PCORI to fund nearly $50 million for HCV research

The Patient-Centered Outcomes Research Institute, or PCORI, Board of Governors approved a PCORI Funding Announcement (PFA) that will provide up to $50 million for clinical effectiveness research studies focusing on effective ways to diagnose and treat hepatitis C virus infection, according to a company release.

The development of the PFA will focus on four key points: finding the most effective screening methods and testing strategies to help lower infection rates, provide alternatives to delivering the proper care to high-risk populations, evaluate “trade-offs” between SVR and adverse event rates associated with various treatment regimens, including antiviral treatments, and compare the benefits and consequences of beginning therapy as soon as diagnosis of HCV occurs compared with surveying a patient’s progress and beginning treatment when infection progresses to liver disease or other infections, according to the release.

“HCV is a major health threat that can have devastating consequences for infected people and their families,” Joe Selby, MD, MPH, executive director of PCORI, said in the release. “Recently approved medications are immensely promising and offer vast improvements over previous therapies, but as yet there’s no ‘real-world’ evidence of their long-term effectiveness nor comparative evidence to help inform decisions about screening, diagnosis, and treatment of HCV.

“In response to the feedback we’ve received from many health care stakeholders, and with the approval of our Board, PCORI will issue a funding announcement in the next few months to support CER that will build the evidence needed to better inform practice and address questions important to patients.”

In a separate release, Donna Cryer, chief executive officer and president of the Global Liver Institute, praised the PCORI announcement.

“The liver community appreciates the recognition by PCORI that [HCV] represents both a public health challenge, with more than 3.2 million people in the US and 350 million globally currently living with the virus, and a public health opportunity, with a new generation of curative therapies available,” Cryer said. “The urgency with which PCORI has stepped in to support the development of an ethical, collaborative process to build the body of high-quality information to guide researchers, patients and their care teams to make the most of this opportunity further demonstrates the value PCORI provides to the health care system.”