Harvoni

sofosbuvir / ledipasvir

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This is a summary of the European public assessment report (EPAR) for Harvoni. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Harvoni.

For practical information about using Harvoni, patients should read the package leaflet or contact their doctor or pharmacist.

What is Harvoni and what is it used for?

Harvoni is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

Harvoni contains the active substances ledipasvir and sofosbuvir.

How is Harvoni used?

Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.

Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir. The recommended dose is one tablet taken once a day. There are several varieties (called genotypes) of hepatitis C virus Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3. The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly. For further information, see the summary of product characteristics (also part of the EPAR).

How does Harvoni work?

The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply. Sofosbuvir blocks the action of an enzyme called ‘NS5B RNA-dependent RNA polymerase’, while ledipasvir targets a protein called ‘NS5A’. By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.

Sofosbuvir has been authorised as Sovaldi since January 2014.

What benefits of Harvoni have been shown in studies?

Harvoni was investigated in three main studies involving a total of around 2,000 patients infected with hepatitis C of genotype 1 who did not have failure of liver function. 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 12 weeks after the end of treatment.

In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients. Around 94% to up to 99% of patients given Harvoni alone tested negative for the virus 12 weeks after the end of treatment. The addition of ribavirin was not needed for most patients.

Results of the studies also showed that patients who have compensated cirrhosis (scarring of the liver but who maintained liver function) had a higher likelihood of clearing the virus when treatment was extended to 24 weeks. Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.

Supportive data showed that Harvoni in combination with ribavirin would be of benefit for some patients with genotype 3 virus. Benefit was also shown for patients with genotype 1, 4, 5 and 6 with or without cirrhosis and/or for those who had received a liver transplant.

What are the risks associated with Harvoni?

The most common side effects with Harvoni (which may affect more than 1 in 10 people) are fatigue (tiredness) and headache. Harvoni must not be used together with the cholesterol medicine rosuvastatin or with St John’s wort (a herbal preparation used to treat depression). For the full list of all side effects and restrictions with Harvoni, see the package leaflet.

Why is Harvoni approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Harvoni’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that treatment with Harvoni, with or without ribavirin, is of high benefit to many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated cirrhosis. Although studies are limited in patients with decompensated cirrhosis, these patients may benefit from extended treatment with Harvoni and ribavirin. Regarding safety, the treatment is well tolerated.

What measures are being taken to ensure the safe and effective use of Harvoni?

A risk management plan has been developed to ensure that Harvoni is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Harvoni, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Harvoni

The European Commission granted a marketing authorisation valid throughout the European Union for Harvoni on 17 November 2014.

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

Name Language First published Last updated
Harvoni : EPAR - Summary for the public BG = bălgarski 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public ES = español 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public CS = čeština 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public DA = dansk 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public DE = Deutsch 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public ET = eesti keel 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public EL = elliniká 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public EN = English 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public FR = français 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public IT = italiano 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public LV = latviešu valoda 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public LT = lietuvių kalba 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public HU = magyar 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public MT = Malti 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public NL = Nederlands 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public PL = polski 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public PT = português 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public RO = română 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public SK = slovenčina 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public SL = slovenščina 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public FI = suomi 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public SV = svenska 04/12/2014 23/02/2016
Harvoni : EPAR - Summary for the public HR = Hrvatski 04/12/2014 23/02/2016
Name Language First published Last updated
Harvoni : EPAR - Risk-management-plan summary (English only) 04/12/2014  

This EPAR was last updated on 28/07/2016 .

Authorisation details

Product details

Product details for Harvoni
NameHarvoni
Agency product numberEMEA/H/C/003850
Active substance

sofosbuvir / ledipasvir

International non-proprietary name (INN) or common name

sofosbuvir / ledipasvir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AX65
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 Harvoni
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union17/11/2014

Contact address:

Gilead Sciences International Ltd
Flowers Building
Granta Park
Abington
Cambridge CB21 6GT
United Kingdom

Product information

Product information

22/07/2016  Harvoni -EMEA/H/C/003850 -PSUSA/00010306/201510

Name Language First published Last updated
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016
Harvoni : EPAR - Product Information EN = English 04/12/2014 28/07/2016

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
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  
Harvoni : EPAR - All Authorised presentations EN = English 04/12/2014  

Pharmacotherapeutic group

Direct-acting antiviral

Therapeutic indication

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Harvoni : EPAR - Public assessment report EN = English 04/12/2014  
CHMP summary of positive opinion for Harvoni EN = English 26/09/2014