THE PRIORITIZE STUDY evolved out of HCV-TARGET to address unanswered questions regarding the chronic infection known as HCV. HCV is a devastating disease that impacts millions of Americans and contributes to impaired quality of life, morbidity, and premature death. As we enter a new era of well‐tolerated therapies with high cure rates, we have a unique opportunity to begin to eradicate this chronic infection. However, since all‐oral therapies were introduced into practice; significant gaps in current evidence, high cost of treatment and exclusive insurance contracts have limited provider and patient treatment choices and access to these medications. To narrow the evidence gaps, this randomized, pragmatic clinical trial will compare the effectiveness of currently approved all‐oral therapies to better understand the real‐world efficacy and outcomes that matter most to patients and stakeholders.
In 2011, members of the PRIORITIZE research team established a large, real world, observational treatment registry called HCV-TARGET to follow patients prescribed HCV therapy at multiple centers in the U.S., Canada, and Europe. Although HCV-TARGET continues to produce high-quality observational cohort data to rapidly inform clinical guidelines and enhance treatment safety and efficacy, the study researchers believe that a well-designed randomized controlled trial is critical to impact practice and policy at the level needed to improve patient-centered outcomes for all HCV patient populations. The data generated in the PRIORITIZE study will be instrumental for patients, physicians, payers and policy makers to make sound and rational treatment decisions. Comparative data from this study can inform clinical, policy and insurance guidelines so that cost is not used as the sole criterion to evaluate the interventions. Most importantly, the data can help patients and physicians make more informed treatment decisions.
The PRIORITIZE study is led by co-PIs at three universities: David R. Nelson, M.D., at the University of Florida (UF- Clinical Coordinating Center); Michael W. Fried, M.D. & Donna Evon, Ph.D. at the University of North Carolina (UNC- Data Coordinating Center); and Mark Sulkowski, M.D., at Johns Hopkins University. Additional experts at each of the three universities as well as the University of Michigan (Dr. Anna Lok will lead analyses on liver fibrosis progression modeling) will contribute to the project. In addition, the PRIORITIZE study will utilize the operational infrastructure of the existing HCV-TARGET Research Network. UF serves as the Clinical Coordinating Center (CCC) and UNC serves as the Data Coordinating Center (DCC) for HCV-TARGET; they will perform the same roles for PRIORITIZE.
PRIORITIZE will be implemented using the fully functional HCV-TARGET infrastructure and up to 45 committed clinical HCV-TARGET sites. HCV-TARGET developed standardized, centralized chart data abstraction methods along with detailed data monitoring to increase the efficiency and quality of an observational registry while also minimizing costs typically associated with performing post-marketing clinical research. The HCV-TARGET sites participating in PRIORITIZE were selected for their historical enrollment patterns, contributions to the network and based on the HCV drug prescription market analysis that was used to identify centers with high approval percentage for HARVONI® prescription.
The Veterans Affairs Health System is the single largest HCV care provider in the US, with a prevalence rate of 5.4 percent (three times that of the general US population) and over 170,000 Veterans in VA care with confirmed chronic HCV. For the PRIORITIZE study, Dr. Tim Morgan will lead a VA consortium of up to 10 VA centers enrolling a total of up to 500 patients.