ViiV Healthcare has unveiled positive initial findings from the Cabotegravir plus Rilpivirine in the US to optimise and measure implementation and experience (CUSTOMIZE) trial.

The clinical study is aimed at finding the best ways to implement the investigational once-monthly, long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV-1 into clinical practice.

The company’s team has worked together with physicians, nurses, clinic administrators, and patients across various medical practices, including federally qualified health centres, academic medical centres and private physician offices since the start of CUSTOMIZE study.

CUSTOMIZE trial investigator Paul Benson said: “Long-acting treatments have the potential to transform how we approach HIV management by replacing daily pills with monthly dosing and require a fresh look at how they can be implemented in our clinics.

“It’s exciting to see initial findings from CUSTOMIZE showing that a high number of healthcare providers were able to work through the challenges faced in their ‘real-world’ settings and that there is acceptance of the implementation of the once-monthly regimen of cabotegravir and rilpivirine for people living with HIV, by those that participated in the study.”

CUSTOMIZE trial showed positive overall healthcare provider and clinic administrator perspectives

CUSTOMIZE is a single-arm, multicentre study designed to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinic practices to deliver the injectable regimen of cabotegravir and rilpivirine to HIV patients.

Cabotegravir plus rilpivirine is an investigational regimen indicated for the treatment of HIV-1 infection in patients who are virologically stable and suppressed.

The study involved a suite of educational items, training aids, treatment and resource planning tools, appointment reminders and patient-directed support items.

Sustainment of implementation strategies was assessed through surveys and semi-structured interviews of staff study participants, along with patient study participants.

The primary endpoint changed from baseline to the injection site visit at Month 12 in site survey responses for acceptability, appropriateness and feasibility.

The study demonstrated positive overall healthcare provider and clinic administrator perspectives, with a large proportion indicating the acceptability, appropriateness, and feasibility of implementing the long-acting regimen at the beginning of the study and after four months of implementation.

The cabotegravir plus rilpivirine regimen was approved in Canada in March 2020 and is currently being reviewed by the European Medicines Agency (EMA) and other global regulatory authorities.

ViiV Healthcare chief medical officer Harmony P Garges said: “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.”