It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead’s NS5B polymerase inhibitor sofosbuvir and J&J’s NS3/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-naïve 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’s what it is.
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 ‘difficult-to-treat’ 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 – GT6 are sparse, and experience in special populations (HIV co-infected; HBV co-infected; the pre-cirrhotics and post-transplant immunosuppressed) is still accumulating.
This lack of broader and deeper detail knowledge is to be expected at this stage. But why this flurry of new “Guidelines” which most likely will need updating every time a new study is published?
Since the beginning of 2014, we have seen the
• Jan 7 JSH Guideline for the Management of Hepatitis C Virus Infection
• Jan 29 (updated March 12) Joint AASLD / IDSA / IAS-USA Hepatitis C Guidance
• April 9 WHO Hepatitis C Guideline
• April 11 EASL Clinical Practice Guideline
“Interim” 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 “Guideline” should confer more than ’15 minutes of fame’.
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 “Guideline” seems ill-advised. Call it a “preliminary recommendation”, an “interim status update”, an “expert summary” or something similar but let’s not call every waypoint a “Guideline”.
Paraphrasing it in HCV terms: Guidelines should be like SVRs and have some staying power…