Incivo

telaprevir

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

What is Incivo?

Incivo is a medicine that contains the active substance telaprevir. It is available as tablets (375 mg).

What is Incivo used for?

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

It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.

The medicine can only be obtained with a prescription.

How is Incivo used?

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

Three Incivo tablets should be swallowed whole twice a day with food for a period of 12 weeks. Alternatively, two Incivo tablets can be taken every eight hours with food. Treatment with ribavirin and peginterferon alfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.

How does Incivo work?

The active substance in Incivo, telaprevir, is a protease inhibitor. It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle. This stops the hepatitis C virus from replicating in the infected host cells of the body. When Incivo is added to peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.

How has Incivo been studied?

Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected. Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin.

A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment. In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of treatment.

What benefit has Incivo shown during the studies?

In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo. In the second study, 88% of patients receiving Incivo for three months tested negative for hepatitis C compared with 24% of patients receiving placebo. The third study showed that in patients treated with Incivo, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients receiving them for one year.

What is the risk associated with Incivo?

The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash. For the full list of all side effects reported with Incivo, see the package leaflet.

Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients. Incivo must not be given in combination with several other medicines, including those which are affected by or affect the YP3A gene and Class Ia or III antiarrhythmics. For the full list of restrictions, see the package leaflet.

Why has Incivo been approved?

The CHMP considered that adding Incivo to standard treatment represents a major advance in treating the most common type of hepatitis C virus. The Committee noted that in both previously untreated patients and patients who had already been treated, adding Incivo to standard treatment considerably increased the number showing no sign of infection after six months. In addition, treatment could be shortened for many patients and the benefits could be seen across different patient types with different degrees of liver damage.

The Committee noted that the main risks identified were severe rash and the possibility of the virus developing drug resistance, but considered that these risks were manageable. The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.

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

The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.

Other information about Incivo

The European Commission granted a marketing authorisation valid throughout the European Union for Incivo on 19 September 2011.

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

Name Language First published Last updated
Incivo : EPAR - Summary for the public BG = bălgarski 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public ES = español 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public CS = čeština 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public DA = dansk 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public DE = Deutsch 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public ET = eesti keel 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public EL = elliniká 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public EN = English 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public FR = français 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public IT = italiano 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public LV = latviešu valoda 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public LT = lietuvių kalba 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public HU = magyar 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public MT = Malti 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public NL = Nederlands 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public PL = polski 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public PT = português 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public RO = română 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public SK = slovenčina 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public SL = slovenščina 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public FI = suomi 03/10/2011 26/06/2013
Incivo : EPAR - Summary for the public SV = svenska 03/10/2011 26/06/2013

This EPAR was last updated on 22/09/2014 .

Authorisation details

Product details

Product details for Incivo
NameIncivo
Agency product numberEMEA/H/C/002313
Active substance

telaprevir

International non-proprietary name (INN) or common name

telaprevir

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 Incivo
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision15
Date of issue of marketing authorisation valid throughout the European Union19/09/2011

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

Product information

24/07/2014  Incivo -EMEA/H/C/002313 -II/0026/G

Name Language First published Last updated
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014
Incivo : EPAR - Product Information SV = svenska 03/10/2011 22/09/2014

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
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011
Incivo : EPAR - All Authorised presentations SV = svenska 03/10/2011 10/11/2011

Name Language First published Last updated
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 03/10/2011  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):

  • who are treatment naïve;
  • who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Incivo : EPAR - Public assessment report SV = svenska 03/10/2011 15/05/2012
CHMP summary of positive opinion for Incivo SV = svenska 22/07/2011  

Authorised

This medicine is approved for use in the European Union