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NICE recommends Daklinza for multiple HCV genotypes

The National Institute for Health and Care Excellence has recommended Daklinza for the treatment of hepatitis C virus genotypes 1, 3 and 4 infection in England and Wales, according to a press release from Bristol-Myers Squibb.

“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,” Anna Maria Geretti, MD, PhD, FRCPath, professor of virology and infectious diseases, Institute of Infection & Global Health, University of Liverpool, England, said in the release. “In the past, there have been limited treatment options available and therefore, this decision is an important milestone.”

Daklinza (daclatasvir, Bristol-Myers Squibb), an NS5A complex inhibitor, is currently approved in combination with Sovaldi (sofosbuvir, Gilead Sciences) for 12 weeks in patients with HCV genotype 3 without cirrhosis and for 24 weeks in patients with cirrhosis with the optional use of ribavirin, according to the release. Therapy options for HCV genotype 3 patients in England have been limited and previously included interferon.

Douglas Manion, MD, head of specialty development at Bristol-Myers Squibb stated in the release: “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 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.”

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended daclatasvir be approved to treat chronic HCV genotype 3 in adults in July 2014.

The FDA approved daclatasvir for the treatment of HCV genotype 3 infection in July, after clinical data showed 98% of the treatment-naive patients without cirrhosis and 58% of treatment-naive patients with cirrhosis achieved sustained virologic response with a combination regimen of daclatasvir and sofosbuvir.

Disclosures: Manion reports being employed by Bristol-Myers Squibb. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Geretti at the time of publication.