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2017 Chronic Hepatitis Drug Pipeline

January 19, 2017

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The drugs that are in various stages of development for chronic Hepatitis B and Hepatitis C are transforming the outlook for chronic viral hepatitis.
2017 Chronic Hepatitis Drug Pipeline

In 2017, we are getting closer than ever to eliminating the burden of chronic, viral hepatitis. The pharmaceutical industry is continually evolving in this area – creating safer, more effective therapies to get rid of chronic Hepatitis B and chronic Hepatitis C.

Hepatitis B

According to Timothy M. Block, PhD, Co-Founder and President of the Hepatitis B Foundation and its Baruch S. Blumberg Institute, excitement and anticipation of a cure for Hepatitis B is growing, partially due to the success of Hepatitis C being “curable.” The currently approved oral antivirals for Hepatitis B do a good job of suppressing viral DNA levels, but none of them reliably achieve a functional cure – which is a sustained reduction in virus and other disease markers in the blood even after a drug is stopped. As such, there is still a need to develop new drugs that attack different pathways of the Hepatitis B life cycle to eventually achieve a cure.

There are more than 30 new Hepatitis B drugs being developed that differ from the currently approved therapies [interferons and nucleos(t)ides]. In general, the new Hepatitis B drugs are either:

  • Direct-acting that target the virus
  • Indirect-acting that target the human host

Direct-Acting Hepatitis B Drugs in Development

siRNA = Short for “silencing” RNA, these are nucleotide drugs that interfere with and cause the destruction of the viral RNA.

  • ARB-1467 is currently in phase II development*
  • ALN-HBV is currently in preclinical trials
  • Hepbarna (BB-HB-331) is currently in preclinical trials
  • ARB-1740 is currently in preclinical trials
  • Lunar-HBV is currently in preclinical trials

*Four phases of clinical research are conducted before a pharmaceutical drug is approved by the FDA. Each phase carries out a different type of research, lasts for a certain time frame, and uses a different amount of people. Phase I tests 20 to 100 people with the disease or condition for safety and dosage. Phase II tests up to several hundred people for efficacy and side effects. Phase III lasts for 1 to 4 years and tests 300 to 3,000 volunteers who have the disease or condition for efficacy and monitors any adverse reactions. In Phase IV, several thousand people with the disease or condition are now monitored for safety and efficacy. Learn more about clinical research and FDA-approval.

TDF Pro Drugs = A modified tenofovir drug that can get into liver cells more easily.

  • CMX 157 is currently in phase II development

Entry Inhibitors = These interfere with Hepatitis B getting into liver cells via attachment to a specific viral protein called ‘preS1’ and a specific liver cell protein.

  • Myrcludex B is currently in phase II development

Capsid Inhibitors = Interfere with viral capsid formation, which is the protein shield that covers and protects the viral DNA.

  • Morphothiadin (GLS4) is currently in phase II development
  • NVR 3-778 is currently in phase II development
  • AIC 649 is currently in phase I development
  • JNJ56136379 is currently in phase I development
  • HBV CpAM is in preclinical trials
  • AB-423 is in preclinical trials

HBsAg Inhibitors = Interfere with the production of Hepatitis B surface antigen (HBsAg), which is needed for the virus to enter and exit the liver cell.

  • Rep 2139 is currently in phase II development
  • Rep 2165 is currently in phase II development
  • RO7020322 (RG7834) is currently in phase I development

Antisense Molecules = Binds to the viral mRNA to prevent it from turning into a viral protein

  • IONIS-HBVRx (GSK3228836) is currently in phase I development
  • IONIS-HBVLRx (GSK33389404) is currently in phase I development

Indirect-Acting Hepatitis B Drugs in Development

Therapeutic Vaccines = These drugs use vaccine technology to stimulate immunity as a potential therapy.

  • GS 4774 is currently in phase II development
  • INO-1800 is currently in phase I development
  • HB-110 is currently in phase I development
  • TG1050 is currently in phase I development
  • HepTcell is currently in phase I development
  • TomegaVax HBV is in preclinical trials

Innate Immune Defense Pathway = Compounds that activate the innate immune system.

  • GS 9620 is currently in Phase II development
  • RO6864018 (RG7795, ANA773) is currently in phase II development
  • SB9200 is currently in phase II development

Host Acting Pathway = Compounds that induce programmed cell death

  • EYP001 is currently in phase 1 development
  • CRV 431 (CPI 431-32) is currently in preclinical trials

Hepatitis C

2016 was an amazing year for Hepatitis C drug progress. In 2016, Harvoni and Viekira Pak were the most likely prescribed Hepatitis C medications. In addition, Zepatier, Viekira XR, Technivie and Epclusa were approved by the FDA to treat Hepatitis C. Used for different Hepatitis C genotypes, these medications boast a very high success rate, eliminating the Hepatitis C virus in 95 to 100 percent of patients.

However, there is always room for improvement. The following pharmaceutical companies are leading the way:

Gilead

This combination consists of sofosbuvir, velpatasvir and voxilaprevir to treat people who had failed previous therapies and to provide higher cure rates for those who had not been previously treated (genotypes 1 through 6). The cure rates in phase 3 clinical trials were 95 to 98 percent. This led to being granted Breakthrough Therapy designation by the FDA for those with genotype 1 who had failed a previous course of therapy that contained a NS5A inhibitor and being submitted in December 2016 for approval to treat all genotypes.

AbbVie

The combination of glecaprevir (ABT-493) plus pibrentasvir (ABT-530) was used to treat genotypes 1, 3, 4, 5 and 6 for a duration of just eight weeks. This combination was granted Breakthrough Therapy designation by the FDA for those with genotype 1 who had failed a previous course of therapy that contained a NS5A inhibitor. In December 2016 AbbVie applied to the FDA to market and treat all Hepatitis C genotypes with this drug combination.

Janssen

  • Samatasvir – currently in phase 1 development for genotypes 1, 2, 3 and 4, and in a phase II study with Olysio (simeprevir) in treatment-naïve patients with genotype 1b or 4.
  • AL-335 (odalasvir) – currently in a phase IIa study for genotype 1.
  • ACH-3422 and Odalasvir (ACH-3102) and Sovaprevir – currently in phase II studies in for genotype 1.
  • Odalasvir plus sofosbuvir is in phase II development for genotype 1.
  • Odalasvir, AL-335, and simeprevir in treatment-naive and treatment-experienced patients with and without cirrhosis for genotypes 1 through 6 are in a phase IIb study.

Merck

MK-3682 (polymerase inhibitor), grazoprevir (protease inhibitor) plus ruzasvir (NS5A inhibitor) with and without ribavirin to treat genotypes 1, 2 and 3 is currently in phase II development. This same combination is also being evaluated in an ongoing phase II study to treat people with genotype 1 who had failed a previous course of a direct-acting antiviral therapy (Harvoni or Zepatier).

The investment in finding better therapeutic solutions for chronic Hepatitis B and Hepatitis C is immense. The complexity in combining drugs is increasing in the effort to find cures for these viral menaces. Our hopes are high as the race heats up to find both direct and indirect-acting antivirals for Hepatitis B and better, safer, less expensive, pan-genotypic solutions for Hepatitis C.

http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2017/advocate0117.pdf#AASLD, HCV Medications: Current Standard of Care, Alan Franciscus, Retrieved January 8, 2017, HCV Advocate, January 2017.

http://www.hepb.org/news-and-events/free-newsletters/fall-2016-b-informed-newsletter/explaining-the-hepatitis-b-drug-pipeline/, Explaining the Hepatitis B Drug Pipeline, Timothy M. Block, PhD, Retrieved January 8, 2017, hepb.org, 2017.

http://www.hepb.org/treatment-and-management/drug-watch/, Drug Watch: Compounds in Development for Chronic Hepatitis B, Retrieved January 8, 2017, hepb.org, 2017.

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HepatitisCentral.com 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 HepatitisCentral.com will not be responding to questions or comments posed in article comments.

  • hepette

    IT COSTS SO MUCH I CANT AFFORD IT!

    • Doddy Suhono

      You can find sovosbuvir +Daklatasvir for less than US$ 2,000.for 12 weeks treatment in India, Thailand or Indonesia, it’s generic but it works very well.

      • Keikee

        If she (Hepette)can scrape together the $2000 plus airfare to India and back. Much better than the $$$$$$ Big Pharmaceutical is raking in for the treatment. Effing ridiculous. Makes me so freaking mad. There should be a law against it. I’m surprised insurance co haven’t fought against this, what seems like price gouging to me……

      • Becky Colborn

        Is there a help line to tell you where to go in India? My insurance denied me here.I have had it for 30 years this year.

        • Doddy Suhono

          There is no help line on these drugs, but the manufacturer is Mylan Laboratories Limited, F-4 &F-12, MIDC,Malegoan, Sinnar, Nashik – 422113,Maharashtra, INDIA.
          My understanding, Mylan produces these drugs under license from US Pharma Coy (Gilead and….forgot the name) for patients in 3rd world countries, so I don’t know if they can take the order from US/Europe…so the alternative solution is to get the drugs in India, Thailand or Indonesia directly, I am an Indonesian based in Jakarta

  • Veronica Pugnotti

    I’m living in Ireland I’m Italian can I find this cure here too???? Are they avalible in Europe??

    • Andy

      Hi Veronica, Harvoni is available in the UK on the NHS. After 25+ years of genotype 1 and much suffering, I completed treatment in October last year and am now virus free. Its taken a while since treatment, but I’m finally starting to feel healthier! Check up with your health practioner, but I’d bet its available in Ireland. All the best of luck on your journey to SVR (sustained virologic response) – clearing the virus!

  • whamo

    My Harvoni was $500 a day, and lasted 12 weeks, but it worked. Insurance covered most of it. Now if I can just find a new kidney I’ll be fit as a fiddle.

    • Ronnie Childs

      Hang in there, sir. I got a liver transplant and now I’m fit as a fiddle. It can happen. AFTER the transplant I was treated successfully with Harvoni after “flunking” interferon et alia 3 times.

      • Terrylf1

        I failed Harvoni, and I now have cirrhosis, but you give me hope. I know there are new drugs being tested too, so who knows. Can I ask how long ago you had your transplant? I really don’t know much about quality of life issues, but it sounds like yours is good.

        • Ronnie Childs

          Bummer you failed Harvoni. That’s pretty unusual. Hang in there–there’s new medicine coming along all the time now. I had my transplant in November 2014. You’re quite right, my quality of life is EXCELLENT. I feel perfectly normal, to the extent that I know what normal is. My cirrhosis had been dragging me down a lot more than I had realized. Those effects were completely gone when I awoke from surgery. I am not exaggerating.

          • trotter

            I know u must have been near death before the transplant, but how lucky u are to be one of the lucky few who got a transplant. Even if your Hep C comes back, the new txs have been very effective in putting people in remission. WOW, a new lease in life.

          • Ronnie Childs

            Thank you. You are 100% correct–I still haven’t gotten over the thrill of the new lease on life. Also, you’re right about the new drugs–There’s no longer a need to fear a hep C relapse. But fortunately I wasn’t near death; mainly I was fatigued as all get-out, hard to walk up stairs, tired and weak, and ITCHING like a maniac–that was the worst part because it was driving me insane. But I was hanging in there pretty well. In fact, I was still working (a very soft job with sympathetic and cooperative bosses–Otherwise, no way) As you say, I was lucky, all the way around.

  • scubagirl65

    Finally there are all sorts of generic drugs coming out that are way cheaper. I am travelling to Thailand to pick up my 3 month course of generic Harvoni for $1200 usd however just today I found an online pharmacy that is $240 cheaper but the kicker is that they only provide 28 pills per bottle just short of 30 days which if you have to go o course of 12 week treatment you would have to buy another bottle for 6 pills!! WTH I have been diagnosed for 22 years and fortunately have never been sick – I just want to get rid of this virus for good!!

    • Terrylf1

      I found out I had Hep C after my liver became cirrhotic so I had a hard time getting approval for Harvoni. Unfortunately, I was one of the 3 or so percent for whom the 12 week course didn’t work. I was using Illinois Medicaid at the time so extended treatment was out of the question, I was lucky to be approved at all.

      You would think that after spending the money for 12 weeks of Harvoni it would be common sense to cover one more month of treatment. I had shown not detected after four weeks, but had a very low count of 120 at the end of 12 weeks.

      I started out at 6 million per deciliter so, in my mind, I should have been given one more month.

      • scubagirl65

        It’s so ridiculous! I am originally from Canada but now living in Mexico and they don’t have any treatment for Hep C -they are doing trials of the interferon etc now in Mexico City apparently.

        The blood tests down here to find out viral load etc are so expensive! Plus no doctor is going to know how to really treat me as they have no experience with the drug. I guess I will have to be my own doctor which I have done for years.
        I absolutely hate the pharma companies. but you can’t kill this thing with herbs….I am usually natural all the way and stay away from pharma on any scale.

        I am sorry to hear that they won’t give you one more month of treatment when you are so close however I did find the generic drug online and 1 mth bottle is $330 usd for 28 pills – you might have to go on your own to completely eradicate the virus.

    • Dan Bergdoll

      Even the $32,000.00 bottle only has a 28 count