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
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
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Approved name |
Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
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International non-proprietary name (INN) or common name |
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir
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Associated names |
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-20/1438
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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
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Authorisation model |
Centrally authorised product(s)
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Key dates and outcomes
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Procedure start date |
17/03/2016
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PRAC recommendation date |
01/12/2016
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CHMP opinion/CMDh position date |
15/12/2016
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EC decision date |
23/02/2017
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Outcome |
Risk minimisation measures
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All documents
Procedure started
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
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
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
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
Direct-acting antivirals for hepatitis C Article-20 procedure - Notification (PDF/57.22 KB)
First published: 18/03/2016
Last updated: 18/03/2016
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
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
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex III (PDF/13.6 KB)
First published: 16/12/2016
Last updated: 16/12/2016
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B (PDF/81.02 KB)
First published: 16/12/2016
Last updated: 16/12/2016
EMA/824717/2016
European Commission final decision
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
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
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
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
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
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
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
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
Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC assessment report (PDF/339.32 KB)
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
News
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16/12/2016
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16/12/2016
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02/12/2016
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02/12/2016
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28/10/2016
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30/09/2016
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02/09/2016
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10/06/2016
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13/05/2016
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15/04/2016
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18/03/2016