The University of North Carolina School of Medicine is one of four lead sites in a new, landmark clinical trial now underway to study the effectiveness of three hepatitis C medications.
A $14.9 million research contract from the Patient-Centered Outcomes Research Institute, or PCORI, is funding the trial, the PRIORITIZE Study, at 46 centers nationwide. Lead sites for the study are University of Florida Health, the University of Michigan, Johns Hopkins University and UNC.
The study’s principal investigator is David R. Nelson, MD, director of the University of Florida Clinical and Translational Science Institute. Michael W. Fried, MD, director of the UNC Liver Center, is a co-principal investigator.
Approximately $3 million from the PCORI grant will fund UNC’s role in the study.
Fried directs the data coordinating center for the study, which will collect and analyze safety and effectiveness data from all 46 sites. Approximately $3 million from the PCORI grant will fund UNC’s role in the study, Fried said. Other UNC personnel will play key roles in the study including Monika Vainorius, MD, associate director of the data coordinating center; Paul Stewart, PhD, from the Department of Biostatistics in the UNC Gillings School of Global Public Health; and Donna M. Evon, PhD and Jama M. Darling, MD, of the Division of Gastroenterology and Hepatology.
The initial patient has been enrolled and is one of 3,750 people who will be randomly assigned one of the medications as part of the five-year trial.
In addition to comparing the effectiveness of the three oral medications, researchers will learn more about how the treatments perform when used by a diverse group of patients that includes minorities and people with other medical conditions. PCORI decided to fund research about the efficacy of hepatitis C medications because they were only tested previously in carefully selected patient populations and never against each other. That leaves physicians and patients with no comparative evidence about the drugs’ effectiveness.
Pragmatic clinical studies test a treatment’s effectiveness in “real-life” situations, such as typical academic and community-based outpatient clinics, and also can include a wider range of study participants, making their findings more generally applicable.
“Most clinical trials are done in a very selective group of otherwise healthy individuals. We know the real world is quite different. It involves a diverse group of patients — people who may be older, have a lot more health disparities and get their health care delivered in many different ways,” said Fried.
The study is comparing AbbVie’s Viekira Pak, Gilead Sciences’ Harvoni and Merck & Co.’s Zepatier, which was approved earlier this year by federal regulators.
The study is comparing AbbVie’s Viekira Pak, Gilead Sciences’ Harvoni and Merck & Co.’s Zepatier, which was approved earlier this year by federal regulators. AbbVie and Merck are providing free medications and support worth hundreds of millions of dollars for the trial. Such a large, ambitious and expensive clinical trial couldn’t happen without a unique partnership involving the nonprofit PCORI, the pharmaceutical industry, patient stakeholders, and academia, Nelson said.
One of Fried’s patients, Summer Wadsworth-Delciotto of Pittsboro, N.C., co-chairs a group of HCV patient consultants working on the research team. She said that participating in previous clinical trials of hepatitis C treatments was a life-changing experience for her. Not only was she cured, the clinical trials were a way to help others.
“We now have highly effective, relatively painless treatment options for hepatitis C. As patients, we have the opportunity to share our treatment experiences with other patients as well as the medical community. [For others], participating in this new study is a way to lend a voice to the direction of medical treatment,” said Wadsworth-Delciotto.