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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/377766/2016

EMEA/H/C/004126

EPAR summary for the public

Zepatier

elbasvir / grazoprevir

This is a summary of the European public assessment report (EPAR) for Zepatier. 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 Zepatier.

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

What is Zepatier and what is it used for?

Zepatier is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.

Zepatier contains the active substances elbasvir and grazoprevir.

How is Zepatier used?

Zepatier 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.

There are several varieties (called genotypes) of hepatitis C virus. Zepatier is recommended for use in patients infected with hepatitis C virus genotypes 1a, 1b and 4 who may or may not have compensated liver cirrhosis (scarring of the liver but the liver is still able to work adequately).

Zepatier is available as tablets which contain 50 mg elbasvir and 100 mg grazoprevir. The usual dose of Zepatier is one tablet taken once a day for 12 weeks. In some cases, treatment may be longer and Zepatier may be used together with another medicine called ribavirin. For further information, see the summary of product characteristics (also part of the EPAR).

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How does Zepatier work?

The active substances in Zepatier, elbasvir and grazoprevir, block two proteins essential for the hepatitis C virus to multiply. Elbasvir blocks the action of a protein called 'NS5A', while grazoprevir blocks an enzyme called 'NS3/4A protease'. By blocking these proteins, Zepatier stops the hepatitis C virus from multiplying and infecting new cells.

What benefits of Zepatier have been shown in studies?

Zepatier with or without ribavirin has been investigated in eight main studies involving around 2,000 patients infected with hepatitis C virus of various genotypes whose liver was working normally or adequately. In all studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment. Looking at the results of the studies together, 96% of patients with genotype 1b virus (301 out of 312 patients) tested negative for the virus after 12 weeks of treatment with Zepatier. For patients with genotype 1a virus, 93% of patients (483 out of 519 patients) treated with Zepatier tested negative compared with 95% (55 out of 58 patients) on Zepatier with ribavirin. For patients with genotype 4 virus, 94% of patients (61 out of 65 patients) treated with Zepatier tested negative compared with 100% (8 out of 8 patients) treated with Zepatier and ribavirin. Benefit was also seen in patients also infected with HIV or who had chronic (long-term) kidney disease. The available data in patients with genotype 3 virus were not sufficient to support the use of Zepatier for this genotype.

What are the risks associated with Zepatier?

The most common side effects with Zepatier (which may affect more than 1 in 10 people) are tiredness and headache. For the full list of all side effects reported with Zepatier, see the package leaflet.

Zepatier must not be used in patients with moderately or severely reduced liver function (Child-Pugh class B or C cirrhosis). It must not be used together with medicines such as the antibiotic rifampicin, certain HIV medicines and ciclosporin (used to prevent organ rejection) since Zepatier may affect the way these medicine work. It must also not be used with the herbal remedy St. John's wort (used for depression and anxiety), or the epilepsy medicines carbamazepine and phenytoin because these medicines may affect the way Zepatier works. For the full list of restrictions, see the package leaflet.

Why is Zepatier approved?

Zepatier has been shown to be highly effective in clearing the hepatitis C virus genotypes 1a, 1b and 4 from the blood of patients with or without compensated cirrhosis, including patients also infected with HIV or who have chronic kidney disease. In most of the studies, treatment with Zepatier was not compared with another treatment or no treatment. This was considered acceptable because chronic hepatitis C virus is very rarely cured without treatment and, at the time the studies started, other antiviral medications such as Zepatier were not available. Zepatier was well tolerated with a favourable safety profile.

The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zepatier's benefits are greater than 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 Zepatier?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zepatier have been included in the summary of product characteristics and the package leaflet.

Other information about Zepatier

The European Commission granted a marketing authorisation valid throughout the European Union for Zepatier on 22 July 2016.

The full EPAR for Zepatier 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 Zepatier, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2016.

Zepatier

EMA/377766/2016

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