What is Zepatier - Elbasvir - Grazoprevir used for and what is it used for?
Zepatier is an antiviral medicine indicated for the treatment of chronic (prolonged) hepatitis C in adults. Hepatitis C is an infectious disease caused by the hepatitis C virus that affects the liver.
Zepatier contains the active ingredients elbasvir and grazoprevir.
How is Zepatier - Elbasvir - Grazoprevir used?
Zepatier can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in managing patients with chronic hepatitis C.
There are several varieties (called genotypes) of the hepatitis C virus. Zepatier is recommended for use in patients infected with hepatitis C virus genotype 1a, 1b and 4 with or without compensated liver cirrhosis (scarring of the liver without compromising the liver function).
Zepatier is available as tablets containing 50 mg of elbasvir and 100 mg of grazoprevir. The normal dose of Zepatier is one tablet once a day for 12 weeks. In some cases the treatment may last longer and Zepatier can be taken in combination with another medicine, called ribavirin. For more information, see the summary of product characteristics (included with EPAR).
How does Zepatier - Elbasvir - Grazoprevir work?
The active ingredients of Zepatier, elbasvir and grazoprevir, block the action of two proteins that are essential for the multiplication of hepatitis C virus. 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 multiplication of hepatitis C virus and the infection of new cells.
What benefit has Zepatier - Elbasvir - Grazoprevir shown during the studies?
Zepatier, with or without ribavirin, has been evaluated in eight main studies involving around 2, 000 patients with hepatitis C virus infection of various genotypes whose liver functioned normally or adequately. In all studies, the main measure of effectiveness was the number of patients whose blood tests showed no evidence of hepatitis C virus 12 weeks after treatment. Considering the results of the studies as a whole, 96% of patients with genotype 1b virus (301 out of 312) tested negative for the virus 12 weeks after the end of treatment with Zepatier. Regarding the genotype 1a virus, 93% (483 of 519) of patients treated with Zepatier were negative compared to 95% (55 of 58) of patients who took Zepatier with ribavirin. Regarding the genotype 4 virus, 94% (61 of 65) of patients treated with Zepatier were negative compared to 100% (8 of 8) of patients who had taken Zepatier and ribavirin. A benefit was also observed in patients infected with HIV or in patients suffering from chronic renal failure (protracted). The available data relating to patients with genotype 3 virus were not sufficient to support the use of Zepatier for this genotype.
What are the risks associated with Zepatier - Elbasvir - Grazoprevir?
The most common side effects of 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 should not be used in patients with moderate or severe impairment of liver function (Child-Pugh class B or C cirrhosis). It must not be used in combination with medicines such as the antibiotic rifampicin, some HIV medicines and ciclosporin (used to prevent organ rejection) since Zepatier can interfere with the action of these medicines. Furthermore, it must not be used together with St. John's wort (an herbal medicine used for depression and anxiety) or carbamazepine and phenytoin antiepileptic drugs as these medicines can interfere with the action of Zepatier. For the full list of limitations, see the package leaflet
Why has Zepatier - Elbasvir - Grazoprevir been approved?
Zepatier has been shown to be highly effective in eliminating the genotypes 1a, 1b and 4 of hepatitis C virus from the blood of patients with or without compensated cirrhosis, including patients also infected with HIV or suffering from chronic renal failure. In most studies, treatment with Zepatier was not compared with another treatment or with no treatment. This was considered acceptable as chronic hepatitis C very rarely heals without treatment and, at the time the studies were started, no other antiviral medicines such as Zepatier were available. Zepatier was well tolerated and showed a favorable 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 - Elbasvir - Grazoprevir?
Recommendations and precautions for the safe and effective use of Zepatier that health professionals and patients must follow are included in the summary of product characteristics and the package leaflet.
More information on Zepatier - Elbasvir - Grazoprevir
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 on Zepatier therapy read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
