Victrelis

boceprevir

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This is a summary of the European public assessment report (EPAR) for Victrelis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Victrelis.

What is Victrelis?

Victrelis is a medicine that contains the active substance boceprevir. It is available as capsules (200 mg).

What is Victrelis used for?

Victrelis is used to treat adults with chronic (long-term) hepatitis C genotype 1 (a disease of the liver due to infection with the hepatitis-C virus) in combination with two other medicines, peginterferon alfa and ribavirin.

Victrelis is to be used in patients with compensated liver disease who have not been treated before or whose previous treatment has failed. Compensated liver disease is when the liver is damaged but is still able to work normally.

The medicine can only be obtained with a prescription.

How is Victrelis used?

Treatment with Victrelis should be started and monitored by a doctor experienced in managing chronic hepatitis C.

The recommended dose is four capsules three times a day (a total of 12 capsules a day). It should be taken with food (a meal or light snack). If taken without food, the medicine may not work properly.

The patients must first take peginterferon alfa and ribavirin for four weeks, after which they will add Victrelis to the treatment for up to 44 weeks, depending on several factors such as the patients' previous treatment and results of blood tests during treatment. For more information on how to use Victrelis, including its combination with peginterferon alfa and ribavirin and the length of treatment, see the summary of product characteristics (also part of the EPAR).

How does Victrelis work?

The active substance in Victrelis, boceprevir, is a protease inhibitor. It blocks an enzyme called HCV NS3 protease, which is found on the hepatitis-C virus of the type-1 genotype and is involved in the virus’s replication. When the enzyme is blocked, the virus does not replicate normally and this slows down the rate of replication, helping to eliminate the virus.

How has Victrelis been studied?

The effects of Victrelis were first tested in experimental models before being studied in humans.

Two main studies involving 1,099 previously untreated and 404 previously treated patients with chronic hepatitis-C genotype-1 infection and compensated liver disease were carried out. In both studies Victrelis was compared with placebo (a dummy treatment). All patients also received peginterferon alfa and ribavirin. The main measure of effectiveness was the number of patients who had no detectable virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.

What benefit has Victrelis shown during the studies?

Victrelis was effective at curing patients with chronic hepatitis-C genotype-1 infection who were also treated with peginterferon alfa and ribavirin. In the study of previously untreated patients, 66% of patients who received Victrelis for 44 weeks (242 out 366) were cured, compared with 38% of those who received placebo (137 out of 363).

In a second study in patients in whom previous treatment had failed, the cure rate was 67% (107 out of 161) for patients who received Victrelis for 44 weeks compared with 21% (17 out of 80) for those receiving placebo.

Victrelis was also shown to be effective in some patients whose treatment was shortened following blood tests in which the virus could no longer be detected in their blood.

What is the risk associated with Victrelis?

Victrelis in combination with peginterferon alfa and ribavirin can lead to a higher rate of anaemia (low red-blood-cell counts) than is seen in treatment with peginterferon and ribavirin alone. The other most common side effects with Victrelis are fatigue (tiredness), nausea (feeling sick), headache and dysgeusia (taste disturbances). For the full list of all side effects reported with Victrelis, see the package leaflet.

Victrelis must not be used in people who are hypersensitive (allergic) to boceprevir or any of the other ingredients. It must not be used in patients with auto-immune hepatitis (hepatitis caused by an immune disorder) or in pregnant women. Victrelis can slow down the rate at which certain medicines are broken down in the liver. These medicines can be harmful at high levels in the blood and it is important to avoid taking them when taking Victrelis. For a list of these medicines see the summary of product characteristics (also part of the EPAR).

Why has Victrelis been approved?

The CHMP noted that Victrelis in combination with peginterferon alfa and ribavirin significantly increases the number of patients cured of chronic hepatitis-C infection. This was an important improvement on results seen with only peginterferon alfa and ribavirin together. The main increase in side effects seen when adding Victrelis to treatment was anaemia. However, the Committee decided that the medicine’s benefits outweighed its risk and recommended that it be granted marketing authorisation.

What measures are being taken to ensure the safe use of Victrelis?

The company that makes Victrelis will ensure that all doctors expected to prescribe the medicine are provided with an educational pack with detailed information on the medicine, including information on the risk of anaemia and other side effects.

Other information about Victrelis

The European Commission granted a marketing authorisation valid throughout the European Union for Victrelis on 18 July 2011.

For more information about treatment with Victrelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Victrelis : EPAR - Summary for the public BG = bălgarski 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public ES = español 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public CS = čeština 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public DA = dansk 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public DE = Deutsch 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public ET = eesti keel 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public EL = elliniká 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public EN = English 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public FR = français 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public IT = italiano 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public LV = latviešu valoda 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public LT = lietuvių kalba 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public HU = magyar 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public MT = Malti 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public NL = Nederlands 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public PL = polski 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public PT = português 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public RO = română 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public SK = slovenčina 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public SL = slovenščina 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public FI = suomi 03/08/2011 30/08/2012
Victrelis : EPAR - Summary for the public SV = svenska 03/08/2011 30/08/2012

This EPAR was last updated on 11/04/2014 .

Authorisation details

Product details

Product details for Victrelis
NameVictrelis
Agency product numberEMEA/H/C/002332
Active substance

boceprevir

International non-proprietary name (INN) or common name

boceprevir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AE
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Victrelis
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision14
Date of issue of marketing authorisation valid throughout the European Union18/07/2011

Contact address:

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

21/03/2014  Victrelis -EMEA/H/C/002332 -II/0027

Name Language First published Last updated
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014
Victrelis: EPAR - Product Information SV = svenska 03/08/2011 11/04/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012
Victrelis : EPAR - All Authorised presentations SV = svenska 03/08/2011 12/04/2012

Name Language First published Last updated
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  
Victrelis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/08/2011  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Victrelis : EPAR - Public assessment report SV = svenska 03/08/2011  
CHMP summary of positive opinion for Victrelis SV = svenska 20/05/2011  

Authorised

This medicine is approved for use in the European Union

More information on Victrelis