIV and its associated comorbidities while developing a cure for the virus, as well as investigating treatments for tuberculosis, hepatitis B virus, and other emerging infectious diseases.

LATITUDE investigators enrolled patients with HIV who experienced challenges maintaining adherence to daily oral ART as prescribed and who were screened for evidence of viremia to ensure HIV in their blood had not developed resistance to the study drugs.

Patients enrolled in the trial received a three-drug oral ART regimen that included dolutegravir and bictegravir-based regimens to achieve viral suppression, while also receiving comprehensive and incentivized adherence support. Patients were randomly assigned to either take long-acting injectable ART every four weeks or to continue on their daily oral ART regimen.

A planned interim review by a Data and Safety Monitoring Board (DSMB) evaluated the totality of the study’s endpoints, concluding that the data showed the superior efficacy of long-acting ART compared with daily oral administration of the current standard of care. As such, the DSMB recommended all eligible participants be offered long-acting injectable Cabenuva.

In the press release, ViiV Healthcare stated that the full data set will be presented at an upcoming scientific conference.

References

1. LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges. ViiV Healthcare. News release. February 21, 2024. Accessed February 21, 2024.

2. CABENUVA [product information]. Research Triangle Park, NC: ViiV healthcare; February 2022. Accessed February 21, 2024.