Alain Litwin, MDOctober 18, 2015 - BRONX, NY - A research team led by Dr. Alain Litwin at Montefiore Health Systems and Albert Einstein College of Medicine has been approved for a five-year, $14 million research funding award by the Patient-Centered Outcomes Research Institute (PCORI) for a study titled "Patient-Centered Models of HCV Care for People Who Inject Drugs".
A multicenter trial involving 1,000 participants, the study will examine both directly observed treatment (DOT) and patient navigation (PN) models for treating hepatitis C virus (HCV) in people who inject drugs, aiming to determine which model produces the best results and is preferred by patients. Participants will be randomly assigned to the DOT group, in which they will take HCV medication under a staff member’s observation, or to the PN group, in which they will receive a biweekly take-home blister pack of medication (an electronic monitoring system will evaluate adherence) with education and support from a patient navigator and peer. The trial will also examine rates of re-infection in patients who have cleared the virus after treatment.
Participants will be recruited from methadone clinics, community health centers, needle exchange programs, community-based organizations, homeless programs, and participants in other research studies. 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, and University of New Mexico Health Sciences Center.
Stakeholders in the study include the Centers for Disease Control and Prevention, New York City Department of Health and Mental Hygiene, New York State Department of Health, Treatment Action Group, National AIDS Treatment Advocacy Project, 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, Gilead Sciences, OraSure Technologies, Quest Diagnostics, and Monogram Biosciences.
"It is a great privilege to be working with a stellar group of patients, researchers, advocates, providers, and policy makers as we investigate the optimal community-based models of care for increasing access to HCV prevention and care for people who inject drugs,” Dr. Litwin said.
PCORI issued a call for hepatitis C virus research proposals in response to input from patients and other healthcare stakeholders who identified HCV infection as a top health concern. HCV affects more than 2.5 million people in the United States, the majority of whom are undiagnosed, according to the Centers for Disease Control and Prevention. Many people with chronic HCV infection do not develop symptoms, but about one-third will eventually develop liver disease if untreated.
New oral medications offer significant improvements over previous therapies, but they were tested in specialized settings and carefully selected patient populations. There is very little “real-world” evidence available yet of their long-term effectiveness in a wider range of patients and no comparative evidence to help inform care decisions.
“PCORI is pleased to support Montefiore Einstein's patient-centered study, which will provide evidence needed to enable people infected with hepatitis C virus and those who care for them to make better informed choices about their treatment and care,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with Montefiore Einstein to share the results.”
Dr. Litwin's study was selected for PCORI funding through a highly competitive review process in which patients, clinicians, and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria.
Dr. Litwin's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.
