December 8th, 2013

Simeprevir and (Especially) Sofosbuvir Are Great Leaps Forward — and They Will Cost Plenty

CHepatitis C has been potentially curable for decades, but it’s hardly been easy. “I feel like I’m slowly killing myself,” said one of my patients, memorably, during week 24 of a planned bazillion-week course of interferon-ribavirin. (Actually it was only 48 weeks, but seemed like a bazillion weeks.)

Then in 2011 came the addition of telaprevir or boceprevir to the interferon-ribavirin, which made a cure more likely, but the treatment even worse. Rashes. Need for fatty meals. Tons of pills. Taste disturbance. Anal discomfort. (“Like shitting glass,” another memorable quote.) Anemia. And for the providers, having to manage these side effects and the complex “response-guided therapy” algorithms was no picnic.

Now, with the approval of simeprevir in November and in particular sofosbuvir Friday, HCV cure just got a whole lot easier. Both are one pill a day. Both have far fewer side effects than any existing HCV drug. Sofosbuvir adds the benefit of having almost zero important drug-drug interactions. (Simeprevir has many.)

The main problem with these new treatments is, frankly, their cost. They are very expensive — 12 weeks of simeprevir will be $65,000, of sofosbuvir $80,000. These costs are offset somewhat by reduced need for monitoring with safer therapies, a shorter course of interferon and ribavirin (if you go that route), and presumably down the road, prevented cases of cirrhosis, hepatocellular carcinoma, and liver transplantation.

And of course, few individuals will actually pay full price out of pocket for these treatments, just like few actually pay for their MRIs or their angioplasties or their stay in the ICU. Treating HCV is not like cosmetic surgery; it’s potentially lifesaving. And as with other expensive but lifesaving treatments, we’re hoping there will be generous patient-assistance programs for those who can’t pay.

But for those without coverage, people in other countries, or those charged with managing pharmacy budgets, this cost is a major hurdle.

All of which leaves me thinking that as of December 8, 2013, these are the best options for genotype 1 HCV infection (cost estimates approximate):

  1. Simeprevir + sofosbuvir for 12 weeks. PROS: More than 90% cure rate in the COSMOS study. Two pills once daily (it’s amazing even to write that.) CONS: The COSMOS study was very small. Simeprevir can lead to photosensitivity and has many drug-drug interactions. The Q80K polymorphism may reduce response to simeprevir. This regimen is not “FDA approved.” Cost = $145,000.
  2. Sofosbuvir + ribavirin for 24 weeks. PROS: Cured 76% of HIV/HCV co-infected patients in the PHOTON-1 study. May well do better in HCV mono-infected. Regimen is “FDA approved” for interferon-ineligible patients, which could help get insurance coverage. CONS. Ribavirin, and all its side effects. 24 weeks seems long compared to 12 weeks. Response rate is lower than other options listed here, which would require re-treatment. Cost (not including ribavirin) = $160,000.
  3. Sofosbuvir + interferon + ribavirin for 12 weeks: PROS: 90% cure rate in the NEUTRINO study. Only 12 weeks of interferon and ribavirin. Cost = $90,000. CONS: Interferon. Ribavirin. Enough said.

All are a lot better than what we had just last week. All of them contain sofosbuvir. And all are expensive.

What is the best way to treat HCV genotype 1 today?

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12 Responses to “Simeprevir and (Especially) Sofosbuvir Are Great Leaps Forward — and They Will Cost Plenty”

  1. Steven P says:

    Regarding your question as to the best way to treat HCV genotype 1, wouldn’t another (more) effective option be Sofosbuvir + simeprevir + ribavirin for 12 weeks for a patient previously unsuccessfully treated with peg-interferon and ribavirin for 48 weeks and who is now at stage 3?

    • Paul Sax says:

      Steven — it could be that RBV is needed for this pt population, but the data from the COSMOS study of sofosbuvir plus simeprevir are limited by the small sample size in each treatment arm.


  2. MARILYN says:


  3. Kim says:

    Been on simeprevir &sofosbuvir for 11 days with no side effects!
    This is much better than interferon & ribarviron.

  4. Anonymous says:

    Hi Steven
    I just started on sofosbuvir semeprevir and ribavirin yesterday
    non responder on peg interferon 48 week geno 1 stage 4

  5. katie says:

    my mom is very ill she has hepatitis c with liver problems,she has cerosis and we are still judging what to do,in Georgia we can not get sofosbuvir,or simeprevir

  6. katie says:

    so far i got the information that in Egypt the cost of the treatment of hepatitis c with sofosbuvir is 900$ but only the army gets this medicine,so it means that people who are ill have to wait for magic because the medicine is so expensive

  7. Mark says:

    This is going to take some time to get straightened out. First, there is the issue of the prohibitive cost. There are no clear indications yet as to what insurance will and will not cover. Even at 80% coverage (for those with decent insurance), 15-20 K out of pocket is a lot of money for most people. Secondly, there is no information available as to whether cirrhosis is reversed to any appreciable extent following successful clearance of the virus and thirdly, there is no evidence whatsoever regarding whether the probability of liver cancer would be reduced. Only time will tell. In the meantime, the pharmaceutical companies will rake it in.

  8. Anonymous says:

    have stage 4 liver w/cirrhosis am starting on the simeprevir/sofosbuvir combination for 24 week. did interferon injections years ago with bad reactions. just trying to see how this might affect liver, not that it can get worse was not able to be put on transplant list, but was told should of been on transplant list last year, little over age limit and work comp issues. doctor is great but refuses to talk in terms I understand. question is how this might be on my liver?

  9. Allen says:

    Has anyone received a discounted price by the drug company that manufactures these new drugs? Also has insurance covered a % of the cost? If so, How much % discounted, and what insurance company?

  10. Howard says:

    I’ve had hep C genotype 1a for approx 35 years, and have had no serious problems with my liver in all that time.I’ve tried interferon with daily shots back in the 90’s but it failed. Years later I also tried inteferon + ribavirin for a year but the virus came back again
    I just started in a clinical study of approx 300 people in the US and Canada sponsored by Jansenn R&D. The purpose is to study the effectiveness of simeprevir in combination w/sofosbuvir in subjects w/genotype 1 without cirrhosis.It is an open label study(no placebo) of 8 or 12 week treatment regimen.50% receive 8 week and 50% receive 12 weeks.I ended up in the 8 week group and started the drugs approx 9 days ago.If you are included in the 8 week study group and do not respond to the study drugs according to levels determined by study protocol you can be switched to the 12 week study group.
    They are trying to see if 8 weeks will be enough instead of 12 weeks.
    They will continue to monitor me for about 10 months.
    The study covers the cost of the drugs and all medical tests and appoinments.
    Hopefully this finally cures me,I have my fingers crossed.

  11. ziegler says:

    Sofosbuvir + peg-interferon + ribavirin, now in my 3rd week.

    I did peg-interferon + ribavirin for a year 2005-6. Really a nasty experiance and hard to tuff out.

    Though not succesful, I feel it stretched my time out for the development of sovaldi (sofosbuir).

    So sad for the people in Georgia. I feel vey fortunate. Craig, in Oregon

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

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NEJM Journal Watch
Infectious Diseases

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