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Setback for Incivek

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Treatment for Hepatitis C Genotype 2

Interferon-Free Hep C Combos to Watch for in 2013

Nicole Cutler L.Ac. January 2, 2013

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For those delaying treatment, we should see progress in 2013 on interferon-free drug regimens for Hepatitis C.

Pegylated interferon and ribavirin have been used to treat Hepatitis C since 2001; and it was another ten years before a new class of drugs to improve treatment were approved. As such, 2011 was the year that two protease inhibitors; Incivek and Telaprevir, joined the Hepatitis C arsenal. Fortunately, experts believe that new medications to fight this challenging virus will emerge before another decade goes by. The pharmaceutical race to produce better, safer, more effective biologics to cure Hepatitis C has intensified – making 2013 the year to keep an eye out for new and improved Hepatitis C drug regimens.

Even though triple therapy that relies on pegylated interferon alfa, ribavirin and a protease inhibitor (Incivek or Telaprevir) has drastically raised the likelihood of successful Hepatitis C treatment, there is still room for improvement. In a recent physician survey, approximately half of surveyed physicians reported intentionally delaying treatment for some Hepatitis C patients until new interferon-free regimens become available. In addition, nearly half of these physicians also reported that many of their Hepatitis C patients are denying treatment in anticipation of the new treatments in development.

The inability to tolerate interferon (an injected medication) is fairly common. Interferon’s side effects are often severe, requiring many people to discontinue their course of treatment – one of the biggest obstacles to a successful outcome. Typical interferon side effects include insomnia, anxiety, depression, severe fatigue, headache, fever, muscle and body aches, no appetite, bad taste in mouth, nausea, vomiting, diarrhea, hair loss, skin rash, reaction at injection site, chest pain, shortness of breath, vision changes, thyroid problems, anemia, low white blood cell and low platelet counts.

Fulfilling the following three elements would create the ideal Hepatitis C treatment plan:

  • Simple Dosing – A once daily, all-oral pill regimen.
  • Effective – Highly effective in all Hepatitis C populations, regardless of disease severity or genotype.
  • Low Impact – Highly safe and tolerable, with few, mild side effects.

Many experts believe that eliminating interferon represents one of the more promising routes. In the hope to get closer to ideal Hepatitis C treatment, the following new classes of drugs are in development:

  • Nucleoside/nucleotide polymerase inhibitors
  • Nonnucleoside polymerase inhibitors
  • NS5A inhibitors
  • Host targeting agents

Currently, there are a large and varied number of investigational Hepatitis C regimens in Phase III trials. Listed by pharmaceutical company, in no particular order, four of the interferon-free combinations to watch for in 2013 are:

  1. Boehringer Ingelheim – Faldaprevir (protease inhibitor) + BI 207127 (non-nucleoside NS5B inhibitor) + ribavirin
  2. Bristol-Myers Squibb – Daclatasvir (NS5A inhibitor) + asunaprevir (NS3 protease inhibitor)
  3. Gilead – Sofosbuvir (nucleotide analog polymerase inhibitor) + ribavirin
  4. Abbott/Enanta – ABT-450 (protease inhibitor) + ABT-333 (non-nucleoside polymerase inhibitor) + ABT-267 (NS5A inhibitor)

The four combinations listed above are not the only players in the quest for an ideal interferon-free Hepatitis C regimen. However, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead and Abbott/Enanta have delivered extremely encouraging data on their investigational drug combos in 2012. Some experts believe there is a chance that one of these drug combos will become available in 2013; others claim at least another year is required. Regardless of the exact timing, those intentionally delaying Hepatitis C treatment in hopes of a better, easier, safer drug regimen have a lot to look forward to in the New Year., Many Physicians who Treat HCV Have Begun 'Warehousing' and Preparing HCV Patients for the Next Generation of Interferon-Free Treatments to Become Available, According to a Recent BioTrends Report, Retrieved December 30, 2012, Decision Resources Group, 2012., The Road Ahead: An Update on Investigational Agents and Strategies for HCV Management, Raymond T. Chung, MD, Retrieved December 30, 2012, Clinical Care Options, LLC, 2013., Sofosbuvir Effective in Phase 3 Study for Hepatitis C, Retrieved December 30, 2012, Haymarket Media, Inc., 2012., Enanta’s Lead Hepatitis C Compound ABT-450 Advances into a Phase 3 Clinical Trial Through its Collaboration with Abbott, Retrieved December 30, 2012, Enanta Pharmaceuticals, Inc., 2012., Combination of Faldaprevir, Non-nucleoside Inhibitor, and Ribavirin Achieves High SVR12 in HCV, Richard Robinson, Retrieved December 30, 2012, HCPLive, 2012., Side Effects Guide: Entire Lesson, Retrieved December 30, 2012, US Department of Veteran Affairs, 2012., Daclatasvir, Asunaprevir Regimens Boast High Cure Rates in Hard-to-Treat Hep C, Retrieved December 30, 2012, Smart & Strong, 2012.



Setback for Incivek

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Treatment for Hepatitis C Genotype 2

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Comments provides information regarding hepatitis and liver disease. Comments are available to the community in order to discuss these topics and obtain answers to questions through community members. The Editors at will not be responding to questions or comments posed in article comments.

  • Alexander

    Hi, I’m 68 non-responder to PegInterf/Ribivarin TX 2001. Waiting for non interferon based study here in New Zealand. Any suggestions?

    • believe it or not..try drinking grapefruit juice,,just Google grapefruit juice (grapefruit) and hep c

      • APRIL

        do not believe you should be using Grapefruite juice with any drugs. it causes more side effects.

        • The Editors

          This might be of interest: “Update: What You Need to Know About Grapefruit and Hepatitis C”

          • Kathy

            I just found out I have Hep C and found this on a site as I have been studying other alternatives because of the horror stories with interferon. This is one that I found.


            750mg lacoferrin,

            500mg garlic extract 3 times day 1hr before food,2hrs after food,.

            Monolaurin can be taken up to 2,400mg 3 divided doses.Monolaurin removes fatty sheath surrounding virus.Hep c virus cloaks itself with sheath so immune system can’t recognise it and therefore eradicate it,unlike other uncloaked viruses ie cold.when fatty sheath is removed you need something strong that is anti viral to work with immune system ie lactoferrin,garlic and or olive leaf.lactoferrin stops virus entering cells.quercitin works in similar and other ways to eradicate virus.I only found out i had Hep C two years ago after contracting it from transfusion 30 yrs.ago.I wish you every success,if i can do it so can you.It took 8 months in all.

      • Alexander

        Oh Brother!

      • Yes, but DO NOT take it on the all oral treatments. it reduces efficiency of meds.

  • Joan

    I finished the Incivek, Ribivirin and Interferon treatment at the end of September. I was Hep C negative from the 4th week of treatment and just found out last Friday that I positive for Hep C AGAIN! This was my 3rd go round with treatment since 2004. I’m just beside myself and at 58, I do not know if I’ll do another treatment. This last treatment just sucked the life out of me. To really make treatment so intolerable, I have a 29 yr old son who was born with Special Needs and has to rely on me for everything, bathing, feeding, diapering, etc.
    I wish everyone good luck with your treatment!!!

    • OMG I FEEL FOR YOU-after 2 times of SOC, I stopped all treatments due to the intense sides. The triple therapy sounded awful to go thru I am so sorry your misery failed you. It sux. Here’s a site I am involved with
      we are trying to get 2 companies to re-engage their trials. anyway just another resource for you. you might contact margaret about your experience as we are gathering data to affirm the issues with all current treatments.

    • Tim

      Wow Joan, I’m so sorry, I to finished the triple therapy in June 2012 with victrelis and suffered through the relentless rash and the other horrible sx only to find out in November I failed to evict the squatter. I feel I wasted 28 weeks of spending time with my grandson and promised myself unless my liver get to be in dire straights I’m going to wait for the silver bullet that at least raises the odds better than 75 per cent.

    • Joan, the interferon free treatments will be available in the next year, or two, at most. The side effects are minor to ńone and the results are amazing! Don’t give up.

  • tiredwaiting

    Hi Joan, I wish you every bit of good luck that one could possibly be given. I guess that your story just proves that there is always someone that has it worse. Although I always tell people that knowing this doesn’t make me feel any better; if anything it makes me feel worse. My situation is somewhat close,in that I am 51, and was treated in 04, only to also test positive soon there after. My wife left me soon after that, because I was not fun anymore. I have held back treatment because the Interferon, especially made me a bit nuts, and I lost much of my memory, and sense of humor for quite some time. Now I am in the waiting game, and very frustrated by the amount of time it has been taking. When I lost my wife, I also lost my health insurance as well, so I am not sure about getting treatment, even when it becomes available to the public, but I am trying to build up my business, so I can at least get insured again.

    I truly wish for you the very best, and hope and pray that you can somehow hold on to enough strength to keep on going. It would be understandable if you were not able to, but I have a feeling that you are one strong lady. You have already proven that. Be well, be strong, and keep pluggin’. You and your son deserve that all elusive miracle. I hope you see it soon.

    • Carol Bradstreet

      You’ll be able to get health insurance again due to “Obama” care. Perhaps by then some of these newer treatments will come out that will work for the rest of us.

    • Jacquelyn Fromm

      That is all terrible. I wish you much luck with everything in 2013. I know how it is to lose a spouse and insurance. It is terrible.

  • KG

    Joan: I just went through the same thing and probably won’t do it again. The treatment was just horrible and the outcome disappointing.

  • Nagy Aslan

    I do not know how to thanks all the people who were co operated in this project ? Thanks for God Thanks for them.
    I hope the drug will be in hand of poor patient and will appear as fast as possible.

  • Carol Bradstreet

    Ditto. I don’t think Incivek is all it’s cracked up to be. I had the horrid rash with it (before the black box warning by the FDA), and got down to non-detectable levels of virus. As I side note, I also achieved that with the Ribavirin and Pegasys as well. Upon completion of treatments (I’ve had 3 now) the ELISA test still showed me as positive for HCV, gen. 1. I’m 59 now. I am waiting for the NS5A inhibitors to get on the market. I don’t think I’ll do another treatment before then.

    • APRIL

      Its a virus, it doesnt go away; it goes into remission with the drugs. it can come back if the remission doesnt hold

      • April, you are misinformed. If a person is undetected 6 months after treatment ends they are cured. They will always have antibodies but the virus itself is gone. When the non interferon therapies are approved, even more patients will be cured.

        • babstrce

          And that will be a blessed day.

  • Donald Duck

    You dumb jerk. You will be ELISA test positive for a long time after the virus has been diminished to non-detectability. The ELISA measures antibodies to HCV, not HCV itself. Your immune system will continue to make those antibodies for a number of years even in the absence of virus.

  • what about duration of treatment with these agents??I mean when we are prescribing these drugs to patients we should follow the same guidelines as with Pegasys and Ribavirin.Is there any effect of genotype on decision of treatment initiation??

  • kph1955

    I’m going into a study next week that is taking place in Miami, Fl.. The study involves taking 3 types of anti-viral drugs developed by Abbott Laboratories. The doctor in charge of the study told me, the 30 previous people in the study group all cleared the virus and all were undetectable. The pills are taken for 12 weeks. It looks like that this could be the cure. The only adverse side-effect reported was slight nausea. I’ll learn more in the coming weeks.

    • I live in FL..close to So FLo..I’d love to find out about this study as I have Hep C with a fairly high viral load, and I do NOT want that awful cocktail of poisons that are being used for a 50% cure rate!

      • Hopeful

        Ditto, I am in the same shoes your in and also would like to here about this study. I feel just as you do…

      • kph1955

        Yes, Miami Research Associates, Sunset Blvd. South Miami Florida 305-598-3125. Ask for Marty, she does the intake. Good luck and God bless.

    • Ric

      Went through the Abbott trial phase 2 and virus free for 3 years.
      Best part no side effects !

      • Jacquelyn Fromm

        Wa drug did you take that had no side effects. Thanks.

        • mik007

          It seem’s that Ric has abandoned us i would be most interested in this also,no side effect’s would be GOD sent.

          • kph1955

            The drugs I’m taking from Bristol Myer’s Squibb, all oral, have no side effects. I feel like a million dollars. I’m sure the Abbott drugs which are similar to Bristol Myer’s don’t have adverse side effects either. These drugs have not been released as of yet, but I was told that the drug companies are looking for FDA approval late this year or early next year.

      • kph1955

        Fantastic.. I hope the Bristol Myer’s drugs work just as well. Day 11, I went undetectable. Hopefully after the meds are stopped in 9 weeks, I’ll remain undetectable.

    • Ronald

      I am a patient at U of Miami liver Disease Ctr. for 11 years. I am a non responder to interferon/ ribaviron treatment back in 2002. Can you tell me who I’d have to contact to get on one of these studies.

      • kph1955

        Sorry for being so late to answer. Yes, Miami Research Associates, Sunset Blvd, South Miami…305-598-3125 ask for Marty, she does the intake. I don’t know if they’re taking new subject, but it’s worth a try.

    • Jacquelyn Fromm

      Please let me know how it goes when you get home. Very curious about the drug being used and side affects. Thanks.

      • kph1955

        I’m sorry I’m answer these posts so late, just got on line. Anyway, It’s day 15, but the lab is slow, only results up to day 4 are in. Day 1, viral load was 5 million and day 4 it was down to 9 thousand. Absolutely no side-effects. I feel great. Miami Research Associates are doing this trial they’re on Sunset Blvd in South Miami..Dr. Schwartz is in charge of the trial.

    • lorraine

      If possible can you tell who and where can I contact to go into this study. I live in Miami too. And I already had the Interferon treatment which did not work. Although I feel fine my Dr. this year told me to go back in June with a biopsy and tests and see this year where I am standing. He said not to redo the interferon again. I have been in the Schiff Group in the University of Miami and my Dr. is in Mercy Hospital. email me [email protected]

      • Kevin

        Sorry, just saw your post. Miami Research Associates on Sunset in South Miami…Dr. Schwarz is heading the trial. If you call them ask for Marty (Martha), she does the intake.

    • christi mallen

      hi pls. tell me what is the name of tht pill for hep husband is a hep C patient and all he took detox pills and check ups from the his doctor….it would help so much ..hope to frm u…tnx

    • blipette

      So how did the test go?

  • PdxBB

    Hopefully one or more of these companies will find a “Interferon” free cure! I have not taken the current cure mainly due to the Interferon! But, I am willing to try a ‘new cure ‘if and when they come up with one.

    • Jacquelyn Fromm

      That ISP the same thing I am diing. I really do not think I could get through the side affects to be honest with you. That is why I have not went through with the treatment, i am hoping for an easier treatment drug.. hope I do not wait too long. That worries me at times also. Thanks. Jackie

      • babstrce

        I’m in your boat Jackie. It really hit me hard last night & I’ve been crying ever since. I’m terrified of Interferon. I feel sick, fatigued & depressed enough as it is. Barbara

  • Leslie

    I completed the the treatment in September using the interferon, ribaviron and Victrellis. In October my viral load was back. I am curious about whether the new medications will be effective for those of us who were unsuccessful with the current medications.



  • Ronald

    I wonder how the Insurance part works if You are a Medicare recipient? I wonder if Medicare Part D or Part B will cover eseis expensive drugs when they comes out.

    • Joan

      Yes Medicare Part D did cover the new med Incivek because it is cheaper to cure than to do a transplant. Good luck!

  • fJohnny

    I just has my third shot yesteday for hepatitus B, vaccine, I was prescribed the interferon and antivirals, for Hep.C type 2, I haven’t got them from the pharmacy I asked about them yesterday and they said they would have to reorder the Pegasus, I told them not too. Currently I take vitamins yeast, milk thistle, super b complex, multi vita-min, lycine and fish oil, ginseng, bilboa, colon clnsr and C. I recently quit smoking ciggerettes and a’m using nicotine patches also. John

  • Joan

    Please do not let my misfortune of going back to positive scare anyone away from trying the treatment. I’m still waiting for the next new drug. I refuse to go down with the ship!!

  • Been there

    I lost my vision about 4 months into the treatment with Ribavirin and Pegasys/Interferon. Luckily my vision came back after stopping the treatment, but the virus came back. I think it’s worse to go blind than to have the virus. Let us hope the new drugs are safer, because for the last 2 decades the new drugs have been worse than the old drugs – and I don’t mean just drugs for hepatiis but a lot of new drugs – have you seen those commercials on TV – the side effects are everything including death.

  • I have started the Abbott quad trial called Turquoise. So far I only have very mild itching. Compared to interferon this treatment is a walk in the park. I really don’t even know I am treating.

  • Tee

    Why dose the FDA take so long, yes I no they need to CK things out, but come on guys lets go!!! Also dose any one no of a trial w/ the new durgs going on????

  • Tom KC56

    Why does the FDA take so long? Easy answer. People don’t realize how big the problem is, if they don’t have it. In the 80’s, everyone was on the AIDS bandwagon. Guess what? Drugs were pushed thru in record time. Public perception & awareness is where the problem lies. I recently received a transplant myself, but still suffer from the disease. Interferon didn’t work. This isn’t unusual when you suffer from genotype 1A. The cure rate goes down considerably. We need a grass roots effort to contact Congressman, Senators & even the President. We need this disease in the nwes as much as possible.

  • tpod

    I will not poison my body with interferon i have consempated cirrohsis which means my liver works even though i have this “bug” I had a friend die from these drugs so i will wait Ive had it for yrs so whats a couple more I dont drink or drug and try to eat right Another thing I suffer from depression and my dr told me i could become suicidal or homicidal on this poison thing is I would NEVER hurt myself or ANYONE else No thanks Dr ill wait! Good luck to you all

  • ted

    i been on interferon treatment for 19 weeks now. the virus went undetectable on my 8th week. .
    I just had my second blood transfusion due to low platelet counts. now i’m off all meds,and the doctors say the viris will come back. What a waste of time and money. my first 3 weeks I was bed riden and got every side affect you could get. it was the worst experience I’v ever went through.

  • marilyn

    IF you have not done so please go to this is what we are fighting for…a humane cure with no ribavirin or interferon. Gilead has half of the cure and Bristol Meyrs has the other half. When these 2 pills were taken together they got 100% cure rate of hep c, genotype 1a. After this trial Gilead stoppedd working with Bristol and now want to fool around trying duplicate Bristol’s pill. We want and need a humane cure now not later

  • Hope

    I’m type 4 and went on treatment 2 times last one was in 2011 with in incivek I was clear at week 8 then broke threough,side effects were horrible. Any ideas to help me if the new meds would work for G type 4


  • Kevin

    This is day 7 of my testing Bristol Myer Squibbs new all oral treatment. 4 pills two times a day, 12 hours apart. Day 1, they checked my viral load, I took the medication and they then took blood every hour for eight hours. Amazing. Before I took the meds that day my viral count was 5 million, by the 5th blood test, five hours later, my count dropped to 300 thousand. Days 2-6 results aren’t back yet, but the doctor is guessing that by today, day 7, my count should be close to zero is not zero. This was proven in 60 previous test subjects. All have cleared the virus, even Genotype 1s. The first group has been followed up for a year and there has been no relapse. Exciting news. I have experienced no side-effects, not even nausea. Nothing. The drugs should be released late this year or early next year. The trials are being conducted at Miami Research Associates. I really don’t know if they’re taking new test participants. It’s a miracle…..Kevin

  • Paige Harper

    I have just begun a new regimen with the Gilead drug combo Sofosbuvir and another drug in one pill plus 6 ribavirin a day. So far no horrendous side effects. I did the regimen with interferon, telaprevir, and ribavirin and though it cleared my viral load it decimated my body. I had a new biopsy last month which confirmed cirrhosis due to Hep C so I am hoping this new combo will work for me and others who could not tolerate Telaprevir and have cirrhosis. This trial is at Shands at the University of Florida in Gainesville.

  • Frank

    I have started the Interferon riboviron on three separate occasions. Each time I ended up in the hospital within a week. Finally my MD said “You must not be able to tolerate the drugs” I have been waiting years for something new. I hope it comes soon. It only gets worse.

  • Bristol-Myers Squibb – Daclatasvir (NS5A inhibitor) + asunaprevir (NS3 protease inhibitor)
    I am on this trial which is mainly successful to genotype1b. Protease inhibitors have a messy side effect profile. I have cleared the virus, but suffer from fatigue and diahrea. The treatment regimen is 24 weeks. Hopefully FDA will approve combination therapy of Gilead’s sofosprevir and Daclatasvir, since that is most successful combo with only 12 weeks of treatment. i would advise anyone to get on an all oral trial without ribaviren if they can. i just wish Gilead was not so greedy to creat their own NS5A, because so far theirs are not as successful for all genotypes. Recent press release announces they still refuse to partner but will concede to combo drug therapy, which is a step in the right direction. I am somewhat healthy and almost died from interferon. Great news that will be treatment of the past soon!!!

    • Kevin

      I’m taking the Bristol Myers meds too! This is day 15 and zero side effects. I’ve never felt better. I guess the meds react differently to each individual person. My count is down from 5 million to 9 thousand as of day four. Haven’t gotten the results back from day 5 to 14 yet. The lab is so slow.

  • Cesar V.De Guzman

    I hope that the four interferon free combinations will be coming this year for highly effective treatment and less side effects will be prescribe for undenial treatment of hepatitis c of all genotype.

  • Kevin

    I got my day 4 results back from the trial I’m in. Taking the Bristol Myer Squibbs all oral treatment. Day one my count was 5 million, by day 4 the count was down to 9 thousand. I’m in day 15 of taking the meds. I’m waiting for days 5-15 to return. The doctor believes I should be at zero by now. Also, he told me that once cured, one has a life-time immunity to Hep C. Anyway, I feel great, I’m not experiencing any side effects (which if they occur, are minimal. And no more body itch. The meds should be approved and released sometime late this year or early next year.

  • sam.a

    Anyone in az im unisured i have never had treatment. I work full time but i work just enough to get by. I cant get a good insurance plan thatll accept preexisting conditions and thats cost feasible. Ive been looking into all this news about cures but can someone like me get in? How will i know ill make it to then? :/ help me out sam.a

  • kph1955

    I just received my viral load for day 6 of the Bristol Myer’s all-oral treatment. The viral load on day 6 was 1,046. It went down from 5 million on day one to a little over a 1000 on day 6. Today is day 16, so the results won’t be back until late next week. The doctor tells me if I’m like the 60 other participants before me, it should be zero by now. He told me the virus has not returned in any of the other 60 people. So hopefully this will hold true for me. I’ll keep you posted.

  • kph1955

    One other thing. I have had zero side effects from the medications. None. I feel great, the best I’ve felt in years.

    • gdean

      Could you please tell me more about this. My husband is having a horrible time with Ribavirin, and Incivek.. bleeding from the rectum, direahrea and more..

  • kph1955

    I’m in day 21 of taking the new all-oral Bristol Myer Squibb’s Medications. I just received my day 11 results. Day one the viral load was 5 million, day 11 it was undetectable. I have had zero side effects; absolutely none. I feel 100% better. My energy is back, the muscle aches and pains are gone. As I said in an earlier post, the other subjects who took this medication for 12 weeks have been virus free for 1 year after a 12 week treatment with the all oral medications. I’m hoping that after I stop the meds in 9 weeks, my load will be undetectable in a year just like all the others. The doctor in charge of the study told me that they haven’t had one relapse yet. So hopefully these meds will be put on the market by the end of this year or the beginning of the next. Good luck and God bless to all.

  • lisanico

    I was treated 3 times with no success… I would gladly take all the horrible side effects that I went thru if only it worked!! Hopefully they find something soon before it does anymore damage 🙁

  • Margo

    Did the second time treatment now with Pegasys, incivek and ribavirin. 12 & 24 weeks post treatment and the Svr has been achieved!!! I couldn’t believe it but it happened. Guys don’t wait for new treatments to come out, go for the triple therapy. It’s not easy but doable!

  • wk

    If Gilead Science would work with Bristol Meyers we would have a cure. Its all about money. The gov’t puts their nose in many things but for some reason won’t touch this.