Sovaldi

sofosbuvir

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

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

What is Sovaldi and what is it used for?

Sovaldi is an antiviral medicine that contains the active substance sofosbuvir. It is used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus) in adults. Sovaldi is used in combination with other medicines.

How is Sovaldi used?

Sovaldi 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.

Sovaldi is available as 400 mg tablets. The recommended dose is one tablet taken once a day with food. Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa and ribavirin. Several varieties (genotypes) of hepatitis C virus exist, and the duration of treatment with Sovaldi will depend on the genotype of the virus and on which medicines are used together with Sovaldi. For further information, see the package leaflet.

How does Sovaldi work?

The active substance in Sovaldi, sofosbuvir, blocks the action of an enzyme called ‘NS5B RNA-dependent RNA polymerase’ in the hepatitis C virus, which is essential for the virus to multiply. This stops the hepatitis C virus from multiplying and infecting new cells. Sovaldi works against all genotypes of the hepatitis C virus.

What benefits of Sovaldi have been shown in studies?

Sovaldi was investigated in four main studies involving a total of 1305 patients infected with hepatitis C. In all four 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.

  • The first study involved 327 previously untreated patients who were infected with hepatitis C virus of genotypes 1, 4, 5 or 6, and who were given Sovaldi together with two other antiviral medicines, peginterferon alfa and ribavirin, for 12 weeks. In this study, 91% (296 out of 327) of patients tested negative for hepatitis C 12 weeks after the end of treatment.
  • The second study involved 499 previously untreated patients who had hepatitis C of genotypes 2 or 3. In this study, patients given Sovaldi together with ribavirin for 12 weeks were compared with patients given peginterferon alfa and ribavirin for 16 weeks. Treatment with Sovaldi was as effective (67% patients - 171 out of 256 – tested negative) as peginterferon-based treatment (67% of patients - 162 out of 243).
  • The third study was done in 278 patients with genotypes 2 or 3 hepatitis C virus who could not take or did not want to have treatment with interferon. This study compared 12 weeks of treatment with Sovaldi and ribavirin with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin tested negative for hepatitis C 12 weeks after the end of treatment, whereas none of 71 patients taking placebo were free of the virus.
  • The fourth study was done in 201 patients with hepatitis C virus (genotypes 2 or 3) who did not respond to previous treatment with interferon or whose infections came back. This study compared Sovaldi and ribavirin taken for 12 weeks with Sovaldi and ribavirin taken for 16 weeks. In this study, 50% (51 out of 103) of patients taking Sovaldi and ribavirin for 12 weeks tested negative for hepatitis C, whereas 71 % (70 out of 98) of patients treated for 16 weeks tested negative.

Additional studies showed that Sovaldi in combination with ribavirin decreased the risk of infection of the new liver with hepatitis C virus in patients undergoing transplantation, that Sovaldi is also effective in patients coinfected with hepatitis C and HIV, and that the outcome of patients with genotype 3 infection could be improved by extending treatment to 24 weeks.

What are the risks associated with Sovaldi?

The most common side effects with Sovaldi in combination with ribavirin and peginterferon alfa were similar to those commonly reported with ribavirin or peginterferon alfa and included fatigue (tiredness), headache, nausea (feeling sick) and insomnia. Sovaldi did not increase the frequency or severity of these side effects.

For the full list of all side effects and restrictions, see the package leaflet.

Why is Sovaldi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Sovaldi’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that adding Sovaldi to standard treatment is of benefit to patients. Sovaldi allows the infection to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which may cause serious side effects and is not well tolerated by many patients).

The Committee also considered that, if given before a liver transplant, Sovaldi in combination with ribavirin can prevent re-infection of the liver, which in the absence of treatment occurs nearly always and results in a poor prognosis. In addition, virus resistance to Sovaldi is very uncommon and Sovaldi works against all types of hepatitis C virus.

Regarding safety, the Committee noted that, although there is limited information in some patient populations such as those with decompensated liver disease (where the liver is damaged and no longer works properly), no side effects specific to Sovaldi have been identified, and those observed are mainly due to combined treatment with ribavirin or interferons.

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

A risk management plan has been developed to ensure that Sovaldi 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 Sovaldi, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Sovaldi

The European Commission granted a marketing authorisation valid throughout the European Union for Sovaldi on 16 January 2014.

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

Name Language First published Last updated
Sovaldi : EPAR - Summary for the public BG = bălgarski 05/02/2014  
Sovaldi : EPAR - Summary for the public ES = español 05/02/2014  
Sovaldi : EPAR - Summary for the public CS = čeština 05/02/2014  
Sovaldi : EPAR - Summary for the public DA = dansk 05/02/2014  
Sovaldi : EPAR - Summary for the public DE = Deutsch 05/02/2014  
Sovaldi : EPAR - Summary for the public ET = eesti keel 05/02/2014  
Sovaldi : EPAR - Summary for the public EL = elliniká 05/02/2014  
Sovaldi : EPAR - Summary for the public EN = English 05/02/2014  
Sovaldi : EPAR - Summary for the public FR = français 05/02/2014  
Sovaldi : EPAR - Summary for the public IT = italiano 05/02/2014  
Sovaldi : EPAR - Summary for the public LV = latviešu valoda 05/02/2014  
Sovaldi : EPAR - Summary for the public LT = lietuvių kalba 05/02/2014  
Sovaldi : EPAR - Summary for the public HU = magyar 05/02/2014  
Sovaldi : EPAR - Summary for the public MT = Malti 05/02/2014  
Sovaldi : EPAR - Summary for the public NL = Nederlands 05/02/2014  
Sovaldi : EPAR - Summary for the public PL = polski 05/02/2014  
Sovaldi : EPAR - Summary for the public PT = português 05/02/2014  
Sovaldi : EPAR - Summary for the public RO = română 05/02/2014  
Sovaldi : EPAR - Summary for the public SK = slovenčina 05/02/2014  
Sovaldi : EPAR - Summary for the public SL = slovenščina 05/02/2014  
Sovaldi : EPAR - Summary for the public FI = suomi 05/02/2014  
Sovaldi : EPAR - Summary for the public SV = svenska 05/02/2014  
Sovaldi : EPAR - Summary for the public HR = Hrvatski 05/02/2014  

This EPAR was last updated on 05/02/2014 .

Authorisation details

Product details

Product details for Sovaldi
NameSovaldi
Agency product numberEMEA/H/C/002798
Active substance

sofosbuvir

International non-proprietary name (INN) or common name

sofosbuvir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code

Publication details

Publication details for Sovaldi
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union16/01/2014

Contact address:

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

Product information

Product information

16/01/2014  Sovaldi -EMEA/H/C/002798 --

Name Language First published Last updated
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - Product Information HR = Hrvatski 05/02/2014  

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
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  
Sovaldi : EPAR - All Authorised presentations HR = Hrvatski 05/02/2014  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Sovaldi : EPAR - Public assessment report HR = Hrvatski 05/02/2014  
CHMP summary of positive opinion for Sovaldi HR = Hrvatski 22/11/2013