What is Daklinza and what is Daclatasvir used for?
Daklinza is an antiviral medicine used in combination with other medicines in the treatment of hepatitis C (an infectious disease of the liver, caused by the hepatitis C virus) chronic (protracted) in adults. It contains the active substance daclatasvir .
How is Daklinza used - Daclatasvir?
Daklinza can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C. Daklinza is available in tablets of 30 and 60 mg. The maximum recommended dose is 60 mg once a day. Daklinza should be used in combination with other medicines to treat chronic hepatitis C, including sofosbuvir, peginterferon alfa and ribavirin. The combination of medicines to be used and the duration of therapy depend on the genotype of the hepatitis C virus responsible for the infection and on the nature of the patient's liver problems, for example if there is cirrhosis of the liver or if the liver is not functioning properly. For more information, see the package leaflet.
How does Daklinza - Daclatasvir work?
The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus, called "NS5A", which is essential for virus multiplication. By blocking this protein, the medicine prevents the hepatitis C virus from multiplying. Various genotypes of hepatitis C virus exist and Daklinza has been shown to be effective against genotypes 1 to 4.
What benefit has Daklinza - Daclatasvir shown during the studies?
Daklinza, used in combination with sofosbuvir (with or without ribavirin), has been shown to be effective in eliminating all traces of hepatitis C virus in the blood in a main study involving 211 adults. Patients who participated in the study were infected with genotypes 1, 2 or 3 and all underwent 12 or 24 weeks of treatment. Most of the patients had not been treated previously for hepatitis C, although some were suffering from a genotype 1 infection resistant to standard therapies (based on telaprevir or boceprevir - the so-called NS3 / 4A inhibitors - in combination with peginterferon alfa and ribavirin). 12 weeks after the end of the planned therapy, approximately 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 of 26) and 89% of patients with genotype 3 infection (16 of 18) showed no signs of infection in the blood. Additional studies conducted on patients with genotype 4 infection indicate that Daklinza is as effective against genotype 4 as it is against genotype 1.
What is the risk associated with Daklinza - Daclatasvir?
The most common side effects with Daklinza used in combination with sofosbuvir with or without ribavirin are fatigue, nausea and headache. For the full list of all side effects reported with Daklinza, see the package leaflet. Daklinza should not be used in combination with any medicines that may reduce its effects. For more information on medicines that are contraindicated for concomitant use with Daklinza, see the package leaflet.
Why has Daklinza - Daclatasvir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Daklinza used in combination with other medicines has been shown to be effective in the treatment of hepatitis C, even in subjects with genotype 1 resistant to previous therapies. There was no trace of the virus in the blood of almost all the patients who participated in the main study. As for safety, Daklinza was well tolerated and the side effects appeared similar to those reported by patients treated with placebo. The Committee therefore decided that the benefits of Daklinza outweigh its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Daklinza - Daclatasvir?
A risk management plan has been developed to ensure that Daklinza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Daklinza, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Daklinza - Daclatasvir
On 22 August 2014, the European Commission issued a marketing authorization for Daklinza, valid throughout the European Union. For more information on Daklinza therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2014.
