New findings from CUSTOMIZE suggest the once-monthly injection therapy was feasibly implemented and generally favored to once-daily tablets.
New findings presented at the International AIDS Society (IAS) 2021 Conference on HIV Science this weekend showed once-monthly cabotegravir plus rilpivirine (Cabenuva) injection is feasibly implemented for use across nearly 2 dozen clinic types in the US, for the treatment of HIV.
The 12-month findings of the Cabotegravir plus Rilpivirine Long Acting in the US To Optimize and Measure Implementation and Experience (CUSTOMIZE) trial showed that nearly 100% of surveyed healthcare staffs from private practices, university clinicals, and federally-qualified health centers agreed the therapy was feasible to implement.
Another three-fourths of the staffs believed optimal implementation of cabotegravier plus rilpivirine—initially approved by the US Food and Drug Administration (FDA) in January—was optimally implemented in their practice within 3 months.
Initiated in 2019, CUSTOMIZE sought to interpret the successful integration of the long-acting regimen for the treatment of HIV-1 following its authorized use in US clinical practices, across a variety of clinical settings. Along with gauging perspective of 23 care staffs at 12 months, investigators surveyed 100-plus people living with HIV who participated in the clinical trial.
All but 1 (n = 22 [96%]) of healthcare staffs agreed or completely agreed that long-acting cabotegravir plus rilpivirine was feasibly implemented; another 18 (78%) believed the regimen was optimally implemented within 1-3 months, with only “minor adjustments” to each clinic’s logistics in use.
Among recipients, 99 of 102 (97%) expressed interest in continued long-acting treatment versus switching to daily oral therapy at 12 months. Investigators observed that 100% of the 102 participants with available viral load results were able to maintain viral suppression, per <50 copies/mL, over 12 months.
Injection site reactions were reported in 78 of 109 (72%) participants who received ≥1 injection through 12 months.
What’s more, additional analysis to observe the impact of the COVID-19 pandemic on implementation of cabotegravir plus rilpivirine found consistent rates of opinion on extremely/very acceptable monthly clinic visits (95% vs 86%), positivity about long-acting HIV regimen care (100% vs 98%), and preference for long-acting regimen over daily oral tablets (95% vs 92%) among those impacted by COVID-19 versus those who were not, respectively.
COVID-19 impact was defined by CUSTOMIZE investigators as missed or rescheduled injection visits, quarantine requirement, and clinic closure.
In a statement accompanying the findings, Maggie Czarnogorski, MD, MPH, head of Innovation and Implementation Science at ViiV Healthcare, stressed the importance of understanding how a “new experience” like once-monthly injection HIV treatment impacts healthcare providers and people living with HIV.
“Over the course of a year, even with the added challenges of COVID-19, the barriers that providers and patients thought they would face turned out not to be as concerning as originally thought,” Czarnogorski said. “What’s more, the risk of failure with this therapy has always been low, and this is reflected in the data showing that all the people living with HIV who participated in the trial maintained viral suppression, and many found that monthly visits with their healthcare professional were valuable and had a positive impact on their overall HIV care.”