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Previously Unforeseen Risk Tarnishes Hep C Wonder Drugs

November 22, 2016

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Researchers share their unwelcome realization that liver cancer acceleration may be associated with Hepatitis C treatment.
Previously Unforeseen Risk Tarnishes Hep C Wonder Drugs

The improvement in Hepatitis C treatment success marks a dramatic change in the prognosis for most Hepatitis C diagnoses. New direct-acting antiviral drugs boast viral eradication rates in the high 90th percentile, rendering hope that the Hepatitis C virus can be eradicated. Until recently, the only major obstacle surrounding these Hepatitis C medications has been their outrageously high cost. However, a large-scale prospective study has revealed a surprising caveat – revealing that the direct-acting antiviral drugs for Hepatitis C may not be the panacea the medical community had been hoping for.

Side Effects

Like all potent medications, the drugs used to eliminate Hepatitis C are likely to have side effects. Prior to 2014 when direct-acting antiviral drugs started getting approved by the U.S. Food and Drug Administration, the drugs used to treat chronic Hepatitis C had many severe side effects. Thankfully, the newer Hepatitis C treatments have fewer and milder side effects.

The most common adverse reactions to direct-acting antiviral medications for Hepatitis C include:

  • Fatigue
  • Diarrhea
  • Headache
  • Nausea
  • Insomnia
  • Skin Rash/Itching

Liver Cancer

Although none of the side effects listed above are pleasant, they are certainly minimal when evaluating their potential benefit of eradicating Hepatitis C. That was true until an Italian researcher presented results of his study at the American Association for the Study of Liver Diseases (AASLD) annual 2016 Liver Meeting in Boston, MA.

According to lead investigator Alfredo Alberti, MD, professor of gastroenterology at the University of Padova in Italy, direct-acting antiviral drugs could worsen liver cancer. If future investigations into this association support Alberti’s results, direct-acting antiviral drugs may present more hazard than benefit to our health. Some details from Alberti’s study include:

  • Dr. Alberti and colleagues followed over 3,000 patients with Hepatitis C infection for an average of 300 days after beginning direct-acting antiviral therapy.
  • Direct-acting antiviral drugs do not appear to increase liver cancer risk for people with Hepatitis C and cirrhosis.
  • Direct-acting antiviral drugs appear to make previously undetected cancers worse and harder to treat.
  • 50 percent of those studied who developed a tumor early during Hepatitis C treatment or just after stopping treatment developed a more aggressive type of tumor than what is typically seen.
  • The severity of hepatocellular carcinoma (primary liver cancer) seemed to correlate with the antiviral therapy over a 540-day follow-up period.
  • The incidence rates of liver cancer were no different in those who received direct-acting antiviral therapy and those who did not receive the therapy.
  • Alberti and his colleagues hypothesized that when viral replication is halted, dramatic changes in the immunologic and molecular microenvironment occur in the liver, which impact tumor suppression mechanisms. This change allows or promotes the growth of previously undetected liver cancer cells.

Conclusion

In putting Alberti’s conclusion into a larger perspective, valuable information in the battle against Hepatitis C is gleaned. Just like the need for physical therapy to help someone recover from orthoscopic knee surgery, a rehab for liver health may be necessary following Hepatitis C viral eradication.

After the presentation of this large-scale study, more investigation into the risk of liver cancer growth acceleration from direct-acting antiviral medications for treating Hepatitis C is warranted. Until a definitive conclusion is drawn, Alberti’s work sends two clear signals.

  1. Patients with Hepatitis C who receive treatment with direct-acting antiviral medications must be monitored for hepatocellular carcinoma.
  2. Even if the Hepatitis C virus has been eliminated, liver monitoring and care must persist.

Eliminating the virus has been the goal of Hepatitis C treatment since the infectious agent was first identified. However – Alberti’s study brings a larger picture into focus – the overall health of the liver. Viral eradication without severe side effects may only be step one of treating Hepatitis C. The second step may be finding ways to return the liver to a healthy microenvironment.

https://www.hepmag.com/basics/hepatitis-c-basics/hepatitis-c-treatment-side-effects, Hepatitis C Treatment Side Effects, Retrieved November 13, 2016, Smart + Strong, 2016.

http://www.medscape.com/viewarticle/871831, Direct-Acting Antivirals for Hep C Might Worsen Liver Cancer, Neil Osterweil, Retrieved November 13, 2016, WebMD, LLC, 2016.

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  • Sandy Robertson

    I’m confused as to my situation. I had hep c eliminated by Harvoni for 8 weeks. I had fibrosis but no cirrhosis. I imagine my hospital would monitor my liver for awhile as a matter of course. Am I in danger of cancer to a greater degree than before or is this only saying those who had cancer already might get worse?

    • Ian Sykes

      I am in the same boat having cleared the virus with Harvoni for 12 weeks. I had hep C for 30 years and developed cirrhosis to a degree. It is saying that we are at an increased risk of developing HCC due to the microenviroment being knocked out of sync. I have been getting my Bloodwork checked as well as an ultrasound every six months. God I am also being monitored for hep B reactivation which was also found to be a side effect

      • zenseekercu

        Ian, this is a quote from the article: “The incidence rates of liver cancer were no different in those who
        received direct-acting antiviral therapy and those who did not receive
        the therapy.”

        What it did say is that in previously undetected hepatic carcinoma, the tumors can be more aggressive. “Alberti and his colleagues hypothesized that when viral replication is
        halted, dramatic changes in the immunologic and molecular
        microenvironment occur in the liver, which impact tumor suppression
        mechanisms. This change allows or promotes the growth of previously
        undetected liver cancer cells.” Note that is says “previously undetected liver cancer cells.”

        My physician monitors me, as I had a “hot spot” in my liver detected. The MRI was done to see the amount of fibrosis I had, as I was thought to be early stage cirrhotic. It was decided that it was a mass of scar tissue, but I continue to be monitored on a semi-annual basis. I would hope that all physicians monitor their patients after HCV treatment, particularly those who have a more advanced fibrosis.

        • Lydia Cox

          I was cleared of the virus one and a half years ago after 12 weeks of Harvoni. I had the virus for 35 years, following a transfusion after the birth of my first child. My second child also had Hep C and was cleared with interferon/ Ribavirin 10 years ago. I did that treatment 12 years ago for 48 miserable weeks and it didn’t work. Harvoni was a walk in the park in comparison. The only lingering side effects were morning headaches which continued for 8-9 months after treatment. Before treatment with Harvoni, I was a relatively healthy and active 62 year old. I had 0-1 fibrosis and a suspected hematoma on my liver, most likely from the biopsy I had before interferon treatment. About one year ago, 6 months following Harvoni, my hair started falling out. I have suffered from severe joint pain in my hips and shoulders, fatigue and a very sensitive digestive system.
          This article has me scared. I feel this study is the tip of the iceberg.
          I understand your fears and I hope we are not in for more bad news.

          • zenseekercu

            Lydia Cox: Insist on having your thyroid checked. Mine quit working after one of the old treatments of Ribavirin and interferon. That is most likely where your issues have come from. I am now on thyroid meds (cheap) and they help, although I still have issues with hair falling out. Also, your thyroid can worsen over time, so make sure you continue to monitor your hormone levels of T3/T4.

          • Sandy Robertson

            Harvoni wasn’t too bad. My doc warned me to wait for it as he said interferon was awful. Only side fx were stomach ache and skin problems. My seborrhoeic dermatitis has gotten worse post treatment whereas I know other people’s vanished. I now bruise very easily and get flaky skin, that sort of thing. I figure any powerful med that cures hep c is likely to mess in some way with your innards. I do feel 100% better though at nearly 64.

          • survivor

            I had hep C gen 1 since 1982 and had
            developed cyrosis since 2005 after
            trying 4 treatment with interferon+…..
            i was finaly cured with harvony in march 2015 , I had fibrosis stage F4 in 2005 and started taking vitC (E300)
            betwen 6 to 10gr a day + silymarine
            3x250mgr+ALA+acetyl cysteine+regular tumeric(spice) 1 full tea spoon 3x a day+zinc+selenium+
            biter almonds (5 a day) +choline bitartrate since a couple of years , my
            fibrosis had reduced to F3 when i started treatment , and was down to
            F2 when I tested a week ago….even thoug the doctors had told me that
            cyrosis was ireversible if ancient…..

          • zenseekercu

            @survivor Interesting. I completed a successful treatment with Olysia and Solvaldi in the spring of 2014, after having diagnosed HCV since 2002. My fibroscan put me at a level of 14.3, whatever that means. My doctor told me I had mild cirrhosis. I was also told I would always have cirrhosis, even though it may improve a tiny bit.

          • Sandy Robertson

            I’m not a tech expert but you seem to be using fibrosis and cirrhosis as interchangeable terms? My understanding is fibrosis is reversible, cirrhosis not. So if F3 and F4 are referring to fibrosis it seems to me logical your score can reduce post cure, but not cirrhosis. Wee bit confused by your post.Good luck.
            I see post to me from Johnny doesn’t seem to say anything – glitch? Happy holidays to all.

          • Johnny

            Johnny

    • Inc.

      The way it reads is if you already have “UNDECTED CANCER” while treating.

  • old timer

    Same situation as Sandy. I KNOW my Doc will continue with ultrasound, blood and MRIs probably until he retires or I croak.

  • PaulfromTexas

    Getting well is one thing….STAYING well is on us, folks….demand your dox do followups every 90 days for the first yr, if there’s no cirrhosis….and do not allow ” no virus” to fool you into lethargy.
    You may have no virus but you still have liver disease.

  • Champ86

    Sounds like the Cure, means a long tern cash flow to me, like buying a house, paying it off and having neighborhood association fees, that never end,

  • Julie Tanner

    What about parkinson

    • Merry Cook

      I’m concerned about Parkinson’s as well. My grandfather passed after his battle with this disease. I completed treatment with Sovaldi and ribavirin before Harvoni was approved. So far so good even with stage 4 cirrhosis. What have you heard about Parkinson’s related to Hep C treatment? Thanks

  • Julie Tanner

    I have a friend stage 4 hep c cirrhosis no problems ever cured with harvoni my own atp is norm @5. Just the same i would have perfect health without hep c.

    • jules

      Don’t understand this. What?

      • Julie Tanner

        I got a touch of Parkinson’s from hep c ashkenazi jew ancestry.

  • Julie Tanner

    Afp

  • Inc.

    So we buy your supplements to keep our liver healthy right? What away to advertise.

  • TheBitterEndd

    I’m glad this is being exposed. I always knew it was not a good idea and that Holistic therapies are a better choice.

    • David Pieper

      Good luck with that one. If you think you can cure hep C with herbs and green tea you are in need of psychiatric help.

    • Inc.

      Dumbest comment EVER!

    • Cassy Johnston

      I think you are wrong…unless you have cancer. I am happy to be hep c free. It in itself is a death sentence for most so if I end up being one of the ones that had undetected cancer Im still going to die but if Im not I am healing.

  • David Pieper

    What an irresponsible and sensationalist piece of journalism. There are enough “war stories” from the interferon-based treatments to frighten people off curing their hep C, without adding to it with this misinformation. Treating your hep C, will not eliminate liver cancer if you already have it, but for the vast majority of people with hep C, curing hep C will prevent you from developing cirrhosis or liver cancer.

  • Byron White

    “What an irresponsible and sensationalist piece of journalism. There are enough “war stories” from the interferon-based treatments to frighten people off curing their hep C, without adding to it with this misinformation,” says one reader in the comments below.
    “So we buy your supplements to keep our liver healthy right? What away to advertise,” says another reader below.
    Please “Hepatitis Central” we are expecting more honest and better articles without trick headlines to get us into your material. Once more and I have to unsubscribe. I hope others will also consider what this “publication” is feeding us and why.

    • Cassy Johnston

      You should read the article carefully. It says if you have cancer the antivirals make the cancer worse. If you dont have cancer it doesnt. As it is a new drug they will find side effects as it goes. I did 12 weeks of Harvoni what this is telling you is be aware…make your follow ups.

  • Bob

    I had HEPC for over 35 years and was cured with Harvoni after 28 days with zero side affects!

    • Johnny Bumpass

      I’ve had a liver transplant because of Agent Orange AND…Hepc type two. Got rid of hip but docs think treatment caused me to develop cirrhosis again!

    • Johnny

      Had Hepc type 2 since Vietnam. Took Harvoni and ribivirin for 8 weeks. The hepc cleared but doc said I now had cirrhosis again supposedly from the treatment. I’d had a transplant a little over 5 years ago. Supposedly the maker of Harvoni never ran any trials on liver transplanted patients. I asked them! The transplanted liver will always be in a weakened state because your own immune system attacks the liver as being a foreign object. My doc didn’t seem to care or know because I had two things trying to defeat my liver…. Just stated i needed to get rid of the hepc to eradicate one of them. I take immunosuppresive drugs to keep my body from attacking it so much. I as others had no problems with the Harvoni but had and still having skin problems on my scalp. I started hurting so bad from ribivirin had to cut dosage in half. Felt like my backbone was in a vice. Was in tears hurt so bad. So pass it on to friends. As others have said taking treatments fresh off the shelf so to speak can wreak havoc!

  • CoyoteJohn

    I just finished 12 weeks of Epclusa for my Hep C, Genotype 1A. I had Hep C infection for at least 40 years and was treated unsuccessfully with Interferon. My viral load was “undetectable” at 8 weeks and will know in the next month or so if I am “cured”. I have compensated cirrhosis (according to blood tests) and was told that I will have to have liver scans every 6 months for the rest of my life. I knew liver cancer was always a possibility but this article kind of lets the wind out of my sail. When my wife hears about this, it will harder on her but as they say, no one gets out of this life alive anyways. It is hard to understand all the implications of this study but I appreciate all the insights of the other commentators. They seem to be more accurate and hopeful than the article.

    • Hair

      I just finished 12 weeks of epclusa and am got a great report last week from the doctor…..no virus at all undetected yay but for some reason been tired after treatment? Maybe my body adjusting so happy to get rid of this virus and treatment was not bad headache and fatigue good luck to all and God bless .

      • CoyoteJohn

        Great to hear, Hair! I will have my follow-up in a couple of weeks and am very hopeful. I, too have felt somewhat worse after treatment. Strange? I actually was sleeping better during treatment. Now, I wake in the middle of the night, worried about something insignificant and don’t feel as rested in the morning. I am glad I took the treatment and believe the article above was somewhat over-blown. I have dealt with so many ups and downs with HCV that whatever comes my way in the future, I will, with God’s help, get through it. God bless you too!

    • Brenda Casey

      Hi Coyote john,,i just finished treatment in DEC with Epclusa 12 WEEKS.So far my viral load in undetectable.i go back in MARCH for blood work and ultra sound on my liver.I have type 1 hep c/cirrhosis stage 4..I feel good about this treatment.i have great doctors at Vanderbilt Hospital..I get scans ever 6 months of my liver to make sure there are not cancer issues.My brother died in 2011 of Hep c/cirrhosis and liver cancer.He was not able to take treatment at that time.. I hope you continue doing well.,thanks for your post…brenda

      • CoyoteJohn

        Hi Brenda! So sorry to hear about your brother. I lost my brother to “chemically induced Lupus”, most likely from Agent Orange. I miss him a lot. I’m not nearly as bummed out about all the controversy swirling around all these anti-virals as I was when I first read this article. I am glad that I made the choice to be treated and will deal with whatever comes my way. Dying from cirrhosis just didn’t seem to be a good alternative. I get my next blood test in February and see the Infectious Disease specialist in March to determine if the Epclusa did the trick. I wish you well and will be praying that you have a “non-detectable” result from your blood test. I read that they are working on reversing the effects of cirrhosis and the regeneration of the liver. That would be a huge benefit for those of us who have beat the virus but still have the cirrhosis. I trust in God to get me through, whatever happens down the road. One day at a time! John

  • Dee

    I have to say, this article first frightened me then confused me. I have been cured for 4 years. I thought I was past the worst. Now I see this?!

  • Paula

    Has anyone experienced cardiac. anomalies on Epclusa. It is now showing posts marking side effects of serious bradycardia. The warning used to be when taken with Amirodarone, but now any beta blocker. Use of, or pacemaker were needed. Google Epclusa and cardiac toxicity. Also. Some postmarking research shows activation of breast and lung cancer genes. I don’t know what to do. I have genotype 2b for 10 years. Any suggestions?

  • Nancy

    Any new drug that the billion dollar companies sell for an enormous profit have not been used long enough to do a proper study. It can take 10 plus years for most researchers using the scientific method to conduct a study just on the side effects of each treatment for HCV.
    According to a Canadian study, most “Baby Boomers” got infected with Hep C from grade school Drs & nurses using glass syringes to inject vaccines. Glass cannot be sterilized enough to kill the blood to blood viruses. Plastic syringes were not commonly used until the sixties. Many Drs simply preferred the glass, or some, because of cost, did not use plastic syringes until the 1970s. The drug companies would have mist people believe the virus was from having sex and/or doing drugs, or both. Because who did not party in the 60s, 70s, & 80s?

    • CoyoteJohn

      The Canadian study is interesting. I experimented with IV drugs in 1969, 1970 and always figured that I got Hep C from that. I always blamed myself and when others, infected with Hep C claimed they had never done IV drugs, I would roll my eyes and give them the old, “yeah, right” sort of look. I guess it doesn’t really matter where I got infected but I’m now more understanding of those who claim that they never used drugs. It would also seem to me that the public would be more sympathetic and more inclined to pressure the drug companies to moderate the prices they are charging for these life saving therapies if it wasn’t just a disease of a bunch of “degenerate junkies”.

  • RealityBites

    Pieper- this article appears to be an honest reflection of a valid study. Why are you so negative?

  • Brenda Casey

    I found out in 98 that i had hep c type1..I did the interferon & ribs treatment as well.Yes i thought i was going to die.I would say it was like chemo..I had to stop after 5 months.I just finished treat of 12 weeks with EPULSA it is made by same company as HARVONI..Only 2 side effects. A slight headache& tired a little late afternoons..It was great compared to the old meds..So far my hep c is undected in blood work.I have stage 4 hep c/cirrhosis.. Just want to say i hope all gos well for you.Sounds like you have had a time with you health.. GOD BLESS,,BRENDA

    • high maintenance

      Good, good, good for you Brenda. Take care of that liver now nothing is destroying it. I’m glad I can cook now without worrying about getting cut & passing it on.
      We are blessed