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FDA Approves Daclatasvir (Daklinza) for Chronic Hepatitis C Genotype 3 Infections
The FDA has approved daclatasvir (Daklinza, Bristol-Myers Squibb) for use with sofosbuvir (Sovaldi, Gilead Sciences) to treat patients with hepatitis C virus (HCV) genotype 3 infections. Daclatasvir is the first drug that has demonstrated safety and efficacy in the treatment of HCV genotype 3 infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infections.
According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV. Of these individuals, approximately 10% have HCV genotype 3. Some people with chronic HCV infections develop cirrhosis over many years, which can lead to complications, such as bleeding, jaundice, fluid accumulation in the abdomen, infections, or liver cancer.
The safety and efficacy of daclatasvir in combination with sofosbuvir were evaluated in a clinical trial involving 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infections. The subjects received daclatasvir 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post-treatment. The study was designed to measure whether a participant’s HCV was no longer detected in the blood 12 weeks after finishing treatment (i.e., a sustained virologic response [SVR]), suggesting that the participant’s infection had been cured.
The results showed that 98% of the treatment-naive subjects with no cirrhosis of the liver and 58% of the treatment-naive subjects with cirrhosis achieved an SVR. Of the participants who were treatment-experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved an SVR. The labeling for daclatasvir includes a “limitations of use” statement to inform prescribers that SVR rates are reduced in HCV genotype 3-infected patients with cirrhosis.
Safety data were available for approximately 1,900 patients with HCV treated with the recommended dose of daclatasvir in combination with other anti-HCV drugs in clinical trials. The most common adverse events associated with daclatasvir plus sofosbuvir were fatigue and headache.
The labeling for daclatasvir includes a warning for health care providers and patients that serious symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone was co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir. The co-administration of amiodarone with daclatasvir in combination with sofosbuvir is not recommended.
Daclatasvir was reviewed under the FDA’s “priority review” program, which allows an expedited review of drugs that treat serious conditions and that, if approved, would provide significant improvement in safety or effectiveness.
Source: FDA; July 24, 2015.