Chronic hepatitis C virus (HCV) infection affects more than 3 million Americans and is a major cause of liver disease, cirrhosis, and liver cancer. Although several new drugs have now made it possible to cure almost all individuals with this infection, several obstacles remain. First, most persons with the disease are not aware of the infection so the Centers for Disease Control and Prevention (CDC) has recently recommended testing of all persons at risk and in the age groups where the disease is most common. Second, access to treatment is restricted by the complexity of treatment, the limited number of healthcare practitioners familiar with the disease, insurance coverage, and the high cost of the most recently approved antiviral drugs.
To address some of these issues the American Association for the Study of Liver Diseases (AASLD) partnered with the Infectious Diseases Society of America (IDSA) in association with the International Antiviral Society USA (IAS-USA) to appointed a volunteer Panel of experts in HCV research and patient care to develop a web-based and continually updated resource, as practical recommendations for clinicians, at www.HCVguidelines.org.
The rapidity of change in this field makes development of a formal published Guideline impractical so the work is referred to as HCV GUIDANCE. This distinction in the name -- Guidance vs. Guidelines -- is essential. The primary goal of this document was to facilitate the most rapid implementation of optimal care for our infected patients. The panel relied on peer-reviewed reports (papers published in the medical literature and abstracts presented at major national and international scientific conferences), FDA submission data, and expert consensus to develop recommendations to assist clinicians treating patients infected with HCV. Some of this supporting material does not meet the rigid criteria required to support a published Guideline
For example, the Food and Drug Administration allowed some recent phase 3 studies to utilize historical controls rather than existing standard of care since that regimen was well known to be poorly tolerated and have suboptimal efficacy. Furthermore, we believe that the long process of preparing and publishing a formal clinical practice guideline would delay release of new and important recommendations, and might compel or require physicians to continue the use of obsolete, toxic and less effective regimens. Nonetheless, the panel has gone to considerable effort to comply with as many of these criteria as feasible while still accomplishing its goals.
Although the HCV GUIDANCE has been welcomed and well received by most clinicians and patients, it has been the target of criticism by some. Most of this criticism results not from the recommendations themselves but from the financial burden that treatment places on patients, insurers, and the government. Cost is a very important concern and the cost of treating hepatitis C has been forecast to triple by 2016 [Economist, Jan 7]. Indeed, although AASLD, IDSA, IAS-USA, and the experts on the panel are quite cognizant of the short-term financial burden placed on payers by the costs of these drugs, we chose not to address this issue in the initial release of our recommendations. Indeed, our perspective in developing this GUIDANCE was solely the interest of the patient, recognizing that others would necessarily have a primary focus on cost and availability of other resources. However, the most recent addition to the HCV GUIDANCE is a section called "Who and When to Treat" which begins to address the issue of healthcare resources and societal cost. This new section focuses on how to first direct treatment to those who would derive the greatest and most immediate benefit from therapy. However, to fully address the issue of cost, healthcare practitioners and systems, insurers, government, and especially the pharmaceutical companies all need to share the responsibility of ridding our population of this infection.
Another criticism of the HCV GUIDANCE has been a perceived financial conflict of interest, particularly with regard to relationships with commercial manufacturers of HCV drugs or products. In fact, 16 of 27 members of the writing panel have no personal financial relationships with such commercial entities and the only relationship of an additional 3 members is service as a data safety committee member. The criteria we used are clearly stated on our website and have tried to be as consistent as possible with the standards provided by the Institute of Medicine (http://www.iom.edu/reports/2011/clinical-practice-guidelines-we-can-trust.aspx). It must be specifically stated, however, that in order to recruit the most informed experts on hepatitis C to our panel we did not consider industry support for clinical research that was paid directly to the institution (not the investigator) to be a conflict of interest.
Finally, the HCV GUIDANCE is funded directly by the AASLD and IDSA, plus support for evidence collection on HCV testing provided by the CDC; no commercial funding was sought or accepted. Considering the exceptional level of expertise represented by this writing panel, this relative lack of conflict is truly remarkable. However, we clearly recognize that any publication, recommendation, guideline, or editorial review has inherent biases. These do not necessarily negate the conclusions of the recommendation if they are clearly stated and transparency is to maintained. We openly acknowledge that our bias remains the best interest of our patients. Often, critics of our guidance are biased by the influence of their sponsorship or by a focus on cost alone, though this is rarely disclosed in their criticism. Cost is important, but the opinions of cost biased groups do not refute our recommendations. All opinions must be considered in their proper context.