ViiV Healthcare Launches Injectable HIV Treatment Study

October 01, 2020 - ViiV Healthcare recently announced the start of a study that will evaluate the best approaches to implementing an investigational HIV treatment that needs to be injected into patients twice a month. 

The study, called the Cabotegravir and Rilpivirine Implementation Study (CARISEL), will recruit clinical staff at 18 diverse practice sites across different healthcare systems in France, Spain, Belgium, Germany, and the Netherlands.

Nearly 450 individuals living with HIV and 54 clinical staff members will take part in two parts of the one-year study.

The goal will be to find the most practical and efficient ways to implement an injectable treatment regimen administered every two months, including how to boost the frequency of clinic visits to administer the treatment.

“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,” Laurent Hocqueloux, MD, CARISEL investigator from Orelean’s Hospital in France, said in the announcement. 

“The CARISEL trial will 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.”

Patient study participants will receive the long-acting regimen of cabotegravir and rilpivirine every two months and complete surveys regarding their perspectives towards the different aspects of the regimen.

Staff participants will also take part in a study examining different implementation strategies to uncover potential barriers around medication storage, appointment scheduling, and patient support, according to the announcement. 

Additionally, participants will have access to tools to support education, proper treatment administration, and injection training. 

The CARISEL study is part of ViiV Healthcare’s Implementation Science program, which focuses on improving the delivery of HIV treatment and care outside clinical trials. 

Currently, clinical trials run under the program are working to improve access to testing, clinical care, and effective treatment, globally. 

“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,” said Harmony P. Garges, MD, MPH, chief medical officer at ViiV Healthcare. 

“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.” 

Results for the CARISEL trial are expected in 2021. 

Back in 2012, Gilead earned FDA approval for a daily oral medication for HIV prevention called Pre-Exposure Prophylaxis (PrEP), making the California-based pharmaceutical company a leader in the HIV drugs market.

Studies have shown that PrEP, with a brand name Truvada, reduces the risk of getting HIV from sex by about 99 percent when taken daily and 74 percent among people who inject drugs. 

But at the end of May, a global HIV prevention study found that the cabotegravir was 69 percent more effective than among key patient populations compared to the current standard of care, including Truvada.

The study consisted of nearly 4,600 men who have sex with men (MSM) and transgender women who have sex with men. Each participant received a maximum of three years of blinded study medication. 

Researchers found that cabotegravir was significantly more effective in preventing HIV acquisition in the study group when compared to the current standard of care, 200 milligrams of emtricitabine/tenofovir disoproxil fumarate and 300 milligrams of (FTC/TDF) tablets. 

Among 50 individuals who contracted HIV, 12 were randomized to the cabotegravir arm and 38 were randomized to the FTC/TDF arm. This meant that HIV incident rate was 0.38 percent in the cabotegravir group and 1.21 percent in the FTC/TDF group.