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Merck Plans to Discontinue Boceprevir for Hepatitis C by December 2015

Merck will stop selling its HCV protease inhibitor boceprevir (Victrelis) by December of this year, and no new patients should be started on the drug, the company announced in a recent "Dear Healthcare Professional" letter. While the first-generation HCV protease inhibitors improved the effectiveness of pegylated interferon plus ribavirin, they are no match in terms of efficacy or tolerability for the newer interferon-free combinations approved over the past 2 years.

The advent of direct-acting antivirals that target various steps of the HCV lifecycle brought about a revolution in hepatitis C treatment. Triple therapy containing one of the first 2 DAAs -- boceprevir or Vertex's telaprevir (Incivek or Incivo, also recently discontinued) -- demonstrated significantly higher sustained response rates than the old standard of care for people with HCV genotype 1 (approximately 60%-75% vs around 50%). But both drugs add their own side effects, including anemia and skin rash, and must be taken in combination therapy lasting up to 48 weeks.

In contrast, next-generation DAAs can be used in all-oral, interferon-free regimens like Gilead Sciences' sofosbuvir/ledipasvir (Harvoni) and AbbVie's Viekira Pak. These regimens produce cure rates in the 90% to 100% range -- even for difficult-to-treat patients including prior non-responders, people with liver cirrhosis, and people with HIV/HCV coinfection. The new drugs are usually taken for 12 or 24 weeks and are very well tolerated.

Unlike Vertex, Merck has not left the hepatitis C field and is currently testing DAAs including its HCV protease inhibitor grazoprevir (MK-5172) and NS5A inhibitor elbasvir (MK-8742).

Below is an edited excerpt from Merck's recent letter from U.S. market president Bob McMahon announcing the discontinuation. See the for VICTRELIS Indications and Usage and Selected Safety Information.

SUBJECT: Merck Voluntarily Discontinuing VICTRELIS (boceprevir) 200 mg Capsules

January 2015

Dear Health Care Professional:

We would like to inform you that Merck has decided to voluntarily discontinue the manufacture and distribution of VICTRELIS in the United States by December 2015. Please note that this is a business decision by Merck. This decision is not based on any safety or efficacy findings with this product. Due to the scientific advancement, changes in treatment practices, and the consequent reduction in the demand for VICTRELIS, Merck plans to discontinue commercial supply of VICTRELIS in the United States.

Merck remains committed to the treatment of chronic hepatitis C. To ensure all patients currently undergoing therapy with VICTRELIS are able to complete up to 48 weeks of treatment, Merck will continue to supply VICTRELIS to wholesalers through December 2015 on an as-needed basis from existing inventories. Remaining inventory is set to expire on December 31, 2015. We recommend that no new patients be initiated on VICTRELIS moving forward.

Bob McMahon

President, US Market

Merck Sharp & Dohme Corp.

1/21/15

Source

B McMahon, Merck. Merck Voluntarily Discontinuing VICTRELIS (boceprevir) 200 mg Capsules. Dear Health Care Professional letter. January 2015.