Vertex Drug for Hepatitis C Shows Durable Virus-Killing Ability in Tough-to-Treat Patients

11/1/08Follow @xconomy

More data is rolling in from Vertex Pharmaceuticals on its lead drug for hepatitis C, and it looks like the medicine is continuing to live up to its own high expectations. The Cambridge, MA-based company said today that telaprevir’s effect on killing the virus is remaining durable on follow-up analysis, and the drug appears to just about as good in a more convenient twice-daily pill form instead of its standard three-times-a-day dosing schedule.

The data dump came in front of a prime audience of physicians attending the American Association for the Study of Liver Disease annual meeting today in San Francisco. The results appear to match up pretty consistently with what Vertex has reported previously, which I wrote about in this advance story.

To recap what’s at stake, telaprevir is aiming to be a first-in-class protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease. An estimated 3.2 million people in the U.S. have hepatitis C infections, and about 170 million have it worldwide. Telaprevir must be taken with a pair of standard drugs, pegylated interferon alpha and ribavirin, which cause flu-like symptoms and must be taken for almost a year. The Vertex drug is highly anticipated, though, because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and in half the time. If approved, the product could generate $2.6 billion in U.S. sales in 2013, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.

“These are strong and striking early results,” says Freda Lewis-Hall, Vertex’s executive vice president for medicines development.

In the spirit of helping you keep all this data straight, because there’s a lot of it, we’re breaking this down into bite-size chunks. .

—The ’107 study. This trial of patients who didn’t respond to previous treatment, produced data from more patients who were followed over a longer period than was previously reported. Researchers found that 68 of 104 patients, or about two-thirds, who got telaprevir along with standard drugs had no evidence of the virus in their blood after four weeks. That effectiveness appeared to be long-lasting. Researchers found that 41 of 71 patients (58 percent) followed for 24 weeks still had no evidence of the virus in the blood. Importantly, telaprevir is showing that it can wipe out the virus about 43 percent of the time in the toughest patients of all to treat—those who didn’t respond at all to a prior round of therapy.

The last time Vertex reported results from this trial, at a European meeting in April, it didn’t have any follow-up data that extended this long, or such strong data for what are called “null responder” patients. Of course, there were side effects, though. About 8 percent of patients dropped out of the study because of adverse events, with about half of them quitting because they developed a rash, the company said.

—The C208 study. This trial is about convenience for patients. Telaprevir is designed to be taken three times a day in combination with standard drugs, and its ongoing final-stage clinical trials are enrolling patients on that dosing schedule. But the company also wants to know if it might be equally good in a more convenient twice-daily form. The results of this study suggest it could be. Researchers found 76 of 82 patients (93 percent) had their virus completely wiped out in the blood after three months on the usual telaprevir-containing regimen, while more than 80 percent in a comparison group did that well on a twice-daily telaprevir dose. “The question is do we continue to study twice-daily regimens based on what we see? The answer is yes,” says Lewis-Hall.

—Prove 3. Not a lot of news on this one. The Prove 3 study of telaprevir for patients who failed on previous therapy, first released in June, found that 60 of 115 patients (52 percent) who got the Vertex drug along with the standard drugs had no signs of the virus after about three months of follow-up after finishing treatment, the company said. That number is consistent with what Vertex is reporting to doctors at the liver meeting. It notes that 34 of 114 patients (30 percent) in a control group taking the standard meds had undetectable amounts of virus in the blood after they were three-quarters of the way through their nearly yearlong course of treatment. The true test of what’s considered a “clinical cure” is when patients have no sign of virus a full 24 weeks after they finish treatment, and that data isn’t yet available for release at this meeting, Vertex says.

About 16 percent dropped out of the Prove 3 study early because of adverse events, while just four percent of patients in the control group quit, the company says. In the final analysis of the Prove 2 study, which enrolled patients who were new to treatment, about 14 percent dropped out because of adverse events, compared with half that many in the control group.

When looked at altogether, Vertex now has more than 1,000 patients who have been analyzed for the safety of its drug.

Based on my conversation with Vertex’s chief commercial officer, Kurt Graves, heading into the meeting, it doesn’t seem like this data will surprise physicians who have been following the telaprevir story. He sounds like he’ll be keeping an eye on competitors like Schering-Plough’s boceprevir and other types of antivirals in development, like polymerase inhibitors and NS5A inhibitors, which might be combined with telaprevir. We’ll keep a close eye on this to see if anybody makes any big steps forward or back.

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  • http://veragroves vera groves

    hi my name is vera and I have hep c and I have toke all the treatment there is and it did not help so I hope that I can get this study and try it so please give me all help that you can with that vertex I would like try it .

  • jim

    i also would like to volunteer for the study. i have been doing the trials since 1995

  • http://nil zahid

    my friends wife is suffring with hapatitis c since last five years,she took interfran injection course also but after that her hepatitis c lab report is still positive.plz help her in this regard ,how she can get vertex drug as she livs in pakistan,and i want to know more about this,thanks,

  • Bob

    Hi
    My name is Bob,I am a Pastor and I have Hep C. I would be willing to volunteer for the study. I don’t drink or smoke and I have never had therapy before. I am 55 years old. Thank you for you consideration. Bod

  • Sam Carroll

    Sam, Hi I just finished my 12 week on Interfearon, after blood work results I’m told my viral load # is out of range & was discontiued from treatment. In twelve weeks it went down from 423,000 to 97,000 still not good enough for them, Right now I still have three week of medicine left, And plan on taking that untill gone. So both Ribivin & pegasys are still at full strenth in my system, I think that I would be an excellant canidate for your Vertex study, Thank you for any help you can give me………….

  • http://xconomy Daniel Finnan

    Hi,My name is Dan and I’ve had Hep c since 1995.I’ve never been treated accept for taking colodial silver for the desease.I am a 49 year old male and would like to volunteer for the study. Thank you for your consideration.

  • Karla Lair

    Hello, My name is Karla, I was diagnosed with Hepc in 2000 while pregnant with my son, you can imagine how devastating that was for me, I went into a deep depression for a few years in denial and finally underwent treatment with interferon and ribavarin. Unfortunately, it was no help. I live in Cedar Hill, TX and I would like to become a candidate for the trial drug. Thankyou for any help you can offer me.

  • Eric Gustafson

    Hi Luke,

    Thanx for your reports regarding Telaprevir.
    Perhaps I could be of assistance in the proving of this new product. I am a 54 year old male who was diagnosed with HepC Type 1A in October of 2006. High viral counts are evidence that the virus has been active in my system for many years. Since discovery of my ailment I have been reporting to my gatrointestinal specialist regularly 4 times a year for a blood draw and analysis. A liver biopsy in November of 06 revealed minimal damage with no bridging and ultra sounds reveal nothing worthy of remark.

    Blood draw of 2/5/09 indicated ALT of 47
    Viral count: HCV RNA PCR was 3,160,000 IU/ml
    6,320,000 copy/ml.

    I have received no treatment to date aside from 2 months of Ursodiol, observation and total abstinence from alcohol.

    I can be contacted by email should I be considered a valuable candidate for study.

    Sincerely,
    Eric Gustafson

  • john ferrante

    Approximately 4 years ago I went through a 7 month interferon bout with no visible success. I do drink moderately and after the unsuccessful bout with interferon I began drinking again. I since have quit drinking and would be game for trying telaprevir for study. I am told by my doctor that my Hepatitis C is a tough kill. Like to find out if that’s true.

  • Faith Jewett

    Please send me information on Telaprevir thank you

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

    Here are a couple of places to look for updated information on hepatitis C clinical trials.

    NIH database on clinical trials:
    http://clinicaltrials.gov/

    Vertex:
    http://www.vrtx.com/current-projects/Clinical-Trials.html

    Phone:
    877-634-VRTX (toll free)
    617-444-6777

  • http://janis7hepc.com/hepatitis_c_research.htm Tina Myer

    Just wish to point some of you in the right direction.
    Getting into a trial can be most certainly a life altering experience.
    Some members in our forum have been in the Vertex Trial and have cleared the virus / still clear 6 months after completing treatment or SVR. Cured by some standards.

    You may wish to talk to our friends in our chat room or on our message boards.

    If you go to our “Treatment Stories” Section of our site you will be able to follow some of these people. Because we have so many people clearing the virus on standard HCV therapy and new therapies not all of them are documented on our web site.

    Our site has been around since 2001 and I
    myself cleared the virus SVR in a trial back in 1999.

    We have more then a few people that have treated successfully with the New Inhibitors since 2008. Some of these people are even in the follow up studies.

    Hope we can help

    Tina @ Janis and Friends Web Site and Blog

    http://janis7hepc.com/index.htm
    http://hepatitiscnewdrugs.blogspot.com/

    Hepatitis C/Swine Flu/ H1n1 / The Information

  • Ray Carsjens

    I have went through treatment 2 times. Once in 2001 for 11 months rabivirin and 1 weekly shot, second time shots everyday for 11 months with pills, and still had to be taken off just short of completeing TX, with a viral load of millions of millions. I am waiting to start Vertex pills Jan 4 2010, please anybody email me if you have tried these tabs, I want to know side effects ect.
    661 366 3089 I went through hell both times in Treatment.? Love you all God be with all fof Us. Thanx Ray

  • Daniel Finnan

    I have undergone 21 weeks on pegases 1 and two but had an alergic reaction by the 21st week.I broke out in hives,had phscological difficulties and was taken off in 2010.My viral count has doubled since.It would be great if I were to be concidered for the Vertex study.

  • tony perg

    when will telaprevir be approved for use in u.s.a. ?