Published: Aug 11, 2014
All patients with chronic hepatitis C (HCV) can benefit from new treatment regimens but some should get therapy more urgently than others, according to new guidelines.
Patients with advanced fibrosis or who have had a liver transplant are at the "highest need for urgent treatment," according to Donald Jensen, MD, of the University of Chicago Medical Center, co-chair of an HCV guidelines panel organized by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, in collaboration with the International Antiviral Society-USA(IAS-USA).
Patients with less advanced fibrosis but other life-threatening complications, such as cryoglobulinemia, should also be at the head of the list for new direct-acting treatment regimens, Jensen told MedPage Todayduring a teleconference on the new guidelines.
The societies launched their guidelines in January to help physicians cope with an expected demand for treatment as new regimens reach the clinic.
Unusually, the guidelines are online and under constant revision, making them a "living document" that can cope with a rapidly changing field, according to Michael Saag, MD, of the University of Alabama at Birmingham, the guidelines co-chair for IAS-USA.
The latest addition, reporters were told, is a section on when -- and in which patients -- to initiate therapy.
An estimated 3 million to 4 million Americans have chronic HCV and about half are not aware of it. Many will develop advanced liver disease or liver cancer.
The advent of the novel direct-acting agents -- the first were approved in 2011 -- offers the possibility of eradicating the disease in a "very high percentage" of patients, Jensen said.
The guidelines argue that all patients with chronic HCV could benefit from treatment -- but some need it more urgently than others, he added. Not all patients "can receive treatment immediately upon the approval of new agents," he said.
"From a clinical perspective, we are most concerned with those with severe liver disease," he said.
The guidelines do not directly address the issue of the cost of the some of the new agents, which has raised concern about the impact on the healthcare system if many thousands of patients seek therapy.
"We hope that the cost issues will be sorted out in another venue," Jensen said, "but it's really patient-directed care that we're concerned about."
"We understand that the system is struggling because these medications are expensive," Saag added, "and we need to provide some at least indirect guidance on who has the highest priority."
The CDC is currently recommending that all Americans born from 1945 to 1965 be tested at least once for HCV, since studies suggest that about 2 million of them have the virus.
One goal of the guidelines is to create a larger clinical workforce capable of treating patients with HCV, especially if that testing takes hold and a large number of people suddenly begin demanding treatment.
"There aren't enough hepatologists in the United States to see all these patients," Saag said. "These guidelines will be able to help educate not only those who are very expert in the field about new and emerging treatment trends, but also to educate those who are perhaps new to the treatment of hepatitis C."
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