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How Do Older Folks Fare on the New Hep C Meds?

October 3, 2017

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Especially because of the current recommendations to screen patients born between 1945 and 1965 for Hepatitis C, understanding the efficacy and safety of Direct Acting Antivirals on the elderly population is imperative.

Recent improvements in Hepatitis C treatment represent a major win for healthcare. Manufactured to target the Hepatitis C virus, Direct Acting Antivirals (DAAs) have a very high success rate for viral elimination. While the previously used interferon-based treatment regimens averaged a 50% success rate, the new DAAs average a viral eradication rate in the high 90th percentile.

However, the elderly population is not necessarily included in these encouraging statistics.

According to the World Health Organization, life expectancy increased by five years between 2000 and 2015. This increase is the fastest life expectancy rise since the 1960s. As such, it is no surprise that elderly adults represent a rapidly growing proportion of our population. Unfortunately, the likelihood of complications from Hepatitis C, coexisting illnesses, and overall mortality is higher in elderly populations.

Adults over 70 years old are underrepresented in the trials evaluating DAAs for safety and efficacy. Especially because of the current recommendations to screen patients born between 1945 and 1965 for Hepatitis C, understanding the efficacy and safety of DAAs on the elderly population is imperative.

4 Studies in 2017

Thankfully, the need to treat adults over age 65 has been recently addressed in four separate studies published this year:

  1. In a study published in the January 2017 edition of the Journal of Medical Virology, Japanese researchers studied 844 patients with chronic Hepatitis C genotype 1b. Recognizing that the elderly population must be included in the data, nearly half of those studied were over age 70. They found that those treated with the DAAs daclatasvir and asunaprevir achieved a high success rate, even in those over age 70.
  2. In a study published in March 2017 in Hepatology Research, researchers specifically focused on the elderly. The safety and efficacy of daclatasvir and asunaprevir was evaluated for 321 elderly patients with Hepatitis C genotype 1b. They found that daclatasvir plus asunaprevir was well tolerated and effective for participants without pre-existent NS5A resistance-associated variants or simeprevir failure, regardless of fibrosis status. The overall success rate was 90%; under age 65 was 94.5% successful, ages 65-74 was 88% successful, and those over age 75 had a 90% success rate. Thus, treatment was slightly less effective for patients older than 75 years old compared to those less than 65 years old.
  3. In a study published June 2017 in the Journal of Clinical and Experimental Hepatology, researchers studied the clinical outcomes of patients aged 70 years or older treated for Hepatitis C genotype 1 with several different DAAs at a single tertiary care center. With a success rate of 96%, those aged 70 years or older with genotype 1 achieved high success rates with newer sofosbuvir-based DAAs without any undue adverse events.
  4. In a study published in August 2017 in Gut and Liver, researchers aimed to evaluate the safety and efficacy of daclatasvir with asunaprevir in patients with Hepatitis C over 75 years old. This population was targeted for their study because the elderly were excluded from the Phase III trial. With a study sample of 110 patients, daclatasvir with asunaprevir was determined to be a safe treatment – even in patients over age 75. When participants without pre-existing NS5A resistance-associated substitutions and prior simeprevir failure were selected, an extremely high success rate was achieved regardless of advanced age.

Adults in their 70s and 80s (or older), are almost universally considered to be higher risk for medical therapies – Hepatitis C treatment included. Because of the high likelihood of comorbidities, this elderly population is often excluded from clinical trials. Despite their exclusion, recent studies demonstrate that even older patients benefit from DAA therapy for Hepatitis C.

 

https://www.ncbi.nlm.nih.gov/pubmed/18184025, Hepatitis C virus infection in the elderly: epidemiology, natural history and management, Cainelli, F, Retrieved August 13, 2017, Drugs & Aging, 2008.

https://www.ncbi.nlm.nih.gov/pubmed/22290404, Viral Hepatitis in the Elderly, Carrion AF, et al, Retrieved August 13, 2017, The American Journal of Gastroenterology, May 2012.

https://www.ncbi.nlm.nih.gov/pubmed/27142311, Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis, Ogawa E, et al, Retrieved August 13, 2017, Hepatology Research, March 2017.

https://www.ncbi.nlm.nih.gov/pubmed/27256744, Favorable efficacy of daclatasvir plus asunaprevir in treatment of elderly Japanese patients infected with HCV genotype 1b aged 70 and older, Akuta N, et al, Retrieved August 13, 2017, Journal of Medical Virology, January 2017.

https://www.ncbi.nlm.nih.gov/pubmed/28651903, The elderly and direct antiviral agents: Constraint or challenge?, Fabrizio C, et al, Retrieved August 13, 2017, Digestive and Liver Disease, June 2017.

https://www.ncbi.nlm.nih.gov/pubmed/28663671, Efficacy and Safety of Sofosbuvir-Based Direct Acting Antivirals for Hepatitis C in Septuagenarians and Octogenarians, Snyder HS, et al, Retrieved August 13, 2017, Journal of Clinical and Experimental Hepatology, June 2017.

https://www.ncbi.nlm.nih.gov/pubmed/28798288, The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients, Taki S, et al, Retrieved August 13, 2017, Gut and Liver, August 2017.

http://www.who.int/mediacentre/news/releases/2016/health-inequalities-persist/en/, Life expectancy increased by 5 years since 2000, but health inequalities persist, Retrieved August 20, 2017, World Health Organization, 2017.

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  • First of all my appreciation for not trying to jam the “Harvoni ‘CURE’ ” down my throat, when I know better. I’m 70. This disease has been ravishing my body…..seems like forever! It has been a very long painful road to the inevitable, especially since my age population seems to have been pushed out out the ‘SVR’ equation. Understand I do not say that with contempt, but reality. Remember that at my age this virus has been conquering my body from the top of my head to the tip of my biggest toe…..that’s a long time and too much damage. NO, I do not enjoy living in pain and being ‘ill’! But trust me, in short order I will be succumbed by not the hepatitis c virus, but by the significant damaged it has inflicted upon me in it’s invasion. Save your efforts for the younger generation and provide THEM a chance to live a happy, healthier remaining life!!

    Therefore, I chose to live in– TODAY, here and now. To use my time to the best of my mental, physical and spiritual ability! I live on faith, HOPE for better days and the vision of the ‘light at the end of the tunnel’ and I am grateful! Grateful for being able to still enjoy those things, which I may have missed had time turned out otherwise. So to the rest of us ‘baby boomers’, no matter how we got here….. first, GET REAL! and then do the best you can and NEVER GIVE UP HOPE! Miracles DO HAPPEN…….thanks!

    • CoyoteJohnKerr

      Very sobering comments. All of us have to come to terms with our circumstances in life and I applaud you for choosing to accept your lot with dignity and grace. I had Hep C for at least 40+ years and chose to ignore it for 20+ years after failing Interferon treatment and feeling hopeless. I never returned to drug use but drank alcohol as if I was uninfected, ignoring common sense and medical advise. 2 years ago, I had a spiritual awakening, gave my life to Christ and gave up my selfish and destructive life style. I decided to try and do something about my Hep C, went to my doctor and she referred me to an Infectious Disease Specialist. He determined that I had cirrhosis but that it was non-symptomatic and that it was important for me to undergo the treatment to stop the progression of the disease. I did 12 weeks of Epclusa and the treatment was successful. My doctor feels that with proper diet and exercise, complete abstinence from alcohol and drugs and avoidance of toxic substances and chemicals, that I should be able to live a “normal” life. He is also convinced that the liver, even with cirrhosis, can adapt and even possibly rejuvenate and that in the near future, there will be advancements in medical science to actually regrow liver cells. Of course, there are other factors like increased chances for liver cancer that will continue to remind me that life is a gift and that I need to live every day as if it is the last.

      I am so sorry that your disease has progressed to the point that you are suffering but also rejoice that you still have joy and a love of life. I also respect your hope for the younger generation even while enduring pain and hardship. Your story gives me a greater understanding of the responsibility I have to serve others and try and make the world a better place, having been given a 2nd chance in life. I thank God that you have found peace and I pray that what time you have left on this earth, that they will be filled with joy, knowing that life is eternal and there will be a better place waiting for you on the other side.

      In God’s love
      John

      • trotter

        Really nice things to say. The only thing I’d change is when u say that Cirrhosis is reversible. The liver can regrow and heal itself UP TO Cirrhosis. Then it is scarred and dead in that area. We can only hope they keep researching and don’t forget about us: ones who are in remission, but still can die of Liver Cancer. Make sure u go every 6 months to get an Ultrasound and bloodwork to make sure ur ok. Being in remission is great.

        • Darla Madera

          Trotter, could you please explain what you meant about stating, “ones who are in remission, but still can die of liver cancer?” Just after the FDA pushed Harvoni thru, an infectious disease Dr. put me thru the treatment ~ 3 mos. later, 1 last blood test from him & “finished.” *no detectable HCV. 2 yr’s later, my chart’s red flagged for HIV & HCV blood tests, even tho’ I’ve not had any risky behavior since about 2000 (if one doesn’t count blood transfusion since treatment). Why ultrasound/blood work, if in remission? Many thanks!

          • trotter

            Darla, I was speaking of all of us that already had Cirrhosis, got treated and am in remission, but even though the Hepatitis C is no longer progressing, Cirrhosis keeps progressing. So far, no treatment for it.

    • trotter

      Suzan, all I’m going to tell u is I got Hep C at 23,diagnosed at 43, did 1 yr. Interferon/Ribaviran treatment, waited a few yrs., another 1 yr. tx, few more yrs., started 2 more treatments, ended up in ER, did 3-month treatment and was absolutely amazed when told I’m in remission.
      I did Olysio/Sovaldi tx. with little side effects – good thing because I feel awful. I’m still fighting my Cirrhosis, but, have Hep C in remission.
      For me, the new treatments were my miracle. My doctor told me I wouldn’t live until the new treatments came out in 2014. I only made it since the FDA fast-tracked them.
      Suzan, whether u try the tx. or simply accept life/death, I wish u peace.