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

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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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