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FDA approves Daklinza for chronic hepatitis C genotype 3 infections
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The FDA announced the approval of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C genotype 3 infections.
Daclatasvir (Daklinza, Bristol-Myers Squibb) is the first drug to demonstrate safety and efficacy in three HCV genotypes without requiring co-administration of interferon or ribavirin, two FDA-approved drugs used for the treatment of HCV infections, according to an FDA press release.
“Today’s approval provides a new option for patients with [HCV genotype 3 infections], including those patients who cannot tolerate ribavirin,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Edward Cox
Investigators conducted a clinical trial to evaluate the safety and efficacy of daclatasvir in combination with sofosbuvir in 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infections.
Participants received a combination of daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks after treatment ended.
The studies aimed to measure whether a participant’s virus was no longer detected in the blood 12 weeks after finishing treatment, which would suggest a participant’s infection had been cured, according to the press release.
Ninety-eight percent of the treatment-naive participants with no cirrhosis of the liver and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response, according to the release.
Within the treatment-experienced participant population, 92 percent of participants with no cirrhosis of the liver and 69 percent with cirrhosis achieved sustained virologic response.
The most common side effects associated with daclatasvir in combination with sofosbuvir were fatigue and headache, according to the release.
Daclatasvir carries a warning for patients and health care providers following reports of serious slowing of the heart rate and cases requiring pacemaker intervention, according to the press release. These events occurred when amiodarone was co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir.