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Possible 8-Week Cure for Patients with Hepatitis C

February 15, 2017

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Learn more about a new, investigational Hepatitis C drug that has been granted priority review by the FDA. It is meant to help patients without cirrhosis who are new to treatment.

Investigational Hepatitis C Drug Granted Priority Review

By Jennifer Barrett

The FDA has accepted AbbVie’s New Drug Application (NDA) for and granted priority review to its investigational, pan-genotype regimen of glecaprevir/pibrentasvir (G/P). The treatment is being evaluated for its ability to treat all major genotypes (GT1-6) of chronic hepatitis C virus (HCV).

The NDA is based on data from 8 studies which evaluated more than 2300 patients in 27 countries across all major HCV genotypes and special populations.

Continue reading this entire article:
http://www.pharmacytimes.com/product-news/investigational-hepatitis-c-drug-granted-priority-review

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28 Comments

  • Sandy Robertson says:

    Eight-week cures are already possible in some cases with existing drugs. I was cured in eight weeks with Harvoni as I was treatment naive, and despite having had hep c genotype one for decades I was not cirrhotic. In fact, I had no detectable virus after four weeks.

    • Ann says:

      I too was cured after 30 some odd years with genotype1. Harvoni did the trick . Although there were no side affects while taking the drug, since then , coincidentally , strange things are happening in my body. My feet and ankles have gone numb and I get recurring , painful cramps in feet and legs.. I swear they cannot tell what is causing it but I KNOW it has to be related to the treatment and I am paying dearly in the aftermath

      • Sandy Robertson says:

        Sorry to hear that. I have seborrhoeic dermatitis on my neck under my hair and it is very hard to cope with. I know some people with hep c who also had it were pleased to find it vanished once cured. However, in my case I now have skin issues all over my body too. Places like my navel, my ears and one side of my scrotum itch and get sore, and my chest and legs itch too.
        My hospital just noted this as a possible side effect but aren’t convinced it’s related to treatment because they say they usually only see skin problems on those who have Ribavarin in addition to Harvoni. The only suggestion was to see my GP, but as there’s no cure for seborrhoeic dermatitis and I’ve tried everything and seen my doc already. . .
        All I can say is: it’s better than having hep c. Your issues seem worse and I hope you can get help.

  • Stephen says:

    I want all to be forewarned that unless you have a specific Geno type lab test to determine your specific Hep-C, an 8 week Harvoni treatment may be a waste of time and money. I took Harvoni for 8 weeks, 6 months after treatment my hep-c viral load was back to the same viral load before treatment. I am now taking epclusa with ribavarin for 3 month treatment, more expensive than Harvoni. so far not so good with mid treatment blood test. I am a geno type 1

    • grouchomars says:

      Sorry to hear that Stephen Harvoni was GIFT from GOD to me after a HORRIFIC experience with Infon/riba. In early 2000 My TX was 48 weeks by week 16 I thought I was going to DIE from the HORRIBLE side effects it caused!!! My V/L did drop but I couldn’t take the mental & physical TORMENT That I was experiencing!! Took Havoni for 12 week in 2015 Buy week 4 my V/L dropped from 18 mil to 3 hundred points and was ND after 8 weeks with virtually NO Side effects!! I am OFFICIALLY SVR!!!! Good Luck!!

    • Glenn Batchelor says:

      Sorry to hear I also am type1

    • Fed up says:

      I’m so sorry for your status. I’m 1 and waiting on to be approved to take Epclusa. I have always avoided ALL meds and now here I am ;/

    • Connie Cary Weinholtz says:

      i also relapsed after 8 weeks of harvoni….

      • Sandy Robertson says:

        Am sorry to hear of Stephen and you relapsing after Harvoni. I’ve been told that my hospital hasn’t seen anyone have hep c come back after they’ve been clear for 24 weeks, if it’s going to happen it’s usually sooner.

  • Oz says:

    I wonder How much they are gona sale this one, they making dtuck but you can not efford it,

    • Glenn Batchelor says:

      Probably unaffordable

    • Fed up!! says:

      If Hep C was required to be tested in the annual panel of blood tests we take NONE of us would have Cirrhosis right now from blood transfusions!! However doctors and the government make money for us all to be suffering from Uncurable Cirrhosis instead of curable hep c before it gets to this point. I’m a raw vegan that has never drank or did drugs yet here I am too. NOT that ANYONE with any lifestyle choice should be living with something that could have been avoided if hep c were mandatory in blood panel test.
      I had blood transfusion 1983!!!! Was NOT told by any doctor I had hep c until JAN 2017, with added Cirrhosis!!!
      Now charging me for all kinds of test and meds!! Hmmm where were all these test the last 33 years!! I have five surgeries and a child in the last 33 years!!! Pulled all my labs and radiology records and see now that docs have known for years and NOT One has to me!! Hmmm epidemic ??? Yeah government and medical murder of Americans!!!! Doctors don’t make money on healthy people!!
      Anyone interested in joining me in making hep c testing mandatory or in the blood panels they make you take at annual physical?? They are sure ready to test you for diabetes, heart disease etc —ALLLL things they can make you take RX for!!

      • Don Hall says:

        Hang in there I had hepatitis C for 28 years I had to finally quit my job and get rid of everything and claim indigent in order to get the drug company to help me out with the treatment. My buddy has cirrhosis of the liver and had hepatitis C and get treatment and is cured from hepatitis C and his liver is doing fine at the moment no problems so hang in there there’s light at the end of the tunnel

      • Michele Adams says:

        The hepatitis C virus was discovered in 1989. Prior to that, it was associated with blood transfusions, but was called non-A, non-B hepatitis because the virus could not be identified. It is now known that there are several genetic types (genotypes) of the hepatitis C virus.

        There was no test at that time of your transfusion in 1983. Nor did anyone know of the grand significance of the disease at that time.

        I don’t think there should be mandatory blood panels at physicals. Mandatory blood tests are a clear violation of constitutional rights. Also, I would suggest making sure you have all your life insurance policies in place first if you are going to mandate that hep c blood panels are a requisite to annual physicals.

      • Champ86 says:

        Right on, I got so sick of the implication of IV drug use, I searched for years, until I found the time & place, I got “Non-A Non-B” in the 70’s, it was a hospital, one run by my faith, no less, I chose them over a nearby inner-city Hosp. out of fear of something like this. Well, it was only because I went acute, shortly afterwards, not years later, that I was able to run out a timeline. And find the source.
        You’re fed up. I’m Pissed Off, these cures are, at first, funded by tax dollars, while the scientists get Govt paychecks & then, when it’s good they get millions selling the patent to Pharma, yeah a double dip.
        Then Pharma spends less than $5 a pill manufacturing it and charges US a full $ 1,000.00, that’s so wrong, it’s like being played for a sucker. paying Tax $ to the NHS, again when the ‘discoverer’ sells it, for millions. Then we get held hostage for cures that cost a few cents, to make, but a Thousand Bucks to take.
        And, oh yeah, their PR Dept. is telling the world,
        “It’s their fault, they mainline dope.”
        Just to insure we won’t get a lot of sympathy trying to prices lower, where they should be.
        What a Rip-off, if a Union did anything like that, they’d be charged, imprisoned, fined out of business. I say, they’re criminals.

        • Fed up says:

          I agree Champ!
          I want the government criminally responsible! They add 20 tests I your annual panel. Why wouldn’t they add Hep C since such a issue! And that could NOT cause terminal Liver issues IF you were made aware sooner than 33 years later!!

          But as I said doctors and government and pharmaceutical companies do NOT make money getting you well the quick and easier route.

          Prayers with you. I’m so mad too!

  • Robin Newlon says:

    Michele Adams, you are so correct. Because HCV was considered an “epidemic”, drug companies were not required to perform the same tests required by the FDA. Therefore they were able to release their drugs immediately! And now that Trump has taken away the pharmaceutical regulations that were there to protect us, who knows what meds will be recommended!
    I’m type 1a with very mild fibrosis of 1. Abbvie supplied the 12 wk course of Viekira Pak XR & Ribavirin at no cost because my insurance (express scripts) denied my claim twice. I finished in Dec ’16. I have NO idea what the long term effects will be simply because long term trials were never done. Look it up. But I do know the long term effects of Ribavirin and pegulated interferon and those side effects still haunt me.

    • Michele Adams says:

      Thank you so much for sharing your story Robin Newlon, and also, the little known fact that ‘epidemic’ drugs are not under the same stringent regulations as other drugs that are required by the FDA. I can tell you Robin, that I was not aware of that fact, and it makes me even more concerned than before. Thank you! As always, one must do as much research as possible before embarking on new drugs. After learning as much as possible, weighing in on risks vs benefits, only then (and even then, with the utmost hesitation) can we at the least make an educated decision on what is best for us. I have a friend whose ‘brain’ is literally fried from the drug Ribaviron that was prescribed along with the Interferon. This friend swears to this day, it was more the Ribaviron that cooked his brain, way more than the affects of the nasty interferon. However, of course his doctors would not even acknowledge his experience. – (interferon in their opinion (Dr’s), the nastier of the two). In disgust, my friend told his Dr’s – “You take the damn drug”! “Then you tell me!”. These drugs are very hard on the human body. Very. I do wish you the best.

  • shahriar says:

    Why don’t you guys try the generic versions ?? Its far more cheaper than that originators. i know some name of generic drug having a very good output.

  • David Varshavsky says:

    Hi everyone, please take note that ALL pharma companies base their success “cure” rates (95% to 100%) on being SVR negative at 12 weeks post treatment!! That means NOTHING!! Interferon achieved that, and then a few weeks later it was back! and with side effects to last a very long time, Pharma companies do not tell you how many people have died during or after treatment, or how many have committed suicide during treatment (I wonder why) So when you hear next about a “new” miracle drug with a success rate of 95% based on being SVR negative at 12 weeks post treatment consider it useless!! Only when they come up with a drug that will keep you SVR negative for YEARS and with minor to no side affects, only then think about entering a treatment program. All of these new “miracle” drugs have NOT been tested long enough, only recently a new study revealed that some of these new drugs that “eradicate” Hep C, actually also accelerate liver cancer!! Now, if you don’t understand the medical language, or what certain things mean, or you just feel completely lost, talk to someone who knows, you can call help lines to start with, have a good and trusted doctor, like a family doctor, perhaps a friend that has been through it, or if you want you can email me on [email protected] and I’ll try to help you as much as I can.

  • Sheri Fisher says:

    I was involved in a clinical trial, I had zero virus detected at two weeks! It has been over a year and I am still negative! The only side effects I had were headache and fatigue! Liver ultrasound negative. My fibro score was 3-4.

    • Liz Cargile says:

      I need to find a clinical trial in my area. Just not sure where to start. Any info is welcomed, I have been referenced to Harvoni. Just no health insurance and I’m resourced out.

      • Mary says:

        Try and sign up for ACA aka Obama care. I’m on passport. My doctor contacted the drug company. They send it a coupon.
        You have to pay for the insurance based on income, but the Harmonic cost a fortune without coupon.

  • Hendra S says:

    if you still need sovosbufir (sovaldi) by gilend I will give you an interesting offer price of $ 5000 / bottle is the postage to your place

  • Hendra S says:

    if you still need sovosbufir (sovaldi) by gilend I will give you an interesting offer price of $ 5000 / bottle is the postage to your place

  • Terrig Noel says:

    Has anyone tried Harvoni? How long does treatment last? What are the side effects?

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