AbbVie’s all-oral, short course (12 weeks for the majority of patients), interferon-free treatments VIEKIRAX (ombitasvir/paritaprevir/ritonavir) and EXVIERA (dasabuvir) are now licensed for use in the UK with or without ribavirin (RBV) for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. VIEKIRAX is also licensed for use in the UK with RBV in non-cirrhotic, genotype 4 (GT4) chronic hepatitis C patients.1,2 The availability of VIEKIRAX and EXVIERA in the UK follows the granting of an EU Marketing Authorisation (MA) from the European Medicines Agency (EMA).
Hepatitis C is a blood borne virus that is spread when an infected person’s blood enters the bloodstream of another person.3 Some 75-85 percent of patients infected with HCV go on to develop the chronic form of the disease.3 Chronic hepatitis C is a silent, progressive disease that can lead to liver damage, scarring of the liver (cirrhosis), liver cancer and death.4 More than 200,000 people in the UK are chronically infected with hepatitis C.5 Of those chronically infected, only an estimated 3% are treated each year, despite the advent of treatments that can offer viral elimination.5
“New treatments, such as AbbVie’s triple combination regimen containing three directly acting anti-virals, offer both naive and treatment experienced patients, including those with 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. “Such highly efficacious, better tolerated and shorter treatments irrevocably change the field from interferon-based care.”
VIEKIRAX and EXVIERA is the first treatment 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.1,2 VIEKIRAX and EXVIERA, with or without 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 experienced a relapse and 0.5 percent experienced on-treatment virologic failure.1,2 Discontinuation rates due to adverse reactions was low (0.2 percent),1,2 and in those receiving VIEKIRAX and EXVIERA without RBV, the overall rates of discontinuation due to adverse reactions was zero percent.
Charles Gore, Chief Executive of The Hepatitis C Trust, welcomed the news of AbbVie’s UK licences, commenting: “We are now seeing a real paradigm shift in the way HCV can be treated; for many patients, these new treatments represent curative therapies, and therapies that are significantly more tolerable than interferon-based regimens. With the licensing of AbbVie’s treatments there is now more choice for treating people affected by HCV. The next important step will be for the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) to ensure access to the range of new therapies being licensed”.
1 VIEKIRAX tablets (ombitasvir/paritaprevir/ritonavir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.
2 EXVIERA tablets (dasabuvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.
3 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 December 2014
4 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
5 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 (date accessed 02/12/14)