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Treat sickest hepatitis C patients first, new US guidelines recommend

BMJ 2014; 349 doi: (Published 14 August 2014) Cite this as: BMJ 2014;349:g5163
  1. Michael McCarthy
  1. 1Seattle

When access to hepatitis C treatments is limited, patients who are the sickest or who pose the greatest risk of transmitting the virus to others should be treated first, says a new guideline update 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.1

With the advent of highly effective but very costly hepatitis C treatments, such as the $1000 (£600; €748) a pill drug sofosbuvir, public and private payers in the United States have been debating how to pay for the treatment of an estimated 3-4 million US residents who have chronic liver disease as a result of hepatitis C infection.

Although the guidelines did not specifically address the cost of treatment, in a telephone press briefing the guideline panelists acknowledged that cost was a concern—but they noted that it was not the only basis for identifying patients who needed treatment immediately and those who could wait.

“We can’t treat all 3-4 million patients immediately, so there has to be some way of prioritizing treatment,” said Donald Jensen, director of the Center for Liver Diseases at the University of Chicago Medical Center and the panel co-chair. “We also know that treatments and therapies will improve over time, and as those therapies improve it may even be better for some of those people who can wait.”

The new guidelines recommended that patients who should have the highest priority for treatment were those with advanced hepatic fibrosis or compensated cirrhosis, those who had received liver transplants, and those with severe extrahepatic complications of hepatitis C infections. This last group would include patients with such complications as end organ damage due to cryoglobulinemia, such as membranoproliferative glomerulonephritis or central nervous system vasculitis.

Next in priority should be patients at high risk of complications, the guidelines said, such as those with HIV 1 infection, hepatitis B coinfection, porphyria cutanea tarda, or insulin resistant type 2 diabetes—as well as those at high risk of transmitting the infection, such as men who have sex with men, injection drug users, prisoners, and patients on long term hemodialysis.

In US prisons, hepatitis C seroprevalence ranges from 30% to 60%, and the acute infection rate runs at about 1% a year. The guidelines noted, “Successful treatment of HCV [hepatitis C virus] infected persons at greatest risk for transmission represents a formidable tool to help stop HCV transmission in those who continue to engage in high risk behaviors.” They added that, in people whose treatment could be deferred, the urgency for therapy could be determined by tracking the progression of fibrosis over time.

“Although an ideal interval for assessment has not been established, annual evaluation is appropriate to discuss modifiable risk factors and update testing for hepatic function and markers for disease progression. For all individuals with advanced fibrosis, liver cancer screening dictates a minimum of every six months [for] evaluation,” the guidelines recommended.


Cite this as: BMJ 2014;349:g5163


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