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.
AGA Resource
Through the AGA Roadmap to the Future of Practice, AGA offers a Hepatitis C Clinical Service line to support high-quality patient care, which is available at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c.