The NS5A replication complex inhibitor Daclatasvir (Daklinza), has been approved by the U.S. Food and Drug Administration (FDA), Bristol-Myers Squibb Company announced Friday. The approval was for treatment of patients with difficult-to-treat genotype 3 hepatitis C (HCV), in combination with sofosbuvir (Sovaldi), a viral NS5B polymerase blocker.
Daclatasvir is the first chronic hepatitis C virus (HCV) genotype 3 treatment to feature a 12-week, once-daily, all-oral dose regimen. Sofosbuvir, developed by Gilead Sciences, was approved by the FDA. in 2013, and Bristol-Myers Squibb’s Daclatasvir, is already approved in Europe and other regions.
Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb, said:
“The U.S. approval of Daklinza means that chronic HCV genotype 3 patients may now complete treatment in just 12 weeks with an all-oral, once-daily regimen. We believe this Daklinza-based regimen may be a solution to improving the standard of care for these patients. This approval is the result of many years of partnership with the HCV community to address the complexities of genotype 3, and an important achievement in our ongoing Daklinza development program, which focuses on patients that are most challenging to treat.”
US cost information for daclatasvir is not yet available, although sofosbuvir is fairly expensive on it’s own, retailing for around $84,000 per course of treatment.
Approval was based on the Phase III ALLY-3 clinical trial. This trial involved 152 patients with chronic HCV genotype 3 infection and compensated liver disease.
In the trial, the Daklinza plus sofosbuvir regimen demonstrated cures, defined as sustained virologic response rates 12 weeks after completing therapy (SVR12), in 90% of treatment-naïve and 86% of treatment-experienced chronic HCV genotype 3 patients. SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history.
In the more difficult-to-treat patients with cirrhosis, SVR12 rates were reduced (63%). These SVR12 rates were achieved with 12 weeks of therapy without the use of ribavirin.
David R. Nelson, M.D., Professor of Medicine, Molecular Genetics and Microbiology Director, UF Clinical and Translational Science Institute, and Assistant Vice President of Research for the University of Florida, said:
“The treatment landscape for HCV has radically evolved in recent years, and while we have achieved impressive SVR12 rates in genotype 1, genotype 3 still represents a clinical challenge. Not only are genotype 3 patients more complicated to manage, but the aggressive nature of their disease means there is a greater urgency to treat them. Daklinza in combination with sofosbuvir gives healthcare providers a new option to achieve a high overall SVR12 rate in this difficult-to-treat patient population.”