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ViiV Healthcare Announces Start of First-Ever Study to Identify and Evaluate Approaches to Implementing its Once-Monthly Injectable HIV Treatment in Clinical Practice

London, 8 July 2019 - 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.”

Implementation Science program is launching “call for proposals” to identify innovative research projects to optimize cabotegravir and rilpivirine health service delivery in the US

As part of its efforts to ensure facilities are prepared to introduce monthly injectable HIV treatment, ViiV Healthcare is also inviting research proposals for Investigator Sponsored Studies (ISSs) in the area of implementation science designed to better understand how to effectively deliver monthly injectable HIV treatment in the real-world setting. Beginning August 2019, an online submission form to submit a letter of intent will be made available through www.hivimplementationscience.com. The submission deadline for the letter of intent is November 1, 2019 and final proposals are due November 15, 2019.

About CUSTOMIZE

CUSTOMIZE is a single-arm, multicenter, one-year evaluation of the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinic practices to deliver the once-monthly, injectable regimen of cabotegravir and rilpivirine to appropriate patients living with HIV. The study will evaluate both qualitative and quantitative measures across a range of clinic types, including university hospitals as well as private and public clinics, with varied geographic and demographic representation.

A suite of educational items, training aids, treatment and resource planning tools, appointment reminders and patient-directed support items will be made available as part of this study. These items and tools will be directed toward HCPs as well as patients and will comprise the study toolkit. Staff study participants from each site (physician/PCP, nurse/medication administration personnel, administrator/clinic manager) will take part in this study, including participation in surveys and interviews. Sustainment of implementation strategies will be assessed via surveys and semi-structured interviews of staff study participants as well as patient study participants. The primary endpoint is change from baseline to the injection site visit at Month 12 in site survey responses for acceptability, appropriateness and feasibility.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

Source: GSK

Posted: July 2019

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