It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead\u2019s NS5B polymerase inhibitor sofosbuvir and J&J\u2019s NS3\/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-na\u00efve patients with GT1, an interferon- and ribavirin-free regimen is now on the horizon. With it comes a much shorter treatment time, much better efficacy (i.e., SVR), and much less toxicity. Seems like a break-through, right? Yes indeed, that\u2019s what it is.<\/p>\n
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However, not everything is settled. Our safety data are from clinical registration trials mainly and as such are limited. There is clearly a lot of excitement about the prospects of shorter duration Rx even for \u2018difficult-to-treat\u2019 phenotypes but not all the data are in. New PIs and new MoA drugs are on the horizon and will need to be assessed and compared to the current crop of frontrunners. As of today, the data for GT2 \u2013 GT6 are sparse, and experience in special populations (HIV co-infected; HBV co-infected; the pre-cirrhotics and post-transplant immunosuppressed) is still accumulating.<\/p>\n
This lack of broader and deeper detail knowledge is to be expected at this stage. But why this flurry of new \u201cGuidelines\u201d which most likely will need updating every time a new study is published?<\/p>\n
Since the beginning of 2014, we have seen the
\n\u2022 Jan 7 JSH Guideline for the Management of Hepatitis C Virus Infection
\n\u2022 Jan 29 (updated March 12) Joint AASLD \/ IDSA \/ IAS-USA Hepatitis C Guidance
\n\u2022 April 9 WHO Hepatitis C Guideline
\n\u2022 April 11 EASL Clinical Practice Guideline<\/p>\n
\u201cInterim\u201d should be the word prominently displayed in the title of all these “Guidelines”, preferably with a time stamp. I applaud the concept of a constantly updated website (like HCVguidelines.org) but the notion of a true \u201cGuideline\u201d should confer\u00a0more than \u201915 minutes of fame\u2019.<\/p>\n
These are exciting days, reminiscent of the early HIV treatment break-throughs. Finally, SVR rates of >90% are achievable. But nomenclature matters: While keeping up with the string of new clinical publications is important, the need to communicate every twist of this evolving story in the form of a \u201cGuideline\u201d seems ill-advised. Call it a \u201cpreliminary recommendation\u201d, an \u201cinterim status update\u201d, an \u201cexpert summary\u201d or something similar but let\u2019s not call every waypoint a \u201cGuideline\u201d.<\/p>\n
Paraphrasing\u00a0it in HCV terms: Guidelines should be like SVRs and have some staying power…<\/p>\n","protected":false},"excerpt":{"rendered":"
It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead\u2019s NS5B polymerase inhibitor sofosbuvir and J&J\u2019s NS3\/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-na\u00efve patients with GT1, Continue reading So Many HCV \u201cGuidelines\u201d: Can\u2019t We Wait Till the Dust Has Settled?<\/span>