Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) contains the active substances elbasvir and grazoprevir.

How is Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) used?

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

How does Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) work?

The active substances in Zepatier (elbasvir 50 mg/ grazoprevir 100 mg), 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 (elbasvir 50 mg/ grazoprevir 100 mg) stops the hepatitis C virus from multiplying and infecting new cells.

What benefits of Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) have been shown in studies?

Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg). For patients with genotype 1a virus, 93% of patients (483 out of 519 patients) treated with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) tested negative compared with 95% (55 out of 58 patients) on Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) with ribavirin. For patients with genotype 4 virus, 94% of patients (61 out of 65 patients) treated with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) tested negative compared with 100% (8 out of 8 patients) treated with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) for this genotype.

What are the risks associated with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg)?

The most common side effects with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) (which may affect more than 1 in 10 people) are tiredness and headache. For the full list of all side effects reported with Zepatier (elbasvir 50 mg/ grazoprevir 100 mg), see the package leaflet.

Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) works. For the full list of restrictions, see the package leaflet.

Why is Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) approved?

Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) 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 (elbasvir 50 mg/ grazoprevir 100 mg) were not available. Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) was well tolerated with a favourable safety profile.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) benefits are greater than its risks and recommended that it be approved for use in the EU.

Searching where to buy Zepatier (elbasvir 50 mg/ grazoprevir 100 mg)?

You can purchase brand original Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) in MTO Pharma online pharmacy. Contact us to place the order, or order Zepatier (elbasvir 50 mg/ grazoprevir 100 mg) yourself on our website.

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