Vertex Maps Out Combo Drug Game Plan for Treating Hepatitis C

3/8/10Follow @xconomy

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the clinical trial that will test this idea. It will enroll 100 patients mostly in the U.S. The telaprevir dose will stay the same for everybody. Some will just get a low or high dose of VX-222, taken as a twice-daily oral pill, in combination with telaprevir. Others who enroll will get Vertex’s two experimental antivirals in addition to the standard pegylated interferon alpha and ribavirin.

The study’s primary objective is to measure safety, but assuming that checks out, Vertex really wants to answer two big questions in this study, Kauffman says. Can the antiviral combo treatment cure a satisfactory number of patients without having to subject them to the standard treatments? And can people be clinically cured in half the time with the new combination of antivirals?

How good is good enough? Kauffman didn’t give an exact number, but he noted that a little more than 80 percent of people in one previous Vertex study with telaprevir and the standard drugs have had undetectable amounts of virus in their blood for a full 24 weeks after completing their course of therapy. That’s what is considered a clinical cure, what is known medically as a “sustained viral response” or SVR. This new combo trial will ask that same question, and when the data comes back on SVR scores, it “has to be right up there” with the results from previous studies, he says.

Of course, the drug has to be well-tolerated, too, especially since it could be taken by millions of people with a chronic condition that isn’t immediately life-threatening. Telaprevir is known to be associated with skin rash, and the standard therapies are also associated with anemia. Vertex will want to comb through this data carefully to see whether adding another antiviral into the mix will add any new side effects, Kauffman says.

But the number everyone wants to see is a high SVR score among the two antiviral drugs alone. Enrollment in the study should be done by the end of June, and interim results should be available by the end of 2010.

“No one has proven the point that you can get an SVR without pegylated interferon and ribavirin,” Kauffman says. “It’s a leap that has to be made, and we want to be the first to make it.”

There are plenty of tough competitors chasing the same goal, although they are all attacking the problem in slightly different ways, Kauffman says. Bristol-Myers Squibb is developing a protease inhibitor to be used in combination with an NS5a inhibitor; Roche and its partners Intermune and Pharmassat are developing a nucleoside polymerase inhibitor with a protease inhibitor; and Gilead Sciences is also testing drugs from those two classes. Vertex is the only one testing a tandem of a protease inhibitor and a non-nucleoside polymerase inhibitor, Kauffman says.

Will two antivirals be strong enough together, or will somebody have to craft a cocktail with three different kinds of drugs to be potent enough? That’s still one of the unanswered questions that Vertex wants to know, Kauffman says. Others are sure to question the data that comes from a regimen lacking in the standard therapy, wondering whether those two drugs can produce a long-lasting cure, or whether the virus will bounce back. Vertex says it is confident that if its combo drug can eradicate the virus for 24 weeks after therapy, then it will have achieved a long-lasting clinical cure.

This trial will give Vertex a lot to think about as it prepares for the next steps of development in its antiviral combo. And this is all going on in parallel with three pivotal trials of telaprevir in combination with the standard meds. Kauffman oversees two separate medical teams at Vertex that have their eyes on the ongoing pivotal trials of telaprevir (which represent the present) as well as the telaprevir/VX-222 studies (representing the future).

“Vertex wants to be the leader in hepatitis C, so that means you always have to look ahead,” Kauffman says. “But you don’t want to take your eye off the ball either.”

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  • http://conomyboston cheryll

    If this is true , i know i would seek out the treatment,and try it. i have cronic hep c,but wont endurethe 12 month long sickness with only 30% chance of it helping.
    i would like to find out more about this treatment and how i can get involved in its use.

  • http://HEPCENTRAL rOBERT

    PUT ME ON TRIAL TEST TO SEE IF IT REALY WORKS

  • http://hepatitiscentral julie heizyk

    i would be interested having relapsed once

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

    Vertex has a hotline for patients who want to check into whether they are eligible for clinical trials. Here’s how to find more.

    http://www.vrtx.com/current-projects/Clinical-Trials.html
    Clinical Trials & Medical Information:
    Phone:
    877-634-VRTX
    617-444-6777

  • marvin lyons

    This is good news for the hep-c community. I hope and pray that it works. The interferon and peg cause me temporary blindness.

  • Michele

    My husband did the pegintron/ribavirin shuffle three times. The first two times the side-effects were miserable but his viral load dropped to undetectable for several months until it gradually returned. The third and last time he developed interferon psychosis, which leaves him with no current treatment option. A new combo therapy without interferon would be a life-saving dream come true.

  • Diane

    I hope and pray that a new drug therapy minus interferon will be developed. Was on the combo therapy and although everyone on treatment gets hemolytic anemia, I developed auto-immune hemolytic anemia, meaning my own white cells were targeting my red cells, caused by interferon. If anyone knows about non-interferon based trials, please post. I’ve got alot of living to do….

  • Sallie Little

    My son has hepatitis c and has a family of 6 total, and has to work. He cannot take the interferon and work. Is there anything he can take with the midication and still work? At this time he is not taking the medication!!!
    Thank you for your reply.

  • Patrick DeHart

    Hello folks, I am a Vietnam era veteran as well as a veteran of the year long Hepatitus C treatment in 2007-2008. I am so glad to hear about this good work that the research scientists are doing that I could cry. I went through the Ribavirin-Interferon treatment at the VA in Fayetteville, Arkansas. God bless their hearts because they are the best. However, I was labeled a non-responder which is just not true in my case. I was under 50 bugs per milliliter from the first viral load blood test all the way through the therapy. At the end, I was absolutely clean, no virus. I felt great and I even went back to college to finish my Degree which I’m still doing. Unfortunately, after six months, the Hepatitus C came back by a factor of Ten. The bottom line is that I am more than ready to try anything that has twice the cure rate and at only half the time of the miserable year that I spent on my couch. I have the best wife in the world and she helped me make the whole year. There is a staggering large vanguard of veterans from the late 1960′s to early 1970′s that have Hep C. Some believe that it was the poorly sanitized Jet Injectors (innoculation guns). In any case, I once again thank the researchers. Warm Regards, Patrick DeHart

  • Steve Walls

    Great stuff, a stand alone protease inhibitor is the answer.I hope the drugs companies give up on interferon and ribavirin, but you & I both know that drug companies never give up on drugs they have heavily invested in. Hopefully they will develop a conscience and develop the new therapies asap, as most people would get treated.
    There is an antibody that has been discovered which hopefully the drug companies haven’t bought & shelved, which clears hep c.Steve

  • cheryll

    great comments,i too wish “they” would wake up,and find a different answer, ihaven’t heard too many g ood stoires about the first type of treatment,alot of people areatillbeing used as guinie pigs it sounds like.
    I would love to help discover the cure of a med to help.
    I don’t understand how they ca nfind something for aides,and not hep c

  • kimellen

    This is wonderful news…if I weren’t in school, and already looking at joint surgery, I would absolutely enroll in the trial for this. I am still asymptomatic, and feel my health is better off for not taking the interferon/ribo proticol…I’m in the medical field and have done a lot of reading..if you maintain a healthy lifestyle…no drinking and drugging…your chances are good. But all other comments are right..its time for a cure!

  • Donna

    I am hoping and praying this is true. I have had Hep C for 27 years now and been through the trials of Pegalated Interferon and Ribavirin. It was hard! I was classified as a non-responder. I have been asymptomatic since then. I lost my dad and aunt this last year, both from liver Cancer due to Hep C. We all contracted it about the same time. My life style is good and has been for many many years but my test results keep getting worse. I am ready for that cure!

  • http://vertex wm. donner

    all i hear is about relapsing after treatment 6-18 mo after treatment. are there any people out there that are still clear of the virus 5+ years on? i never hear of any and am beginning to think it never goes away. great for the drug companies. am coming up on 24 wks of standard treatment plus first 12 wks were also with experimental drug. standard flu symptoms all the time, horrible eczema, and am feeling a little nuts and miserable to everyone. is it really worth it?

  • Cheryll

    I have been to difffernt sights,and i have heard of very few who the first treatment helped. unless thier viral load was low,seems to me they are still experimenting.
    it would be cool if we could some how get the government tosee out comments and actual results of the other verses different aproches.

  • http://Hep-C Robert

    I was diagnosed in 2008 my viral was low at 400,000 after 12 weeks of treatment it spiked to 1 million, I have also compensated scerosis, hep-c virus only lives 6 hours outside the body. These companies are bound to find the cure. I have also decided to start taking livercell for my liver. My doctor has told me that we will start treatment again, I also considered stem cell therapy

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