CUSTOMIZE was designed to identify methods of implementing an experimental once-monthly, long-acting regimen antiretroviral therapy against HIV-1 into clinical practice.
On July 4, 2020, initial findings from the CUSTOMIZE (Cabotegravir plus Rilpivirine in the US To Optimize and Measure Implementation and Experience) trial were presented at the Virtual 23rd International AIDS Conference (AIDS 2020).
CUSTOMIZE was designed to identify methods of implementing an experimental once-monthly, long-acting regimen antiretroviral therapy (ART) against HIV-1 into clinical practice.
The treatment combination is made up of ViiV Healthcare’s cabotegravir along with rilpivirine from Janssen Pharmaceutical Companies of Johnson & Johnson. A monthly injectable treatment regimen offers alternatives to taking a daily oral dose of ART, which can feel alienating for people living with HIV.
Investigators worked with physicians, nurses, clinic administrators, patients, and other stakeholders across a range of medical practices. Health care systems involved in the trial aimed to find the most practical ways to implement monthly injectable treatment regimen into their HIV care.
If approved in the future, long acting injectables could “create a paradigm shift in HIV treatment, including increasing the frequency of clinic visits from once or twice per year to every month,” according to a ViiV statement.
After 4 months of study, the majority of clinical staff continued to perceive the implementation of monthly injectable regimens as acceptable, feasible, and appropriate for people living with HIV. Importantly, there was also a substantial decrease in the perceived weight of factors staff previously thought would be barriers to implementation of an injectable regimen.
Halthcare providers and clinic administrators from 8 participating sites were surveyed on the acceptability, appropriateness, and feasibility, as well as perceived facilitators and barriers, and responses were positive overall. A majority proportion (>84%) indicating they “agreed” or “completely agreed” with the acceptability, appropriateness, and feasibility of implementing the long-acting regimen both at the start of the study and after 4 months of practical implementation.
At the study start and by month 4, acceptability (91.4% and 91.6%), appropriateness (99.1% and 94.8%), and feasibility (90.4% and 84.4%) were consistent and remained high.
The top 3 barriers perceived by clinic staff were the patient’s ability to keep monthly appointments (80.8%), patient access to transportation to and from monthly appointments (76.9%), and the timely ability of clinic staff to make patients aware of missed injection visits (73.1%). These categories of perceived barriers saw a decrease among clinic staff to 37.5%, 37.5%, and 45.8%, respectively after 4 months of study.
According to the 24 healthcare providers and clinic administrators surveyed, patients may be a good fit for the regimen if they are “tired of taking pills” (88.5%), “have concerns about disclosure of their HIV status” (80.8%) and “experience stress or anxiety over daily adherence with their oral medications” (80.8%).
“Challenges can emerge when an investigational treatment moves from the controlled setting of a clinical trial to the real-world setting. The difficulty that patients sometimes face getting access to transportation and keeping monthly appointments were front of mind for the healthcare providers who were part of CUSTOMIZE, but they ultimately found these perceived barriers weren’t as significant as they thought. Exploring innovative solutions to these real-world challenges is precisely why ViiV Healthcare is a leader in the field of implementation science, which aims to identify what works best in healthcare settings, why it works, and how these findings can be applied to improve the lives of people living with HIV,” explained Harmony P. Garges, MD, MPH, Chief Medical Officer at ViiV Healthcare.
ViiV, a sponsor of AIDS2020, was founded as a joint venture by pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) in 2009; both companies consolidated their HIV assets in the new company.
The CUSTOMIZE trial is ongoing. Another study will examine implementation of the long-acting regimen of cabotegravir and rilpivirine among European clinics later in 2020.
Segment Description: Ian Frank, MD, Professor of Medicine at the Perelman School of Medicine, University of Pennsylvania, discusses upcoming treatments for people with HIV.
Jason Tokumoto, MD, infectious disease clinician at the University of California San Francisco Medical Center, discusses the evolution of HIV treatment.