Saving Your Liver May Cost an Arm and a Leg

As noted in my most recent post, the FDA has just approved two new medications to treat Hepatitis C: Incivek (Vertex's telaprevir)and Victrelis (Merck's boceprevir). According to www.drug.com, Dr. Douglas Dieterich, a professor of medicine in the division of liver diseases, at Mount Sinai School of Medicine in New York City, said that the approval of Incivek and Victrelis "represent the first real advances in the treatment of hepatitis C in 13 years."

This advancement is the best news Hep C patients have received in years - but celebrations may be premature. The astronomical costs of these meds could be an overwhelming barrier to treatment.

A May 25, 2011 post on the HBV and HCV Advocate Blog featured the Fair Pricing Coalition's stance on the price set for Incivek:

...the Fair Pricing Coalition (FPC) is appalled at the price set by Vertex for Incivek,” said FPC member Lynda Dee. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $49,200 per 12 week course of Incivek treatment will adversely affect the ability of people with HCV to access this new drug and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline.

“Merck’s Victrelis costs $48,400 for 48 weeks of treatment. Now Vertex has set a price approximately four times greater than Victrelis for twelve weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous.

The FDA label recommends that 12 weeks of Incivek be taken with pegylated interferon and ribavirin for either 24 or 48 weeks, depending on a patient’s response to the regimen. The WAC price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $30,000. The $49,200 WAC price for 12 weeks of Incivek will more than double the already exorbitant 48 week price of pegylated interferon and ribavirin.

The FPC also cites an expected "...30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs."

More information is available in the story and at http://fairpricingcoalition.org/.

Just last night I watched a television news show about the high quality, low cost health care available in Thailand, where hospitals are actively working to attract patients from other countries, including the US. My heptologist traveled there earlier this year and also commented on how good the health care is. Maybe we should move?

Photo by Marc Garrido i Puig

Great News for Hepatitis C Patients (Well, for Some of Them)

Along with other people infected with the Hepatitis C virus, I was elated when the FDA approved two new medications - telaprevir and boceprevir - both of which have proven much more effective in achieving sustained virologic response (SVR) than the current course of treatment. For people like me who have genotype 1 Hep C, the hardest to treat, the news is especially good.

Yet I just learned that treatment with one of these new medicaations may not be in my immediate future, if at all. Turns out that immunosuppressants have a negative interaction with the drugs, so liver transplant patients with Hep C can't tolerate them; at least, not for now.

Well, this just sucks. For five years we've waited for these drugs to reach the market, hoping that this would clear my Hep C and give me a chance to be realistically hopefully, and seriously consider the future, make plans, expect to be around for a good long time, enjoy some grandchildren.

But right now, the future just seems dark.

Photo by nikstyles

FDA Gives Two New Hep C Medications Priority Review Status

Back in 2006, when I had my liver transplant, the heptologists at my transplant center told my husband and me that a new medication for treating Hepatitis C was in clinical trials and would be available the following year. We heard the same news in 2007, 2008, 2009 and 2010. Our skepticism is understandable, don't you agree?

Yet it appears that in 2011 our long wait will end. The FDA is giving Priority Review status to telaprevir, which was developed by Vertex Pharmaceuticals for people with genotype 1 chronic hepatitis C. In addition, Prioirity Review has been given to boceprevir, an oral hepatitis C virus (HCV) protease inhibitor developed by Merck.

The FDA gives Priority Review designation "...to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists... The goal for completing a Priority Review is six months." The target review date for telaprevir is May 23, 2011 (I could not find a review date for boceprevir).

Both medications show better cure rates and, for some people, reduce the treatment time. Furthermore, they will be the first drugs that directly target the Hepatitis C virus.

I don't know how quickly the drugs will reach the market after FDA approval but I hope it doesn't take long. My poor liver has taken enough abuse from this devastating virus.

Photo by Nina Briski