A research team at Montefiore Health System and Albert Einstein College of Medicine led by Alain Litwin, M.D., was awarded $14 million by the Patient-Centered Outcomes Research Institute (PCORI) to determine how best to treat hepatitis C among people who inject drugs (PWID), a group with a high rate of infection. A follow up portion of the study will also seek to understand why some patients develop resistance to therapies for the hepatitis C virus (HCV), which causes the damaging liver disease.
"This study has major implications for controlling hepatitis C infection and reinfection rates," said Dr. Litwin, attending physician, internal medicine, Montefiore Health System and professor of medicine, Albert Einstein College of Medicine. "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 reinfected. 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 national, multi-site study, titled Patient-Centered Models of HCV Care for People Who Inject Drugs, will involve 1,000 PWID infected with HCV. Investigators will compare two models of care that have proven effective: directly observed treatment (DOT), where patients take medication in front of a staff member, and the Patient Navigator (PN) model, where 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.
Guided by a national stakeholder group led by the Centers for Disease Control and Prevention, the study will be conducted in conjunction with 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, University of California, San Francisco, University of New Mexico Health Sciences Center, and The New York City Department of Health and Mental Hygiene. Other key stakeholders in the study include Treatment Action Group, National AIDS Treatment Advocacy Group, Harm Reduction Coalition, National Alliance for Medication Assisted Recovery, Medication Assisted Recovery Services, Hepatitis Support and Mentor Group, Project Inform, Hepatitis Education Project, National Viral Hepatitis Roundtable, New York State Department of Health, New York City Department of Health, Gilead Sciences, OraSure Technologies, Quest Diagnostics, and Monogram Biosciences.
An estimated 146,500 New Yorkers and 2.7 million Americans have chronic hepatitis C, although about half do not know that they are infected. Hepatitis C is a liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong condition. Hepatitis C is usually spread when blood from a person infected with hepatitis C enters the blood stream of someone who is not infected. Today, people most often become infected with hepatitis C by sharing needles or other equipment to inject drugs. In additional to conducting research to help doctors better care for those with addictions, Montefiore offers an array of substance abuse programs.
This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.