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The Latest Hepatitis C News at the Annual Liver Meeting

The 66th annual Liver Meeting begins tomorrow. Sponsored by the American Association for the Study of Liver Diseases (AASLD), it is the premier event devoted to liver health in the U.S. I am confident that the meeting will be packed with not-to-be-missed hepatitis C information. To stoke your appetite, here’s information about a much anticipated hepatitis C treatment that will likely be discussed at the meeting:

On October 28, 2015, Gilead submitted a new drug application to the FDA for a new hepatitis C treatment. If approved, the combination sofosbuvir/velpatasvir (GS 5816) would be the first all-oral, single-tablet regimen to treat all six hep C genotypes. The ability to cure all genotypes is referred to as pan-genotypic. (Note: Genotype 7 is a provisional genotype, as only one case has been isolated.)

Co-formulated into a single once-daily pill (SOF/VEL), sofosbuvir (approved as Sovaldi in December 2013) is a nucleotide analog polymerase inhibitor; velpatasvir is an investigational pan-genotypic NS5A inhibitor.

The application to the FDA is supported by data from four clinical trials:

The ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies treated 1,035 patients with SOF/VEL for 12 weeks: 98 percent achieved a sustained virologic response (SVR) following 12 weeks of completion of 12 weeks of treatment (SVR12 is the term used for virological cure.)

The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis, and reported the following results:

  • SOF/VEL with ribavirin for 12 weeks: 94 percent achieved SVR12
  • SOF/VEL without ribavirin for 12 weeks: 83 percent achieved SVR12
  • SOF/VEL (no ribavirin) for 24 weeks: 83 percent achieved SVR12

The most common adverse events were fatigue, nausea and headache.

The FDA designated SOF/VEL as a Breakthrough Therapy, which is granted to investigational medicines that may offer major advances in treatment over existing options. Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year. My guess is that it will be available in mid-2016.

I don’t suppose it is too soon to talk about price. Shall we start sending messages to Gilead now, requesting an affordable price tag?

Stay-tuned for more information about this and other hepatitis C research. I will post regular updates to my blog at HepMag.com. I’ll also post to Twitter @LucindaPorterRN and Facebook LucindaPorterRN. Twitter users may follow the meeting at #Liver15.

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Comments on this entry are closed.

  • Rod November 12, 2015, 8:06 AM

    The above treatment is surely a welcomed one ,however I am growing increasingly concerned about the approx. 5-10 % of patients treated that ultimately fail their regime and then are left with long term resistance variants to all the current medications approved.I hear and read very little about research in this area.

    Given the number of people currently treating(hundreds of thousands)this will certainly add up to many thousands of patients ,some with chirrosis that will be left out in the cold.
    In my opinion,truly “breakthrough therapy would be one that can rescue this group of unfortunate patients.

    • Lucinda Porter November 12, 2015, 8:47 AM

      Thank you for your well-measured comments With the liver meeting beginning tomorrow, perhaps there will be research that extends genuine hope to those who need it. With more than 2200 posters and presentations plus the anticipation of at least 2 or more treatments coming out next year, we are getting closer. Let’s hope we get there soon enough.

  • Rod November 12, 2015, 9:02 AM

    ” perhaps there will be research that extends genuine hope to those who need it”————————————–
    Yes Lucinda,lets hope so. As I mentioned above for every 100 folks currently being treated there are 5 to 10 that are left with resistant mutations to all the current regimes with no known trials going on looking at this particular subset
    Yes .we must stay hopeful that Pharma will consider this ever rapidly growing group.

  • Rod November 12, 2015, 10:52 AM

    I see my second comment was not posted. I find that interesting and I guess somewhat distressing ,given all I was saying is what is on the mind of many HCV patients,especially thousands who have already tx. and failed .
    Is this blog not for “all” of us interested in “all” aspects of HCV and its treatments?
    Is it not prudent to discuss something that could effect many thousand of patients going forward.
    If you would like to send a comment to my personal email at ” sandrdoyle@rogers.com it would be appreciated.


    • Lucinda Porter November 12, 2015, 12:02 PM

      Rod – the only reason why your second comment wasn’t posted was because I was out at appointments and this is the first time I was near a computer. I am just one person and the only one who publishes the comments.

      And although there was absolutely nothing controversial in your statement and what you said was exactly something I would have said, I will point out that it isn’t a blog for all. This is my own personal blog and there are certain things I don’t publish, such as spam (we certainly don’t need to sell any Viagra here!)

      So, please be patient with me. I am leaving town for the liver meeting,and I do take vacations. I will publish your comments eventually.

  • Rod November 12, 2015, 12:13 PM

    Thanks Lucinda and my apologies for being somewhat impatient.Hope you enjoy the conference.

    • Lucinda Porter November 12, 2015, 12:25 PM

      You are a good sport Rod – thanks for taking my defensiveness with good humor.

  • Rod November 12, 2015, 12:22 PM

    No Viagra here??…..damn

  • Sam Holt November 15, 2015, 4:55 PM

    Hi Lucinda,

    We started a Buyers Club for HepC medication in Australia some months back as it’s unavailable in Australia at this time. Our laws allow for patients to legally import a 3 month supply of medication from overseas and our clinical team have removed the medical risks of personal importation through a stringent process that includes comprehensive local testing of medication. We have had a large number of US patients arrive (mostly un-announced) in Australia to get a local prescription and obtain medication because their US insurer will not provide access until they are F3/F4. I was wondering what your experience has been with your readers desperately seeking treatment and if you’d have any interest learning more about what we are doing (www.fixhepc.com). Kind Regards – Sam