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Breaking News: FDA Approves New Treatment for Hep C (Genotype 1)

November 25, 2013

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Janssen Therapeutics’ OLYSIO™ (simeprevir) has been approved by the FDA. It is a prescription medicine used with other antiviral medicines to treat genotype 1 chronic hepatitis C in adults. Learn more about how OLYSIO™ works.

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced today the U.S. Food and Drug Administration (FDA) has approved OLYSIO™ (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. OLYSIO™ may benefit patients with chronic hepatitis C, including those who are treatment naive or who have failed prior interferon-based therapy.

Chronic hepatitis C is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the United States.

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http://www.news-medical.net/news/20131123/FDA-approves-OLYSIO-%28simeprevir%29-for-treatment-of-chronic-hepatitis-C-infection.aspx

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  • who cares,Iam 63 and found out in 2000,that Id been living with this virus since 1983, so let me get this straight, the hep c is in all your organs, yet this pill is going to do what?? remember this, “We arent here to stay” Iam about 24,000 days old…do maybe Ive got another 20 years…depending..if I dont get hit by a hit and run driver, suicide, early death to who knows what…the economys in the toilet….unless you have family that cares, or money…your on your way out…sign me, who the f… cares

    • Gus

      pegylated interferon and ribavirin caused me to lose my vision, so adding a 3rd drug is not an option for me. We need new drugs that don’t use pegylated interferon and ribavirin. Luckily my vision returned after I stopped treatment but I still have virus.

      • jeff barrie

        Gus, as you know doctors are all about killing the disease. The host is just an afterthought.

        • usingthatexamplethen..

          omg lol i love it.. true..

    • mik007

      littlesky I agree with you I just spent the last 1/2 hour wrighting a complement ,wish now has disappeared, if I can find the energy I will wright another one…….

      • Free At Last

        I had HEP-C and underwent Ribavirin + Intaferon treatment in 2002. i thought it was the worst hell I had ever experienced and it did not work. After retiring at age 63 I tried Ribavirin and pegalated Inteferon again but this time they added Incivic (not sure of any of the spellings). I thought the two drugs were bad but the three combined were HELL to infinite power. I was on them for one year. It was very very hard. I saw this decease kill my mother so I knew how it works. Only my stubbornness, determination, and my wife got me through and, this time it worked. I have been HEP-C free for four months know. The most lasting after effect from the meds was seven cavities due to dry mouth and I take care of my teeth. My advice to anyone considering treatment…WAIT! The side effects can be challenging.

    • usingthatexamplethen..

      yes.. i fear the medicine way worse than my symptoms.. they suck… make it hard to work.. achy body pain, joint pain, extreme fatigue, insomnia, itchy, fever, sweaty clammy, diarrhea.. i just learn to adjust my diet.. and live with the rest.. do not drink any alcohol or symptoms are times 10! no alcohol ever!! i watch how often i take ibuprofen.. i never take acetaminophen.. and i have been sick since early 80’s too.. i am 50 and have had it for over 25 years. I watched family members go thru cancer treatments until they passed.. several.. and one survived but had all of their female organs removed and breasts.. i am not going out like that.. the medicine is POISON to whole body.. not just the sickness.. no matter what you have.. i will take the disease route and that is what i am doing.. living with it .. i take benadryl for the itching and swelling problems.. hives and red skin.. some of that comes from using ibuprofen.. but some days pain is too bad to work so have to take something.. then counter the side effects with benadryl… i take it at night.. helps me sleep so it helps the insomnia.. take benadryl.. go nitey night.. then next day maybe take ibuprofen it really huring in all my fingers and body joints and achy in down thru muscles from joints.. back and feet and toes.. and neck.. those days.. i take ibuprofen.. but i know it is bad for liver so try not to if can help it.. but the itchy skin and hives and low grade fever.. fatigue that never ends.. full deep body exhaustion.. like you feel in middle of night when get up to use bathroom and body clock is down.. i have that feeling durind day.. sometimes drink caffeine.. diet coke to keep going thru work day.. then come home and crash in hot bath only to take benadryl to go to sleep.. i dont know how else to cope.. but i am scared of the medicines.. and apparently from what some have said for a good reason.. my vision is going bad fast.. and i always had excellent sight until after age 40 .. now at 50.. i cannot read anything at all without glasses.. driving getting more difficult to read street signs.. names of streets.. can see the big ones.. but i am too young to go this blind.. i dont know if it has anything to do with hep c or i am just getting old.. but headaches .. low grade headache is normal.. have one now.. every now and then a bad migraine.. but thank GOD NOT OFTEN.. those are totally debilitating..have old migraine meds in a drawer from decades ago that still works if have one tho.. just take it right when it starts.. and it will work.. if wait too long then the medicine just chases all the horrible stages of messed up vision and nausea to intense horrid pain and light sensitivity and then when that finally stops.. brain feels sore like its bruised for a day.. i dont know if those are associated with hep c.. but they suck when they happen.. maybe once a year or less for me tho.. thats good.. i retain water.. my ankles swell.. not sure if its part of the hep c.. but i have to cut tops off socks.. cant have em around ankles.. and take water pills every now and then.. i am so used to feeling sick .. i have forgotten how to feel normal.. so sick is normal for me.. some days my eyes are red and glazed and face swollen.. eyes swollen and ankles swollen.. i take benadryl and water pill and drink tons of water to flush my system.. it gets better.. i would be lost without benadryl, water pills, ibuprofen.. without them i would be itchy, covered in hives, fevered and like i have a bad flu all the time.. your body can only handle so much diarrhea.. i use protein powder meal replacements… and bananas and only eat tiny portions and never eat spicy hot food at all or greasy fried food.. and i get by with better results.. but if i eat fried food.. it makes me sick to stomach.. and other end too.. so i have learned over time what my digestive system will react to.. and that i can never drink even one for some occasion.. i pay dearly for days after.. it sucks being sick.. but the scary medicine scares me waaaaaaaaaaaay worse.

  • jeff barrie

    interferon has so many nasty side effects. I wouldn’t take this treatment.

    • Jeff Cox

      I agree Jeff, Interferon is absolutely horrible! It makes no sense to me that a company is spending time and money developing drugs that you have to take with interferon when there are companies developing drugs or treatments that you don’t have to take with interferon. Gee I wonder which treatment people will choose?

  • jackie james

    Not for me! Hang in there everyone treatment without INTERFERON is on it’s way. If I don’t make it till it does well I quit the interferon just in time to live the time I have left being able to do things! I thank GOD everyday that I changed my life and I’m loving every minute of it!

    • Debra L. Bradshaw

      interferon is already a thing of the past!

  • Glenn A

    I did the Telaprevir and it worked. Damn near killed me. IF is a walk in the walk compared with that stuff. So it’s great to see more options out there.

  • Kerrigan

    I did the Telaprevir which supposedly had a high cure rate. It gave me problems with my colon which won’t go away. And it didn’t cure it at all. Cure rate turned out to be less than 1/10 what they were touting. Then the FDA “black labeled” the drug because it was killing too many people. The promises are always huge when they are trying to get we the patients to try it. The therapy was worse than the virus. Been living with it for 50 years. No more chemo for this kid.

  • Pompom

    I agree with little sky-
    Also, I would wait a year to see the effects the newest remedy has on people. Then again, if the symptoms are bad, perhaps you have little to lose.
    Probably the best remedy, until something spectacular arrives on the market is enjoy each day.

    “Consider your illness as a gift of receiving a great personalized story book with all of the pages numbered boldly. You actually have the opportunity to know just how far into the book you are. To some extent, you can help script the story. Hopefully, you will write your story so that it is non burdening, rewarding and meaningful. ”
    Please quote me

  • Luc

    Luc
    Hi I do have hep c for more than 20 years. Personally I dont no anybody that interferon with whatever others meds worked with genotype 1. I saw alot of my friends died or are diying or eventually got a lever transplant. All my friends tried the treatment before. So at this point I am not interested to treatment. I hope that they will find something better soon. Because I am 50 and most of my friends that started to have problems were around 52 to 56 years old.

    • gail p.

      you are right. I am 62 an had HepC Genotype 1 for at least 30-40 yrs. I did not do Interferon because my friends who did it were miserably sick and died anyhow. I just this year participated in a clinical trial of an all-oral, interferon free treatment (pills only) and my HepC was completely cleared within 4 wks of starting the RX and has stayed clear for months since I finished the meds. This new stuff that is in the pipeline now really works. I am completely cured and I also feel much more “alive” with energy to do things.
      Hang in there. These new drugs will soon be available to everyone.

      • Ron

        For the past 20 years I’ve been holding off treatment waiting for something better to come along. Your words have given hope, and i thank you for that.

      • BW

        So, what drug did you take? How long has it been since you have been cured.

      • Kris Semelsberger

        Hi Gail P. i am also wondering what did you get that cured in 4 weeks and it was a pill form?? I am 49 years old and I to took shots. I was not cured and if I try that it will make my case worse. I also have a bad heart so I would love to be cured of the hep C so I could focus on my haert issue? please let me know what this pillis and where you were able to test it//

      • brendaelk

        Thank you Gail, I get so discouraged wondering if I will ever feel better. I have had hep c for 30 years or more and want to treat as soon as I can get the new treatments with out the interferon. Your post made me feel hopeful!

        • Free At Last

          Wait until latter this year. They are zeroing in on it very quickly now. I was cured with Pegalated Intaferon, Ribavirin, and Incicavic but the, yet to come out drugs, are reported to be pretty much side effect free. I am 63 and had Geno type 1. I feel much better now and the quality of my life has improved.

      • Julia

        I also was fortunate to be in the Gilead clinical trial for 1A patients last summer that was a once-daily oral pill (sofusbuvir+Ledipasvir) for three months. I had zero side effects and seven months after completing treatment I am still cleared and expected to stay that way. Hang in there people, by the end of this year or early next this, and other treatments without Riboviran or Interferon will be more readily available to the public. We are finally there, after waiting years for a livable treatment that works for 98-99% of those trying to get SVR. Try to get into the clinical trials if you can, that’s the cheapest way to go of course… if not, apply for financial aid from the manufacturer.

  • RussianWinters

    I did peg plus riba for 48 weeks. I didn’t get an SVR, but it did reset me to 10 years prior and gave me time to wait for a cure. The sides were tough but for me manageable.

    The significance of the 3rd drug in the combo (or in some cases 4 drugs) is that it may be possible to do the combo for 24 or even only 12 weeks. The worst effects on red and white blood cells kick in around 24 weeks.

    I could do 12 weeks on an interferon combo if I needed to.

    I’m just waiting to see if they can get a combo-treatment that’s 12 weeks or less or if the non-interferon treatment is out first.

  • vew459

    I am 54, geno1a, stage 2-3. back in 03 I found out i have HepC, treat or die, I jumped in without researdhing which probably not much stats anyways at the time,9 wks tx Peg-interferon/Riba before loosing my vison, hair,weight,rash,bruised head to toe (aneima), mind,put in psych ward,left with fibromyalgia,cryglob,degenrative bone issues,depression n hard to tolereate meds, I am waiting for that non-interferon/riba miracle cure to come out! yr after yr! I started stage 0-1 fibrosis now stage 2-3.I have lost many on line friends over the yrs n have seen many cure,relapse n many blessed that have stayed svr.I just had neck surgery c4-5&c6-7 fused with plate screws n kadaver bone, gotta wear this collar 8 wks, I was going to do the sofobusfir/riba in jan but I am holding out for non-riba because of my adverse reactions, just don’t want to chance anymore , I have suffered enough! I wish a happy new yera to everyone with the HOPE of all curing!

  • Liz Troye

    I’m so pleased and excited about this centuries HCV 1a progress. Praying the FDA and the pharmaceutical companies can all work together for patient access. 🙂

  • luvbebop

    will this new one be only for geno type 1 ppl? I am geno type 2 stage 3.

  • Ghimd

    The Interferon helped me , However Riba. was horrible. Continued with just Interferon and had very little side effect. In fact I had more energy after a week or two. I try to keep a detox program and take the sylimarin and phosphatidylcholine ( lecithin). My liver will always show the Hep-C , but enzymes are fine and stabile. Of course do not drink alcohol and try to keep a clean environment and diet. I have gone through thyroid cancer and throat cancer and am doing fine, but is a constant job keeping a clean diet and environment. Been 10 years and feel great. Would be great to have another option for people other than the standard treatments as it seems to work on a small percentage of people. I was told I most likely had the Hep-c for 30 years, and have no adverse affects. I think in part because I work hard at staying away from toxins. Especially with the cancer. I will never do chemo again. Good luck to you all. We are all different and what works for one may not work for another. Stay positive and stay informed.

  • Debra L. Bradshaw

    hep c diagnose detection only came to light in 1989. Interferron was nasty, it ruined my thyroid in the 90’s. I swore I’d never do another treatment. 24 yrs later my new Dr. talked me into it. I am SO grateful. Absolutely nothing like past cures!!!!! 2 months i am side effect free for most part & virus free & medicare part d thanks to aca [obamacare] is paying. my cost approx. 4 bucks a month