Two grants totaling $29.5 million to fund two patient-centered comparative research studies on clinical effectiveness focusing on the hepatitis C (HCV) virus infection have been approved by the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors.
The board also approved another $14 million to research the best way to help people who inject drugs and who are infected with the hepatitis C virus.
The grants for the studies were awarded after PCORI received feedback from the healthcare community that HCV is now a top health concern, particularly among injection-drug users, according to a press 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,” said Joe Selby, M.D., M.PH., executive director of PCORI. “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 $14 million grant was awarded to Montefiore Health System and Albert Einstein College of Medicine in New York to fund research focused on finding the best treatments for people who inject drugs and are infected with HVC.
The study is titled “Patient-Centered Models of HCV Care for People Who Inject Drugs” and will include 1,000 people who inject drugs (PWID) who suffer from HCV. Two models of care will be compared: directly observed treatment – where patients take medication in front of a staff member; and the Patient Navigator model – where patients take their medications at home and receive education and support from healthcare staff.
The project will be conducted by Alain Litwin, M.D., who is an attending physician at Montefiore and a professor of medicine at Albert Einstein College of Medicine. Litwin will investigate which treatment models work best for HCV-infected people who inject drugs, and also look further into the reasons behind why some patients develop a resistance to certain therapies for HCV.
“This study has major implications for controlling hepatitis C infection and re-infection rates,” Litwin said. “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.”
Among a total of 24 grants distributed, nearly $54 million are now on their way to various clinical effectiveness research studies that will focus on rare conditions and comparing treatments for conditions like non-cystic fibrosis bronchiectasis, urea cycle disorders, and syringomyelia.