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Hep C Drug Pipeline: New Additions and Three Combos to Watch for in 2014

Nicole Cutler L.Ac.

January 2, 2014

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A handy guide to show which drugs are available now and who the top contenders are for an anticipated 2014, interferon-free, Hepatitis C cure.

Analysts believe that 2014 will be a tremendous year for advancements in Hepatitis C therapy. Excitement is growing as we inch closer to approval for an improved, highly effective, safer drug combination that experts say could cure many people of Hepatitis C.

For the most common strain in the U.S., Hepatitis C genotype 1, the current standard therapy generally combines three drugs:

  • pegylated interferon
  • ribavirin
  • a direct acting antiviral (DAA)

Direct acting antivirals are medications that attack the ability of the Hepatitis C virus to replicate. Different DAA’s interfere with the Hepatitis C replication cycle at different stages. Telaprevir (Incevik) and boceprevir (Victrelis) are protease inhibitors – one type of DAA. Although adding one of these protease inhibitors to interferon and ribavirin treatment boosts treatment success from 50 percent up to 75 percent effectiveness, they are both associated with some extremely distressing side effects including anemia, rash, anal itching and rectal burning.

The greatest promise for improved treatment regimens lies with an interferon-free Hepatitis C drug protocol. Primarily because interferon is associated with so many severe side effects, the race for an approved, interferon-free, Hepatitis C regimen is heated. Interferon-free regimens are expected to have a higher success rate, be better tolerated and enable treatment of people who cannot take interferon. The most substantial breakthroughs for Hepatitis C treatment seem to revolve around DAA cocktails, with drug resistance posing the biggest challenge. Hence, experts believe a cure lurks in finding just the right mixture of DAA’s without interferon.

At the end of 2013, two new DAA’s were approved, both of which were approved by the FDA in conjunction with pegylated interferon and ribavirin for treating Hepatitis C genotype 1. They are:

  1. Olysio (simeprevir) – Approved by the FDA in November 2013, simeprevir is an NS3/4A protease inhibitor made by Janssen Pharmaceuticals. Simeprevir requires 12 weeks of triple therapy and 12 weeks of double therapy (just interferon and ribavirin). With an effectiveness of around 80 percent, simeprevir’s main side effect is rash and photosensitivity.
  2. Sovaldi (sofosbuvir) – Approved by the FDA in December 2013, sofosbuvir is a polymerase inhibitor made by Gilead Sciences. Sofosbuvir requires just 12 weeks of treatment and has an estimated 90 percent success rate.

Unfortunately, both simeprevir and sofosbuvir are currently dependent on interferon for treating Hepatitis C genotype 1.

Three of the interferon-free, DAA drug combinations that are currently in Phase III trials at the end of 2013 include:

  1. Abbott/Enanta Combo – This triple combination involves ABT-450 (a protease inhibitor), ABT-267 (an NS5A inhibitor) and ABT-333 (a polymerase inhibitor). Preliminary results indicate after 12 weeks with ribavirin, 96 percent of treatment-experienced patients with genotype 1 had a successful outcome.
  2. Boehringer Ingelheim – Boehringer Ingelheim’s faldaprevir (protease inhibitor) and deleobuvir (polymerase inhibitor) are also combined with ribavirin in Phase III trials. Faldaprevir has proven to be effective against a relatively common, yet troublesome, Hepatitis C variant known as the Q80K mutant. While Phase II trials delivered success rates around 85 percent (even on patients with cirrhosis), interim results for the Phase III trials have not been made public yet.
  3. Gilead – Sofosbuvir (polymerase inhibitor) was just approved by the FDA in December 2013 in combination with pegylated interferon and ribavirin, but it is also in an interferon-free Phase III trial with ledipasvir (NS5A inhibitor). Without interferon or ribavirin, preliminary results demonstrate that sofosbuvir and ledipasvir have cure rates well over 90 percent in as few as 8 weeks. A previous study of sofosbuvir, ledipasvir and ribavirin showed a 100 percent Hepatitis C success rate.

While there are many more drug combinations being studied, these three appear to be the most advanced as we start the New Year. Many people have chosen to wait until better Hepatitis C treatment options become available, and it seems that 2014 might be ushering in those improvements. With the right combination of DAA’s, a safe, effective treatment without interferon appears close. We expect great things from Abbott and Enanta, Boehringer Ingelheim and Gilead (as well as a long list of other potential contenders), and are looking forward to turning the corner on Hepatitis C – so it can officially be rendered a curable illness.

References:

http://blogs.hepmag.com/lucindakporter/2013/10/a_bright_future_for.html, A Bright Future for Hepatitis C Patients, Lucinda K. Porter, RN, Retrieved December 29, 2013, Smart + Strong, 2013.

http://consumer.healthday.com/infectious-disease-information-21/hepatitis-news-373/new-hepatitis-c-drug-approved-682860.html, New Hepatitis C Drug Approved by FDA, Retrieved December 29, 2013, HealthDay, 2013.

http://hcvadvocate.blogspot.ca/p/quick-reference-guide_21.html, Quick Reference Guide DAA’s, Retrieved December 29, 2013, Hepatitis C Support Project, 2013.

http://hepatitiscnewdrugs.blogspot.com/2013/12/gileads-sofosbuvir-and-ledipasvir.html, Gilead’s Sofosbuvir and Ledipasvir Outstanding Late-stage Hepatitis C Data, Retrieved December 29, 2013, hepatitiscnewdrugresearch.com, 2013.

http://hepatitiscnewdrugresearch.com/quick-facts–direct-acting-antivirals-telaprevirboceprevir.html, Quick Facts – Victrelis/Boceprevir, Incevik/Telaprevir, Retrieved December 29, 2013, hepatitiscnewdrugresearch.com, 2013.

http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=1883481, Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in Sapphire-11 Study, Retrieved December 29, 2013, Enanta Pharmaceuticals, 2013.

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/15_august_2013_hcv.html, Boehringer Ingelheim announces full patient enrolment for two of its pivotal Phase III interferon-free hepatitis C clinical trials, Retrieved December 29, 2013, Boehringer Ingelheim, 2013.

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/16_december_2013hcv.html, Hepatitis C: Phase III data show Boehringer Ingelheim’s faldaprevir* is effective even in patients with common drug-resistant viral variant, Retrieved December 29, 2013, Boehringer Ingelheim, 2013.

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm376449.htm, FDA Approves New Treatment for Hepatitis C Virus, Retrieved December 27, 2013, US Food and Drug Administration, 2013.

http://www.fiercebiotech.com/press-releases/first-interferon-free-regimens-treatment-hepatitis-c-virus-are-expected-lau, The First Interferon-Free Regimens for Treatment of Hepatitis C Virus Are Expected to Launch in 2014 in the United States and Europe and Will Experience Aggressive and Widespread Uptake Through 2021, Retrieved December 29, 2013, FierceMarkets, 2013.

http://www.gilead.com/news/press-releases/2013/4/data-from-phase-3-studies-of-gileads-sofosbuvir-for-hepatitis-c, Data from Phase 3 Studies of Gilead’s Sofosbuvir for Hepatitis C To Be Presented at 48th Annual EASL Meeting; Findings Published Online Today in The New England Journal of Medicine, Retrieved December 29, 2013, Gilead, 2013.

http://www.medscape.com/viewarticle/777475_2, Current Prospects for Interferon-free Treatment of Hepatitis C in 2012, Catherine AM Stedman, Retrieved December 29, 2013, WebMD, LLC, 2013.

http://www.medscape.com/viewarticle/813197, FDA Panel Recommends Approval of Simeprevir for Hepatitis C Troy Brown, RN, Retrieved December 29, 2013, WebMD, LLC, 2013.

http://www.natap.org/2013/CROI/croi_07.htm, ELECTRON: 100% SVR Rate for Once-Daily Sofosbuvir Plus Ledipasvir Plus Ribavirin Given for 12 Weeks in Treatment-Naïve and Previously Treated Patients With HCV GT 1, Jules Levin, Retrieved December 29, 2013, 20th Conference on Retroviruses and Opportunistic Infections, 2013.

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Posted by Nicole Cutler L.Ac. on January 2, 2014

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  • http://www.facebook.com/people/Brian-Dusel/1487136392 Brian Dusel

    This article fails to mention the fact that genotype 1 patients with cirrhosis must treat much longer than 12 weeks. AND, the Solvadi cure rate is much lower for cirrhotic patients! Gilead’s HCV treatment will probably turn out to be just one more big flop, just like Vertex incivek!

    • ChrisOnyc

      I had type 1a Hep C and cirrhosis and did a phase three 12 week clinical trial last year of the combination of Simeprevir and Sofosbuvir and Ribavirin and I was cured of Hep C and am still Hep C free 9 months after ending the trial. Even my cirrhosis has reversed itself to a degree and my hepatologist tells me I’m now a stage 3 instead of 4. I had little to no side effects on the trial drugs and I feel better now than I have in years! Only 12 weeks of treatment for a cirrhotic and no sx and I’m cured! Once this combination of DAAs is FDA approved, you’ll be cured very easily!

      • GovtReform

        Thanks Chris. It sounds like I’m in the exact same boat as you were. I’ve been treated twice already. About 10 years ago with Peg/Riba and a couple years ago with Peg/Riba and Incv. I’m stage 4, but still compensated. 45 years old with 2 kids. I have an older brother who died from this. I just keep hanging on, eating right, exercising and HOPING for a cure.

        • ChrisOnyc

          Definitely get yourself on treatment with any of these DAA combos as soon as they’re approved by the FDA as they have 98-100% cure rates in clinical trials (on cirrhotics too!): Gilead drugs Sofosbuvir plus Ledipasvir , or Sofosbuvir plus Simeprevir which I took, or the Abbvie combo of 3 DAAs. As a cirrhotic, you may need to take Ribavirin with the DAAs but it really didn’t give me any adverse side effects. Believe these combos should be approved within a year so hang in there! There are wonderful, easy cures coming soon!

      • shadowcat

        Chris: I think that’s great! And I don’t want anyone to think I am against those trying these regimes. they do work for some people & some people can handle the treatments quite well. I do envy you lucky folks as you were able to stick w/ it & clear the virus & get back to living your lives. I hope that day will come SOON for the rest of us , whom for whatever reasons, have not been able to withstand the treatments currently available.

        • Joan

          I aprieciate shadowcats ohnesty and ChrisOnyc and I agree with shadowcat doctors and pharm. alike try to promote Chris exsp. and fail to Mention Shadows, I’ve been fighting a rare cancer and found out I had hep c too… neither doctor seems to look at the two together , the weekend amuned system the side affects from both, which leaves me doing nothing … because I’m afriad treatment will destroy me.. the cemo treatments don’t work for the time of cancer I have, so i’m waiting another year in hopes … It seems sometimes the drug. companys don’t care who life it is..

    • Brama

      Brian, gilead’s treatment and soon to be coming combo of Sofosbuvir and Ledipisvir will more than likely lead the pack in terms of cure rates. It is currently showing to have a cure rate of over 96-100% with nominal side effects. It is a once per day pill sofos/ledip combo, and even with RIBA, most people on the discussion forum experienced little to no side effects. This combo is going to be a game changer in terms of oral therapy. You watch… The new drugs they are coming out with are totally different.

  • Rene44

    What about genotype 2?

  • rettajane

    It is GREAT news!,only, (is it)just a cure for those that can afford it…or,will our insurers pay the exorbitant prices?

  • pete

    just another tease, I am so over all the mail when nothing gets done

  • Gus

    First 2 studies are no good and not much help to victims who had to stop the old treatment because of life threatening symptoms caused by Ribaviron or Interferon. The 3rd study is without Ribaviron and without Interferon so this is the only treatment hopeful for many victims.

  • shadowcat

    Regardless of what is available now or in the near future; I have one comment to all if not most physician’s & other’s in the medical field: Quit downplaying this disease & the side effects from taking any available “treatments”! When I was 1st diagnosed, all that was available was Interferon & Ribavirin. I was told I might get a “little” depressed & “maybe” a “little” rash – all symptoms that were “easily” manageable. For any of you familiar with these drugs you know neither is easy to endure: “riba-rash from hell” Severe depression, anemia, hair loss, recurring & possible lifelong damage to kidneys & other organs, vision impairment, etc to name a few. Several years later when Telaprevir came out my Dr told me there were hardly any side effects & even tho I only lasted 2 weeks before I was so ill from the taking the 3 medications & not being able to eat – to this day he still acts as if the side effects were negligible. Do they have their heads stuck in the sand or simply where the sun doesn’t shine? Could all the stories I read online from folks on treatment lies? Are they just whimps over exaggerating their pain? And, why do they refuse to refer to Hep-C treatments using interferon as anything else but chemo-therapy? Just 2 wks ago I saw my Dr & he excitedly told me about the “game changer” Sofosbuvir – & was ready to write me out a script right then & there. I try to keep up on new releases & I had not heard of anything for my genotype 1 that was currently available w/o using interferon – which is knows I can’t tolerate. Again, he said the side effects were negligible & I reminded him he said the same thing about Telaprevir. I said I would have to think about it & get some more information. When I went online & saw that sofosbuvir is really (currently) intended for use w/ interferon for G1 I was really upset that he downplayed this important fact. It’s great companies are finally jumping on the wagon for a cure-even if it is only about profits for them. I really don’t care as long as they cure me & do it w/o killing me in the process! But I do take issue with so many in the medical field downplaying this disease, the symptoms all of us struggle with daily & the fierce side effects from all the current chemo/treatments.

    • rvt

      Interferon is a hellish treatment – if it can be called treatment. The side effects will kill a person faster than Hep-c.

    • Mario Strada

      I think your doctor is right. The site effects are going to be perfectly manageable and really not that big of a deal.

      For him.

    • Joe Pinga

      I too was on interferon and ribavirin with a geno type 1. I was on the drug for way too long; 2 year’s to be exact all for nothing. Now i live with the worst case of Psoriasis i ever seen i on anybody, and it has been a total hell trying to hide it is so embarrassing. I definitely agree with shadowcat, they should call it what it is CHEMOTHERAPY! and quit down playing the side effects.

      agree with shadowcat, they should call it what it is CHEMOTHERAPY! and quit down playing the side effects.

    • Luckyman5

      Agrreed with everything shadowcat said. Side effects were more than fierce. Within 24 hours of starting tripple therapy with incivik I knew I would not be able to continue working any job. A few more hours and realized I could not handle the pain and nausea even if I spent the 48 weeks in bed on morphine. Here’s hoping for a realistic cure in 2014.

    • Ben

      You need a new MD!

    • Blessed

      I was diagnosed in 1997, having traced my infection prior to 1987. Unfortunately at that time the regiment was strictly interferon, extended month after month. Then adding Ribavirin. This regiment was a 2-2/12 year process that took 7 years out of my life! From the very first injection it was like clockwork for me: exactly 4 hours and I was extremely ill with agonizing pain. Yes, suicidal thoughts became more and more frequent. The quality of my life slipped away. Fortunately, my doctors will not put me on anything else again until it’s been out for at least several years. Fast track treatments are just that. It doesn’t include the whole population, only a handful. I have been blessed that I will not be a “guinea pig” again!

    • nebulus

      Took the combo solvadi & ribavirin: This medicine is too horrible to function with. Sick to stomach, confused, hard to concentrate, feel disconnected, (the disconnect was unbelievable – felt neurotic) nauseous, extreme fatigue, headache, nervousness, heavy muscle pain/tightness, labored breathing, itching. Cannot work/function to support myself, had to discontinue treatment. Am I the only one out there who cannot handle this so called miracle treatment? Feel like an outcast. Ouch. All I hear about is the high price tag and how good it is. I suffered terribly from it. The side effects are not manageable at all!

      • lindsey

        so sorry to hear that! I am currently on that treatment with little to no side effects.

        • donna

          I hope to hear from someone. Are you taking interferon as well? I’m on triple therapy. It is horrible. HAve been sick and in bed for the better part of 6 weeks. Can’t manage the side effects. Glad to see you are are making are making it without problems. Are you doing anything special? I’m consuming approx 6 to 7pints of water a day.

          • Erin Elsner

            I hope that people that are doing the toxic three are aware that you will lose all of your white and red blood cells to fight infection. It is called bone marrow depression. No one will tell you this because there is too much money to be made by these drugs.

      • donna

        I know how you felt. I am in week 6 of treatment. Solvadi, rabiviran and interferon. I want to quit but last weeks blood work shows no virus present at this time. Like you I ha e horrible side effects. I don’t know what to do. And your right I had to take FMLA and it should be called chemotherapy.

        • Jennifer

          My name is Jennifer I just completed solvaldi, riba, and peg for 12 weeks. Have some overall hair loss, experienced rash, on celexa, asked for it b4 treatment, job was on rocks and I couldn’t have rage. Worked, slept, lost 20lbs, which I would love to keep off. I am clear of virus. I want to know who relapses with this treatment? Anyone know? Genotype 1a, off the charts viral load. Fibrosis stage one. Also, one more thing, would love to get a tattoo to celebrate achievement, too risky?

      • ROB

        you are not alone. I had to discontinue after 2 weeks, it almost killed me. My doctor didn’t understand, I just couldn’t continue. The damage may be permanent I’m still not right a month later. Maby something new will come to market soon. I don’t have much time. Good luck. ROB

    • Myron Hardiman

      Your race also plays a part. When I elected to take ribavirin and interferon. The studies had little information on the effect on African American I still chose to take the treatment. After approximately 7 months later my kidneys failed and I had to get a transplant.

  • Linda

    How soon will the interferon free treatment be available

  • sheilah

    I completed this treatment Dec 2, 1012. STILL struggling w/ the aftermath of all the side effects…. The Docs have NO CLUE what this does to a REAL PERSON. THE (3rd) YEAR FROM HELL. so far, i am still showing undetectable, but i will never repeat that nightmare again……. Prayers for a new med that will help all. s.

  • billy97

    I personally know 3 people who were cured by the old inf/rib regimen so it definitely worked for some.
    When I tried it I lasted 5 weeks and ended up in the hospital for 2 weeks and on an I-v for another six.
    It took another 2 years for me to get healthy enough to start Victrelis. As soon as the victrelis was added it knocked me over. It destroyed my blood but was highly effective against the hepC. It was a struggle just to eat and take the meds. After 18 weeks I had to have a blood transfusion and had a near-fatal sepsis the day after. Treatment was stopped and was a failure. I should say that I probably have a higher tolerance to pain and was determined to endure any side effect in order to be cured. I did not want to give up. It was terrible.
    My treatment was to be 48 weeks. It is clear to me that the long regimen increases the chance of failure. A fast acting and less harmful drug is needed.
    I agree that this should be called chemo. Interferon is an old cancer chemo drug anyway. People would understand what is going on without a lot of explanation. A lot of modern cancer treatments may be more tolerable and definitely shorter.

  • Di

    I am geno type one. Does anyone know if the soon to be out Gilead treatment will be naïve still?

  • peg

    how does this work if you have been a nonresponder and are a transplant

  • haertjoy

    Yes, I am still UD at 9 months past my last dose of Sofosbuvir and Ledaspivir. I’m so thrilled not to be impaired by the disease anymore. This cure is a reality. Now, we must focus on patient access. Unbeknownst to me, I had so many emotional and mental problems related to the virus wearing and tearing me down. Now I feel the difference with greater mental clarity and emotional stability. Thank-you to all who made this possible and who continue to do so for loved ones friends and many others.

    • http://batman-news.com Violin74

      This is good to hear of emotional and mental stability. Hmm.. can I blame Hep C for a divorce ? RRRGggh

  • Guitar7

    My G I doctor is trying to talk me into waiting until the end of the year when the ” interferon free ” treatment will be available. She said it is almost a sure thing at the end of the year or the beginning of the year. With a 95 % cure rate right now with Interferon I am tempted to take the treatment now. What is your take ? Would you wait until the new treatment comes out or would you use the one now with interferon ? Any feedback on this is appreciated.

    • http://batman-news.com Violin74

      My Gastro just today stated the same thing; to wait until the ‘interferon free’ treatement was available (in November) and to email him then. He stated waiting to take it without the need for interferon would be just about 0 missed days of work and nill on the side effects. Sounds good to me!! I never took any action throughout the years on any of the medications because the side affects from what peopel were saying were not worth being changed into a dragon. I too, am wanting to take the treatment now but am torn. I REALLY want to get rid of this virus too !

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