July 3, 2016
Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.
One of the ways ID and hepatology hepatitis C experts like to show off is by discoursing on the nuances of cleverly named clinical trials, and how these impact treatment guidelines.
It usually goes something like this:
In the EP-CILEON [I made that up] study of [insert HCV regimen here], treatment-experienced patients with genotype [insert non-genotype 1 patients here, usually genotype 3], compensated cirrhosis, and baseline viral loads greater than [some large number], the SVR [why can't they say "cure"?] to the 12-week regimen was only [insert some number here that we could have only dreamed about in the interferon era, but well shy of the 95% mark we expect today -- let's say "82%"]. That's why these patients need to be treated for [a longer duration than 12 weeks, a number also divisible by 4] weeks, with the addition of weight-based ribavirin [as opposed to fixed-dose ribavirin? when would we do that?].
Fortunately, these obscure study results are then quickly incorporated into the excellent HCV guidelines, so we mortals can just look them up.
With the FDA approval last week of velpatasvir/sofosbuvir (VEL/SOF, Epclusa), however, bragging rights to these arcane details might now be irrelevant, kind of like knowing how to text with a flip-phone.
The new option makes things pretty simple, really. For patients with HCV genotypes 1-6 (that's all of them, if you're keeping track), here's what to do:
Or if you prefer, from the package insert:
Credit: Gilead Sciences, Inc.
In several clinical trials (published right here in the hallowed pages of the NEJM), VEL/SOF cured 95-99% of those treated, including patients with tricky genotype 3. Side effects were infrequent, and, as we've come to expect with modern HCV therapies, discontinuations due to adverse events wonderfully rare (0.2%).
Of course you're thinking -- Sounds good, but what does this new treatment cost? Because that, after all, has been the major challenge in HCV therapy the past two years: Access.
The simple answer is that the price is around $75,000 for a 12 week course.
And that is potentially good news, as demonstrated by the following (approximate) list "prices" for various treatment courses, the most relevant comparisons for the VEL/SOF option bolded:
I wrote "potentially" good news, since these numbers are before negotiated prices. The negotiated price is the deal made between the pharmaceutical companies and the payers, behind closed doors and opaque to patients and providers, but quite relevant when we want to prescribe something.
Hardly any insurance plan or pharmacy benefit manager pays these full prices -- it's sort of like the sticker price on the car in the showroom, a starting point for discussion. However, it differs from buying a car in that there's no easy internet research to find out what the plans actually pay. We prescribers and patients get a relative idea when the prescription either sails through or gets blocked in favor of something else.
But a quick glance at the clinical trials data and the sticker prices shows that VEL/SOF could easily become the recommended treatment for genotype 2 (good riddance, ribavirin!) and genotype 3. For the latter, this is not only based on price; sofosbuvir plus daclatasvir needs to be given for 24 weeks, with ribavirin, in all genotype 3 patients with cirrhosis. So VEL/SOF really is an advance -- this is a simple, safe, and effective 12-week treatment for all genotypes that will rarely need ribavirin, except when there is decompensated cirrhosis (Child-Pugh 2 or 3).
And for those who are not very hepatically inclined, and wondering what the heck Child-Pugh is, it is a commonly used scoring system to assess the prognosis of patients with cirrhosis.
Take it from Charlie, our beloved clinic nurse, who had this email exchange recently with a pharmacy over getting HCV treatment approved for one of our patients:
Such a great line, had to share.
Hey, since I started this post with a parody of sorts, here's one on TED talks making the rounds that could not be more spot-on.
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