US regulators approve new hepatitis C drug

May 14, 2011

US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.

Also known as boceprevir, the drug is a that prevents the liver-disease causing virus from multiplying and studies have shown it "significantly" boosts recovery rates, the Food and Drug Administration said.

It received unanimous support last month from an 18-member panel of experts who advise the FDA on whether new drugs should be brought to market.

"Victrelis is an important new advance for patients with ," said Edward Cox, of the FDA's Center for Drug Evaluation and Research.

"This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' compared to currently available therapy."

The existing two-drug treatment of pegylated interferon and ribavirin for genotype 1 was approved by US regulators in 1998.

Doctors reviewing studies on the boceprevir last month as part of an FDA advisory panel said it would greatly improve the cure rate for hepatitis C, a liver disease that affects about 180 million people worldwide.

Currently only about half of patients are helped by drug therapy.

Victrelis was evaluated in a pair of phase III clinical trials with 1,500 adult patients, and both showed that two-thirds of patients who took the three drug combination had no detectable virus in their blood 24 weeks later.

There is currently no vaccine for the , and the Centers for Disease Control and Prevention estimates that more than 12,000 people die each year of liver disease and associated with the illness.

Most people infected with hepatitis C live symptom-free for years, but once it is discovered it is often too late for it to respond to the two-drug treatment.

In the past the disease could be spread through contact with infected blood products, and is still contracted by drug users sharing needles, or straws during the use of cocaine, or by unprotected sex with a sufferer.

Explore further: New treatment approved for rare form of hemophilia

add to favorites email to friend print save as pdf

Related Stories

US panel gives nod to Merck hepatitis C drug

Apr 27, 2011

A US government advisory committee on Wednesday unanimously voted to urge the Food and Drug Administration to approve a new drug made by Merck to fight hepatitis C, a disease which attacks the liver.

Game changer: Hepatitis C drug may revolutionize treatment

Mar 30, 2011

The drug boceprevir helps cure hard-to-treat hepatitis C, says Saint Louis University investigator Bruce R. Bacon, M.D., author of the March 31 New England Journal of Medicine article detailing the study's findings. The re ...

New treatment for hepatitis C

May 14, 2008

Researchers at the University of Oklahoma Health Sciences Center have found a new use for an old drug. Their findings appear online in the American Journal of Gastroenterology.

FDA says Merck drug successfully fights hepatitis

Apr 25, 2011

Federal health officials said Monday a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have been used for 20 years. But the agency has questions ...

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

12 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments : 2

Adjust slider to filter visible comments by rank

Display comments: newest first

SemiNerd
4 / 5 (3) May 14, 2011
I have a lot of friends that will be saved by new hep C treatments. This is a great day!
Elissa
5 / 5 (1) May 14, 2011
Japan came out with the 3 drug lead in not too long ago. THIS 3 drug lead in, worked for people in the later stages of Hep.C (stage 3, grade 3 and stage 4 grade 4). Pegasus-interferon did nothing to stop the replication of cells in these last stages. Is this 3 drug lead in the same as the 3 drug lead in used in Japan for the last 2 stages of Hep. C? If it is, we may have a badly needed winner. I'm in stage 3,grade 3 now and getting checked for cirrhosis and if I have advanced to stage/grade 4. I will try this new 3 drug lead - in,IF it stops cell replication. The underlying side effects of the interferon is harrowing. It can lead to depression/suicide because it moves very quietly and sneakily. Lots of confusion = why am I crying? or why does everything seem like a bombshell. When one are this ill, one is not thinking properly,anyway and a hard hitting drug like Victrelis is NOTHING to take lightly. The side effects are devastating. I have seen them first hand.I just mite notgo ther