FDA approves victrelis, the first new hepatitis C drug in 20 years


Hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States.  According to Centers for Disease Control and Prevention (CDC) approximately 3.2 million persons have hepatitis C in the United States. Hepatitis C can lead to chronic liver problems, liver cancer, cirrhosis and death. The disease is the leading cause of liver transplants in the U.S.  Recently FDA approved Merck’s Victrelis that is designed to treat Hepatitis C with a cure rate of 66%. 

What is the main cause of Hepatitis C infection?
Hepatitis C is spread mainly through sharing needles such as those used for illegal drugs and tattoos or through blood transfusions before 1992 when screening began.

How about Merck’s Victrelis drug?
Merck’s Victrelis (boceprevir) drug approval by US FDA is a major advancement for Hepatitis C patients.  FDA advisory panel voted in favor of Victrelis approval in April 2011 with 18-0 vote. There is positive vibe in medical community as a new drug for this infectious disease has entered the market after two decades.  Victrelis is expected to help transform treatment of the potentially fatal disease with higher cure rates and shorter courses of therapy for some patients.

“Victrelis is an important new advance for patients with hepatitis C,” Dr. Edward Cox, head of the FDA office of antimicrobial products, said in a statement.

“There are so many patients who are just waiting for a new treatment option. There hasn’t been anything new in 10 years,” said Dr. Eliav Barr, Merck’s head of infectious diseases research.

The FDA approved Victrelis for adults with hepatitis C who were never treated or who failed previous treatments.

What does clinical data say about effectiveness of Victrelis?
The clinical studies conducted by Merck exhibited that the cure rate...

for Victrelis reached 66 percent which is an improvement over the 35 to 40 percent seen with current drugs. 

Vertex Pharmaceuticals Inc is expected to win FDA clearance later this month for its Hepatitis C drug. Vertex drug is reported to have cure rate of 79%, ~13% higher than Merck’s Victrelis.

The clinical data showed that both the Merck and Vertex medicines in combination with standard drugs reduced the curing time in some patients by half as compared to the current therapy of the injectable drug interferon and a pill called ribavirin. The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

What are side effects of Victrelis?
The most common side effects reported with Victrelis were fatigue, anemia, nausea, headache and taste distortion, the FDA said. The drug label recommends monitoring for anemia.

The new medicines work by blocking a protein called protease that the virus needs to replicate. The generic name for the Merck drug is boceprevir. It must be taken three times a day with food.

I think the new drugs bring positive news for Hepatitis C patients, who have been at Mercy of older treatment options.  If you are fighting Hepatitis C infection, consult your doctor regarding Victrelis.


9 Responses

  1. oerwh says:

    I have Hepatitis and I am an engineer who works for the largest herpes dating and support site STDsMatch. com. I have to tell you a secret, you can choose not to
    believe me. But the truth is that this site has more than 1,880,000 members and about 80% members are good looking in my estimation.

    Unfortunately, STD rates soar worldwide and most people with STDs don’t even know that they have them. So do use a condom to protect yourself!!!!
    The government should grant more money for STD education to lower the rates of STD transmission.

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