The UK’s National Institute for Health and Care Excellence (NICE) has recommended Bristol-Myers Squibb’s (BMS) daklinza (daclatasvir) to treat adults with chronic hepatitis C virus (HCV) infection in England and Wales.
The drug is an oral, once-daily medication used in combination with other agents, and was specifically recommended to treat certain patients with HCV genotypes 1, 3 and 4.
In the UK, around 214,000 people are expected to have chronic HCV, with approximately 100,000 of these estimated to have genotype 3, a difficult-to-treat and often aggressive form of chronic HCV.
HCV genotype 3 is associated with accelerated progression of fibrosis compared to other genotypes, which can make treatment time critical, the company said.
University of Liverpool Virology and Infectious Diseases professor Anna Maria Geretti said: "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.
"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."
According to recent research, the risk of cirrhosis for patients infected with HCV genotype 3 is 31% greater than for those with HCV genotype 1.
In the EU, Daklinza is indicated in combination with other medicinal products to treat chronic hepatitis C virus (HCV) infection in adults.
Bristol-Myers Squibb Specialty Development head Douglas Manion said: "The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe.
"England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland in recognising 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 genotype 3 HCV, daklinza is currently approved in combination with sofosbuvir for 12 weeks to treat patients without cirrhosis and for 24 weeks in patients with cirrhosis with the optional use of ribavirin based on clinical assessment of the patient.
The company noted that 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.