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Hepatitis C Meds Impact Liver Transplant Outlook

July 10, 2017

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Hepatitis C treatment is so successful that it is repairing people’s livers and removing certain individuals from the liver transplant waitlist.

The evolution of direct-acting-antivirals (DAA) for treating Hepatitis C infection has progressed enormously in the past several years. In addition to DAA’s extremely high success rate at eliminating the Hepatitis C virus from the bloodstream, these medications can also reverse damage to the liver. This additional benefit of treating Hepatitis C even applies to people with a severe enough form of liver disease to be on the liver transplant list. New research shows that treatment with DAAs can remarkably improve the liver function of patients with decompensated cirrhosis, allowing the delisting of 1 out of 5 patients on the liver transplant waitlist.

Decompensated Cirrhosis and MELD

Decompensated cirrhosis is when the liver is extensively scarred and unable to function properly. Without treatment, chronic liver disease can progress to decompensated cirrhosis, which is typically defined by the development of one of the following:

  • Jaundice (yellowing of the eyes and skin)
  • Ascites (fluid accumulation in the abdomen)
  • Variceal hemorrhage (internal bleeding)
  • Hepatic encephalopathy (confusion due to liver toxicity)

By the time a person has decompensated cirrhosis, they likely need a liver transplant to increase their odds for survival.

The model for end-stage liver disease (MELD) score is a way to grade the severity of cirrhosis. The MELD score is based on three commonly obtained laboratory parameters:

  1. serum bilirubin
  2. serum creatinine
  3. and international normalized ratio.

The United Network for Organ Sharing (UNOS) adopted the MELD score in 2002 to prioritize allocation of organs for liver transplantation. The MELD score ranges from 4 to 60 points, with higher scores correlating with a lower three-month survival. Patients with cirrhosis and a MELD score of 10 or greater are advised to seek a liver transplantation evaluation.

MELD, DAA and Delisting

According to a European study published in the September 2016 edition of the Journal of Hepatology, around a quarter of people with Hepatitis C and decompensated cirrhosis came off liver transplant waiting lists after DAA treatment. Being removed from the liver transplant waiting list means that liver repair occurred, despite the long-standing belief that damage incurred from cirrhosis is permanent.

The study recruited 142 Hepatitis C patients with decompensated cirrhosis who were candidates for liver transplantation and who underwent direct-acting-antiviral treatment between February 2014 and June 2015.

Of the recruits:

  • 46% received treatment with sofosbuvir (Sovaldi) plus ribavirin
  • 54% received either sofosbuvir plus daclatasvir (Daklinza) or sofosbuvir/ledipasvir (Harvoni)

Participants were followed for over two years, including their time on treatment, during which time half underwent a liver transplant. However, an astonishing 24% of participants were delisted from the liver transplant list.

Delisting:

  • was strongly associated with a baseline MELD score below 16.
  • also occurred in a small number of patients with higher MELD scores.

Delisted patients experienced significant improvement in liver-related outcomes over time. The average follow-up after delisting was 58 weeks.

  • MELD score decline – The median MELD score declined dramatically from 14 at baseline to 9 at the last follow-up visit.
  • Ascites decline – Patients with any ascites fell from 82% at baseline to 24% at the last follow-up visit.
  • Hepatic encephalopathy reduction – Hepatic encephalopathy almost disappeared, with 29% experiencing mild hepatic encephalopathy at baseline to 3% at the last follow-up visit.

The therapeutic value of the DAAs is likely to save many lives in two ways:

  1. The DAAs being used for Hepatitis C (Harvoni, Sovaldi and Daklinza) can kill the Hepatitis C virus and reverse cirrhosis.
  2. The delisting of decompensated cirrhosis patients will free up more livers for other transplant candidates.

The concept that Hepatitis C treatment is powerful enough to eliminate the virus AND reverse cirrhotic liver damage is exciting. Based on this study’s results, all oral DAAs were able to reverse liver dysfunction. However, those with lower MELD scores have a higher chance of being delisted.

There is no doubt that DAA therapy is changing the impact of Hepatitis C. The study demonstrating the delisting of patients with decompensated cirrhosis from the UNOS registry is a big deal – and is bound to qualify patients for therapy quicker, improve the health of those who have lived with the virus for decades, and reduce the wait time for those in dire need of a liver transplant.

http://onlinelibrary.wiley.com/doi/10.1111/apt.13798/full, Optimal timing for hepatitis C therapy in US patients eligible for liver transplantation: a cost-effectiveness analysis, B. Njei, et al, Retrieved July 2, 2017, Alimentary Pharmacology and Therapeutics, September 2016.

http://onlinelibrary.wiley.com/doi/10.1002/hep.29137/full, Treatment of patients waitlisted for liver transplant with all-oral direct-acting antivirals is a cost-effective treatment strategy in the United States, A. Ahmed, et al, Retrieved July 2, 2017, Hepatology, July 2017.

https://www.hepatitis.va.gov/patient/complications/cirrhosis/decompensated.asp, What is Decompensated Cirrhosis?, Retrieved July 2, 2017, US Department of Veteran Affairs, 2017.

http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-prognosis-cirrhosis/core-concept/all, Evaluation and Prognosis of Patients with Cirrhosis, Karla Thornton, MD, MPH, Retrieved July 2, 2017, Hepatitis C Online – AWS, 2017.

http://www.hivandhepatitis.com/hcv-disease-progression/hcv-liver-cancer-hcc/6055-easl-2017-hepatitis-c-treatment-allows-1-in-4-to-come-off-liver-transplant-waiting-list, EASL 2017: Hepatitis C Treatment Allows 1 in 4 to Come Off Liver Transplant Waiting List, Keith Alcom, Retrieved July 2, 2017, hivandhepatitis.com, 2017.

https://www.ncbi.nlm.nih.gov/pubmed/27212241, Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study, Belli LS, et al, Retrieved July 2, 2017, Journal of Hepatology, September 2016.

https://www.ncbi.nlm.nih.gov/pubmed/28348470, Potential Liver Transplant Recipients with Hepatitis C: Should They Be Treated Before or After Transplantation?, S. Vihar, Retrieved July 2, 2017, Journal of Clinical and Experimental Hepatology, March 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.

  • Hair

    I’m one that took hep c meds in 2016 and went to the dr last week! And praise god still clear of the virus.

  • Dru McCarthy

    If the DAA drugs were taken and killed the virus, should one continue to take those drugs to reverse the cirrhosis?

  • David Varshavsky

    What a load of crap, there’s a petition going around at the moment to force the FDA to release a list of ALL side effects from the Harvoni treatment, liver failure, kidney failure, renal failure, heart attacks, chronic fatigue, joint pains and rushes two years after treatment, some people are dying in growing numbers!! Why no one is releasing those numbers… oh wait a minute, they are all virus free…and some very dead as well. I’ve had this virus between 35 and 45 years, I have stopped drinking alcohol and I take Milk Thistle, and I try to eat liver friendly foods, and guess what? my liver is healing!! I rather keep the virus than clear it with the new “miracle” meds and risk all those unreported side effects or even death. I don’t believe a word those misleading farmaciutcal companies are saying, they are only telling one part of the story, the part that suits their greedy agenda. Investigate, research and find out the truth before you start any treatment!! And remember that not long ago those doctors who are recommending the new treatments are the same doctors who were recommending Interferon!! I wouldn’t give Interferon to a sick dog, let alone to a human being. It’s your choice and your call. Good luck to all of you.

    • Corey Brunskill

      I so much agree with you, I have been 31 yrs with it and in 2013 tried one of there new drugs at the time but you still took the rib, inter, pega,and Victrellis. It cleared nothing and I went through 6 months of giving myself a needle in my stomach once a week, sick as a dog, lost my hair, and guess what I still have it but worse, it apparently gave me that mutation Q80 , something , that helps it mutate faster in your blood, how nice , they no longer prescbie it.
      I have not been able to eat properley, l feel so much worse than before, my hair will not grow very good, and these drugs are only treated for 2 yrs if that but no one has tested long term effects because they are giving them to people before they can, my doc wanted me to go on Harvoni and I said no, I don’t want to be a guinea pig anymore, . When I see how these people are in 10 yrs then maybe, but not this soon. Like you say all the damage it has been causing , anyone that is coinfected with Hep b , is getting so sick it brings the Hep b out in full force, is it really worth it to get sicker ,I regret ever doing it, my life has never been the same. Thanks for listening and I really like your post it was honest not candy coated. Thanks

    • Darla Madera

      Am not faring well at all, Harvoni treatment in Spring of 2015 and lately feeling as if bodily systems are so not right. Many adverse side affects you mentioned plus much more ~ “black box medication,” on med container…… why?

    • CoyoteJohnKerr

      Hi, David
      I am not here to defend the drug companies but people complain just the same when they are not allowed to take the drugs before extensive testing. Actually, I have heard more people complain about not getting these drugs until years after exhaustive research, controlled studies, etc.
      I am going on a year of being viral free after 12 weeks of Epclusa. I too got Hep C back in the late 60s or early 70s. I went through all the treatments available and the Hep C virus came back every time until the Epclusa. I have compensated cirrhosis but am feeling better than I have in years. I am abstaining from all alcohol and drugs and continue with my liver detoxifiers such as milk thistle. I am sure that there may be some side effects out there but the internist that I go to (and actually trust), says that the benefits so far outweigh the negatives by 10-1 (my paraphrase). Time will only tell but to wait another 10 years for most of us would have surely not been realistic. I hope all the best for you, David but would encourage all the rest of you who are waiting to listen to both sides of the story, the good and the bad and then make up your own minds. So far, I am so thankful that I took to the treatment. It was a piece of cake compared to the interferon and other treatments before the new anti-vitals such as Harvoni and Epclusa.

  • Miss Him

    I’m glad that you are doing OK David Varshavsky. We did EVETHING to beat this. The tone of your post kinda ticked me off. I wish that this therapy would have been available 8 years ago. After attempting to clear the virus first with the original interferon and riba unsuccessfully, my husband then PEG and riba x 2, Did not clear. and the side effects horrible which stopped him the last time. Just about the time the new drugs came onto the market, he developed HCC. Got too sick to receive transplant after being listed. We did liver healthy foods, took milk thistle etc. He had hep C since the early 70s. and died in 2012.SO technically he lived 42 years with the virus. I wish he would have had the chance to take the DAAs. Maybe he would still be here.

  • Mary Ledvina

    I went through Harvoni treatment last year and I’m free Thank You God and the research from UOM.

    • Zulema

      How did you go about getting treated ? My dad has been trying for the past 2 years and they keep putting it to the side

    • MER 1949

      so glad you are hep c free I was just diagnosed with blood work done for prolia shot by rheumy want to gastro and had active 1a probably had it 45 yrs from bad blood or bad tattoo palor back then My dr send script for harvoni to special pharmacy and have to wail 2-4 weeks for approval. Did you have any side effects from harvoni? Also when you had hep c did your skin itch and if so what did you do about it? I am so nervouse about harvoni reading some negatives. Please help me ease my mind.

  • Bahrom Raja

    I’m a post liver transplant patient, Thank God got it for free and also a second chance.After 6 month being operated I asked for Hep C treatment theys just say no because there is a 2nd chance,Then 6 yrs down the road they panic me Viral Loads is 15+millions so I heve to do the 48 weeks treatment but in 16 weeks it’s all cleared.But the so called Physician told me to complete the treatment,I wasn’t impressed ,something wrong with bile duct beacuse I live faraway from the city ,rang them to send me the form etc etc.They asked me how do I knew about the problem because the result is all good just keep up with the treatment.I just told them just give to me stop asking question,so they setup an appointment before the operation,trying to cancel it. I just took me shirt off they just shocked just told then bugger your bloody test I knew my body well so they hurry curry me to the operation room,gee it was so pain then driving back after 2 day from hospital I lost me wheel lucky just crash into farm. I wasn’t impressed and complain the the department head telling him to stop the treatment it nearly killed me.I honestly don’t believed in their treatment and prescription drugs especially Mycophenolate. I just stay healthy think healthy. So that me motto all me blood test looks good.Amen

  • Tim Hobbs

    Went through Harvoni treatment 2 yrs ago,no side effects, less viral load every month,gone when I finished, but 6 mos ck up tested positive again. Just finishing Vosevi some headache & fatigue, clear after first month, think we got it this time.

  • Shelly

    I was infected with her. C in 1988. In 2013 my doctor recommended I do interferion because my viral load was a million and a half. I too was very sick. With 2weeks left of treatment and had slept off 38 pounds. They pulled me off and hospitalized me. My platelets we’re at .29. 6 months later the viral load came back as a relapse. After all that it didn’t work. They kept shining need on saying the new one coming out in a few months is better. Before I did them I had no symptoms and felt fine. Still to this day the side effects are permanent. I began feeling sick more than I felt good. Having internal bleeding fluid on my stomach. My children we’re having children and they all cried that they need me and so do the babies. So I finally decided to try new treatment. Mentally I was afraid after the last time. The new doctor said if I started dropping weight like the last time they would have to adjust the ribvaron. That’s when I realized I lost 38 pounds and was never even weighed let alone any med adjustment. Along with ribvaron I had savaldi and dacklenza. I had no side effects except had to be careful not to make decisions to hasty that may effect me long term. I ended up quitting my job. Long time coming and best thing I ever did. I traveled 120 miles to and 120 back and forth to my daughter’s house. I stayed there 4 days a week and was home for 3 . She needed someone to take care of my grandson. After 6 months as of may I am considered hep c free. Not sick any more. So two different experiences one negative one positive.