DisclosuresAugust 27, 2014
EU Panel Endorses Daclatasvir (Daklinza) for Chronic Hep C
New Hepatitis C Guidelines Are Evolving Documents
HCV Therapy: High Rate of Viral Clearance, No Injections
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The European Commission has approved daclatasvir (Daklinza, Bristol-Myers Squibb) to treat adults with chronic hepatitis C virus (HCV) infection in combination with other drugs, the company announced today.
The approval follows an endorsement in June by the European Medicines Agency Committee for Medicinal Products for Human Use.
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, in combination with other drugs, provides a "shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens," the company says.
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.
"HCV is a challenging virus to overcome," Michael P. Manns, MD, professor and chairman, Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Germany, said in the release. Daclatasvir, when combined with other compounds, "often results in cure among even the hardest-to-treat patients," he added.
Recommended regimens and treatment durations for daclatasvir-based regimens include:
For HCV genotype 1 or 4 without cirrhosis: daclatasvir plus sofosbuvir for 12 weeks. Consider prolongation to 24 weeks for patients with prior treatment, including a NS3/4A protease inhibitor.
For genotype 1 or 4 with compensated cirrhosis: daclatasvir plus sofosbuvir for 24 weeks. Consider shortening treatment to 12 weeks for previously untreated patients with cirrhosis and positive prognostic factors such as IL28B CC genotype and/or low baseline viral load. Consider adding ribavirin for patients with very advanced liver disease or with other negative prognostic factors, such as prior treatment experience.
For genotype 3 with compensated cirrhosis and/or treatment experienced: daclatasvir plus sofosbuvir plus ribavirin for 24 weeks.
For genotype 4: 24 weeks of daclatasvir plus 24 to 48 weeks of peginterferon alfa and ribavirin. If the patient has HCV RNA undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for 24 weeks. If the patient achieves undetectable HCV RNA, but not at both treatment weeks 4 and 12, daclatasvir should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Daclatasvir monotherapy is not recommended. The Summary of Product Characteristics will be available online. Commercial availability of daclatasvir in the EU will be determined by individual member states.