A Long-Acting Injectable for HIV Therapy Shows Efficacy Over Daily Oral Regimen

ViiV Healthcare has recently unveiled interim analysis results from the Long-Acting Therapy to Improve Treatment Success in Daily Life (LATITUDE) phase 3 trial across 31 US states. This study assesses the efficacy of Cabenuva (cabotegravir + rilpivirine), a long-acting injectable antiretroviral treatment (ART) for HIV, highlighting its efficacy in maintaining viral load suppression compared to the traditional daily oral therapy, particularly in individuals facing challenges with ART adherence.

The planned interim review conducted by the Data Safety Monitoring Board (DSMB) considered the totality of the study endpoints and concluded that long-acting ART demonstrates superior efficacy over the daily oral standard of care. Following this interim analysis, the DSMB recommended that all eligible participants be offered the long-acting injectable option of cabotegravir + rilpivirine.

Head of R&D at ViiV Healthcare, Kimberly Smith MD, MPH, emphasized the significance of these findings.

“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

The study targeted participants with a history of challenges in adhering to daily oral ART and evidence of viremia. These individuals were initially provided comprehensive adherence support while on a guideline-recommended, three-drug regimen of oral ART to achieve viral suppression. They were then randomized to either continue with their daily oral ART or switch to the long-acting injectable ART (cabotegravir + rilpivirine) every 4 weeks.

“Roughly two-thirds preferred the long-acting regimen because they didn't have to carry their HIV medications with them like they would if they had a daily oral pill,” said ViiV Healthcare CMO Harmony P. Garges, MD, MPH, said of feedback from patients.²

At the International AIDS Society (IAS) Conference 2023, ViiV Healthcare presented the 12-month patient preference data from the phase 3 SOLAR study. According to investigators, the data showed that 90% of participants who switched to Cabenuva preferred the long-acting regimen to the daily oral pill, Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy). Garges also pointed out that Cabenuva was found to be inferior to Biktarvy.

“There were also emotional and psychological benefits—83% and 61% of participants respectively who switched said they preferred the long-acting treatment as it was more convenient for them or because it stopped them from thinking about their HIV status every day. More than half (59%) cited not having to worry that others may see their pills as a reason they preferred the injections.”²

However, the study's limitations include the full impact of long-acting ART on diverse populations, potential long-term side effects, and the logistical challenges of broader implementation, which require further investigation. As the study continues, further insights will likely provide a deeper understanding of the long-term benefits and practical considerations of implementing long-acting injectable ART in diverse patient populations.

References

1. LATITUDE Phase III Interim Trial Data Indicates ViiV Healthcare’s Long-Acting Injectable HIV Treatment Cabenuva has Superior Efficacy Compared to Daily Therapy in Individuals Living with HIV with Adherence Challenges. New Release. ViiVHC Globalcomms. Published February 21, 2024. Accessed February 21, 2024. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/february/latitude-phase-three-interim-trial-data/
2. Parkinson, J. Long-Acting HIV Injectable Preferable to Daily Oral Regimen. ContagionLive. Published July 24, 2023. Accessed February 21, 2024. https://www.contagionlive.com/view/long-acting-hiv-injectable-preferable-to-daily-oral-regimen