The Protease Inhibitor Era: An Opportunity to Improve the Quality of Care

Abstract

Treatment for chronic hepatitis C virus (HCV) infection is expected to take a tremendous step forward this year when boceprevir and telaprevir undergo review by the United States Food and Drug Administration [1, 2]. These protease inhibitors will be administered in combination with the current standard of care of peginterferon alfa and ribavirin and will mark the first change in treatment in a decade. The addition of a direct acting antiviral (DAA) medication raises a number of new issues for providers of HCV treatment. These medications bring the excitement of improved response rates but also a number of challenges. They will be delivered in a response guided therapy algorithm, and they carry new adverse events and the threat of resistance. In this issue, Gaglio and colleagues [3] present a survey to assess the current knowledge of members of the American Gastroenterological Association and American Association for the Study of Liver Diseases regarding DAA medications and their attitudes regarding the upcoming treatment regimens. Of the 10,082 surveys sent out, the response rate was 21%. Although we can debate the adequacy of the response rate, this sample of 1,320 current treatment providers offers insight into the perceptions of many future providers of these medication regimens. A major concern in our field has been that the added complexity of HCV treatment with protease inhibitors will lead some current providers to cease offering treatment. Among this sample in which 85% provide their own treatment currently, 81% plan to offer treatment in the DAA era, while the proportion referring to a HCV specialist only increased from 6 to 10%. Although these numbers are statistically significant, the survey demonstrates that many current HCV providers plan to continue treatment in the future, and this sample does not provide evidence of a large exodus from HCV treatment. The next question is if these providers of HCV treatment are prepared for the new complexities of these triple therapy combinations. Gaglio and colleagues raise concerns about the 3% of respondents with minimal knowledge of DAA agents given that 59% of these providers report that they plan to offer these treatments in the future. The 77% of respondents who were aware or very aware of the DAA agents but had no participation in clinical trials will also need significant education and support in their initial phase of experience with these medications. These regimens will come with new treatment algorithms and stopping rules. Providers will need to understand viral resistance, including prevention strategies, monitoring requirements, and implications for treatment. Both boceprevir and telaprevir regimens lead to increased anemia, and patients receiving telaprevir need to be monitored for the development of a rash that requires careful monitoring and discontinuation of medication if progressive [1, 2]. There is a natural learning curve to new treatments, and provider enthusiasm for the improved response rates could sour if poor outcomes occur from adverse events. Gaglio and colleagues conclude that ‘‘extensive education of all future prescribers of DAA agents will be required to ensure successful use of these therapies’’. Historically, new therapies in our field have been the focus of industry-sponsored talks by thoughtful leaders and continuing medical education programs. Recently, these strategies have fallen out of favor given their failure to demonstrate improvements in the quality of care [4]. A. J. Muir (&) Division of Gastroenterology, Duke Clinical Research Institute, Duke University School of Medicine, P.O. Box 17969, Durham, NC 27715, USA e-mail: muir0002@mc.duke.edu