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The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.
In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.
Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.
The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.
While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.
Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.
The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.
While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.
Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.
The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.
While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.
Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.
The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.
In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.
Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.
The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.
In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.
Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.
