FDA Approves Daklinza for Chronic Hepatitis C Genotype 3

The Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Daklinza (daclatasvir) when used in combination with Sovaldi (sofosbuvir) for treatment of patients with chronic hepatitis C genotype 3.

This is the first 12-week, oral therapy taken once per day to achieve a sustained virologic response (SVR12) 12 weeks post treatment in a majority of Genotype 3 patients. Genotype 3 is one of the most difficult genotypes to treat and second most common genotype in the United States. An estimated 12% of those diagnosed with chronic hepatitis C have this genotype.

A recent clinical trial enrolled 152 patients, which included 101 who had no prior treatment and 51 who previously underwent treatment. Of those with no prior treatment, 90% achieved SVR12 and 86% who previously underwent treatment achieved SVR12. These were achieved without the use of ribavirin.

For patients with cirrhosis, the chance of achieving SVR12 using Daklinza decreased. Only 63% achieved SVR12 while 96% of patients without cirrhosis achieved SVR12.

No serious adverse events (SAE) were noted in the clinical trial. The most common side effects reported were headache, fatigue, nausea, and diarrhea.

Bristol-Myers Squibb priced the treatment at $63,000, while Sovaldi is priced at $83,000. The combination of the two treatments would cost $146,000. Private insurance companies have negotiated discounts for Sovaldi and similar negotiations are likely to occur with Daklinza.

Loss of efficacy of Daklinza may occur due to adverse drug interactions especially when the treatment is used in combination with other drugs that influence the human gene CYP3A. Also, there is a risk of bradycradia (slow heart rate) when Daklinza is taken combination with sofosbuvir and amiodarone.

Daklinza will be made available within a week.1-3

For more information, visit the press release from Bristol-Myers Squibb.

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