Patients with advanced liver disease or other severe symptoms of hepatitis C virus (HCV) infection should be first in line for an expensive new medication for the infection, according to a new guideline. The guideline, from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, was created with support from the International Antiviral Society–USA (IAS-USA).
An estimated 3 million to 4 million US individuals have chronic hepatitis C infection and many of them remain undiagnosed. The infection may remain symptomless for years, but in individuals for whom the infection does eventually progress, severe liver disease or liver cancer may develop, and some will require liver transplantation. Potentially curative drugs have been available for years, but these therapies don’t work for everyone, require months of treatment, and often have onerous adverse effects.
The emergence of a new treatment for HCV infection, sofosbuvir, has been described as both a major step forward in treating the infection and a potential threat to the viability of the US health care system. The drug, which is sold under the trade name Sovaldi, can cure chronic HCV infections in a shorter time frame than older medications and is believed to have fewer adverse effects. However, its price tag of $1000 a pill—about $80 000 over the course of treatment—has been the focus of intense debate. As discussed in a New York Times blog post, the drug’s cost may drive up health insurance premiums and put a strain on state Medicaid budgets.
The new guidelines sidestep the drug’s costs and focus only on which patients are most likely to benefit from the drug. According to the new guidance, all patients with chronic HCV infection may benefit from treatment. But patients with severe liver scarring or liver disease, patients who have undergone an HCV-related liver transplant, and those with severe nonliver symptoms of chronic HCV infection should be first in line for treatment.
“We are most concerned about those with severe liver disease,” said Donald Jensen, MD, Director of the Center for Liver Diseases at the University of Chicago, during a press briefing. “Those with less severe disease also may benefit, but those without symptoms may be able to wait for better treatments to emerge,” explained Jensen, who co-chaired the panel that wrote the new guidance.
Jensen explained that 30% of patients with chronic HCV infections never progress to symptomatic disease and others may not develop symptoms for years. He noted for these individuals, it may be advantageous to wait until better therapies become available because there are other drug candidates in the pipeline.
Jensen said the organizations that developed the guidance chose to focus on prioritizing which patients are most likely to benefit from the new drug. But he also acknowledged that it would be impossible to treat all patients who are infected with HCV, because there simply are not enough clinicians with the necessary training to meet the demand.
But other panel members during the press conference acknowledged that costs are “the elephant in the room” that also make prioritization necessary.
“We understand the system is struggling because the medication is expensive and we need to give some prioritization,” said Michael Saag, MD, of the University of Alabama at Birmingham and a co-chair of the panel, representing IAS-USA.