Daklinza Approved in UK for Genotype 3 Hepatitis C Treatment

The British health agency in charge of approving costs for drugs has given the thumbs up to Bristol-Myers Squibb to market its hepatitis C drug to include an indication for patients with genotype 3, reversing its recommendation from earlier this year.

In a final guidance released this month, the National Institute for Health and Care Excellence (NICE) recommends daclatasvir for use in England and Wales for the treatment of adult patients with chronic hepatitis C infection, according to a release from the drug company Bristol-Myers Squibb.

The NICE recommendation provides that the drug, marketed by the company under the name Daklinza, could be used to treat certain patients with genotypes 1, 3, and 4.

NICE is tasked with assessing the value of drugs and whether they will be covered under the United Kingdom healthcare system.

The final guidance for Daklinza is expected to be published in November and the drug should be available 3 months later in England and Wales with no further government agency approval needed, according to Emma Wright, Bristol-Myers Squibb communications manager for the UK and Ireland.

Among the six strains of the virus, genotype 3 can be one of the most difficult to treat and often progresses quickly, the release states. The final guidance represents a win for Bristol-Myers Squibb because a recommendation earlier this year from NICE had excluded treatment of patients with genotype 3.

Daklinza is a 60 mg, once daily, oral medication that is licensed in the UK for use with Sovaldi (a drug made by Gilead Sciences) with or without ribavirin and is also licensed for use in combination with peginterferon alfa and ribavirin. It must not be administered as monotherapy.

“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,” Anna Maria Geretti, Professor of Virology and Infectious Diseases at University of Liverpool said in the release. “In the past there have been limited treatment options available and therefore this decision is an important milestone.”

Hepatitis C is bloodborne virus that if left untreated can cause serious liver damage, including cirrhosis, liver cancer and the need for a liver transplant. An estimated 214,000 people in the UK are infected with the virus and about 100,000 of them are believed to have the genotype 3 strain, according to the release.

Daklinza is already approved in Europe to treat chronic hepatitis C infection in adults.

It is also approved in combination with Sovaldi for treatment of genotype 3 for 12 weeks in patients without cirrhosis and for 24 weeks in patients with cirrhosis with the optional use of ribavirin, the release states.

“The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe,” Douglas Manion, MD, head of Specialty Development, Bristol-Myers Squibb said in the release. “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.”