Thursday, October 25, 2012

Will Dropping Interferon Be the Magic Bullet for Reducing HCV Mortality?


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Will Dropping Interferon Be the Magic Bullet for Reducing HCV Mortality?

Mark S. Sulkowski MD - 10/22/2012 More from this author

Let’s start with the basic premise that most individuals with chronic hepatitis C would like to be cured of this potentially life-threatening infection. If this premise is true, why then has the large majority of HCV-infected patients in the United States not been treated with previous and current standard therapies?

Infected but Unaware
First, the majority of HCV-infected Americans is unaware that they are infected. The new CDC recommendations that all persons born between 1945 and 1965 undergo a one-time HCV antibody test are the first step to address this issue but much more work is needed to implement this strategy. Clearly, we need more programs on the national, state, and local levels to identify infected persons and link them to HCV care that includes education about the infection, counseling regarding alcohol cessation, and careful consideration of treatment options.

Adverse Events With Interferon
Second, treatments based on interferon alfa are associated with adverse effects—sometimes quite severe—in nearly all people who receive this agent. Given that most HCV-infected patients do not experience symptoms related to HCV infection itself, I find the fact that treatment will likely cause a decrease in quality of life to be a tough sell on an individual patient level, particularly for those found to have minimal liver disease. Individuals who decline to take interferon alfa are often termed “interferon unwilling”; of course, to some degree, most humans are at least partially “interferon unwilling,” but some will take the therapy based on the potential for HCV cure and prevention of the deadly complications of liver disease.

Currently, my hepatitis C practice is really focused on deciding who needs treatment now with current therapies and who can wait until we see the approval of interferon-free regimens. The decision-making process includes assessment of the patient’s current liver disease; in other words, can they wait a few years until new therapies arrive? The other factor is a judgment call: Can this individual human being tolerate current therapies? I admit that this is not an objective measure; instead, this gestalt is based on comorbid conditions, social factors (family, work, major life events), and of course the person’s willingness to take current therapy. This is really the art of medicine in the application of a powerful but toxic therapy.

On a population level, the problem with interferon alfa is even greater, as multiple studies have found that many HCV-infected patients are “interferon unable,” meaning that these individuals have medical and/or psychiatric conditions that make the delivery of interferon unwise. For example, in a recent analysis for the US Veterans Affairs system, approximately 65% of veterans with chronic HCV infection were deemed ineligible for interferon alfa–based therapy. Could these patients be treated with an intense, multidisciplinary team effort? Maybe, but the point is that we can’t address the public health problem of hepatitis C without “better” therapies. In this case, better means safe, simple and effective.

Potential Solutions
Better treatments will undoubtedly improve the quality of life of patients undergoing HCV treatment as well as that of the healthcare providers who have become accustomed to keeping the ship afloat by treating depression and anemia as well as offering strong words of encouragement. I, for one, am looking forward to the day when the decision to treat is not so complex and I can tell more patients that they are cured—more payoff, less work! Will it be that simple? Short answer: Nope. Yes, many patients will successfully undergo HCV treatment but others will present more challenges—starting with finding them and linking them to care. If we are going to bend downward the trajectory of HCV-related death in the United States, we’ll need to harness significant resources to develop programs to cure hepatitis C.

Your Thoughts?
So, tell me your thoughts. What are the major barriers to uptake of HCV treatment in your practice? How do you think interferon-free regimens with address these barriers?

Mark S. Sulkowski, MD, is Professor of Medicine, Medical Director, Viral Hepatitis Center, Divisions of Infectious Diseases and Gastroenterology/Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Dr. Sulkowski has disclosed that he has received funds for contracted research paid to Johns Hopkins University and consulting fees from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Roche, and Vertex.

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