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FDA approves two new drugs to treat hepatitis C
May 23rd, 2011
06:35 PM ET

FDA approves two new drugs to treat hepatitis C

By the end of this week, adult hepatitis C patients will have access to two new drugs, to add to their arsenal in battling the viral disease that causes inflammation of the liver that can lead to liver failure.

The U.S. Food and Drug Administration approved Incivek (telaprevir) on Monday, and Victrelis (boceprevir) on May 13.  Both drugs are approved for use in combination with the two standard treatment drugs – peginterferon and ribavirin - for a three-drug cocktail.

Incivek and Victrelis are called protease inhibitors, which bind to the virus and prevent it from multiplying.

"There are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” said Dr. Edward Cox, of the FDA’s Center for Drug Evaluation and Research in a written statement. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection."

Clinical trials show that using one of the two new drugs in addition to the standard peginterferon and ribavirin drugs is more effective at eradicating the hepatitis C virus. Less than 50 percent of patients respond to peginterferon and ribavirin when taken alone.

The new drugs also have the potential to shorten patients’ treatments from the standard 48 weeks. In clinical trials, 60 percent of previously untreated patients using Incivek had an early response the drug, and were able to stop treatment after just 24 weeks.

Hepatitis C  kills up to 10,000 people every year in the United States through liver disease and liver cancer, according to the CDC.

More than 3.2 million Americans have the hepatitis C virus, which can be transmitted though blood exposure or sex with an infected person, through unsterilized tattoo and piercing tools, or from being born to a mother with the virus.

Incivek (telaprevir) and Victrelis (boceprevir) were evaluated in clinical trials using 2,250 adults and 1,500 adults respectively.


soundoff (36 Responses)
  1. klebinek

    If you're not familiar with Crohn's disease, read on, its worth doing for those who aren't familiar.
    http://crohnsdiseasediagnosis.blogspot.com/

    May 23, 2011 at 18:49 | Report abuse | Reply
  2. Missy

    Dear Just Saying,
    My sister got Hep.C from a blood transfusion back in the late 70's after a miscarriage, so have some sympathy please.

    May 24, 2011 at 08:36 | Report abuse | Reply
  3. Haveaheart

    Hey..just saying...that's pretty judgmental considering you have absolutely NO clue how any one individual contracts this deadly disease. Thank you for sharing your hate. My brother died 2 years ago waiting for a liver transplant as a result of Hep C which we discovered he contracted as a 17 year old kid getting a homemade tattoo with his friends in the park...kids being kids...any sympathy for him? Watch someone die from this disease...you might think differently.

    May 24, 2011 at 09:26 | Report abuse | Reply
  4. Mrs

    Just Saying, Obviously you know nothing about the disease and your stupidity and lack of compassion really shows. I suggest educating yourself before you post especially when you have no idea what you are talking about. These new medications will give some hope when prior treatments didnt work. I wish success on the patients that tried treatment and it didnt work. God Bless.

    May 24, 2011 at 09:36 | Report abuse | Reply
  5. Gracie

    Just saying-

    You must be a really unhappy person to make such comments. Were you not raised with any compassion? Do you believe that people who are infected with HIV/Aids deserve the disease? Just because a person injects drugs does not make them bad people. People become lost and depressed but perhaps you have never experienced any suffering because it sounds to me like you are a shallow individual who likes to pick on those who are suffering. I hope you or any of your loved ones never have to experience having to live with a painful disease.

    May 24, 2011 at 10:29 | Report abuse | Reply
  6. John

    Just saying, I have this disease and have never used recreational drug needs, nor have I had a blood transfusion. The doctors I have been to are baffled about how I contracted it almost 20 years ago. Before you "just say", educate yourself beforehand.

    May 24, 2011 at 11:45 | Report abuse | Reply
    • Noname

      There is one heck of a lot that is not known about HepC. The blaming everyone of " IV drug use" is so inept. As you have pointed out HepC is not a "one size fits all" explaination as to how someone contracts it. I am a person who has NOT been a drug abuser also and yet I have HepC. I can empathise and I have my theories, my work put me in a position to contract it but how do you prove it? It certainly won't matter to a teabagger once my working life was over! May they suffer a simalar fate of uselessness.

      May 24, 2011 at 21:49 | Report abuse |
    • Elizabeth

      Noname: I hope that you find a cure and relief of your suffering. The "teabaggers" are already useless, or worse than useless: they collect welfare such as tax breaks for oil companies, and take away money that could help others to work. The "teabaggers" are useful for one thing though: because of them it is easier to believe in hell.

      May 24, 2011 at 23:45 | Report abuse |
    • Rob

      I have Hep-c myself,
      I had no idea that I had this horrible disease until I gave blood at a blood drive back in 2001 to help 911 victims.
      The Red Cross informed me by mail and said that they couldn't except my blood that I had the HCVS virus and should see a doctor ASAP. So my Fam. Doc. referred me to a gastroenterologist who tested me and preformed a liver bypass on me.
      After the test came back he stated based on the amount of scaring I had on my liver that I had contracted it approx. 10 years earlier.
      So after finding what the risk factors were and possible ways to contract it. I had done any of these things or ever had a transplant. So one day my gastroenterologist ask me if I was ever in the Military and low and behold I was a desert storm vet.
      So because of a pending legal case I wont get into details about this, but like so many other victims I wasn't a drug user or any of the other things that the very uneducated people in the world associate someone who's has Hep-C with. Its nice to be able to just sit back and judge people while not having a _ucken clue what they are talking about.
      So now 20+ years later I'm total disabled and a single father of a 16 year old daughter who has to see me deteriorate in front of her eyes. I'm not doing a poor me thing its just a really bad disease that doesn't get enough attention. So good luck to all victims & their family's, stay strong get counseling and try to enjoy life before you get to sick and cant do anything.

      May 25, 2011 at 06:28 | Report abuse |
  7. MikesOpinion

    Just saying....
    My 53 year old sister contacted it through a blood transfusion over 20 years ago. She died 3 years ago this June. I pray you never go through the suffering she and her family did with this disease. Perhaps you'll have more compassion then and not ne a total @55 hole.

    May 24, 2011 at 12:17 | Report abuse | Reply
  8. Jefri

    I have this nasty disease also, which I contract through getting a pedicure at a Vietnamese Nail Salon.
    It is the nastiest virus –

    May 24, 2011 at 12:41 | Report abuse | Reply
  9. spain4972

    For those that do not know i got this disease from a small monkey when bitten overseas working on a power plant we were on days off went into the jungle to see the wildlife and i was feeding one and the other didn't like it and bite me on the forearm still have the scars to prove it LOL so don't think just junkies get this disease that shows your stupidity its best you keep your mouth shut if your not in the know for those that don't know how you got this disease think carefully back through your life you will remember something a rusty nail, animal bite cut buy a barbwire fence , its not always connected to drugs that's like saying only gay people get aids.

    May 24, 2011 at 12:55 | Report abuse | Reply
  10. schedir

    I was in a heroin addiction and managed to get myself clean after years of pain. No one wants to end up in addiction, your comment is just sad, but does not surprise me. I had to learn in my time there would be people with views similar to your own. The only way I learned to deal with people like you who hate me just for the fact of being a "junkie" at one time, is to hate them as well 2x as much.

    May 24, 2011 at 13:26 | Report abuse | Reply
  11. CrissyLiz

    My mom got it prior to my birth. Which means I was exposed. I have tested negative for it but how on earth would this have been my fault. You should probably do some research before you make a blanket statement like that.

    May 24, 2011 at 13:51 | Report abuse | Reply
  12. broken

    My baby is a "junkie" and although this is not the life I would have chosen for her....she is a human being and is someone's daughter...mine. And she is loved and trying very hard to beat her addiction. You...on the other hand would be very hard to love...even for a mother...

    May 24, 2011 at 13:53 | Report abuse | Reply
  13. MMAL

    My husband has Hep C & he's never used drugs. So you really should, as many people have said, educate yourself before you make such comments. He has no idea how he acquired it. He has had a liver transplant and has done wonderful, but still has the disease. I hope that he can get on these new drugs & possibly get rid of his Hep C forever! He didn't do anything to deserve what he has. Its just something that happened. Have some compassion for people!

    May 24, 2011 at 14:46 | Report abuse | Reply
  14. Phillydan

    Just saying, my nephew was in a very serious car accident several years ago and via a blood transfusion contacted Hep C.
    Nothing I hate more than a person like you who doesn't know anything about anything, but feel the need to make it clear that you know nothing by writing a stupid comment like above. I would tell you to get educated, but nothing is going to change how your hateful mind thinks.

    May 24, 2011 at 15:12 | Report abuse | Reply
  15. and another thing...

    I contracted Hep C from blood transfusions needed for complications after a C section. I was lucky, 2 years and 2 difficult courses of treatment recessed the virus. However, as a result, my liver is a mess and requires expensive semi – annual testing that I will be committed to for the rest of my life.
    I am so grateful that these new drugs have been approved for those who are battling the disease and who standard cycles of treatments have not worked. Thank you to the scientists and doctors who developed these drugs after years of research. This is a milestone for treatment of a disease that is affecting more and more Americans but, surprisingly, is not talked about much.

    May 24, 2011 at 18:04 | Report abuse | Reply
  16. Paramecium13

    "Incivek and Victrelis are called protease inhibitors, which bind to the virus and prevent it from multiplying."

    That is a terrible explanation of a protease inhibitor. A protease inhibitor prevents the virus from putting the final touches on its proteins before it leaves the cell it replicated in.

    May 24, 2011 at 19:56 | Report abuse | Reply
  17. MZ

    I underwent an unfortunately unsuccessful combo therapy regimen (Interferon/Ribivrin) for Hep C almost 10 years ago, and have been waiting (sometimes not so patiently) for the release of drugs with a higher efficacy. It's taken this long to get these drugs through the ludicrously lengthy FDA clinical trials and approval process. I wonder how many people died of this insidious virus in that time. Is anybody looking at ways to improve this process?

    May 24, 2011 at 22:50 | Report abuse | Reply
  18. Kate

    My husband had Hep C for 32 years. Died 12.4.11
    Liver disease is an awful way to die.

    May 25, 2011 at 07:50 | Report abuse | Reply
    • Dan

      You can see the future?

      May 25, 2011 at 16:48 | Report abuse |
  19. Nancy

    Reading all of the above comments in response to statements made by an ill-informed and small-minded person reminds me yet again how easy it is to spew comments like these and have some people take it as gospel!! How sad. My son has Hep-C thru no fault or action of his own and so now he and all his loved ones are living with the disease. He is being treated with what is currently available and all we can hope for is that the new medicine will soon be available. Perhaps some of the high-rollers in this country who are receiving huge tax breaks would like to donate some of their windfall to medical reseach. If you believe that will ever happen, I have a great bridge I'd like to sell you.

    May 25, 2011 at 14:32 | Report abuse | Reply
  20. Dan

    Have any of you thought about the cost of these drugs? What if you don't have insurance? I can guarantee you they are over $1,000 a month. Would you like to know why? Because the pharmaceutical industry is not held to any standard when it comes to drug pricing. The government does nothing and LITERALLY allows drug companies to charge WHATEVER they want. Look into it. Research the GAO's fight against Merck over 25 years ago. Even CONGRESS is not allowed to know how big pharma spends their money. They claim it's all R&D but it's all marketing. R&D is nothing because they let biotech firms and universities do the research, then they buy the research and sell it for whatever they want. The top 10 drug companies in America on the Fortune 500 list make more money than the other 490 COMBINED!!!

    May 25, 2011 at 16:47 | Report abuse | Reply
    • pharma05

      Vertex is giving their drug away for free to those that are uninsured and make less than 100k. Do your research before shooting your mouth off.

      May 25, 2011 at 19:08 | Report abuse |
  21. pharma05

    I have worked at Vertex (maker of Incivek) for the past 5 years. I cannot explain how happy I am to work for a pharmaceutical company that has pushed so hard to make a medicine that can transform lives. It has been exciting to see how much of an impact this drug can make for someone who has had the heartbreak of being unsuccessfully treated before.

    May 25, 2011 at 18:09 | Report abuse | Reply
    • RAENDO

      WHERE IS YOUR INFORMATION OTHER THAN A MOUSE
      . I CANT FIND IT .THATS REDICULOUS

      May 28, 2011 at 13:30 | Report abuse |
    • RAENDO

      AT LEAST YEA THAT COMP. SAID THEY WOULD TRY HELP PEOPLE

      May 28, 2011 at 20:45 | Report abuse |
    • BJ

      MY SON HAS HEP C HE IS ON AHCESS ARIZONZA'S MEDICAID HOW CAN HE GET HELP WITH PAYING FOR THIS NEW DRUG ?

      November 4, 2011 at 10:49 | Report abuse |
  22. Aardvark

    My father got Hep C from tainted blood during open heart surgery and 20 years later has Liver Cancer. He was not a junkie or a druggie. He is now waiting for a liver transplant, which he was recently turned down for at one hospital. This is agony for our family, we are watching him wither away. He eats very little and sleeps alot, no way to live. Please think before you post cruel things.

    May 26, 2011 at 07:22 | Report abuse | Reply
  23. RAENDO

    WHO CARES HOW YOU GOT IT , THEY ARE TELLING YOU HOW TO AVOID. THERE IS A CURE TO SLOW IT DOWN BUT PEOPLE CANT EVEN BUY IT .. THE PRICE IS BEYOND BELIEF. 40000- 48000 TO TREAT FOR 12 WKS . THAT
    CURE NEEDS TO BE FUNDED TO SAVE LIVES .BOTTOM LINE. PLEASE HELP FUND THE PRICE TO SAVE A LIVE J&J YOU NEED TO STEP UP FOR ALL THE PRODUCTS WE BUY

    May 28, 2011 at 13:26 | Report abuse | Reply
  24. scared.

    this whole fourm gives me an uneasy feeling. I'm 22 years old, contracted hep c at 20, and haven't even got to see a doctor. I did contract the diease from intrevenous drug use, but l don't believe that I shouldn't recieve any help. Regardless of how we got it, i think we all deserve a chance. I have a three year old daughter that depends on me. and sometimes im so tired that i cant move. I had my liver checked, and ultrasound twice, and it's progressivly getting worse. it's scary to see all these comments, makes me feel hopeless. Oh, ive sinced completed a year long treatment program and have been clean for 14 months.

    June 8, 2011 at 23:06 | Report abuse | Reply
  25. Robbie

    Rob, I too contracted HEP C, mine was from bad blood transfusions after a severe care wreck in 1984. It wasn't until a routine physical in 1995 that I found out that I had been carrying this dragon around in me for 11 years and my HEP C was now Chronic and nothing to do but try and get a Transplant. So that is what I set out to do. I contacted the best Hepatologist at UCLA and after 10 years of getting so sick that I actually died twice on separate occasions, and luckily I was brought back both times. When it was ADVISED by Doctors at my local hospital that I should only have a few days left, that is when I finally got my transplant. That was April 23rd, 2005 and I am back doing what I love and alive! I wish everyone on here the best. PLEASE do not ever give up! That is the ONE THING that kept me going was my stubbornness! May these new drugs really work and SLAY THE DRAGON that is HEP C in ALL ITS FORMS and GENOMES!!!!

    June 9, 2011 at 04:09 | Report abuse | Reply
  26. Ana

    I pray for all of you posting on here and even for those making ignorant comments that they might see the light and find compassion. For those who say whoever is making these comments is a Teabagger, I don't think that is the case since I am a conservative and would never blame anyone for contracting a disease, no matter what it is. I had a neighbor, a young man who died of AIDS, and even though that was over 20 years ago I still think of him. It really broke my heart when he died. Talk about a horrible disease! He went from a vibrant young man full of life to someone who looked like he just been released from a concentration camp. What a terrible waste of a beautiful young life.

    July 27, 2011 at 04:45 | Report abuse | Reply
  27. BJ

    HOW CAN A PERSON ON MEDICAID GET THESE NEW DRUGS ? AT LEAST GET SOME FINANCIAL HELP TO PAY FOR THEM. PLEASE RESPOND TO MY E-MAIL THANK YOU BJ

    November 4, 2011 at 11:02 | Report abuse | Reply
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