NICE Issues Positive Guidance for AbbVie’s VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) for the Treatment of Adults with Chronic Hepatitis C in England and Wales1

  • VIEKIRAX + EXVIERA confirmed as cost-effective treatment for adults with genotype 1 chronic hepatitis C virus (HCV) infection, including those with HIV/HCV co-infection, in NICE Final Appraisal Determination (FAD)
  • VIEKIRAX also confirmed as cost-effective treatment option for all adults with genotype 4 chronic HCV infection, including those with HIV/HCV co-infection
  • An estimated 214,000 people in the UK are chronically infected with hepatitis C1, of which only an estimated 3 percent receive treatment in England each year2
  • MAIDENHEAD, UK, October 16 2015 – Today the National Institute for Health and Care Excellence (NICE) published guidance in the form of a Final Appraisal Determination (FAD), confirming that AbbVie’s all-oral, short course, interferon-free treatment VIEKIRAX®3 (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®4 (dasabuvir tablets) is recommended as a cost-effective treatment option for adults in England and Wales living with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. VIEKIRAX® is also recommended for all adults with genotype 4 chronic HCV infection.

    Chronic hepatitis C is a silent, progressive disease that can lead to liver damage (fibrosis or cirrhosis), liver cancer and death.5 More than 200,000 people in the UK are estimated to be chronically infected with hepatitis C.6 Of those chronically infected, only an estimated three percent receive treatment each year, despite the advent of treatments that can offer viral elimination.6

    Charles Gore, Chief Executive, The Hepatitis C Trust, explains: “This is great news. People living with hepatitis C have been eagerly awaiting these new interferon-free treatments and it is now vital that NHS England ensures patients have access to them as quickly and widely as possible. These drugs are cost effective and allow patients to be cured in as little as 12 weeks, so there really is no excuse for delaying treatment and continuing to allow ever-increasing numbers of hepatitis C patients to progress to end-stage liver disease and liver cancer.”

    Having all-oral, interferon-free treatment options, like VIEKIRAX® + EXVIERA®, which provide patients with a high likelihood of achieving a cure (defined as having no HCV detectable in the blood 12 weeks post-treatment completion), helps to transform the lives of thousands of patients worldwide living with chronic HCV infection. The use of VIEKIRAX® + EXVIERA® in GT1 chronic HCV infected patients is supported by a robust clinical development programme in more than 2,600 patients in over 25 countries, including the UK. VIEKIRAX® and EXVIERA® were granted an EU Marketing Authorisations from the European Medicines Agency in January 2015.

    Dr Neil Pumford, UK Medical Director, AbbVie said: “We welcome the NICE decision as we believe that all-oral, interferon-free treatments, like VIEKIRAX® and EXVIERA®, have an important role to play in helping people clear the hepatitis C virus and move on with their lives. We look forward to seeing the NHS England Operational Delivery Networks, which have been in existence since August 2015, implementing the NICE guidance swiftly and in full as soon as possible to benefit all eligible patients”, Dr Pumford concluded.

    About VIEKIRAX® and EXVIERA®
    VIEKIRAX® and EXVIERA® are the first treatments for chronic hepatitis C to combine three direct-acting antiviral agents with distinct mechanisms of action to target HCV at multiple steps in the viral lifecycle.3,4 In a pooled analysis of Phase 3 clinical trials, VIEKIRAX® + EXVIERA®, with or without ribavirin (RBV) (for 12 or 24 weeks) cleared the virus in 97 percent of GT1 patients, including 96 percent of those with compensated cirrhosis. Overall, 1.3 percent of patients relapsed and 0.5 percent experienced on-treatment virologic failure.2,3 The overall discontinuation rate due to adverse reactions was low (0.2 percent),2,3 with no patients receiving VIEKIRAX® + EXVIERA® without RBV discontinuing treatment due to adverse reactions.

    Each tablet of VIEKIRAX® consists of the fixed dose combination of ombitasvir 12.5mg, paritaprevir 75mg and ritonavir 50mg. The recommended oral dose of VIEKIRAX is two tablets taken once daily with food.

    Each tablet of EXVIERA® consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor). The recommended oral dose of EXVIERA® is one tablet taken twice daily (morning and evening). EXVIERA® must always be administered together with VIEKIRAX®.

    AbbVie UK also offers AbbVie Care in hepatitis C, a support programme designed to help people maintain motivation, focus and stability while on treatment with VIEKIRAX® and EXVIERA®.

    Full summary of product characteristics is available at www.medicines.org.uk/emc

    Important Safety Information for VIEKIRAX® and EXVIERA®
    The safety summary is based on pooled data from Phase 2 and 3 clinical trials in more than 2,600 subjects who received VIEKIRA® and EXVIERAV with or without RBV.

    VIEKIRAX® + EXVIERA® with RBV in subjects with GT1 HCV infection (including subjects with compensated cirrhosis)
    In subjects receiving VIEKIRAX® + EXVIERA® with RBV, the most commonly reported adverse reactions (greater than 20 percent of subjects) were fatigue and nausea. The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2 percent (5/2,044). 0.2 percent (5/2,044) of subjects interrupted treatment due to adverse reactions. 4.8 percent (99/2,044) of subjects had RBV dose reductions due to adverse reactions.

    With the exception of increased rates of transient hyperbilirubinemia, the safety profile of VIEKIRAX® + EXVIERA® with RBV in subjects with compensated cirrhosis was similar to that of subjects without cirrhosis.

    VIEKIRAX® + EXVIERA® without RBV in subjects with GT1 HCV infection
    No subjects permanently discontinued treatment or had treatment interruptions due to adverse reactions.

    Contraindications
    Hypersensitivity to the active substances or to any of the excipients.

    Patients with severe hepatic impairment (Child-Pugh C).

    Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings.

    For full details of drug-drug interactions and contraindications with VIEKIRAX® and EXVIERA®, please refer to summary of product characteristics, available at www.medicines.org.uk/emc

    About AbbVie
    AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.co.uk.

    References:
    1 National Institute for Health and Care Excellence Final Appraisal Determination, ombitasvir-paritaprevir-ritonavir with or without dasabuvir for treating chronic hepatitis C, October 2015 https://www.nice.org.uk/guidance Accessed October 2015
    2 Public Health England. Hepatitis C in the UK 2015 Report. Available at https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil... Accessed October 2015
    3 VIEKIRAX tablets (ombitasvir/paritaprevir/ritonavir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd. Full summary of product characteristics is available at www.medicines.org.uk/emc 4 EXVIERA tablets (dasabuvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd. Full summary of product characteristics is available at www.medicines.org.uk/emc
    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 from http://www.medsci.org/v03p0047.htm. Accessed October 2015
    6 Zaltron S, S.L., Biasi L, Baiguera C, Castelli, F, Chronic HCV infection: epidemiological and
    clinical relevance. BMC Infectious Diseases, 2012. 12(Suppl 2): p. 2-7

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