OREANDA-NEWS. Bristol-Myers Squibb (NYSE:BMY) today 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.

“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.

About the NICE guidance

Following a submission by Bristol-Myers Squibb, NICE has issued final guidance on the use of Daklinza, in combination with other medicinal products, for use within NHS England as an option for the treatment of chronic HCV infection in adults. NICE has recommended its use as specified in the following table.

             

HCV
genotype,
liver disease
stage

  

Treatment

  

Duration
(weeks)

   Recommendation according to treatment history
      Untreated   Treated  

Interferon-
ineligible or
intolerant
1 without cirrhosis   Daclatasvir + sofosbuvir   12   Recommended only if the person has significant fibrosis   Recommended only if the person has significant fibrosis   Recommended only if the person has significant fibrosis
4 without cirrhosis   Daclatasvir + sofosbuvir   12   Not recommended   Recommended only if the person has significant fibrosis   Recommended only if the person has significant fibrosis
1 or 4, with compensated cirrhosis   Daclatasvir + sofosbuvir (with or without ribavirin)   24   Not recommended   Not recommended   Recommended
3 without cirrhosis   Daclatasvir + sofosbuvir   12   Not recommended   Not recommended   Recommended only if the person has significant fibrosis
3, with compensated cirrhosis   Daclatasvir + sofosbuvir + ribavirin   24   Not recommended   Not recommended   Recommended

4

   Daclatasvir + peginterferon alfa + ribavirin   24   Recommended only if the person has significant fibrosis or compensated cirrhosis   Recommended only if the person has significant fibrosis or compensated cirrhosis   Not applicable

Significant fibrosis is defined as METAVIR fibrosis stages F3 and F4.
Treated – the person’s hepatitis C has not adequately responded to interferon-based treatment.
 

About the Bristol-Myers Squibb HCV portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing compounds to deliver the most value to HCV patients with high unmet needs. At the core of our portfolio is daclatasvir, an NS5A complex inhibitor which continues to be investigated in multiple treatment regimens and in patients with high disease burden, such as pre- and post-transplant patients and HIV/HCV coinfected patients, as part of the ongoing ALLY Program.

In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic HCV. Since then, daclatasvir-based regimens have been approved in more than 50 countries, including the United States, several countries across Europe, and in numerous other countries in North, Central and South America, the Middle East and the Asia-Pacific region.

U.S. Indication and Important Safety Information (ISI) - Daklinza™ (daclatasvir)

The following ISI is based on information from U.S. Prescribing Information for Daklinza. Please consult the full Prescribing Information for all labeled safety information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.