What is Exviera - dasabuvir used for?
Exviera is an antiviral medicine used in combination with other medicines in the treatment of chronic forms of hepatitis C (an infectious disease of the liver, caused by the hepatitis C virus) in adults. It contains the active substance dasabuvir .
How is Exviera - dasabuvir used?
Exviera can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C. Exviera is available as 250 mg tablets. The recommended dose is two tablets a day, one in the morning and one in the evening. Exviera is always used in combination with another medicine, Viekirax, which contains the active substances ombitasvir, paritaprevir and ritonavir. Some patients taking Exviera are also treated with another antiviral medicine, ribavirin, in addition to Viekirax. There are various genotypes of hepatitis C virus, so 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, as well as on the nature of the patient's liver problems, for example if there is cirrhosis (fibrosis) in the liver or if the liver is not functioning properly. For more information, see the package leaflet.
How does Exviera - dasabuvir work?
The active ingredient of Exviera, dasabuvir, works by blocking the action of an enzyme called "RNA-dependent NS5B RNA polymerase", present in the hepatitis C virus, which is indispensable for the multiplication of the virus itself. This action interrupts the multiplication of the hepatitis C virus and the infection of new cells. Exviera has been shown to be effective against genotypes 1a and 1b when used in combination with other medicines.
What benefit has Exviera - dasabuvir shown during the studies?
In six main studies involving approximately 2 300 patients with hepatitis C genotype 1a or 1b infection, the combination of Exviera and Viekirax has been shown to be effective in eliminating the virus from the blood. After 12 weeks of treatment (with or without ribavirin), the virus had been cleared from the blood in 96% -100% of patients without liver cirrhosis. In patients with liver cirrhosis, treatment with Exviera in combination with Viekirax and ribavirin resulted in a 93% to 100% virus elimination rate after 24 weeks of treatment. In these studies, the addition of ribavirin to Exviera and Viekirax therapy helped increase the elimination rate in subjects with cirrhosis. The rates were particularly high (almost 100%) in patients with hepatitis C of genotype 1b.
What is the risk associated with Exviera - dasabuvir?
The most common side effects with Exviera used in combination with Viekirax and ribavirin (which may affect more than 1 in 10 people) are insomnia, nausea, pruritus, asthenia (weakness) and exhaustion (fatigue). For the full list of side effects, see the package leaflet. Exviera should not be used in women taking ethinyl estradiol, an estrogen found in hormonal contraceptives. It must also not be used in combination with medicines that interfere with the activity of certain enzymes that can increase or reduce the level of the active ingredient in the blood. For the full list of limitations, see the package leaflet.
Why has Exviera - dasabuvir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Exviera used in combination with Viekirax is effective, with or without ribavirin, in eliminating hepatitis C virus, genotypes 1a and 1b from the blood. In almost all the patients who took part in the six main studies the virus had been eliminated from the blood after 12 or 24 weeks of treatment; the elimination rate was particularly high in patients with genotype 1b infection. Regarding safety, although cases of liver enzymes have been reported in subjects treated with Exviera in combination with Viekirax and ribavirin, in general the undesirable effects observed in this combination were well tolerated. The Committee therefore concluded that the benefits of Exviera outweigh the 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 Exviera - dasabuvir?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Exviera used in combination with Viekirax is effective, with or without ribavirin, in eliminating hepatitis C virus, genotypes 1a and 1b from the blood. In almost all the patients who took part in the six main studies the virus had been eliminated from the blood after 12 or 24 weeks of treatment; the elimination rate was particularly high in patients with genotype 1b infection. Regarding safety, although cases of liver enzymes have been reported in subjects treated with Exviera in combination with Viekirax and ribavirin, in general the undesirable effects observed in this combination were well tolerated. The Committee therefore concluded that the benefits of Exviera outweigh the risks and recommended that it be approved for use in the EU.
Other information on Exviera - dasabuvir
On 15 January 2015, the European Commission issued a marketing authorization for Exviera, valid throughout the European Union. For more information about treatment with Exviera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
