NICE Recommends Daklinza (daclatasvir) for Treatment of Certain Patients with Chronic Hepatitis C Genotypes 1, 3 and 4

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The FINANCIAL — Bristol-Myers Squibb on October 15 announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza (daclatasvir) in England and Wales for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. Specifically, NICE recommended Daklinza, an oral, once-daily medication used in combination with other agents, to treat certain patients with HCV genotypes 1, 3 and 4. Approximately 214,000 people in the UK are thought to have chronic HCV, and roughly 100,000 of those patients are estimated to have genotype 3, a difficult-to-treat and often aggressive form of chronic HCV.

“It is a challenge to treat patients with hepatitis C virus infection, including the significant number of patients with genotype 3, whose condition tends to progress rapidly,” said Anna Maria Geretti, Professor of Virology and Infectious Diseases, University of Liverpool. “In the past there have been limited treatment options available and therefore this decision is an important milestone. Daclatasvir in combination with other agents represents a much needed oral treatment regimen that has been shown to cure the infection in the majority of patients, and we have already seen positive results in the real-life setting in patients with advanced disease.”

HCV genotype 3 is associated with accelerated progression of fibrosis compared to other genotypes, which can make treatment time critical. Recent research has also shown that the risk of cirrhosis for patients infected with HCV genotype 3 is 31% greater than for those with HCV genotype 1, according to Bristol-Myers Squibb.

“The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland in recognizing the value of Daklinza for the treatment of genotype 3 HCV, and we are excited to make it available to help address what is still a significant unmet need among the UK HCV population.”

In the EU, Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. In genotype 3 HCV, Daklinza is currently approved in combination with sofosbuvir for 12 weeks in patients without cirrhosis and for 24 weeks in patients with cirrhosis with the optional use of ribavirin based on clinical assessment of the patient. Until recently, treatment options for genotype 3 patients in England were limited, and included interferon. Daklinza plus sofosbuvir, with or without ribavirin, is currently one of only two all-oral treatment regimens recommended by the European Association for the Study of the Liver’s (EASL) treatment guidelines for patients with HCV genotype 3.

 

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