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FDA panel recommends approval of new hepatitis C drug
April 27th, 2011
06:38 PM ET

FDA panel recommends approval of new hepatitis C drug

A new treatment for hepatitis C could soon be on the market if the Food and Drug Administration takes the advice of an advisory committee.  The committee unanimously approved the first of two new drugs to treat chronic hepatitis C genotype 1 infection.  Hepatitis C is a chronic viral disease that causes inflammation and swelling of the liver.

The drug, boceprevir, is a new class of protease inhibitor manufactured by pharmaceutical giant Merck & Co., and would be used in combination with ribavirin and peginterferon–the current standard of care. Boceprevir prevents the virus from replicating, and studies show the three-drug cocktail is more effective than the two-drug regimen.

According to Merck, about 66% of study patients that hadn't been treated or did not respond well to current treatment responded well to boceprevir.

The FDA's outside panel of experts considered the risks and benefits of the drug and determined the benefits far outweigh the risks.

"The benefit for the people who do achieve sustained virologic response  is fantastic," said Dr. Elizabeth Connick, University of Colorado Denver. "This is a miraculous advance."

"The risks are not trivial, but we do know how to manage these risks. Still, there is a lot to learn about using these drugs appropriately," said Dr. Thomas Giordano of Baylor College of Medicine.

"This is going to be a real game changer for our hepatitis C practices, " said Dr. Barbara McGovern, Tufts University School of Medicine. "I can't wait to get back and talk to my patients about it."

Even hard-to-treat patients like African Americans, and people with HIV and diabetes responded extremely well to the boceprevir combination therapy.

Dr. Nizar Zein, section head of hepatology at the Cleveland Clinic says the disease is of epidemic proportions and quite costly. Zein say the new medication will usher in a very important new era for treating the disease.

"We can now say for the first time that we can cure hepatitis C," Zein said. "We are talking about complete cure, cure for life. Several studies have shown that once you achieve that endpoint, the sustained virological response, you will not get hepatitis C ever again and the risk of getting cirrhosis, needing liver transplant will go down substantially."

But this is a powerful drug and a major concern is that drug resistance can develop in patients very quickly if the medication is not taken properly. The proposed dosage is 800 mg three times a day with food.

Treatment can be individualized but Zein says both doctors and patients need to be educated and clear about when and how this drug is to be taken. "If used inappropriately, the virus will rapidly develop resistance to these medications – rapidly, I mean 24 to 48 hours."

Close attention was paid to the drug's side effects. The most common, according to Merck included anemia, abnormally low white blood cell count, fatigue, nausea, headache, hair loss and an impaired sense of taste.

According to FDA's Dr. Poonam Mishra, the most notable safety concern is the additional decrease in hemoglobin– the protein in red blood cells that carries oxygen. Hemoglobin levels lower than normal could mean anemia, bleeding or a number of other conditions. Mishra said anemia was managed effectively during the clinical trials and was reversible after the drug was discontinued. Only a few serious and life-threatening infections were reported.

Martha Saly, director of the National Viral Hepatitis Roundtable, who learned that she had hepatitis C  in 1998 and was successfully treated with interferon,  said even though treatment will be extremely challenging, for the first time she has hope for a universal cure.

"I believe that approval of these drugs will be the biggest thing that has happened in years," Saly said. "I am hopeful that a shortened course of treatment for many patients will equate with a greater ability to tolerate the drugs and manage the side effects, but I fear that the issue of compliance with strict medication regimens might affect treatment success."

Saly says the drugs will help few patients if awareness of the hepatitis C epidemic, improved screening and affordable access to care are not addressed.

More than 3.2 million Americans have hepatitis C, the most common bloodborne infection in the country. According to the Centers for Disease Control and Prevention about 10,000 people die of liver disease and liver cancer directly related to hepatitis C each year. It's usually caused by contact with infected blood products, though it can also be transmitted sexually or contracted through IV-drug use.

The disease is the leading cause of liver cirrhosis, and the need for liver transplants in the United States. Cirrhosis is when scar tissue forms in the liver, replacing healthy liver tissue and blocking blood flow through the liver.

Symptoms included abdominal pain, dark urine, fever, and jaundice but most people don't have symptoms until liver damage has occurred which, according to the National Institute of Diabetes and Digestive and Kidney Diseases , could be 10 years or more.

The FDA is not bound by their advisory committee recommendations but often follow their advice. Merck says it anticipate FDA action on boceprevir by mid-May.

"The positive recommendation brings us one step closer to bringing Victrelis (boceprevir) to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C," said Peter S. Kim, Ph.D., president, Merck Research Laboratories.

On Thursday, the panel will make recommendations on Vertex Pharmaceuticals' telaprevir, the other new drug in this class. The FDA released a preliminary review of telaprevir saying clinical trials showed, when combined with standard treatments, it was more effective than those therapies. Vertex is hoping to beat Merck to the finish line by winning FDA approval first.


soundoff (40 Responses)
  1. Chris

    This sounds great. I just wish Merck had some credibility left.

    April 27, 2011 at 20:57 | Report abuse | Reply
  2. Jeff Gilbert

    Cure rates of 70% are clearly an improvement for genotype 1 patients but with a price tag of $30,000 this hardly qualifies as a "miracle"

    April 27, 2011 at 21:17 | Report abuse | Reply
    • TheTeacherThePreacher

      Yes, but keep in mind that price is before agreements shave been struck with HMO's managed care plans, Medicaid, etc. The HIV antiretroviral drugs are also expensive off the shelf, but they are in almost universal use by HIV patients in the developed world, and are also largely available in Africa and Asia. the price should be considered wishful thiniking on the part of Merck; the drug will get to who needs it.

      April 27, 2011 at 23:13 | Report abuse |
    • Chee

      $30k is nothing compared to the cost of a liver transplant or multiple interferon treatments. This is an awesome news.

      April 28, 2011 at 00:38 | Report abuse |
    • Sherrill Atherton

      Liver transplants are much more costly. You cant put a price on a persons health.Its worth itto live. Yeah if you can affored it which I hope and pray my Insurance will help.I have Care of Oregon Advantage and medicare.I dont get depressed,I was depressed thinking I would die from this now I have hope to live,not die.

      December 16, 2011 at 22:48 | Report abuse |
  3. Alan

    Of course, they'll charge an outrageous price for it. Drug companies ripping off the sick.

    April 27, 2011 at 21:17 | Report abuse | Reply
    • Response

      I'm sorry, Alan, but your response makes me really angry. Deep-down angry. This is fantastic, wonderful news, and you spout conspiracy theory. How do you expect the drug companies to pay for their research? By giving away their drugs for free? Can't you see not one, but two or three steps down the line? Bankrupt pharmaceutical companies can't operate, can't conduct research, can't create life-saving drugs like this one, Victrelis. Maybe stop watching so many Michael Moore movies and actually think through the process of how things work!!

      April 28, 2011 at 07:03 | Report abuse |
  4. sissytoo

    Pressure to throw some more untested poison out on the unsuspecting public.

    April 27, 2011 at 21:30 | Report abuse | Reply
  5. MELINDA

    WILL TRANSPLANT PATIENTS BE ABLE TO TAKE THIS?

    April 27, 2011 at 21:39 | Report abuse | Reply
  6. J.C.

    Lab Rat

    April 27, 2011 at 21:45 | Report abuse | Reply
  7. JBatlanta

    I hope it works. But I am a newly HIV, and cancer patient. so I dont think i would be able to get cured.. and im only 31. I only have myself to blame for everything.

    April 27, 2011 at 21:48 | Report abuse | Reply
    • TheTeacherThePreacher

      Don't give up on treatment, talk to your doctors about this new drug, and may I also suggest that you get screened for depression. Good luck to you!

      April 27, 2011 at 22:58 | Report abuse |
    • mcccccc

      Please put a good amount of time checking into alternative options. There is a lot of information available online that may be able to help you drastically. Just don't give up.

      April 27, 2011 at 23:44 | Report abuse |
  8. hospobot

    I wonder if anyone's insurance will actually cover this drug, ours sure doesn't and I work in the healthcare industry! Designer, experimental, biomed, and the super-expensive are NOT on our formulary. Maybe once again only the rich will benefit...

    April 27, 2011 at 21:57 | Report abuse | Reply
  9. dje

    "Even hard-to-treat patients like African Americans [...] responded extremely well".

    Why are African Americans so hard to treat? Or is this classified information?

    April 27, 2011 at 22:07 | Report abuse | Reply
    • Jim

      HCV has 6 main subtypes. 90% of African Americans infected with HCV have type 1. Type 1 has a poorer response to current treatments than the other types. So, this new drug which supposedly works well on type 1 patients would improve the overall treatment rates, and have an even greater impact on the African American HCV population. No conspiracy, sorry.

      April 27, 2011 at 22:46 | Report abuse |
  10. Lynnypoo

    I was successfully treated with pegalated interfon alpha 2a and ribivirin [please pardon any misspellings], in 2003 for 1 year. If this new drug can shorten the length of treatment hopefully it will also reduce the side effects such as I experienced. I am still dealing with depression, though on a less intense level and memory loss and confusion still haunt me. I think if I had only had to endure it for say 6 months, it wouldn't have been as bad.

    April 27, 2011 at 22:41 | Report abuse | Reply
  11. Lusitano

    I'm 60 years old and in excellent health other than HCV diagnosed way back in 1983. I'm genotype 1a patient. In 2000 I underwent the 2 drug regiment (non peg) for 6 months. The viral load was reduced to 350 down from thousands but not eliminated. The drugs did not cure me. Now I'm wondering if I should try the new treatment when available. Opinions are welcome.

    April 28, 2011 at 00:48 | Report abuse | Reply
    • Response

      It sounds like you might be a good candidate! The article stated that the drug works well on patients who haven't responded to previous treatments. Bad news is, it also sounds like this new drug is used in combination with the drugs you may have already tried. Worth asking the doc about, for sure! Too bad you couldn't get in on the clinical trial. Good luck to you!

      April 28, 2011 at 07:13 | Report abuse |
  12. bernie

    My dad was part of a clinical trial for this drug. He's got type 1 Hep C diagnosed in 2001. He has done the interferon and ribavirin regimen, resulting in the temporary loss of his immune system and a heck of a lot of his white blood cells. It didn't do anything worth the trouble. With the new drug, his viral load was cut significantly, his liver made a remarkable recovery, and he felt better. The trial was cut off abruptly when a very small minority of other patients began showing adverse symptoms. He says he'll take that drug again in a heartbeat.

    April 28, 2011 at 01:27 | Report abuse | Reply
    • Mark

      Thanks for you comments bernie, it souds as though your father and I are just about in the same boat. however I have never taken any of the drugs that have been on the market to date. the fact is, about 6 months ago they tested me for the liklyhood of having a good result. That test has just come out and was developed by the Sini Clinic.After reviewing the results me and my DR's decided to wait and see what happens as far as the FDA approving the new Meds. It looks as though I'm going to get my wish, and I prefer to look at the positive side of things, frankly I'm getting tired of doining anything else. I'm not sure how I'll come up with the funds, but I will somehow. Thanks for sharing, it definitly made my day!

      April 28, 2011 at 10:51 | Report abuse |
  13. sharron

    Yes, the drug is exspensive. It costs $10-$15 BILLION dollars to bring a drug to market. The United States leads in this technology. If the drug did not cost so much, drug companies could not come up with the next generation of medications. Someone has to pay. We need to get people jobs tha provide insurance so they can have coverage and drug plans. Don't complain about the drug companiaes in this country. I do not see any advanced medical techniques or medications coming from Canada, Europe or any other country in the world. Only here in America. I have been a Registered Nurse for 30 years and things are changing so fast. technology is wonderful.

    April 28, 2011 at 01:54 | Report abuse | Reply
    • IDDoc

      Sharron, where on earth did you get that blatently false number ($10-15 BILLION) to bring drugs to market? That is simply not true. It is ridiculously expensive (more on the lines of $200 million) but $10 billion?? Please share with us the source of this absurd figure. Thanks.

      April 28, 2011 at 06:22 | Report abuse |
    • bw

      @IDDOC, I believe Sharron was talking about the entire process of drug development, which begins in a basic research laboratory, must go through screening and medicinal chemistry "tweaking", moves to the pharmaceutical/drug development industry, and ends when the FDA approves it for the market. This process takes 10-15 years usually, and includes all three stages of clinical trials, which also must include animal trials which are incredibly costly but necessary to drug development in this country. Perhaps once in the pharmaceutical industry, it only takes $100-200 million to get it on the market – but this does not take into account the years and $$ spent in basic research to even FIND the drugs themselves. Billions is actually relatively accurate unless you get sincerely lucky with the med chem in the beginning of the process. Here's a link to a study done on the cost of bringing a drug to market from start to finish: http://www.springerlink.com/content/41348hgk17460nm7/fulltext.pdf

      April 28, 2011 at 11:26 | Report abuse |
  14. Terry Brookman

    I beat Hep C with the two drug system in1998 I was the first that I know of they called me the six million dollar man. The treatment was a spin off from AIDS research and cost $1500.00 a week for nine months paid for by Medicate. I had it for so many years that lack of liver function is only 40% and I am now on other medications, soon even those will not be enough soon so my time is short now. The extra few years have not been too much fun with all the side effects of a damaged liver but I am grateful for the time, it gives one a different prospective.

    April 28, 2011 at 03:03 | Report abuse | Reply
  15. Terry Brookman

    I might add, do not take to long to get treatment and please give up alcohol.

    April 28, 2011 at 03:04 | Report abuse | Reply
  16. Jamie Cook

    Will this drug be of any use to HCV positive people who aren't chronic?

    April 28, 2011 at 03:46 | Report abuse | Reply
  17. woo12363

    I was diagnosed with hcv in 2005. I went through treatments it didn't work. I am african-american. I have chronic genotype 1. This news of a new drug has really made me happy. Hopefully I can afford it. Would not mind going through treatment again if this new drug works like they say.

    April 28, 2011 at 04:57 | Report abuse | Reply
  18. J.C.

    I have been on and off treatment since 95 , It has been Hell on Earth for me and every side effect imaginable, I had. The last treatment being last year. I did 44 weeks of interferon with riboviran and a placebo. Taking the meds. always had an a effect on my viral load and I cleared the virous a few times only to have it come back a month later but this is the FIRST time I have been clear for over 6 months.
    I now suffer from thyroid problem's, ( Hashi Moto Disease ) and I believe I have had this from day 1 using INTERFERON. I had to stop at 44 weeks instead of 48 weeks due to Thyroid issues but I am CLEAR of the HEP C, praise Jesus.....

    April 28, 2011 at 09:51 | Report abuse | Reply
  19. curious

    will this work for Hep B patients as well? Responses are welcome....

    April 28, 2011 at 10:56 | Report abuse | Reply
  20. erich2112x

    30% of Hep C patients never develop symptoms in their lifetimes.

    April 28, 2011 at 11:20 | Report abuse | Reply
  21. Sherrill Atherton

    I have only Hep C and Geno1.I have Insurance but Got it in 1992,pretty healthy.But have cirrious and I have tried the Interferon made me very sick.Would this new drug help those syptoms that followed Interferon,like depression,suiciadal thoughts. I cant take antidepressents they work against me they do the oppaset.Please I want so to live.Intsead of being put on a liver transplant that you die before you get one.I take very good care of my self and dont drink I have one year clean and sober and very serious about staying tht way.Very serious about fighting for my life.But the interferon about killed me.Do I have a chance with this new drug.Thank you so much for your time.Both my sister’s died in 05 within a month apart from Hep C I dont want to be the last sister dead.Is ther any hope for me.Sherrill Atherton

    April 28, 2011 at 12:26 | Report abuse | Reply
    • Sherrill Atherton

      My liver spec just told me today that because I did not tolerate the interferon and rib whatever in the past that NO she will not let me go on this new drug beause Over a year ago I did not tolerate the interferon.I'm crying upset,shes not giving me a chance and looking at past instead of this new drug to live,She going to let me die. What do I do Please someone any suggestions.Shes sending me to OHSU to be put on liver transplant that people never get. :(((((((

      May 2, 2011 at 13:27 | Report abuse |
  22. Name*Debbie

    Thank you! God bless you!

    April 28, 2011 at 12:37 | Report abuse | Reply
  23. HDCliff

    I'm a 60 year old male with hep C for many years, geotype 1, I did the 48 weeks treatment with interferon and the side effects were brutal, virus came back stronger, too sick to work, I lost my home, went back on interferon and it killed my white cells and immune system. I've been able to start many awareness and testing programs for hep C and now a Hep C educator, I've used this time left to volunteer for disaster relief and everyday I work with the homeless with Salvation Army, trying to make a differance in the world before I go. Please FDA, approve this drug soon, its my only hope.....

    April 28, 2011 at 12:38 | Report abuse | Reply
    • Sherrill Atherton

      As I said before my Doctor is not going to let me go on it now she is Thank God. I will tolerate the antidepressents because I know Im fighting for my life.Gladly Ill accept what comes at me. Stay positive,have alot of support,stay busy I love life everyday its a gift from God. Im grateful today I have a chance for this new drug to live.I juts pray my Insurance will pay for it. I have Care of Oregon Advantage and Medicare. This diease kills more people than Aids.I had a sister which died of Hep C not her aids Doc said. I have faith,hope,not giving up.As long as I get up everyday theres another day to be grateful,have hope,faith that God has work for me yet to do here. Im grateful My Doctor has agreed to let me go on this new one.Lexapro I took before it worked well,or welbutrin. Dont no one throw in the towel yet as long as you have a breath in you. Then I feel God has a plan for you also. When life gets so tough I have to remember which is tuff at times when life thows you a curve ball let

      December 16, 2011 at 22:27 | Report abuse |
    • Sherrill Atherton

      As I said before my Doctor is not going to let me go on it now she is Thank God. I will tolerate the antidepressents because I know Im fighting for my life.Gladly Ill accept what comes at me. Stay positive,have alot of support,stay busy I love life everyday its a gift from God. Im grateful today I have a chance for this new drug to live.I juts pray my Insurance will pay for it. I have Care of Oregon Advantage and Medicare. This diease kills more people than Aids.I had a sister which died of Hep C not her aids Doc said. I have faith,hope,not giving up.As long as I get up everyday theres another day to be grateful,have hope,faith that God has work for me yet to do here. Im grateful My Doctor has agreed to let me go on this new one.Lexapro I took before it worked well,or welbutrin. Dont no one throw in the towel yet as long as you have a breath in you. Then I feel God has a plan for you also. I have to remember which is tuff when life throws you a curve ball let God swing the bat. Im honest and very sacred yeah! But have hope. Any suggestions would be appreciated and I feel so sad for all of us with this deadly diease! All in my prayers.I go to OSHU Feb 1st to see if Im a canadate.Could use all your prayers.God Bless you all your in mine. Sherrill Atherton

      December 16, 2011 at 22:32 | Report abuse |
  24. nancy

    Will they let those of us with genotype 4 which is similar to 1 use it?

    April 28, 2011 at 15:34 | Report abuse | Reply
  25. john

    i also have hep c and tryed the interferon and riboviron and it made me so sick my doctor took me off the meds after just 16 days so i know i wont be able to do it again.ive put my trust in god in the name of jesus christ.....I AM THE WAY,THE TRUTH, AND THE LIFE

    May 13, 2011 at 23:51 | Report abuse | Reply
  26. jackie

    I ve'. known about my hep c. i got it the 70's been clean of hard drugs since 1993. quit smoking 6 years ago and been clean od alc. 15 months. THEY SAY WHEN YOU HEAR THAT NEWS ITS YOUR LAST DAYS!!! nOT FOR ME IT CHANGED MY HOLE LIFE AND READY TO FIGHT RHIS THING. I WAS IN AZ AN DID 6WKS OF INTERFERON & RIB. i HAD TO MOVE BACK TO tx WHERE i'M ORGINALLY FROM. NOW NO INSURANCE AND IT WAS WORKING AND I CAN FIND OUT HOW TO GET BACK ON THE MEDS. I'M ALSO IN 4TH STAGE OF CHOR. I'VE LEFT IT ALL UP TO GOD ABOVE. AFTER ALL HE BROUGHT ME THIS FAR

    November 10, 2011 at 15:42 | Report abuse | Reply

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