Hepatitis C, now cure rates of up to 100%.
The European Commission has approved Daclatasvir (Daklinza, Bristol-Myers Squibb) to treat adults with chronic hepatitis C virus (HCV) infection in combination with Sofosbuvir, the company announced today.
Daclatasvir blocks the action of NS5A, a protein essential for HCV replication. It is indicated for adults infected with HCV genotypes 1, 2, 3, and 4. In a news release, the company notes that oral Daclatasvir in combination with oral Sofosbuvir provided cure rates of up to 100% in clinical trials, including in patients with advanced liver disease, genotype 3, and those who have previously failed treatment with protease inhibitors.
Daclatasvir is the first NS5A complex inhibitor approved in the European Union (EU) and provides a “shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon and ribavirin based regimens.
Across clinical studies, Daclatasvir-based regimens have been generally well-tolerated, with low discontinuation rates. The most common adverse effects with daclatasvir when used in combination with other drugs are fatigue, headache, and nausea. The safety of Daclatasvir has been demonstrated in diverse patient populations that include elderly patients, patients with advanced liver disease, post–liver transplant recipients, and patients coinfected with HIV, the company says.