PCORI Awards $29.5 Million for HCV; $14 Million for PWID Research

Issue: January 2016

The Patient-Centered Outcomes Research Institute board of governors announced it has approved two grants worth $29.5 million to fund two patient-centered, comparative clinical effectiveness research studies focusing on hepatitis C virus infection as well as an additional grant for research on people who inject drugs and have HCV.

The grants were awarded after the institute received input from the health care community stating that HCV is in fact a top health concern, according to the release. The clinical effectiveness research studies will compare the “trade-offs between different regimens of new oral antiviral medications and different ways to enhance HCV treatment adherence among injection drug users,” according to the release.

“We heard from many people — including individuals with hepatitis C as well as clinicians who treat them, the pharmaceutical industry, payers and others — that with the great promise offered by new antiviral medications, there are also many questions about hepatitis C therapies and care delivery that need to be answered,” Joe Selby, MD, MPH, executive director of PCORI, said in the release. “As the availability and use of the new antiviral medications increases, we’re pleased to support patient-centered [clinical effectiveness research] that will help clinical decision makers to make better informed choices about hepatitis C treatment and care.”

The board also approved 24 awards totaling approximately $54 million, in which various clinical effectiveness research studies will focus on rare conditions and comparing treatments for urea cycle disorders, noncystic fibrosis bronchiectasis and syringomyelia, among others, according to the release.

Treating PWID with HCV

The PCORI also announced it has awarded a grant worth $14 million to Montefiore Health System and Albert Einstein College of Medicine, New York, to fund research focusing on how to best treat injection drug users who have hepatitis C virus infection.

The research will be led by Alain Litwin, MD, attending physician, internal medicine, Montefiore Health System and professor of medicine, Albert Einstein College of Medicine, and will include investigating which treatment model works best for treating patients with HCV who also inject drugs (PWID) and also determine why some patients develop resistance to certain therapies for the treatment of HCV, according to a press release.

“This study has major implications for controlling hepatitis C infection and re-infection rates,” Litwin said in the release. “Unfortunately, people who inject drugs rarely get effective, safe treatments because there is a concern that they won’t take their medication or that they might become re-infected. Determining the best model of care will help us avert grave consequences of chronic infection for many people and reduce the spread of the virus in the communities we serve and beyond.”

The study, titled “Patient-Centered Models of HCV Care for People Who Inject Drugs,” will include 1,000 PWID who have HCV and will be used in comparing two models of care: directly observed treatment, where patients take medication in front of a staff member, and the Patient Navigator model, where patients take their medications home and receive support and education from public health workers, according to the release.

The release further states that the research will be conducted in conjunction with Johns Hopkins Bloomberg School of Public Health, Warren Alpert Medical School of Brown University, Harvard Medical School, University of Cincinnati College of Medicine, University of Washington School of Medicine, University of California, San Francisco, University of New Mexico Health Sciences Center and The New York City Department of Health and Mental Hygiene, among others.

Approximately 146,500 people living in New York City and 2.7 million Americans have chronic HCV, with an estimated half unaware that they are infected, according to the release.

Disclosures: HCV Next was unable to determine relevant financial disclosures for Litwin at the time of publication. Selby reports being employed by PCORI.