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

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
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 cases2 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.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
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

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

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    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

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    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

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    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

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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