First Hepatitis C Treatment Approved in 10 Years

May 16, 2011

On May 13, the FDA announced the approval of Victrelis (boceprevir) to treat Hepatitis C virus in adults.

, Hepatitis C virus (HCV) infection “is the most common chronic bloodborne infection in the United States,” and “approximately 3.2 million persons are chronically infected.” Each year there is an estimated 8,000-10,000 deaths in the US, so researchers have been working to develop new ways to treat the virus. The hard work paid off when last week the FDA announced its approval of Merck’s HCV treatment, VICTRELIS™ (boceprevir). Victrelis is the first treatment “in a new class of medicines known as hepatitis C virus (HCV) protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C.”

In the press release put out by Merck, Dr. Bruce Bacon, professor of internal medicine, Saint Louis University School of Medicine, and a clinical investigator for Victrelis, said, “This is an exciting day for physicians and patients because VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in a decade… Compared to current standard therapy, VICTRELIS can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining as SVR [sustained virologic response]. For many patients, VICTRELIS may allow for a shorter total duration of treatment.”

Matthew Herper, writer of the Forbes.com blog The Medicine Show, wrote that the approval of Victrelis “represents a victory for the drug giant, and could kick off one of the fiercest drug marketing battles in years.” The reason Herper wrote this is because Vertex Pharmaceuticals is also developing a HCV treatment that is expected to receive approval “later this month with a more straightforward and easy-to-understand dosing schedule.” According to an article, “Vertex’s Incivek is also more potent, curing a greater percentage of hepatitis C patients compared to Merck’s Victrelis, at least according to the respective clinical trials run by both companies.” Until Incivek is approved, Victrelis has the HCV market to itself, but when it is approved, there will be a major marketing battle between Merck and Vertex.

HCV Statistics

  1. Infection is most prevalent among those born during 1945-1965, the majority of whom were likely infected during the 1970s and 1980s when rates were highest.
  2. The following persons are at known to be at increased risk for HCV infection:
  • Current or former injection drug users, including those who injected only once many years ago
  • Recipients of clotting factor concentrates made before 1987, when more advanced methods for manufacturing those products were developed
  • Recipients of blood transfusions or solid organ transplants before July 1992, when better testing of blood donors became available
  • Chronic hemodialysis patients
  • Persons with known exposures to HCV, such as health care workers after needlesticks involving HCV-positive blood; and recipients of blood or organs from a donor who tested HCV-positive
  • Persons with HIV infection
  • Children born to HCV-positive mothers
  1. Of every 100 persons infected with HCV, approximately
  • 75—85 will go on to develop chronic infection
  • 60—70 will go on to develop chronic liver disease
  • 5—20 will go on to develop cirrhosis over a period of 20–30 years
  • 1—5 will die from the consequences of chronic infection (liver cancer or cirrhosis)
  1. Chronic HCV infection is the leading indication for liver transplants in the United States.

Resources for health care professionals (courtesy of the CDC):

Guidelines For Viral Hepatitis Surveillance And Case Management

Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease

A Comprehensive Strategy for the Prevention and Control of Hepatitis C Virus Infection and its Consequences

Diagnosis, Management, and Treatment of Hepatitis C: An Update

Hepatitis C Virus (HCV) Infection Testing for Diagnosis

Reference for Interpretation of Hepatitis C Virus (HCV) Test Results

NIH Consensus Statement: Management of Hepatitis C: 2002

What do you think about the FDA approval of Victrelis? Do you think it will be an effective treatment for hepatitis C virus? What about Vertex’s Incivek? Researchers are claiming it might be a better alternative, do you agree?