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Merck’s Hepatitis C Drug Works

April 13, 2015

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Learn more about grazoprevir/elbasvir, Merck’s Hepatitis C drug that has been fast-tracked for FDA approval.

FDA Grants Breakthrough Designations to Merck’s Hepatitis C Candidate

The FDA has granted 2 breakthrough therapy designations to Merck’s chronic hepatitis C virus (HCV) candidate, grazoprevir/elbasvir.

The once-daily, single-tablet regimen originally received breakthrough therapy status for the treatment of chronic HCV genotype 1 (GT1) infection in October 2013. However, the FDA rescinded it in January 2015.

Continue reading this entire article:
http://www.pharmacytimes.com/product-news/FDA-Grants-Breakthrough-Designations-to-Mercks-Hepatitis-C-Candidate

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  • Jojo

    Very sad . Why only Hepatitis C type 1 NOT type 6 & 5 virus !?

    • Brama

      Jojo, there are treatments in trials right now that are aiming for more genotypes. Regulus’s treatment is one. Gilead is also pursuing drugs that treat more genotypes. There is also Benitec Biopharma that is in early stages of a one-shot cure that is hopeful to treat all genotypes. Aethlon Medical has a blood purifier that filters out viruses like hep c and may be a possible combo therapy with drugs for other genotypes. Genotype 1 is the most common type worldwide. That’s why more attention is given to it first.

      • John

        Brama, genotype 1 is not the most common worldwide. It is genotype 4 which is the most common.
        Let me argue it, GT1 is common in N. America, Australia, New Zealand and Europe whereas GT4 is common in most Asian countries , Africa and South America. With the population in those continents, it will be safe to say GT4 is the most common.
        Reason why a lot of attention is paid to GT1, is because companies producing Hep C drugs are in the countries with GT1 and the population in those countries are somehow able to purchase the drugs.

        • chip

          Golly geez one of ya says type one is the most common, the next guy says its type 3, and now after only reading a few of these someone says no,type 4 is the most common….can anyone tell me why so many people are claiming so many differences,you know that makes me not want to believe any of this…right?? I mean just back up and read the past 8 or 9 replies…….Does anyone have facts???

          • Jan Leacock Bradley

            CHIP..I think it depends on what site in which country you read the research . My quote was from The Canadian Liver foundation. There are so many millions of people with HCV and a lot of them in countries where medical testing and research is not that advanced This is probably where the descrepancy lies ..Lets put it this way ..there are too many people suffering from HCV and they need a Pan-Genotype (kills all subtypes) to help us all, no one has all the facts and we are all sharing what we have read ..LOLOL

  • Jan Leacock Bradley

    In the past, HCV genotype 3 was thought to be one of the easiest to cure. As a result there was little incentive to develop newer therapies especially since there were fewer people with genotype 3 in developed countries. Now it has turned out that treatment of genotype 3 is the hardest to cure with HCV inhibitor therapy compared to HCV genotypes 1, 2 and 4. HCV genotype 3 also contributes to the development of steatosis (fatty liver disease) and insulin resistance, both of which can directly influence HCV disease progression including cirrhosis and liver cancer.

    Prevalence
    The worldwide prevalence of hepatitis C is 150-170 million people. But the real prevalence is unknown since most countries have an inadequate surveillance system in place, if any. In this respect, understanding the real prevalence of HCV genotype 3 is difficult, but it is estimated that about 55% (~95 million) of all cases of hepatitis C are genotype 3. The highest concentration of genotype 3 is in Southeast Asia and the Western Pacific countries. HCV genotype 3 is also the most common genotype in India and Pakistan, and accounts for about 30% of the infected population of Greece, Poland, and the Netherlands.
    Interestingly, genotype 3a has been found to have existed 200 years ago,

  • Noseknows

    Just celebrated 3 years virus free. I hope none of you people have to the old treatments. Interferon sucks big time. Good luck.

    • trotter

      Since my 2nd yr.-long treatment of ribaviran/interferon, my brain is permanently harmed. It was proven during some testing. I have a piece of my brain that no longer connects w/one other piece. So, I am distracted and focus on one thing for too long and forget my original thought. I also can’t put 2 ideas together to logically make a third.
      About 7 months ago I took Olysio/Solvaldi and against the odds, my HCV is in remission. Still have Cirrhosis and strong chances for liver cancer.

      All in all, these new txs most definitely are easier and work better, thank God.

  • Big B

    That’s so typical of our countries money oriented worldview!! Governments should be paying for all this research with the mindset that life is valuable. God knows they pay tax the F#*K out of us!!

    • Billy Parks

      Big B
      The dad pay is the government most likely did the research for this drug and Harvoni. The Government, particularly at NIH in Bethesda, Md teams up with a pharmaceutical company. Tax payers pay hundred of millions on research. The the Government gives the rights to the pharmaceutical company. You would think we would get a fair price for the medications we fund!

      To bad the government isn’t in business to make money.

  • Big B

    Been virus free for 12 years now after having Hep. c, g1 for 15 years. Peg. Interferon and Ribivarian worked for me after 11 months of shots and pills! Doing coffee enemas and organics helped me I believe. Hang in there! Hopefully the treatments should be easier now with obama care paying for it. Mine was $2500.00 a month back then. Kaiser paid but now my rates are $1230.00 a month so I guess I am still paying it off. 🙂

  • Wayne

    Just starting the new Hep- C treatment— I’m 63 and RVN vet, I did the Interferon shots with Ribivarain, but it did NOT work on me- now 15 years later I’m going to try this new treatment through the VA. 1 pill per day for 3 months, I hope it works !! the pill is Ledipasvir 90mg/Sofosbuvir 400mg. fingers are crossed !!!

    • Billy Parks

      All the best Wayne. This should be the last treatment you will need. Peace

  • Lanny

    I am in my 8th week of treatment with the drug Harvoni and I am free from the hep c virus , the blood work showed it was not detected. I still have liver scarring but I am going to begin taking supplements for liver health when my treatment is over. My doctor had to fight the insurance company to pay for it because the meds cost $1000.00 each pill. Thank you Lord for this blessing.

  • Rodaja

    Itchycoo Park; What did you do there — I got high!
    Man, the seventies ravaged many of us “Small Faces” who went to Itchycoo Park. I was on 3 different treatments for Hep C -Geno#1. First 2 treatments didn’t work. Tri Treatment worked! The one I was on was Telaprevir, Interferon, and ribavirin. It kicked my butt, but it worked. Treatment was late in regards to developing Cirrhosis (compensated). Three months after 48 week treatment I had an ischemic stroke. Have right side deficiencies. Hey, Rock Is (was) my life, and this is my song (B.T.O.)When the music was over many did not survive. I am very glad though that I survived, I have been SVR for 2 1/2 years now and the Cirrhosis is stable. Man, don’t wait to get treated; Hebrews 13:6 (NWT), be of good courage! Be Altruistic, Get Treatment.

    • Billy Parks

      That’s awesome!

  • Lauran Preacher Webb

    My prescription for Harvoni 90 day treatment is $95, 000.

  • Leslie Lane

    I took Savoldi and Olysio for 12 weeks The cost was almost $157,000 but I got lucky and I had covered all my out of pocket expenses for last year and my insurance covered all of it. I had NO side effects at all. All my blood tests are showing 0% of the Hep C virus in my body now. August will be 6 months since I finished therapy and if I show 0% then I am considered in remission. I tried to take the old treatment with peginterferron and ribroflavin but after 6 weeks I thought I was going to die and had to stop it. My insurance company will not cover this treatment now unless you try the old treatment first and fail. I think it is a shame people have to still suffer through unbearable treatments when there are new options available that work much better at curing you plus have less to no side effects!!! It’s all about MONEY not what’s best for the patient. Blame this on the insurance companies!!! Thank God I got lucky and I hope I stay virus free the rest of my life!!!

    • Billy Parks

      Why blame it on insurance companies? It is the pharmaceutical companies screwing us by charging so much. I don’t blame the insurance companies not wanting to pay these astronomical prices.

      There are several other drugs coming out very soon. And they will keep coming . Then there will be competition in the market which should bring the prices down. We can only hope. It should be affordable to all who need it. Period!

    • Christine McGill

      I am so happy for you. I did the peginterferron & ribroflavin for 3 months. I was not monitored properly at a clinical trial. I went to my Primary care doctor for a regular check up, I felt like I was going to die too. My Dr. called & sent a letter urging me to STOP treatment. My white blood count was under 500 which he said,” I would be treated as a leukemia patient,”. These idiots wouldn’t take any responsibility for my condition. I would not wish this treatment on anyone, it is horrible!! Please be careful if you ever sign up for a clinical trial, they put unqualified people in medical positions they no nothing about. It makes me sick the wonderful insurance companies are making people take this torturous treatment, THAT DOES NOT WORK!!! Be careful out there, I am sharing this so people will not have to learn the hard way. God Bless you <3

  • Amy

    Darn, it’s been16 years since I was diagnosed with hep c. I’m glad there’s good treatment that’s better than the peg interferon and ribavirin I did back in 2000. Without insurance currently and the price of meds looks like I’ll need a transplant by the time my insurance kicks in after I’m married. Sucks, i think that maybe someone else needs the liver more but money does make the call in the long run. I don’t want to die because I can’t afford the meds now and will need a transplant before I can afford them. At least the insurance will be there at my worst. Money and greed makes the world go round, can’t change that. No response needed