What is Viekirax - ombitasvir, paritaprevir, ritonavir and what is it used for?
Viekirax 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. Contains three active ingredients: ombitasvir, paritaprevir and ritonavir .
How is Viekirax - ombitasvir, paritaprevir, ritonavir used?
Viekirax 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. Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir. The recommended dose is two tablets once a day, to be taken with food. Viekirax is always used in combination with other medicines to treat chronic hepatitis C, such as dasabuvir and ribavirin. 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 Viekirax - ombitasvir, paritaprevir, ritonavir work?
The three active ingredients of Viekirax act differently: ombitasvir blocks the action of a protein present in the hepatitis C virus called "NS5A", while paritaprevir blocks the action of another protein called "NS3 / 4A". To multiply the virus needs both of these proteins. By blocking them, the medicine prevents the multiplication of the hepatitis C virus and the infection of new cells. The third active ingredient, ritonavir, does not act directly against the hepatitis C virus but blocks the action of an enzyme called CYP3A which metabolizes paritaprevir. Inhibition of CYP3A slows down the elimination of paritaprevir from the body, allowing the latter to act against the virus longer. Viekirax has been shown to be effective against genotypes 1a and 1b and against genotype 4.
What benefit has Viekirax - ombitasvir, paritaprevir, ritonavir shown during the studies?
In six main studies involving approximately 2 300 patients with hepatitis C genotype 1a or 1b infection, the combination of Viekirax and dasabuvir proved 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 Viekirax in combination with dasabuvir and ribavirin resulted in a 93% to 100% virus elimination rate after 24 weeks of treatment. In the course of these studies, the addition of ribavirin helped to increase the elimination rate in subjects with cirrhosis. The rates were particularly high (almost 100%) in patients with hepatitis C of genotype 1b. Another study showed that Viekirax is effective against genotype 4: administered with ribavirin, after 12 weeks Viekirax had eliminated the virus from the blood of all 91 patients with genotype 4 infection. When Viekirax was administered only in combination with dasabuvir, the virus was eliminated from the blood in 91% of patients.
What is the risk associated with Viekirax - ombitasvir, paritaprevir, ritonavir?
The most common side effects with Viekirax used in combination with dasabuvir 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. Viekirax should not be used in patients with severe hepatic impairment and in women taking ethinyl estradiol, an estrogen present 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 levels of active ingredients in the blood. For the full list of limitations, see the package leaflet.
Why has Viekirax - ombitasvir, paritaprevir, ritonavir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Viekirax used in combination with other medicines is effective in eliminating hepatitis C virus genotypes 1a, 1b and 4 from the blood, even in patients with cirrhosis . In almost all patients with these genotypes treated in the studies the virus had been eliminated from the blood; the elimination rate was particularly high in patients with genotype 1b and 4 infection. Regarding safety, despite cases of liver enzyme increases were reported in subjects treated with Viekirax in combination with dasabuvir and ribavirin, in general the effects The undesirable effects observed in this combination were well tolerated. The Committee therefore concluded that the benefits of Viekirax 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 Viekirax - ombitasvir, paritaprevir, ritonavir?
A risk management plan has been developed to ensure that Viekirax is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the information sheet for Viekirax, 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 Viekirax - ombitasvir, paritaprevir, ritonavir
On 15 January 2015, the European Commission issued a marketing authorization for Viekirax, valid throughout the European Union. For more information on Viekirax therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
