Vertex’s Telaprevir Passes Test in Tough-To-Treat Hepatitis C Patients

4/25/09Follow @xconomy

Vertex’s telaprevir is starting to stand the test of time. The experimental drug for hepatitis C is showing today that it can cure about half of the patients who failed to respond to standard treatments. That’s about triple the cure rate for patients who tried a second round of the existing drugs.

The latest findings were reported today from a study called Prove 3, at the European Association for the Study of the Liver meeting in Copenhagen, Denmark. The study found that 51 percent of patients who took telaprevir in combination with standard drugs for six months were cured and 52 percent were cured by staying on the drug for almost a full year, researchers said. That compares with 14 percent, who were cured with a second round of the standard treatment—pegylated interferon alpha and ribavirin for almost a year.

These numbers are consistent with what Vertex reported in earlier peeks at their data, starting back in June and again in November at the American Association for the Study of Liver Disease. This study included just 115 patients, so the findings will have to be confirmed in ongoing pivotal stage trials before Vertex, which is based in Cambridge, MA and has significant operations in San Diego, can win permission from U.S. and European regulators to market the drug. But analysts are sure to get fired up in anticipation of that happening. An estimated 6 million people in the U.S. and Europe have chronic hepatitis C infections, and about 650,000 showed no improvement with the standard treatment. Telaprevir holds promise because it has shown a greater ability to cure patients of the virus, and it can cut the treatment time in half. That’s significant because standard drugs for hepatitis C cause flu-like symptoms that patients have to endure.

It means Vertex (NASDAQ: VRTX) could generate $2.6 billion in U.S. sales in 2013 when factoring in patients who failed treatment and those who are new to therapy, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.

The cures Vertex is referring to … Next Page »

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  • http://none Johnathan Legg

    i would be very interested in giving vertex a try. can you give information on who to cotact? i am on transplant list but ok right now. thanks, jkl

  • Scott Barkley

    My partner had a liver transplant six years ago, and tried six times to eliminate Hep C, the cause of his liver’s demise. He is now back on the transplant list. He would be very interested in giving vertex a try. Can you tell me how to get in touch with someone.
    Thanks,very much.

  • sheryl

    My husband has Hep c,liver cirrhosis, and a shunt in his liver. He had esophageal varices repair. We are not on the transplant list yet but are going that way. Would he be a candidate for vertex? Please send us any information as soon as you can. Is is available in Idaho? Thanks.

  • http://vertex,s Leo B Ferguson

    I would be interested in trying this new drug. if you can send me any more information on it please do so.

  • robert boisvert

    were do i sign up,i have liver cirrhosis and would like to be considered for a trial,please let me know thanks

  • Barbara Leger

    I am also very interested in this new drug and would like to bwe considered for a trial.

  • Ronald Steepleton

    I would like to be concidered for any new treatments interferon treatments didn’t work.Please submit me for any new needed to be tested drugs

  • Sergey

    I have hepatitis C, genotype 3A, the course had received antiviral therapy. In Kazakhstan there is no treatment of viral hepatitis. Please how to get into the program of studies.Thanks.

  • Stephen

    Getting ready to go back on the new anti viral treatment for the third time. First on intron A for 6 months over 10 years ago then, interferon/ribavirin for a year, now will need to try the new peg interferon. Currently have cirrhosis with severe neuropathy and cryoglobulinemia in both legs, and esophageal varices. Please let me know if they are still looking for participants of this study. Not ready to give up yet… :)

  • David Harrell

    David
    What are the SVR stats on break thru patients alone ? Those of us who had success with combo treatment but broke thru. at 6 mos. from 5k to 700k viral load.

  • Sam Wathen

    50 yr old male with hep C, geno 3, am interested in trying this drug, where can i go and what can i do?

  • Kenneth Delussey

    with all the hype with this new drug alot of people want to know when it will be available to the masses who need it right now

  • Richard J. Solis

    I, have HCV geno1,stage1,frist treatment in 2002 did not take, I`am 68 years old and was told I may be to old for any new treatment.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    There’s no way to predict with real certainty when the Vertex drug, or any other one, for that matter will reach the market. But here is the place to go for current information on clinical trials from the National Institutes of Health, and from Vertex.

    NIH: http://www.clinicaltrials.gov/

    Vertex:
    http://www.vrtx.com/current-projects/Clinical-Trials.html
    Phone:
    877-634-VRTX (toll free)
    617-444-6777

  • G Rosa

    I have HCV,geno 1, diagnosed 1992 ,never had treatment, I have low blood platlet count, I am in need of treatment, and I would like to begin with this medicine. Where do I go ? Help.

  • D. Desirey

    I have Hep C geno type 1, told stage two three years ago after my first bio. I have not had any treatment yet but have been encouraged to begin a treatment. I think I have put it off in case a new improved treatment comes out with a better success rate. I know with geno type 1 there is a less success rate. My husband was on injections three times per week 9 years ago and three months after coming off the treatment (one year tx) his liver enzymes elevated again.

  • Charles Eskridge

    I have Hep c geno, 1 would like to try vertex,have low viral load count, please contact me with any info,God Bless

  • Dave

    I have geno type 4 and have tried the one year program, cleard the virus within the first 6 months but it came back full blown all for what,nobody has info on geno type 4 and im a white male ??can you send any hope for me thanks

  • Nancy M.

    I am geno type 1 diagnosed 10 years ago. 1 year of treatment came back after 4 months. When is this new drug expected to come out for consumers?

  • Herb Lineker
  • Bogal Malczynski

    Dear Sirs,

    I have HCV found almost 10 years ago.
    Please, send me any info re. VX-950 progress.
    I had interferon/ribivirin therapy 5 years ago.
    Thank you,
    Bogal
    Warsaw, Poland

  • http://hepcnomads.co.uk/phpBB3/index.php Ralph Salmon

    “That compares with 14 percent, who were cured with a second round of the standard treatment”?

    This doesn’t sound right, it looks way to low. Then I remembered a friend who posted about a pharmaceutical company making false claims in their trials. I went back to check and guess what

    Schatz Nobel Izard P.C. Announces Class Action Lawsuit Against Vertex Pharmaceuticals, Inc.
    Tuesday, March 18, 2008; Posted: 06:17 PM

    HARTFORD, Conn., Mar 18, 2008 (PrimeNewswire via COMTEX) –The law firm of Schatz Nobel Izard P.C., which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the District of Massachusetts on behalf of all persons who purchased the publicly traded securities of Vertex Pharmaceuticals, Inc. (“Vertex” or the “Company”) (Nasdaq:VRTX) between June 12, 2007 and November 2, 2007, inclusive (the “Class Period”).

    The Complaint charges that Vertex and certain of its officers and directors violated federal securities laws. Specifically, defendants’ statements regarding the development of Vertex’s HCV protease inhibitor, telaprevir or VX-950, for the treatment of hepatitis C and the PROVE 2 trial were materially false and misleading because they failed to disclose unfavorable data regarding VX-950 from the PROVE 2 trial compared to PROVE 1. Specifically, PROVE 1 showed that patients taking VX-950 experienced 16% greater total viral reduction after twelve weeks compared to the control group. The results of PROVE 2, which defendants did not disclose during the Class Period, showed an advantage over the control group of[u] only six percent. [

    When the truth was disclosed on November 2, 2007, Vertex’s stock price dropped from $31.64 to $24.08 in two trading days. If you are a member of the class, you may, no later than May 12, 2008, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a class member that acts on behalf of other class members in directing the litigation. Although your ability to share in any recovery is not affected by the decision whether or not to seek appointment as a lead plaintiff, lead plaintiffs make important decisions which could affect the overall recovery for class members.

    While Schatz Nobel Izard P.C. has not filed a lawsuit against the defendants, to view a copy of the Complaint initiating the class action or for more information about the case, class action cases in general, and your rights, please contact Schatz Nobel Izard P.C. toll-free at , or by e-mail at firm@snilaw.com, or visit our website: http://www.snilaw.com.
    This news release was distributed by PrimeNewswire, http://www.primenewswire.com

    This doesn’t mean I don’t want telepravir to be a success, just that I am a little skepticle of their claims.
    Love Ralph
    Geno 1a Waiting for SVR result in October.

  • http://hepcnomads.co.uk/phpBB3/index.php ralph salmon
  • Bonnie

    I am researching some new ideals for my husband who has undergone 2 treatments of traditional therapy. He just received the results for his 6 months check up and they were not good. I would like more information.
    Thanks

  • Gary M.

    I would be interested in trying this new drug. The interferon treatments didn’t work for me. I have liver cirrhosis and would like to be considered for a trial. If you can send me any more information it would be appreciated.

  • Bonnie Cunningham

    We would also like to know how to get on a clinical trail study. I work at a Medical Research Clinic and we cannot find a doctor in this community to be an investgator of a Hep C study. We know a lot of people who have Hep C.
    Thank you for your help

  • Daryl Chazak

    I have been following vertex 950 for some years and have been hoping at some point to be included in a clinical trial…. I am not sure who to contact. If possible could you forward me info. Thanks…

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Here are the places to look for current information on clinical trials from the National Institutes of Health, and from Vertex.

    NIH: http://www.clinicaltrials.gov/

    Vertex:
    http://www.vrtx.com/current-projects/Clinical-Trials.html
    Phone:
    877-634-VRTX (toll free)
    617-444-6777

  • wendy

    I was diagnosed in 1998 and have not received treatment. I am about to start the combination treatment in a month and was researching, when I discovered the new drug telaprevir. I have genotype 1, which I understand less than 50% are cured with the current therapy. I am very interested in getting more information on telaprevir and how long until it is in the US and if I should hold off and getting the current treatment.

  • Johan

    I have done 24 weeks of telaprivir and ribivirin ( hep.C, type 1 ). My viruscount is zero and from what I understand the doctors call me ” cured ” when the viruscount is still zero in 1/2 year from now.
    During treatment i just missed a few days off work due to calling in sick, though the treatment is tough ( for me ) some go through it without too much side effects.
    From my experience i would recommend to try the treatment if you can.

  • Karen

    Just did my 6 month blood test. The virus is still there. I am genotype 1 stage 3. My nurse had mention this treatment to me last Jan. I would like some more info and possible canidate for the treatment.

  • donny

    I have 5 weeks peg interferon + ribavirin treatment against Hep C. Genotype still on process to findout.
    Please give me some info’s regarding the medication methods. How to get teleprevir in Indonesia.Thk u

  • Mark

    I have had hepatitis c for 20 years. After having two liver transplants I still can’t get rid of my virus. I have tried everything. Hopefully I would like to take this new medication.

  • Jeff

    I have Hep C and,would like to find a way to be on the Telaprevire.Please contact me on how to be included.All the care I will get is through the VA.

  • Malikaz

    I have Hep C, Geno Type 1 since 2004 from a bad blood transfussion after giving operational birth to my baby. The blood transfussion was found to contain hep.B virus and I undergone an operation on my liver. I would like your advice on the treatment at my present state. I have done the RNA test and confirm to have Hep. C genotype 1 this month October 2009. My age is 24 years old.
    Please Help. Contact me by e-mail.

  • laura brown

    i have chronic hep c and cerrohsis i had 2 courses of interpheron therapy and i was a non responder.my platelet count is 37000 at this time i would like to be in trials
    dr. said i might have itp. thanks laura

  • stephanie sedillo

    would like to be update for your e-mail news on vx-950 for hep c.

  • SHIRLEY HARRIS

    PLEASE SEND ME MORE INFO ON THIS NEW DRUG FOR HEP C & ALSO PLEASE TELL WHEN IT WILL BE AVALIBLE FOR THE PUBLIC USE. THANKS

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Shirley,

    Here’s the Vertex clinical trial information toll free hotline, which should be up to date. You can also send an email to the following address:

    877-634-8789 or medicalinfo@vrtx.com.

    Vertex has said publicly that it plans to file its application for FDA approval to start selling telaprevir in the second half of 2010, as indicated in the link below. It will be up to the FDA if or when the drug ever becomes available commercially. The agency typically takes 10 months to review an application.

    http://biz.yahoo.com/e/091109/vrtx10-q.html

    Luke

  • Ron A

    I have tryed interferon twice. failed both times because of low platlets. I would like to try this also. I am starting a trail of eltrombopag this may be good to do both at the same time.
    Regards

  • Donny Widyatmoko

    Hi Ron,
    I got a hep c and have a anti virus (copegus) and pegylated interferon for 3 month. I got a low platelets in the progress and start to bleed. My doctor said, if I got a lower platelets, the dosage of the drugs should be decrease (some patients will have a hep c again in the future when decrease it’s dosage). So, I fight to my platelets.
    Since I was a kid, I was told that guava is a best food for my blood. I tried to eat guava and to drink it’s juice every day.
    Thks to God, now I got a normal platelets again and my medication still on going.
    I believe God always gives our best.
    bstrgds

  • Dave

    Hi Ron,
    Iam four years post liver transplant. I tried Pegylated interferon and Ribovrian prior to transplant. I was cear at one year, but the virus returned at six months. Three years after transplant the viral load was very high. After two months on Interferon and Ribovrian there was only a trace of virus, but I was unable to to tolorate the side effects. I would be very interested in more information on this new treatment.
    Thank you.
    Dave

  • D

    I am very interested in knowing if there are any trials/data available on post liver transplant patients. My son, 18, is only 18 months post transplant, and has been taking Pegysus and Ribovrian since 3 month post transplant. He is already in stage “2″ liver disease.

  • paige

    I have taken pegintron &ribavarin twice.The first time I had a relapse in 60 days.Started treatment again right away.Did another 24 weeks after, 90 days relapsed again.I have genotype 2b which is suppose to be most successful with the treatment.I thought I was rare but reading all this makes me feel better if anyone can believe that. Going for biobsy on 2/12.I hope this new treatment comes out soon.I’m 50.I figure I got this in the 70′s sometime.

  • Karen

    I am stage 3 HVC, did the treatment. Was undetectable after taking it. After 6 months tested again and the virus is half the numbers. Tested again another 6 months still the same. I am interested in doing the treatment.

  • nickki

    i have hep c – tried the pegasys and was told after three months my body wasnt responding and the doctor pulled me off of it. would like more info on this new treatment. would like to be in clinical studies if possible.

  • linda smith

    Please advise me of any current or futher studies that I can participate in.I am a non responder of rivarivin and peginterferon.Geno type 1 .Iam extremely interested in the use of a proteaser in particular teleaprivir.
    thank you
    Linda Smith

  • serge

    i have chronic hcv.had cirrhosis and liver cancer before liver transplant in dec 2008,recurrent hcv,genotype 1.non responder to pegasys ribavirin.1 course in 2004 for 3 months,2 course for 42 weeks after transplant/12 weeks peg+rib,30 weeks pegasys only/.i’m really interested to be in clinical trial.this is my last chance.many thanks.GOD BLESS YOU

  • ronald

    I have finished an 48 week treatment against HCV, Geno Type 1, with Telaprevir+Peg+Riba, in Sept. 2009.
    Side effects weren’t that hard.
    I was one of the 4-weeks-Placebo candidates (8 weeks Telaprevir only).

    +++ I’m HCV free now. +++

    HTH
    Good Luck !

  • maggie smith

    Hi there, My dad has chronic hep c..He now has a liver tumor 3.7cm..Im so scared we dont know if its cancer yet hasn’t been tested yet..But most likely it is since that happens when u have Hep C. He needs to have this trial done ASAP please someone help! Anyone that got the help with telaprevir please tell me your doctors name..I live in Co but would like to go to a doctor in CAli. My dad is all I have please have a heart and give us the connection on how this virus can be cured once and for all. Im giving my dad Apricot kernels just in case its cancer. It’s believed it can cure cancer and shrink tumors. Do your research on Apricot seeds I’m not saying it cures cancer I’ll let u be the judge of that by doing your own research. Email if u can help me with the Telaprevir don’t just say u got cured by taking the pills..Give us the connections to addresses, citys, doctors on where u got helped. thanks high_hopes112@yahoo.com