Biotech, Hepatitis C, clinical trials
Vertex’s Telaprevir Passes Test in Tough-To-Treat Hepatitis C Patients
Luke Timmerman 4/25/09
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 »
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.
4/26/09 10:26 pm
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
5/1/09 10:47 pm
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.
5/2/09 2:03 am
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.
5/5/09 2:12 pm
I would be interested in trying this new drug. if you can send me any more information on it please do so.
5/7/09 10:49 am
were do i sign up,i have liver cirrhosis and would like to be considered for a trial,please let me know thanks
5/10/09 3:44 am
I am also very interested in this new drug and would like to bwe considered for a trial.
5/13/09 9:26 pm
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
5/15/09 1:33 am
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.
5/17/09 10:30 am
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… :)
5/17/09 2:53 pm
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.
5/26/09 7:39 pm
50 yr old male with hep C, geno 3, am interested in trying this drug, where can i go and what can i do?
6/9/09 9:02 am
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
6/15/09 8:06 pm
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.
6/15/09 8:16 pm
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
6/16/09 5:51 pm
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.
6/16/09 7:27 pm
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.
6/19/09 8:37 pm
I have Hep c geno, 1 would like to try vertex,have low viral load count, please contact me with any info,God Bless
6/26/09 10:11 pm
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
7/1/09 2:26 pm
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?
7/7/09 8:00 pm
7/8/09 5:45 am
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
7/9/09 6:04 pm
“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.
7/9/09 6:15 pm
7/14/09 2:45 pm
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
7/15/09 5:16 pm
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.
7/15/09 7:33 pm
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
8/3/09 5:26 pm
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…
8/3/09 5:30 pm
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
8/30/09 11:24 pm
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.
8/31/09 5:22 am
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.
9/24/09 2:20 am
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.
9/29/09 4:01 am
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
10/8/09 10:27 pm
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.
10/20/09 4:08 pm
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.
10/26/09 10:10 am
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.
10/27/09 2:15 pm
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
10/27/09 6:42 pm
would like to be update for your e-mail news on vx-950 for hep c.
11/17/09 2:02 pm
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
11/17/09 2:23 pm
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
11/18/09 10:58 am
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
11/20/09 1:20 am
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