PCORI Awards $14 Million Grant for Study of Hepatitis C Among Drug Users

The Patient-Centered Outcomes Research Institute (PCORI) has awarded a $14 million grant to a research team at Montefiore Health System and Albert Einstein College of Medicine to determine how best to treat hepatitis C virus (HCV) among people who have used injectable drugs. Though HCV can be contracted in other ways, those who inject drugs have a high rate of infection and some unique concerns in seeking treatment.

A follow up portion of the study will also examine why some patients develop resistance to HCV therapies, a growing concern even as newer, more effective HCV treatments contribute to what is essentially a cure for the disease.

Injectable drug users face a host of challenges when it comes to seeking and receiving treatment for HCV. Among those are a lack of knowledge that they have HCV, general denial, and a concern that even with treatment, they may become re-infected with the disease. “This study has major implications for controlling hepatitis C infection and reinfection rates,” said lead researcher Alain Litwin, MD, attending physician, internal medicine, Montefiore Health System and professor of medicine, Albert Einstein College of Medicine, in a release about the grant.

The national, multi-site study, titled Patient-Centered Models of HCV Care for People Who Inject Drugs, will involve 1,000 drug users infected with HCV. Investigators will compare two distinct models of care that have proven effective: directly observed treatment (DOT), in which patients take medication in front of a staff member, and the Patient Navigator (PN) model, in which patients take their medications home and receive support and education from public health workers. The research team will evaluate which model produces the best results and is preferred by patients.

Many organizations will work on the research, including universities (John 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, among others); the Centers for Disease Control and Prevention, The New York City Department of Health and Mental Hygiene; the National AIDS Treatment Advocacy Group; Quest Diagnostics, and Gilead Sciences, the makers of Sovaldi and Harvoni, two of the medications that have led to the revolution in HCV treatment.