New Drugs Open Door to Treating All Patients With HCV

Lara C. Pullen, PhD

August 11, 2014

New direct-acting antivirals hold the potential to cure patients with hepatitis C virus (HCV). As a consequence, the American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America have published new guidelines to help physicians treat the 3 to 4 million Americans who are infected with HCV and who have chronic liver disease. Theirs is an ongoing collaboration that was formed to respond to the rapidly changing field of HCV.

"We are saying that we believe that all patients will benefit from treatment.... That is important, and we are saying that," emphasized David Thomas, MD, from Johns Hopkins School of Medicine in Baltimore, Maryland, during a press conference to announce the release of the latest section of the new Web site.

The Web site was launched in January. The new section is called, "When and in Whom to Initiate HCV Therapy." Dr. Thomas explained the paradox, saying, "We are trying to provide information about relative urgency [of treatment]."

AASLD was formed with the intention of preventing and curing liver disease. Steven Echard, AASLD chief executive officer, explained that with the new drugs, that goal is in sight, and "our focus is how these regimens are modified and applied to specific patient populations." He emphasized that "Our bias remains the interest of our patients." Thus, the new section does not discuss either the cost of these new drugs or the cost of the entire HCV treatment regimen.

Michael Saag, MD, from the University of Alabama at Birmingham, acknowledged, however, during the press conference that the cost issues are really the elephant in the room: "You are right that we do recommend treatment for everyone.... We do help the providers to interact with the system by indicating to them who has the highest priority and who has the next highest priority.... At the end of the day, we understand that the system is struggling because of the high cost of the medicines."

That cost has to be balanced against the obvious benefits to both patients and society that come from lifting the burden of HCV disease. Specifically, treating and preventing HCV can reduce cirrhosis.

"As therapy for HCV has improved, more patients than ever before will be candidates for treatment. A very high percentage of treated individuals can now be cured," explained Donald Jensen, MD, from the University of Chicago Medical Center in Illinois, during the press conference.

He elaborated, however, that less than half of those with HCV have been diagnosed. Thus, the diagnosis and treatment of HCV make up a large problem that, thankfully, now has a solution. Unfortunately, the solution is expensive.

The new document provides the best available information for prioritization of treatment, according to the presenters, and describes a path toward the greatest amount of access for the largest number of patients.

The guidelines identify patients with the highest need for urgent care as those with advanced fibrosis and compensated cirrhosis. In addition, some patients have less fibrosis, but other life-threatening complications of HCV, and these individuals should also be prioritized for treatment. Liver transplant recipients are also a high priority.

The physicians have disclosed no relevant financial relationships.

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