ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of the CUSTOMIZE trial (Cabotegravir plus Rilpivirine in the US to Optimize and Measure Implementation and Experience), which aims to identify and evaluate approaches to implementing a once-monthly, injectable treatment for HIV into clinical practice.
A team from ViiV Healthcare will work with clinical staff at diverse practice sites across the US 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 a monthly injectable treatment regimen if approved, including how to address the increased frequency of clinic visits.
Richard Elion, M.D., Director of Clinical Research at the Washington Health Institute, said:
With daily oral antiretroviral therapies, physicians see their patients once or twice per year. If approved, the injectable regimen of cabotegravir and rilpivirine would require people living with HIV to receive injections from a healthcare provider every month. Although some people living with HIV may prefer once monthly visits to their provider, this would be a paradigm shift in the treatment of HIV, and providers may encounter challenges delivering a smooth service. The CUSTOMIZE trial will help to generate data that enable medical practices to be well prepared for incorporating this novel approach into the clinic setting.
In April 2019, ViiV Healthcare submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the two-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. If approved, the regimen would be the first-ever long-acting, injectable therapy for the treatment of HIV. In June, the FDA granted the NDA Priority Review, a designation for drugs considered significant improvements in the treatment, diagnosis, or prevention of a serious disease. A Priority Review designation means the FDA’s goal is to take action on an application within six months (compared to ten months under standard review). The FDA has set a target approval date of December 29, 2019.
The CUSTOMIZE trial is currently enrolling patients in medical clinics in nine US cities that were chosen to create a representative sample of clinic types, including university hospitals, private and public clinics in rural, suburban and urban areas: Sacramento, Dallas, Kansas City, Jackson, Detroit, Washington DC, Atlanta, Jacksonville and Miami.
Participating medical facilities will receive educational items, training aids, treatment and resource planning tools, appointment reminders and patient-facing materials at the beginning of the study. The sites will determine if or how they will use these materials and may also create their own clinic-developed resources. ViiV Healthcare will facilitate surveys and interviews throughout the trial with the physicians, nurses, administrators and patients, to share best practices and help identify barriers and facilitators to the successful delivery of monthly injectable HIV treatment. Initial results are anticipated by the end of the year.
Harmony P. Garges, M.D., MPH, Head of Global Medical Affairs at ViiV Healthcare, said:
With the CUSTOMIZE study, ViiV Healthcare is aiming to identify and evaluate different approaches to implementing a monthly injectable HIV treatment in the real world, which can be different from the controlled setting of a clinical trial. Experts believe effective implementation of HIV treatment could have the greatest contribution towards ending the HIV epidemic and we believe this study is an important step towards that goal.