Fortunately, these obscure study results\u00a0are then quickly incorporated into the excellent HCV guidelines<\/a>, so we\u00a0mortals can just look them up.<\/p>\n With the FDA approval last week of velpatasvir\/sofosbuvir<\/a> (VEL\/SOF, “Epclusa”), however, bragging rights to these arcane details might now be\u00a0irrelevant, kind of like knowing how to\u00a0text with a flip-phone.<\/p>\n 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:<\/p>\n Or if you prefer, from the package insert:<\/a><\/p>\n In several clinical trials (published right here in the hallowed pages of the NEJM<\/em><\/a>), 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\u00a0HCV therapies, discontinuations due to adverse events wonderfully\u00a0rare (0.2%).<\/p>\n Of course\u00a0you’re thinking — Sounds good, but what does this new treatment cost?<\/em> Because that, after all, has been the major challenge in HCV therapy the past two years: \u00a0Access.<\/p>\n The simple answer is that the price is around $75,000 for a 12 week course.<\/a><\/p>\n And that is potentially<\/em> good news, as demonstrated by the following (approximate) list “prices” for various treatment courses, the most relevant\u00a0comparisons for the VEL\/SOF\u00a0option bolded:<\/p>\n I wrote “potentially” good news, since these numbers\u00a0are before<\/em> negotiated prices. The negotiated price is the deal made between the pharmaceutical companies and the payers, behind closed doors and opaque\u00a0to patients and providers, but quite relevant when we want to prescribe something.<\/p>\n Hardly any insurance plan or pharmacy benefit manager pays these full prices — it’s sort of\u00a0like the sticker price on the car in the showroom, a starting point for discussion.\u00a0However, 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\u00a0get a relative idea when the\u00a0prescription either sails through or gets blocked in favor of something else.<\/p>\n But a quick glance at the clinical trials data and the\u00a0sticker prices\u00a0shows that VEL\/SOF could easily\u00a0become the recommended\u00a0treatment for genotype 2 (good riddance, ribavirin!) and<\/em> genotype 3. For the latter, this is not only based on price;\u00a0sofosbuvir plus daclatasvir needs to be given for 24 weeks, with ribavirin, in all genotype 3 patients with cirrhosis.\u00a0So VEL\/SOF really is an advance —\u00a0this is a simple, safe, and effective 12-week treatment for all\u00a0genotypes that will rarely need ribavirin, except when there is decompensated cirrhosis (Child-Pugh 2 or 3).<\/p>\n And for those who are not very hepatically inclined, and wondering what the heck Child-Pugh is, it\u00a0is a commonly used\u00a0scoring system to\u00a0assess the prognosis of patients with cirrhosis.<\/a><\/p>\n Take it from Charlie, our beloved clinic nurse, who had\u00a0this email exchange recently with a pharmacy over getting HCV treatment approved for one of our patients:<\/p>\n\n
![\"epclusa_pi_pdf\"](\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/07\/epclusa_pi_pdf.jpg\")
<\/a><\/p>\n\n
![\"child-pugh](\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/07\/child-pugh-ha-ha2.png\")
<\/a><\/p>\n