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.

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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

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