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NHS England recommends AbbVie’s VIEKIRAX® and EXVIERA® for the treatment of chronic hepatitis C

More than 200,000 people in the UK are chronically infected with hepatitis C, (1) of which only an estimated 3% are treated each year, despite the advent of treatments that can offer viral elimination. (1)

More than 200,000 people in the UK are chronically infected with hepatitis C, (1) of which only an estimated 3% are treated each year, despite the advent of treatments that can offer viral elimination. (1)

AbbVie’s all-oral, short course, interferon-free treatments VIEKIRAX (2) (ombitasvir/paritaprevir/ritonavir) and EXVIERA (3) (dasabuvir) are now approved to be commissioned for patients in England with genotype 1a and genotype 1b hepatitis C virus infection with compensated cirrhosis, following the publication of NHS England’s (NHSE) Clinical Commissioning Policy Statement for the treatment of chronic hepatitis C in patients with cirrhosis and advanced liver disease. (4)

VIEKIRAX and EXVIERA have been available in the UK since January 2015, following the granting of an EU Marketing Authorisation (MA) from the European Medicines Agency (EMA), however they are yet to receive funding approval from the National Institute for Health and Care Excellence (NICE). Many patients who run the risk of serious harm if treatment is delayed, such as those with compensated cirrhosis, end-stage liver disease or liver cancer, have not been able to access the newest interferon-free treatments that bring with them a high likelihood of cure (defined as having no HCV detectable in the blood, 12 weeks post-treatment completion).

Until now, the only treatment options available have been those based on pegylated interferon (Peg-IFN), the primary limitation of such regimens being the association with severe side effects, including flu-like symptoms and fatigue. The need for safety and efficacy monitoring and support, long duration of treatment (up to 48 weeks) and weekly injections has also made such treatments difficult for many patients.

“Finally, the sickest HCV patients will have a chance to access these highly efficacious, curative therapies that are generally well tolerated,” said Charles Gore, Chief Executive of The Hepatitis C Trust. “NHS England has been promising an interim commissioning policy ever since the implementation deadline for NICE guidance for a new HCV treatment was extended by three months earlier this year. It’s critical that this policy is now implemented swiftly to ensure that people with HCV, who have severe disease and are at risk of serious health issues or even death without treatment, can get rid of the virus.

Hepatitis C is a blood borne virus that is spread when an infected person’s blood enters the bloodstream of another person.4 Some 75–85% of patients infected with HCV go on to develop the chronic form of the disease. (4) Chronic hepatitis C is a silent, progressive disease that can lead to liver damage, scarring of the liver (cirrhosis), liver cancer and death. (5) More than 200,000 people in the UK are chronically infected with hepatitis C. (6) Of those chronically infected, only an estimated 3% are treated each year, despite the advent of treatments that can offer viral elimination. (6)

New treatments, such as AbbVie’s VIEKIRAX and EXVIERA, offer both naive and treatment experienced patients, with genotype 1 and 4, and cirrhosis, a very high likelihood of clearing hepatitis C virus,” said Professor Geoffrey Dusheiko, Emeritus Professor of Medicine, UCL Institute of Liver and Digestive Health and Royal Free Hospital. “The NSHE clinical commissioning policy is long-overdue but welcome, for those patients that have been waiting for what is now imperative treatment to prevent decompensated cirrhosis.

There are other people besides, who do not have cirrhosis, in whom the prevention of cirrhosis is equally important, and whose quality of life and health will benefit from a cure – not to mention the positive impact on public health as the pool of disease is reduced – and they are not included in the interim commissioning policy. Only by all stakeholders in this field collaborating to find innovative ways to fund treatment and structure sustainable care pathways, will access in tandem for those without cirrhosis be possible, and our ambitions to eliminate this often fatal disease realised,” Professor Dusheiko concluded.

References:

  1. Public Health England. Hepatitis C in the UK 2014 Report. 2014. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/337115/HCV_in_the_UK_2014_24_July.pdf. Accessed June 2015
  2. VIEKIRAX® tablets (ombitasvir/paritaprevir/ritonavir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd. Full summary of product characteristics. Available at: www.medicines.org.uk/emc.
  3. EXVIERA® tablets (dasabuvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd. Full summary of product characteristics. Available at: www.medicines.org.uk/emc.
  4. NHS England Clinical Commissioning Policy Statement: Treatment of chronic hepatitis C in patients with cirrhosis, June 2015. Available at: http://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/06/hep-c-cirrhosis-polcy-statmnt-0615.pdf. Accessed June 2015.
  5. Chen SL, Morgan TR. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006;3(2):47–52. doi:10.7150/ijms.3.47. Available at: http://www.medsci.org/v03p0047.htm. Accessed June 2015.
  6. Zaltron S et al. Chronic HCV infection: epidemiological and clinical relevance. BMC Infect Dis 2012;12(2):2–7.


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