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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/203890/2016

EMEA/H/C/003839

EPAR summary for the public

Viekirax

ombitasvir / paritaprevir / ritonavir

This is a summary of the European public assessment report (EPAR) for Viekirax. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Viekirax.

For practical information about using Viekirax, patients should read the package leaflet or contact their doctor or pharmacist.

What is Viekirax and what is it used for?

Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of liver caused by the hepatitis C virus.

It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.

How is Viekirax used?

Viekirax can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing 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 taken once a day with food. Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.

Several genotypes of hepatitis C virus exist, and the combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus the patient is infected with and the nature of the liver problems they have, for example if they have liver cirrhosis (scarring) or their liver is not working properly. For further information, see the package leaflet.

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How does Viekirax work?

The 3 active substances in Viekirax work in different ways: ombitasvir blocks the action of a protein in the hepatitis C virus called 'NS5A' and paritaprevir blocks the action of another protein called 'NS3/4A', both of which the virus needs to multiply. By blocking these proteins, the medicine prevents the hepatitis C virus from multiplying and infecting new cells.

The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir. The inhibition of CYP3A slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.

Viekirax has been shown to be effective against genotypes 1a and 1b and genotype 4.

What benefits of Viekirax have been shown in studies?

In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Viekirax in combination with dasabuvir was effective in clearing the virus from the blood. Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribivarin). In patients with liver scarring, Viekirax treatment in combination with dasabuvir and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.

In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.

An additional study showed Viekirax to be effective against genotype 4: when given with ribavirin, Viekirax cleared this genotype from the blood of all the 91 patients infected with it after 12 weeks. When Viekirax was given with only dasabuvir, the virus was cleared from the blood in 91% of the patients.

What are the risks associated with Viekirax?

The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), nausea, pruritus (itching), asthenia (weakness) and fatigue (tiredness). For the full list of all side effects, see the package leaflet.

Viekirax must not be used in patients with severe liver impairment and in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives. It must also not be used together with medicines that affect the activity of certain enzymes that can raise or lower the levels of its active substances in the blood. For the full list of restrictions, see the package leaflet.

Why is Viekirax approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring. Almost all the patients with these genotypes treated in studies had the virus cleared from their blood. The clearance rate was particularly high in patients infected with genotypes 1b and 4.

Regarding its safety, although there were some cases of raised liver enzymes in patients treated with Viekirax in combination with dasabuvir and ribavirin, side effects seen with this combination were generally 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?

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 package leaflet for Viekirax, including information on the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Viekirax

The European Commission granted a marketing authorisation valid throughout the European Union for Viekirax on 15-January-2015.

The full EPAR and risk management plan summary for Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Viekirax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2016.

Viekirax

EMA/203890/2016

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