Vertex to Discontinue Sale of Telaprevir (Incivek) for Hepatitis C

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Vertex Pharmaceuticals announced last week that it will stop selling its HCV protease inhibitor telaprevir (Incivek or Incivo) as of October 16, 2014. While the first generation direct-acting antivirals are more effective than pegylated interferon plus ribavirin alone, they are no match for newer drugs such as Gilead Sciences' sofosbuvir (Sovaldi) or AbbVie's forthcoming "3D" regimen in terms of efficacy or tolerability.

The advent of direct-acting antivirals that target various steps of the hepatitis C virus (HCV) lifecycle has brought about a revolution in treatment. The first 2 DAAs -- telaprevir and Merck's boceprevir (Victrelis) -- demonstrated significantly higher efficacy than the old standard of care for people with HCV genotype 1 (sustained virological response rates of approximately 60%-75% compared to around 50%). But both drugs, which still need to be taken with interferon and ribavirin for 24 to 48 weeks, add their own side effects including skin rash and anemia.

In contrast, several next-generation DAAs now approved or making their way through the development pipeline can be used in all-oral, interferon-free regimens and produce cure rates in the 80%-90% range, even for hard-to-treat patients including prior non-responders, people with liver cirrhosis, and people with HIV/HCV coinfection. In addition, these new drugs are taken for just 8 to 12 weeks, are very well tolerated in studies to date, and some are effective against multiple HCV genotypes. The new DAAs are expensive, however, and older drugs may continue to be used in resource-limited settings.

Vertex previously announced in May that it would end further investment in research and development of hepatitis C therapies and plans to out-license its investigational HCV polymerase inhibitor VX-135.

Below is an edited excerpt from Vertex's letter to healthcare providers explaining the discontinuation of telaprevir, which notes that new patients should not start the drug at this time.

Discontinuation of INCIVEK (telaprevir) tablets in the United States

Dear Healthcare Provider:

The purpose of this letter is to inform you that Vertex Pharmaceuticals Incorporated will be discontinuing the sale and distribution of INCIVEK in the United States by October 16th, 2014. INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic HCV in adult patients with compensated liver disease. The complete indication for INCIVEK is located at the end of this letter [Editor's note: available online].

This decision has been taken in view of available alternative treatments and the diminishing market demand for INCIVEK.

We request that healthcare providers not start any new patients on INCIVEK at this time because of the discontinuation of the sale and distribution of INCIVEK. Vertex will continue to provide financial support to eligible patients currently prescribed INCIVEK and, for those currently under treatment, will address available drug supply needs to complete treatment regimen. For INCIVEK product support information, please contact: 1-877-824-4281.

Enclosed you will find the complete US Prescribing Information, including Boxed Warning, and Medication Guide.

Should you have any questions, require further information, or wish to report adverse patient experiences associated with the use of INCIVEK, please call

  • Vertex Medical Information at 1-877-824-4281.
  • Alternatively, report this information to FDA’s MedWatch reporting system by phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178), online (www.accessdata.fda.gov/scripts/medwatch) or by mail via the MedWatch Form FDA 3500, to the FDA Medical Products Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787.

[The complete indication for INCIVEK and full prescribing information is available online at http://pi.vrtx.com/files/uspi_telaprevir.pdf]

8/22/14

Sources

Vertex Pharmaceuticals. Discontinuation of INCIVEK (telaprevir) tablets in the United States. Dear Healthcare Provider letter. August 11, 2014.

Vertex Pharmaceuticals. Vertex Reports First Quarter 2014 Financial Results and Provides Updates on Key Business Priorities. Press release. May 1, 2014.

C Helfand. Sovaldi forces Incivek off the hep C market as Vertex calls it quits. Fierce Pharma. August 13, 2014.