April 30, 2014
Seeking to meet a growing need as clinical attention to hepatitis C (HCV) undergoes explosive growth, a pair of professional organizations have teamed up to launch a new reference tool: HCVguidelines.org.
The site is a collaborative effort between the American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA) and International Antiviral Society-USA, all of which are nonprofits aimed at serving health care professionals and researchers, primarily within North America. At its core is a formal report -- still partly in development -- that outlines evidence-based guidelines for HCV testing, treatment and disease management. A panel of 27 liver disease and infectious disease specialists advised the creation of the guidelines.
"We anticipate that this site will be used by practitioners who are well versed in the nuances of antiviral therapy, but also by many who are inexperienced -- or even new to the treatment of hepatitis C," explained David Thomas, M.D., M.P.H., the director of the Division of Infectious Diseases at the Johns Hopkins School of Medicine and a co-chair of the guidance panel, during a call with reporters in January. "Thus we're very clear on our recommendations as to when to use certain drug combinations, and when certain patients should be referred to an expert."
"What we tried to do is approach this as if any one of us were getting a phone call from a practitioner in the community," Michael Saag, M.D., the director of the Center for AIDS Research at the University of Alabama at Birmingham and a member of the guidance panel, elaborated during the January press call. "We tried to make this as real-world as possible, so that a clinician accessing the website who has a patient with any one of these different categories of HCV infection -- a situation with either cirrhosis or not, post-transplant or not, et cetera -- that they would be able to gain that advice as if they were talking to one of us on the phone."
The first iteration of the guidelines, which launched with the public unveiling of HCVguidelines.org on Jan. 29, focus primarily on HCV testing, linkage to care, first-line treatment and retreatment of patients who previously failed HCV therapy, according to Donald Jensen, M.D., the director of the Center for Liver Diseases at the University of Chicago Medical Center and co-chair of the guidance panel. Subsequent additions will include guidelines on the timing of HCV treatment, treatment monitoring and managing acutely infected patients.
Among the unique features of the guidelines on HCVguidelines.org, which are not associated with the U.S. Centers for Disease Control and Prevention's HCV testing and treatment recommendations, are treatment suggestions that are not necessarily reflected in the package inserts of U.S. Food and Drug Administration (FDA)-approved drugs. "The FDA only will approve drugs that have gone through complete, for example, phase 3, rigorous testing, and you can't run a phase 3 study on every possible combination or every possible patient population," Saag said on the press call. "That's actually a major advantage of this guidance, in that it enables experts in the field to look at the emerging data and craft what we would feel the evidence supports that may fall short of what is specifically in a FDA-approved package insert." Saag added that such package inserts also often leave treatment indications vague, while the recommendations at HCVguidelines.org seek to provide more specificity by suggesting particular drugs within particular patient subgroups.
The intent of the new site is to greatly expand the population of health care providers who possess the knowledge necessary to provide well-informed, quality HCV testing and care as the disease itself enters more deeply into the mainstream. "New [HCV] drugs are much more tolerable, and I think, over time, regimens will become much more straightforward," explained Gary Davis, M.D., current secretary of AASLD, on the press call. "I think gastroenterologists [and] infectious disease experts who haven't done this in the past will start to do it. We hope that even other physician groups, even perhaps primary care physicians, will eventually get into treating these patients. It's clear that there are not enough hepatologists or infectious diseases experts to treat all of the patients who are infected in this country, so this needs to be a goal of the future."
In addition, the online-only nature of the guidelines provides an opportunity for the panel of experts that maintains them to keep up with a rapidly evolving treatment landscape. "This is perhaps one of the only guidance documents that is a living document, and it's absolutely necessary in this field because of the rapid development that we have seen [not only] over the last year, but of what we anticipate over the next three to five years," Saag said. "The ability to be nimble, adjust the recommendations -- really, it could be done weekly or monthly -- so that clinicians can have confidence that when they go to this website, they will get the most accurate and up-to-date guidance on the current treatment of hepatitis C, [is] a very exciting prospect that fits perfectly with the rapid changes we're seeing in this field."
Myles Helfand is the editorial director of TheBody.com and TheBodyPRO.com.
Follow Myles on Twitter: @MylesatTheBody.