Vertex Hepatitis C Drug Wipes Out Virus For Toughest-to-Treat Patients

10/28/09Follow @xconomy

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to get better after the standard treatment.

Telaprevir must be combined with a pair of standard drugs, pegylated interferon alpha and ribavirin, which have to be taken for almost a year, and cause flu-like symptoms that make patients feel miserable. The Vertex drug is eagerly awaited by physicians and patients because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and cut the duration of therapy in half for patients who are new to treatment. If approved, the product could generate $2.6 billion in U.S. sales as soon as 2013, according to the investment firm Cowen & Company.

Vertex is running pivotal clinical trials that it hopes will clear the way for the U.S. market introduction of telaprevir in 2011, which could potentially give it the first-mover advantage against deep-pocketed competitors like Schering-Plough and Roche. But besides being first, Vertex wants to set the highest bar for therapy, by recruiting the most difficult patients to treat—the so-called null responders who didn’t see any improvement on prior therapy. If it can confirm the results from this preliminary study in an ongoing pivotal study of 650 patients, called Realize—that it can truly cure more than half of the null responders—then Vertex could have a significant advantage that it hopes will give physicians great confidence in its drug for all kinds of patients.

“It’s important to keep in mind that this was a small study, there was no control, so it has those weaknesses,” says Robert Kauffman, Vertex’s chief medical officer. “But it really does suggest to us that we are on the right track in our ongoing Phase III trial. If those results are confirmed in the Phase III trial, then this will be a real advance in treatment.”

Still, there are caveats. One of the important things that Vertex learned from this smaller study, known as ’107, is that the tough-to-treat patients need to stay on a full 48-week long combination regimen with the interferon and ribavirin. That’s how long patients need to take the existing drugs now, Kauffman says.

This was a point of a lot of discussion within the company, because one of telaprevir’s big advantages in the so-called “naïve” patient population was that it allows patients to cut their course of therapy down to 24 weeks, meaning they don’t have to endure the flu-like symptoms for nearly as long as with the standard therapy. The pivotal study for naïve patients is still designed to test that supposed advantage, but Vertex has found that tougher-to-treat patients are better off staying on the full 48-week long regimen, and enduring all that goes with it, to achieve the clinical cure rates, Kauffman says.

“The null responders really do respond more slowly. They have to stick with the regimen longer,” he says.

This latest batch of data came out too late to be presented at this weekend’s upcoming meeting of the American Association for the Study of Liver Diseases in Boston, Kauffman says. Vertex has other data that it expects to announce in Boston from telaprevir studies, he says.

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  • http://google milagros alvarado

    I have chronic hep c was dx in 2001, I have tried three different medications. I am still hep c pos. I am seeing a dr. at Mr. Sinai Hosp in new york city. I would like to start treatment of vertex what is my option I thinkits wonderful that Vertex can finally help people like me.

  • William Noviello

    I have had chronic hep c for over 10 years. Standaed treatment has not helped. How do I get on a list for the Vertex treatment.

    Sincererly,

    Bill Noviello

  • Gary House

    Wait until Teleprevir is approved before making any decisions.
    I have been geting ozone treatments in Germnat every tear since 1992 and I have nearly conquered any ill feeling, although I felt like death for a long time at the beginning.
    This is not some lull or intermittent improvement.
    I ahve no nausea, no more pain and have not had that “want to die” feeling for many years now.
    Ozone is not a cure, but it strengthened me to the point of where I might not even do another medicine.
    The ozone has to be the drip infusion method dome in Germany as ther is no one in the USA that does it correctly.
    The USA is full of quack ozone Doctors that inject ozone directly into a vein, which is a big mistake.
    In the ozone drip infusion correct German treatment method they take about 200 ml of blood into a vacuum bottle and infuse the ozone into the blood in the bottls.
    In 1992 I could hardly walk and I wanted to die from the deathly nausea, wekaness and deathly feeling all over my body.
    Ozone is the only thing that saved me and I can that from my heart.
    I have not one thing to gain by telling my story.
    Look for a German Doctor or Hellpraktiker that does Ozone.
    I go to Dirk Forstmeyer in Hannover, Germnat.
    He is not only sweet and honest, he has the most modern equipment and I nearly run out of there with energy and peace in my body and soul.
    I love German Ozone !
    It has saved me.
    Anyone cana call me ( GARY 407-409-4682 )
    I know 9f many Ozone Specialists in Germany but I say avoid any and all here in the USA.
    I know how to go there cheap and stay for a month cheap.
    I thank God for Ozone and German Technology !

  • Gary House

    SORRY, I REALLY CAN SPELL BUT I NEED NEW GLASSES AND MAKE A LOT OF TYPOS ! ;-)

  • matthew barbour

    i leave in New York and i had hope that i could defeat this problem in a natural way but im tired all the time having trouble maintaining my wieght i just wante to feel better like when i was physically fit

  • Michele

    Gary, Can Ozone help when you’ve been told that unless you get a liver transplant, you have approx. 1 year to live? Do you know?

  • Paul Boretski

    I am confused. My specialist told me that Vertex trials were not interested in me because am a null responder to Interferon and Ribavarin treatment and that I have cirrhosis. I truly do not know who to believe any more and that is extremely disheartening. I don’t know what is more damaging , the disease or the false hope.

  • Edith Grainger

    I just know that its hard to get treatment here when you cant afford it . I need treatment bad and my ins. will only pay a fraction of the cost. Where do we get help?

  • CARMEN AGUIRRECHU

    PLEASE I HAVE TRIED TWO DIFFERENT COURSES OF TREATMENT FOR MY HEP C. NO IMPROVMENT. I NOW HAVE CIRROSIS CAN THIS MEDICINE HELP
    PEOPLE LIKE ME? I FEEL FINE NO EFFECTS FROM BEING SICK, BUT I WANT TO LIVE I AM ONLY 56 YEARS OLD.

  • jimb

    Got my hopes up till I read it! I am allergic to Ribovarin (I get a rash) Doctor’s took me off treatment. This new Vertex sounds like the chance of Rash or side effects is greater for this type of treatment. So,,,,what if I just take Vertex,without Antiferon and Ribovarin. Is there a possibility it could still help? I’m willing to Guinee Pig.For science and to save my liver..

  • Roma

    Fatty Liver – Drugs for the treatment of hepatic steatosis
    Unfortunately, there is no treatment pharmacological able to completely solve the type of non-alcoholic hepatic steatosis, to said this, the drugs and treatments taken are intended to treat the causes and risk factors underlying the problem

  • Roma

    I recently read on your website that the Vertex-770 is reached in Phase 3 trials, given the good results we had so far on patients. How long will this phase? If the results of this phase were to continue to be positive, when the drug will be available in the U.S., Europe and Italy? Finally would like to know whether this drug is indicated for all missense mutations and in particular for the mutation N1303K. Sincerely