Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision

Table of contents

Current status
European Commission final decision

Overview

 

Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Further studies needed to assess risk of liver cancer with these medicines

On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines. These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.

The review of direct-acting antivirals was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC). It looked into cases of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.

The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.

The PRAC recommendation to include a warning in the prescribing information about hepatitis B re-activation and how to minimise it was endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).

In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.

The CHMP agreed that companies should carry out a study to evaluate the risk of liver cancer returning with direct-acting antivirals. In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with direct-acting antivirals.

The CHMP's opinion was passed to the European Commission, which issued a legally binding decision valid throughout the EU.

Key facts

About this medicine
Approved name
Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
International non-proprietary name (INN) or common name
  • daclatasvir
  • dasabuvir
  • sofosbuvir
  • ledipasvir
  • simeprevir
  • ombitasvir
  • paritaprevir
  • ritonavir
Associated names
  • Sovaldi
  • Olysio
  • Viekirax
  • Harvoni
  • Exviera
  • Daklinza
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-20/1438
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
Authorisation model
Centrally authorised product(s)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
17/03/2016
PRAC recommendation date
01/12/2016
CHMP opinion/CMDh position date
15/12/2016
EC decision date
23/02/2017
Outcome
Risk minimisation measures

All documents

Procedure started

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Addendum to PRAC list of questions (PDF/70.95 KB)


    First published: 15/04/2016
    Last updated: 15/04/2016
    EMA/PRAC/196081/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Review started (updated communication) (PDF/77.79 KB)


    First published: 15/04/2016
    Last updated: 15/04/2016
    EMA/263596/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Addendum to notification (PDF/41.54 KB)


    First published: 15/04/2016
    Last updated: 15/04/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Review started (PDF/75.77 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016
    EMA/199242/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Notification (PDF/57.22 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Timetable for the procedure (PDF/76.14 KB)


    First published: 18/03/2016
    Last updated: 28/10/2016
    EMA/PRAC/196120/2016

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC list of questions (PDF/77.49 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016
    EMA/PRAC/188631/2016

    • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B (PDF/89.56 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017
    EMA/141732/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B (PDF/89.56 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017
    EMA/141732/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III (PDF/415.78 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III (PDF/552.59 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III (PDF/505.65 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III (PDF/715.64 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III (PDF/476.86 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV (PDF/58.19 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III (PDF/604.75 KB)


    First published: 09/03/2017
    Last updated: 09/03/2017

  • List item

    Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC assessment report (PDF/339.32 KB)

    Adopted

    First published: 06/03/2017
    Last updated: 06/03/2017
    EMA/103226/2017

    • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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