September 28, 2020: “ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the start of the CARISEL study (Cabotegravir And Rilpivirine Implementation Study in European Locations), which aims to evaluate the best approaches to implementing an investigational, every-two-month, injectable HIV treatment regimen into clinical practice in Europe.
A team from ViiV Healthcare will work with clinical staff at 18 diverse practice sites across different healthcare systems in France, Spain, Belgium, Germany, and the Netherlands during the one-year study, in which healthcare providers and patients will play an equally important role.
The goal is to find the most practical and efficient ways to implement an injectable treatment regimen administered every two months, including how to address the need for increased frequency of clinic visits to administer the regimen.
Dr. Laurent Hocqueloux, CARISEL investigator from Orléans’s Hospital in France, said: “We’re excited that people living with HIV may have the option to replace daily pills with a long-acting injectable regimen.
If approved, this change means they will need to receive injections from a healthcare provider and visit their physicians more frequently.
The CARISEL trial will help generate data to help prepare medical practices for the changes to current practices that may be needed as a result of this new regimen.
It will also guide us as we incorporate this novel approach into a variety of health systems in Europe, where differences may emerge from country to country in how clinical practices allocate personnel, prescribe the treatment, and administer it to people living with HIV.”
CARISEL will be enrolling approximately 450 people living with HIV and 54 clinical staff members to take part in the two components of the study.
Patient study participants will take part in a single-arm study where they will receive the long-acting regimen of cabotegravir and rilpivirine dosed every two months and complete surveys and interviews that capture their perspectives towards the feasibility, acceptability, and appropriateness of the regimen.
Staff study participants will participate in a two-arm study examining different implementation strategies to support potential barriers around factors including, but not limited to: medication storage, appointment scheduling, and patient support.
Both arms will have access to toolkits aimed to support education and proper treatment administration, as well as injection training.
Similar to patient study participants, staff study participants will complete surveys and interviews with investigators.
The CARISEL study is part of ViiV Healthcare’s pioneering Implementation Science programme, focusing on improving the real-world delivery of HIV treatment and care outside the structured environment of clinical trials.
Implementation science trials led by ViiV Healthcare are ongoing globally to study a variety of issues including improving access to testing, clinical care and effective treatment.
In October, ViiV Healthcare will be completing the final study visits for the CUSTOMIZE study, the eight-site US companion to CARISEL, which focused on identifying and evaluating approaches to implementing the once-monthly, injectable treatment for HIV into clinical practice.
Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “Implementation research through studies like CARISEL and CUSTOMIZE helps us take the scientific innovation we’ve achieved in clinical trials and best apply it to our real-world efforts to improve the care of people living with HIV.
CARISEL will allow us to tailor strategies and create materials to match the specific needs of different clinical settings in Europe and builds on the positive body of evidence we’ve already seen from US practices in the companion study CUSTOMIZE.
ViiV Healthcare is proud to lead the industry in HIV implementation science and we look forward to sharing these findings in the future.”
The initial results of the CARISEL study, which is studying the twice-monthly, long-acting regimen of cabotegravir and rilpivirine, are anticipated in 2021.
The once-monthly long-acting regimen of cabotegravir and rilpivirine was approved by Health Canada in March 2020 under the brand name CABENUVA and is currently under review by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulatory authorities.
The CARISEL study
CARISEL is an open-label, hybrid type phase IIIb trial evaluating implementation strategies for long‐acting cabotegravir and rilpivirine administered every two months in select European healthcare settings.
It is a single-arm, multicentre, interventional study for patient participants and a two-arm, multicentre, non-interventional study for clinical staff participants, with the goal of evaluating the effect of implementation strategies on the degree of acceptability, appropriateness and feasibility of clinic practices to deliver the every-two-months, injectable regimen of cabotegravir and rilpivirine to people living with HIV.
The study will evaluate both qualitative and quantitative measures across arm, clinic type, provider type, and country to determine the most effective implementation strategies and to identify barriers, facilitators, and solutions.
In addition to findings on its implementation, clinical data on the efficacy and safety of cabotegravir and rilpivirine will be evaluated.”