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New Drug Application Submitted for Gilead’s Sofosbuvir

April 16, 2013

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Gilead has taken the next step for bringing an all-oral Hepatitis C treatment to fruition, submitting a new drug application to the FDA for their nucleotide analogue, sofosbuvir.

Gilead Submits NDA to FDA for Sofosbuvir for the Treatment of Hepatitis C

Tue, 04/09/2013

Gilead Sciences today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections.

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http://www.pharmpro.com/news/2013/04/gilead-submits-nda-fda-sofosbuvir-treatment-hepatitis-c

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  • Deb

    I was blessed to be in the Gilead study and am still viral neg. after 5 months! I am a geno 3 and a null responder to interferon. I am 58 with stage 3 fibrosis. I hope this is the “cure” we have all been waiting for.

    • Toto

      Wow you are lucky! I read Sofosbuvir success for genotype 3 is between 57% and 66%. Good on you. I am also genotype 3 F4 and I am wondering if I should just go for interferon+ribavirin with success rate of 80% and be done with it, 57% to 66% feel a little low.

    • Pls help me to get the drugs. I am type 4

      • Patricia Sordiff

        hi,what does type 4 mean? i have hep c,this is know,im going for an ultra sound on my liver because my ankles are swelled up,im very tired and sensitive around where my liver is,im so afraid right now,the reason why i havent gone for hep c treatment,is something that i think is babyish,i didnt want to get a biopsy done on my liver,because i heard it really hurts,so the other day when i finally took myself to be checked this doctor was so nice and actually checked my liver and other things and listened to me,thank you dr …. this guy told me that i didnt have to have a biopsy anymore ,just an ultra sound and blood work,i almost fell on the floor,i was so happy,so hopefully i can get this treatment and be on my way back to health,and i wish you the best of luck also ; )

  • Dwi

    For HCV sofosbufir single treatment or combination with peg ifn and ribavirin?

    • Brama

      Sofosbuvir will be combined with Ribavirin for Geno’s 2 & 3. Then It will be combined with Peg/Int for Geno’s 1, 4, 5, & 6. This is because HCV is actually a patented virus. The patent expires in 2015, and so the race is on to find a cure without Peg/Int, so that when the patent expires, and companies don’t have worry about Peg/Int “royalties”, they sell their own drugs without paying a hefty price to not use Peg/Int. Gilead is hoping to file for 2014 for Sofosbuvir and Ledipisvir (5885) for Geno’s 1,4,5, & 6. So far, trials with this last combo have proved almost 100% for Geno’s 1. If it weren’t for a few people in the trials not following up further with Gilead, it pretty much would be 100% cure rate… and this is almost without any side effects. One person compared it to taking an aspirin. Get ready. Because there are going to be a lot of different drugs hitting the market over the next 5 years for Hep C. There will be a lot of options, and hopefully the cost of treatment will come down too. There is great reason to have a lot of hope in the next few years. It is exciting times for those affected by Hep C.

      • BarbaraT

        Hey Brama. Its been a while. I was just reading some old stuff and I have to ask… How can a virus be patented?

        • Brama

          I guess the patenting laws were loose enough that ‘discoveries’ may have been ‘patentable’, and so the law was changed that things naturally occurring in nature couldn’t be patented anymore…only those things that were created or engineered by scientists. So for example, HIV can’t be patented, but a company has a mutated ‘impotent’ version of the disease that is, I believe. But the law has changed to prevent such injustices in the medical realm…not that there are still a lot of them. Treatment costs for Hep C for one. I sure hope the price drops dramatically with all the competition.

          There was a really good article someone posted regarding Chiron and their patenting of the virus. Try googling it. Otherwise, if I find it again, I’ll reply with the link.

          • FiftyPence

            So I find out my “friend”who was an IV user in the 80s has liver cancer and is terminal. You’re not going to believe this but he jabbed me with his needle once and called me a pussy…there was heroin in the needle…I wasn’t into IV drugs…so I have always been paranoid that I was infected and when I got the news he is dying I went and got tested but don’t know my results as of yet. I start reading about hep c and found all the good news about these new drugs…I remember Steven Tyler saying his Hep c treatment was misery and of course I had my little secret and fear, now I’m not as afraid if these new drugs are what they say they are. I went through benzodiazepine withdrawal which was pretty horrific but I’m ok now and feeling strong again. God bless everyone who reads this, peace and love to you all .

        • Brama

          Also, if you’re looking for a long-term investment to consider, try Aethlon Medical. Right now their stock is only at .18 cents per share, but what they have in the works, I personally believe, will cause their stock to go through the roof in the next few years.

  • Barbara Trice

    I start clinical trials for the 1st the beginning May. It is the Gilead drugs but I don’t no the name of the drug. I’m geno 1 naïve. I’ve had HCV for 40 years and just starting to have problems. They are doing the Abbott as well. I may be in that one. Any comments on which may be better?

    • Brama

      Barbara, from what I’ve been reading from the forum is that Gilead has been having nearly 100% cure rate for geno 1’s. I think you may have found your cure. Do you know what arm you are in? More than likely you are taking Sofosbuvir with 5885 (Ledipisvir). Right now they are trying to determine if Ribavirin is really necessary… and from what I’ve been reading and seeing from people in the trials is that it probably isn’t necessary. I think you’re extremely lucky to be in this trial. In about 6 months, you’ll more than likely be virus free! Gilead’s drugs so far seem to be having the fewest, if any, side effects.

      • BarbaraT

        Thank you. Your comment does a lot of good for my mental state. Are you a Bama Crimson Tide fan 😉 I guess you can tell I am.
        The RN said they are doing site investigation today (Fri, 4/19/13) and should start May 1st.
        I was so scared I was going to have to take the interferon. I feel weak & sick enough as it is. We decided that if I didn’t get in a trial by mid March, I should go ahead with old treatment. I called Gilead & Abbott, before my final decision. They gave me contact info & presto trials coming with in a month. So NO to interferon. YAY. Have a great weekend & God bless and keep you.

        • Brama

          Nope… not a Crimson Tide fan. 😛

          Believe me, Barbara… I’m sure that after your trial, you’re going to feel like a million bucks. You’ll think you’ve been reborn 6 months after you finish treatment. I’m excited for you!

          • BarbaraT

            Ohh, aha. Brama like the bull?
            I can’t wait. My house is a mess & my gardens are atrocious. But 1st thing, I’m going dancing with friends.

          • Brama

            No. Actually, it’s a nickname given to me by coworkers. B-Rama. Hence…Brama. That will be awesome, though. You’ll dance like never before! 🙂

          • BarbaraT

            oh yeah. What is your connection here . You see very knowledgeable.

          • Brama

            I caught it last year with an act of stupidity. From that moment forward I figured I would stay on top of it as much as I could. Knowledge is power. And I refuse to allow ignorance in any situation to stifle me with fear. I still have a lot to learn, but I have learned a lot by being a member of the forum. I highly recommend you do too, Barbara. You’ll find lots of info and tons of support.

          • BarbaraT

            my stupidity was 40 years ago. No treatment whatsoever, I have always told doctors I have HCV but they have never said anything about new meds. or actually anything at all about it. I just happened on Hepatitis Central and its evolved from that. Thank God because the doctors were no help.

          • Brama

            Same here. Most doctors barely know anything about this virus. The GI I saw here basically blew me off. When I told him my symptoms and everything, he wrote it off and ordered an upper GI. When that came back negative, he continued to argue that it wasn’t Hep C. This doctor’s problem was that he didn’t listen to his patients. I know my own body. I could tell something was seriously wrong with my body and mind. All the symptoms were coming back as one thing. But a lot of doctors I heard don’t want to treat Hep C because it isn’t an easy fix. Plus, he was just a GI, not a Hepatologist… so his background in Hep C was embarrassing compared to the little (or much) that I had learned on my own.

          • BarbaraT

            Yeah, but Brama, my rheumatologist should have known enough to NOT load me up with Lortabs. I believe that was the beginning of my downfall. At least my primary doctor is now asking questions & acts like he wants to know.

          • Brama

            Hey, Barbara! How goes the trial? Im excited to hear how its going for you!

          • BarbaraT

            Good morning, Brama. I got the call finally. I start clinical trials for sure on Tuesday (May 7). They are running 3 different ones. I forgot to ask which one I’m in. I’ll call later this morning & find out. I’m so excited. I have been really feeling very sickly for the past 3 weeks.

          • Brama

            I’m so happy for you… in all reality, just getting into the trial is amazing! You should go to the top of this website page, and click on the support tab, and click Hepatitis C forum and join the forum and post a new message under Drugs for Future Treatment. Many people are detailing their trial with what type of meds they are taking, who the trial is with, side effects, duration of treatment, and status of SVR. You’ll meet a lot of people who will encourage you, and who could use your encouragement…. such as myself. Keep me posted! I’d love to hear about your progress! You can reach me in the forum under the username( b_anthony1.)

          • anne

            I am cryiing in excitment,,,ahhh to have life back

          • BarbaraT

            Alas, I was turned down because that particular trial wants no cirrhosis. So I had a biopsy that shows some cirrhosis. Plus my protein & iron are way down. Maybe next time

          • anne

            thanks Barbara, my iron is always high, Dr is thinking of taking out some blood to lower iron…I also have cirrhosis…I just went on trial clinic to see if there is any openings…this disease is consuming..Thanks

      • pls how can one get on clinical trials for type 4.
        Thanks.
        [email protected]

        • Brama

          You seem to be living in the UK. Gilead has a drug combo that they are hoping to start trialing that they hope will be pan-genotype…which means they hope this one combo will treat all genotypes. I dont know about how drug trials work in the uk, but if you join the hepatitis c forum , there are people you can connect with in the uk who can help direct you to resources, and even to drug trials when available in the uk. Hope that helps!

    • pls how do I get on clinical trial.

      I have type 4.

      Thanks

      • BTrice

        go to http://www.clinicaltrials.gov There you can search for 1 near you. My search id hepatitis c Birmingham Alabama. It brings those up that include my city. I’m on a waiting list

    • anne

      I would like to hear more
      [email protected]

  • Theresa Hubley

    Do clinical trials require medical record review from prior medical office visits of the Hepatologist’s files?? I cannt get my medical records because my prior Hepatologist refused to release them!!! Is there anyway I could possibly go on a clinical trial without them!? I’m Hep C 1a infected Fibrosis., and a non-responder…. For many years.. If anyone has information as to my next course of action, please contact me . I’m not too optimistic these days and not feeling well.

    • Brama

      It is illegal in the United States to not release medical records with a signed medical records release. I would personally go into the office and demand your records, and make a public scene in the office lobby until you do. That’s just my opinion of what I would do if it was me. 🙂

      In the meantime, you can check out what clinical trials are taking place by going to http://clinicaltrials.gov/. Search for Hepatitis and look for trials for people with 1a. Make sure to look specifically for trials without Interferon. If a clinical trial says they are not enrolling yet, give them a call anyways. Usually by the time the website says they are enrolling, they are usually full or nearly full already. Hope that helps. And good luck!

    • Brama

      It is not legal for anyone to withhold your medical records if you’ve filled out a records release. If it were me personally, I would go down to my doctor personally and demand my records and to not leave until they did. I would also raise my voice in the lobby so that all the other clients could hear that were not releasing my records if they continued to deny them to me. I would also contact a lawyer if push came to shove.

      Call any and all clinical trial sites that are not doing Interferon studies, and see what they say. It can’t hurt. But definitely try all you can to get your records.

      • BarbaraT

        I agree with you. They are our records & we paid for them.

    • BarbaraT

      Theresa, my understanding from Delphi Forum those records are yours. Perhaps your primary care physician can help you.

  • dwi

    It’s mean sofosbufir not use in single therapy?

    • Brama

      No. It has to be combined with Ribavirin to work for geno 2 & 3’s. It also will be combined with Lepisivir in 2014 to work with geno 1,4,5, & 6. Gilead is also experimenting with another drug to use in combo with Sofosbuvir in hopes that it will cure all genotypes with one treatment.

  • ausie

    any idea when sofosbuvir and ribavirin will be available for purchase?

    • Brama

      More than likely it will be about a year, give or take. Depends on how fast the FDA here in the US approves it.

      • BarbaraT

        Hey, Brama… hope its less than a year or I may be looking at a transplant.

        • Brama

          I thought you were getting into a gilead trial. Did they not accept you based on cirrhosis or something?

  • Jack

    How long it is likely to take to make Sofosbuvir available in markets in India. Kindly let me know.

    • Brama

      I personally don’t know about international markets. You might do better contacting Gilead themselves about a projected date in India.

  • ritchie

    What an appalling situation, when a company can patent HCV, and then hold other drug developers to ransom and compel them to use it. This could only happen in America..

    • Brama

      Well, thank God the patent runs out in 2015, hey?

  • Tim Mullaney

    Hi All: I’m a reporter doing a piece on people waiting for sofosbuvir to treat their HCV. I’d love to hear a patients’ perspective from some of you at [email protected]. thanks and god bless you all…best,t

    • JENNIFER

      TO THE REPORTER, WELL MY HUSBAND IS DYING DAY BY DAY. INTERFERON ABOUT KILLED HIM SERIOUSLY NOW ALL WE CAN DO IS WAIT. i AM AFRAID THAT I AM GOING TO LOOSE HIM. I HAVE TRIED TO GET HIM IN A CLINICAL TRIAL WITH NO RESPONSE. I MUST BE GOING ABOUT THINGS THE WRONG WAY. ANY SUGGESTIONS?

      • BarbaraT

        I’m so sorry about your husband. I’m near his state. I can’t do interferon because my blood is bad (protein & iron). So when I was turned down for an AbVie trial a few weeks ago, I was devastated. My biopsy showed some cirrhosis. I have been trying for trials since Oct. I have found that by the time they show up on clinicaltrials.gov, they have already filled their quota because of waiting lists. Best I can advise is to find out what clinics in your area do clinical trials and have him placed on their waiting lists.

  • Cured!

    I also participated in the Phase III Trial with Gilead having Genotype 1a. My treatment included Sofosbuvir, Ribavirin and Peg. I had my 6 month follow-up last month and my viral load count was still 0.
    I volunteered to be part of the 3 year follow-up. I am very grateful to have been a candidate for this program. I am very hopeful for this to be released quickly by the FDA and put into the market for others looking for a cure. God Bless You!

    • BarbaraT

      Thank you, Cured

  • Seeker of Truth

    I am 64 years old Male in the UK. Have no idea where I got it from or how long I had it. When my Doctor (a lose term in this case) gave me the flu jab in 2011 I just went into free fall I felt so bad . We do bloods and he tells me its not Hep A or Hep B. I ask about Hep C he said he did not test for it, because the test was expensive. so I had to stamp my foot, and get It done. When it came back positive I was devestated . His reaction was to give me a A4 sheet of paper with do’s and dont’s and get me out of the surgery asap. I got a letter from my Health Authority telling me I had a comunicable disease. Then nothing, no help no medicine nothing. I went to my Heptology Clinic where the Consultant had me down as alcoholic, drug and steriod taking troublemaker. Nice start . With no help I started a downward spiral no drink, stopped all supplements and tried to eat healthy. I nvestigated all the options on the web, I refused interferon and ribavirin having read the side effects for older people, so no help at all but I knew things were changing. I moved to another part of the UK and found a consultant who was interested in treating me. I had a liver biopsy that indicated I was cirrotic . because I was so weak and run down I missed two trials, However I am now on the GILEAD trial Sofosbuvir one pill a day with food, a bit of nausea a few times and some dashes to the bathroom but apart from that, I am 28 days in My viral count has dropped really low and I am starting to feel better. I hope they get this out to those who need it. All of us deserve better than we get at the moment. Lots of little things make you feel better or worse. I was lucky.

    • Patricia Sordiff

      hi ,im so happy to hear you are feeling better,i am going to be trying to get help with this,im going to call gilead too,hope they help me,i dont want to die ; (

  • loreni16

    I live in Miami Florida.

    I have tried to find a trial for sofosbuvir from Gilead and nothing…anyone can tell me how I can get into one…genotype 1 answers to [email protected] pls…

  • Ready

    Why is there no new discussion sofosbuvir plus RBV ? Am I missing it I am supposed to start it next week here in the states – so far as I could
    find 3 pills a day for 12 weeks sounds like it’ll be $80K, geez I hope
    not… Can’t see how it will cure people if no one can afford to take it
    (According to my Dr I am a prime candidate- hope insurance will cover
    at least 80%… we’ll see I am waiting to hear back hopefully early next
    week)