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New Hepatitis C Treatment Approved By the FDA

July 27, 2015

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Discover the details behind the FDA’s approval of Daklinza (daclatasvir) for use with sofosbuvir to treat HCV genotype 3 infections.

FDA approves new treatment for chronic hepatitis C genotype 3 infections

The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3.

Continue reading this entire FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm

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  • altered_conscious

    This is the drug (daclatasvir) used in the 2012 trial I was in that successfully cured me (a relapser) of HCV. Daclatasvir was combined with sofosbuvir in the trial, however Gilead, maker of sofosbuvir, chose not to market its drug with Bristol-Myers Squibb’s daclatasvir because it wanted to market its own. I’m glad that this is working for genotype 3 folks.

    • Dodger

      I did the Sofosbuvir with ribivarin and failed. What were your side effects, how long have you been clear of the virus? was the cost super expensive? I just don’t know if my insurance will do the sofosbuvir agaain.

      • Elizabeth Faraone

        You will be able to get generics of Sovaldi and Daklinza in India for a very low price.

        • NILOFER

          When it will be available? ducaltasvir?

          • Elizabeth Faraone

            It is available now in the US. Sovaldi is available in India and I think Daklinza is too, but you’ll have to look into that. Google it.

      • high maintenance

        Sofosbuvir & Ledispar,
        (Harvoni) combo treatments without ribavarin. After just 3 weeks I went from millions in my virual load to Zero!
        I’ve been 0 SVR for over a year now. To God be the glory.
        I hope you get to try the Harvoni, it’s a miracle & hope your insurance will help.

        • Marilyn Auriemma

          Only for genotype 1

        • christine ayers

          Did your insurance deny your claim

          • high maintenance

            I was in a trail treatment with Baylor Dallas & Gilead Research. I’m on Medicare so I don’t know if they would have paid. The director said I had $100,000 + drugs.
            I’m not sure about personal health insurance. Sorry not to be much help.

      • Jim S

        I failed that treatment too. insuance paid for the sovadi and dacavasir too but I failed that too. Im gen 3 waiting on the new drug from gilead in june, good for all genotypes

    • Grace Carly

      Praising God for your healing…Im so excited.

      • Grace Carly

        Can you tell me how the drug effects was on you?I Soon will be taking this med.

    • savi

      pls let us know where it is available in india?

    • jarat

      Hi “altered_conscious”– I was wondering how long you were on the sofosbuvir/daclatasvir trial for. Was it for a 3 month regimen or 6 month? Were you a relapser from the interferon / ribavirin?

    • Jim S

      not all of us. I read about this trial that you participated in as I had just found out I had hcv. gen 3. I first did a 24 week of sovaldi and rivivarin, failed that then tried sovaldi and daklinza when it was released last summer. I just found out a few weeks ago I failed that too. Im stage 3 and am now waiting on the latest from gilead in June to be released. I am no having much hope though

  • namitgee

    How effective is in eradicating with Type 1? I have been carrying it for the past seven years. @Dodger, my doctors tell me to go for Sofosbuvir and ribavirin, saying it’s a sure-fire cure. What is your genotype and how long were you on this medication?

    • Elizabeth Faraone

      Ribavirin is a harmful medicine and I question its effectiveness. For genotype 1, Harvoni is best. And if you are genotype 1b and can’t get Harvoni, Viekira Pak is effective too.

    • Al Boisvert

      you want Harvoni for Genotype 1

      • high maintenance

        Yes you do. 1, That WAS my geno type, now Harvoni gave it a wipe, ( I must be tired )
        Just say No, zilch, NOTTA, to Ribvarin… It doesn’t help when taken Harvoni.

        • B. Hoyt

          The Ribavirin is prescribed along with Harvoni and Viekira Pak if you have cirrhosis. No cirrhosis, then Ribv. is not prescribed. This is the way the VA hospitals are doing it.

          • James Patterson

            Thanks for clearing that up. I did not know that Ribavarin was given w/ Chirrious. I have chirrious so therefore the Ribavarin. After several weeks into my 24 week study, they lessoned my Rib to just one a day, all I know is that it worked. Once again thanks for your reply.

          • luvbebop

            I have cirrhosis type 2b and I took Daklinza/Sovaldi for 12 weeks. I am all clear now and waiting on more labs and ultrasound at the end April to confirm my cure! The info I read about Daklinza didn’t say it was for my genotype but my doctor said yes I could take it and he was right. I’m glad I finally switched doctors to the fantastic one at UCLA. He is great and really knows his stuff when it comes to this disease.

          • christine ayers

            What genotype do you have

    • B. Hoyt

      I am Gino type 1a. I took Viekira w/Ribavirin and it cured me in 12 weeks. But I had to stop the Ribv. after 6 weeks because the side effect were bad. But I am one of those that has a very bad time with Ribv. I will get another blood test after 90 days and if its still gone, I am fully and finally clean! PS/ Viekira Pak by Abbyvie is half the cost of Harvoni. But its 3 pills in the AM and one in PM. (total 4 pills a day). Look into it.

  • Joli Bell

    Please tell us this medication cure for Hepatitis type 6 virus patients ? Help me please !

  • Orewele Goodluck

    Just wanna express my moment of joy for been cured from the deadly HEPATITIS B..
    i have been infected with the Disease over 3 years and already lost hope cos i have already tried so many ANTI VIRAL treatment…. one day while making more research online, i came across a tesimony of a patients Dr Lamano cured from GENITAL HERPES. and i decided to give the said DR a call cos he information was online too..
    We both talked and he agreed on helping me out… He prepared the CURE in portion and requires my Home Address for the D.H.L to deliver the medicine to me and i recieved the Portion after 4 Working Days….
    The cure was prepared from Herbs and he instructed me on how to take it…
    well, henced im cured now i decided to write a review on this so others with similar issues can also give a trial.
    his email is [email protected] or call him on +2349054870144///

  • Marilyn Auriemma

    Can they use it for genotype. 2? I did the sovaldi and ribavarin and it came back. Ribavarin made me sick!

    • luvbebop

      hi I just finished 12 weeks of Sovaldi/Daklinza and I have(had!) genotype 2. After the 1st 2 weeks my viral load went to ZERO. I go next week to get my latest lab results. The side effects from this combo are minimal, just some bad headaches, which I could tolerate !

      • Marilyn Auriemma

        Thank you for replying. Took Sovaldi with Ribavarin and relapsed. Don’t think I took it long enough as the side effects of the ribavarin were killing me. I am hoping this.Dyklenza is not as bad as ribavarin.

        • luvbebop

          I’m hoping you have as good of luck as I have had with Daklinza! The headaches were bad but not as bad as having the disease.Other than that I continued to feel better throughout my treatment with Daklinza. I will hopefully be able to say I am cured after my next lab tests!

          • Marilyn Auriemma

            Good luck! I am really hoping I can make it through this time around!

      • jarat

        Hi luvbebop–I’m just wondering if your treatment is 3 months only or if you are doing 6 months. The reason I ask is because I also got “all clears” on every HCV viral count for 12 weeks but am being told to do 12 more weeks. I have normal liver functions but the doctor is being extremely cautious (I live in China) and is putting all her patients on the 6 month treatment. I would have little problem with that if I wasn’t paying for it out of pocket. I just don’t want to pay for an extra length of treatment that is not needed.

        • luvbebop

          Are you taking Daklinza? I did Sovaldi/Daklinza for 12 weeks . I go back the end of April to get more labs to make sure I am still “all clear”. We aren’t saying I am cured until the next set of lab tests. But by the way I feel I think I am still “all clear!” I do know that people that take the Sovaldi/Ribiviran combo tend to relapse, that is why my fantastic doctor made me take the Daklinza / Sovaldi combo, because there has been less relapses reported. I will swear by this new drug Daklinza, it had minimal side effects and I feel great! I have ended my treatment about 1 month ago and I continue to feel great! Also I “had!” ( I’m not saying “have” anymore!) genotype 2 b. Do you have a different genotype? That could be the reason for longer treatment maybe? Good luck with your treatment! It feels like a brand new life for me!

          • jarat

            Thanks for the reply. Yes, I am taking sofosbuvir / daclatasvir (the generic names for Sovaldi and Daklinza). I am Genotype 3A, but all of the Gilead / Bristol Meyers documentation online says “12 weeks” unless compromised by cirrhosis, which I don’t have. Before this treatment, I got “non-detected” lab results for my last two months of a 7 month go around with interferon / ribavirin. The ribavirin was making it very hard to work every day, so I decided to take a chance and get off treatment. After I stopped treatment in what would have been my eighth month (my doctor wanted me to go 5 more months), I got a viral load count back in the millions. That was with the interferon / ribavirin.

            I am still looking for a definitive reason why I should continue after 4 months on the sofosbuvir/daclatasvir treatment. I bought one extra month for good measure thinking that 3 months was all that would be required. I am now at 3.5 months. Like I said, I have gotten undetected viral loads after every HCV RNA test I’ve had since I started this treatment. I can get the meds fairly cheap here in China, but I still don’t want to be buying meds that do not provide any additional benefit if the manufacturer directions are right about 12 weeks only for my genotype and condition.

            Thanks again for your reply. The sofo/dacla combo certainly seems like a miracle treatment! Best wishes with your follow-up tests.

  • jarat

    I have genotype 3A and I failed interferon / ribavirin after 7 months on. Even though I got “not-detected” after months 6 and 7, I got a viral count in the millions in my 8th month (first month off treatment). I have been taking the sofosbuvir / daclatasvir for 3.5 months now, and got a “not-detected” in my first test at 4 weeks. Also undetected at 12 weeks. My doctor (I live in China) has never treated with these wonder drugs before, so she is being ultra-cautious in having all her patients do 6 months on the sofosbuvir/daclatasvir treatment rather than the 3 months as recommended by the manufacturer (Gilead and Bristol-Meyer). I bought the 4th month of meds just for added assurance before I found out that the doctor wanted me (and all her patients) to do 6 months.

    My questions is: Has anyone else who relapsed after the interferon / ribavirin Tx done a 3 month sofosbuvir / daclatasvir regimen and reached SVR (3 or 6 months SVR post treatment)? Of course, I want to be sure that I do not shortchange the treatment, but I also don’t want to pay for 2 extra months if there is really no need.

    Any response would be appreciated.