Vertex’s Telaprevir Clears Hurdle, Could Halve Treatment Times for Hepatitis C

8/10/10

[Updated. 8:55 am Eastern time. See editor's note.] Vertex Pharmaceuticals’s (NASDAQ:VRTX) lead drug candidate for hepatitis C infection has passed another test. The Cambridge, MA-based company, which has West Coast operations in San Diego, says today that it now has proof that its drug in combination with standard therapies can wipe out the chronic liver damaging disease about as well in 24 weeks as in 48 weeks.

This supplemental Phase III trial, “Illuminate,” gave 540 patients who had never been treated before for their hepatitis C virus the experimental drug, telaprevir, in combination with standard treatments pegylated interferon and ribavirin. In the pool of patients who got the drugs for 24 weeks, the virus was wiped out in 92 percent of patients, while the disease was cured in 88 percent of patients in the 48-week trial arm. Those two pools of patients were those whose virus was not detected at weeks four and 12 of the study. The combination of drugs killed the virus in 72 percent of all patients in the trial. Nearly 7 percent of all patients in the study dropped out because of side effects of the treatment such as fatigue, itchy skin, and nausea. Other patients were either not cured with the telaprevir-based therapy or were put on only the standard treatments after taking telaprevir for 12 weeks. (Editor’s note: This paragraph was augmented to provide additional details about the patient groups in the study.)

These data are expected to be part of the company’s case to gain U.S. and European approval of telaprevir and begin sales next year. This study also follows and confirms the company’s more important results in May from its first pivotal Phase III trial in which telaprevir in combination with traditional therapies wiped out hepatitis C infection in three out of four patients. The next big test for telaprevir will be the second pivotal study of the drug in patients whose disease could not be cured with traditional treatments. The results of that 650-person trial are due to be released in September.

It could be a big deal for patients with hepatitis C virus to be able to be cured of their illness in 24 weeks, or half the time they would take traditional therapies for the disease. The existing treatments often cause flu-like symptoms that make taking them an ordeal for patients, many of whom decide not to continue the drugs. “Patients who had a rapid response to telaprevir-based regimens at weeks four and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy,” Kenneth Sherman, a principal investigator in the study out of the University of Cincinnati College of Medicine, said in the Vertex release.

We’ll see how Wall Street reacts to data from the Illuminate study today, since much of the results only confirm what was shown in the larger pivotal trial of more than 1,000 patients back in May.

By posting a comment, you agree to our terms and conditions.

  • Dave

    What are the results for someone that has gone through traditional treatment and the Hep C came back? Will this new treatment work for them? If it will work for someone like that when is the soonest availability for treatment?

  • Lisa

    This is what it said in the article: “The next big test for telaprevir will be the second pivotal study of the drug in patients whose disease could not be cured with traditional treatments. The results of that 650-person trial are due to be released in September.” I am hopeful of those results as I have done 6 months of interferon/riba – no response. 6 months of peg intron/riba and no response. I then did 1 full year of daily injections of infergen and riba – did receive response, but within a month the virus was back. As soon as this is out – I am on it! I am hopeful it will work this time – I have stage 4 cirrhosis, but still in pretty good health. I believe if all goes well, this should be on the market by spring of 2011. Everyone have faith!

  • Ruth

    My genotype 3a, Hep C, went undetectable after 24 wks Pegasys/Copegus, but it was detected, 24 wks later. I wonder how well combination treatment plus Telaprevir, will work on responder/relapsers like me?

  • Larry

    I am super excited about this new medicine breakthrough. I have went through 2 treatments with the virus (genotype 1) disappearing both times and unfortunately reappeared both times. Once this new medicine is approved, you can count me in for the treatment. Hopefully this time it will keep the virus away.

  • Robert

    I was going to start treatment next month but my Gastro told me to wait for telaprevir.
    I still dont have cirrhosis but i hope it comes out soon and that i can afford the treatment.

    T

  • kathy

    I am so excited about this. genotype 1a. been on 2 standard treatments that did not work. was on a drug study earlier this yr for another drug but was kicked off after i showed a rash. wish i had not done that, but God works in his time & ways. so it must have have been a good thing. so now waiting for the new drugs.. i will be on it come hell or high water.. :)

  • LUzhimeng

    I agree the telaprevir with Peg-IFNIFN-α2a might be improved the EVR & SVR,and suggust only in the early period,Becauce decrease the telaprevir association mutation.

  • cilena upegui

    My mom has not been able to handle the interferon treatment for two times. She lives in Colombia South Americawe and her doctor told her about the Telaprevir. We were really expecting the new drug for December 2010 but her doctor told her that it won’t happen. He mention that the treatment was a posibility here in USA. How can I put my mom in the list of candidates to try this new treatment? I am desperate and I feel that we are running against the clock. Please I need help..I live in Charlotte, NC. Thanks..

  • Debra

    does anyone know when this drug will be available in the USA? How could someone get in the trial group for the new treatment?

  • Renee

    The article does not mention the type of HEP C they are treating. All of us with gen type 1 know there’s little out there for eradicating this type of HEP C.

  • http://xconomy.com Patti D

    I still have not let any of the doctors do anything to me yet, aside from ultra sounds and bloodwork. I am waiting to try to get into the next trials? I pray daily that I will be one of those people that is cured, so I can live to see my children marry and have children! If it takes money, I won’t be able to, if it takes being brave, I can and will be able to!

  • Angela

    My geno-type is 1a, I’m an African American women. The pamplets I was given, while in treatment, stated on standard treatments only 25% of African Americans responded well to standard treatments and most were women, the pamplet also stated they didn’t know why African Americans didn’t respond well to standard treatments. I took the treatment anyway, I was on the combo treatment, taking Peg-Interferon and Ribrovin for 24 weeks. I responded well, and acheived 0 viral load. The side effects were so bad during my treatment. I had to take off from work for 5 months, I could not drive I was so fatigued all I could do was lay down and the weight lost was bad, can you imagine a 6ft woman weighing 150 pounds not a pretty site, and I had no desire to eat at all, I couldn’t taste food. When the depression came, I was removed from the treatment, not being able to reach the 48 week goal. My question is, if I was not able to stand the side effects of the standard treatment, will the side effects of this treatment be less for people to be able to stay on the treatment?

  • http://hcvsupport.org tiny t

    I watched as a few of the third time is a charm folks went through this trial and they have not yet relapsed after the Teleprivar – thank god. go to this site for support through your treatment – It is a godsend. My Boyfriend just finished tx for the second time and could not continue and yes relapsed, but is now waiting for the Teleprivar – Seriously HCVsupport.org is where I got to this link… Treatment of all kinds are supported here… so much information and so much help

  • SAMUEL FRAZIER

    About five years ago,I got terrible ill. Lost 60lb. After many try this try that with my Doctor.I told him if you can t figure out what this is send me to some one who can.After much more Lab work Hep C was diagnoised.Completed 12 months of treatment.With occasional week off.Read {0} virus,6 months later virus was back.Have been living as healthy as I can fearing every little pain maybe beginning of the end for me.I check all I can for next new treatment.This gives me new Hope.HOW can I get on the AS SOON AS POSSIBLE list for this new treatment.I pray nightly for a cure. And give thanks for every day I make it closer to a CURE.

  • Pam E

    Iam waiting for telaprevir to be approved.my doctor thinks this might be the one,,,,

  • jane

    having done 48 weeks for genotype 1a I see doc tomorrow for results of 6 month check Felt good and confident first 3 months but not so sure now. Reading internet most of us types relapse in 6 months……..so I am very keen to find out more about telaprivere in australia.

  • t.demine

    had liver transplant 5 years ago. still have the hepc.drs. will nor treat due to reoccuring hepc,cirrhosis, and bile duct complications. would be willing to try just about anything.
    actual transplant wasn’t bad but i developed the extra problems i.e. diabetes,low platlets,fatigue. good luck to all.

  • Dr Saim Jamil M.phil

    I think 24 weeks is still a long time to cure a patient with injured liver as this organ has the great capacity to heal itself or regenerate when needed. A person suffering from liver injury is already immuno compromised and in such a situation long term bioavailability of medicine in the blood, metabolism by the liver and excretion by the kidneys harms the kidneys and other body tissues as well specially Nervous and Epithelial tissues. Most probably the patient may undergo other pathologies and disorders. No diet regimen is prescribed which is required a lot. No life style is prescribed which a hepatic patient must lead. According to my research 50% is the role of diet in curing a patient 25% is the role of medicine and 25% is the lifestyle emotions, psychologic and moral approach. Medicine only channalise the body and excrete out. It is only food which transformed into blood and then becomes part of the body. By taking care of all these factors patients can be cure in less time as compared to forcing them to take only medicine for the long time with all the unhealthy food moral-less activities and liquors and norcotics. As long as we dont take care of all these three factors there will be no cure or recurrences of HIv,Hep C and other auto immune diseases as practiced by most of the people.

  • Pingback: Telaprevir Improves and Shortens Hepatitis C Treatment | Hepatitis Central