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 used in combination with other medicines to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver.

Sovaldi contains the active substance sofosbuvir.

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, normally for 12 or 24 weeks. Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa and ribavirin. Sovaldi can be used in all 6 varieties (genotypes) of hepatitis C virus. The duration of treatment will depend on the genotype of the virus the patient is infected with and on which medicines are used with Sovaldi.

For further information, see the package leaflet.

How does Sovaldi work?

The active substance in Sovaldi, sofosbuvir, blocks the action of a protein 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.

What benefits of Sovaldi have been shown in studies?

Sovaldi has been investigated in four main studies involving a total of 1,305 adult 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 had no sign of the virus 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 24 weeks. Treatment with Sovaldi was as effective (67% patients - 171 out of 256 – had no sign of the virus) as peginterferon-based treatment (67% of patients - 162 out of 243).
  • The third study involved 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 investigated 12 weeks of treatment with Sovaldi and ribavirin compared with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin had no sign of the hepatitis C virus 12 weeks after the end of treatment, whereas none of 71 patients taking placebo were free of the virus.
  • The fourth study involved 201 patients with hepatitis C virus (genotypes 2 or 3) whose infection did not improve on 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 had no sign of the hepatitis C virus, compared with 71 % (70 out of 98) of patients treated for 16 weeks.

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

Sovaldi is being investigated in one main study in children and adolescents aged between 3 and 18 years infected with hepatitis C virus genotypes 2 or 3. Patients infected with hepatitis C virus of genotype 2 received Sovaldi with ribavirin for 12 weeks and those infected with genotype 3 received the combination for 24 weeks. Blood tests 12 weeks after the end of treatment showed no sign of the virus in 96% of patients (48 out of 50) aged 12 to 18 years. Results in children aged below 12 years are not yet available.

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 (difficulty sleeping). Sovaldi did not increase the frequency or severity of these side effects. For the full list of side effects, see the package leaflet.

Sovaldi must not be used together with certain types of medicines which can reduce the effects of Sovaldi. Such medicines include:

  • rifampicin and rifabutin (antibiotics);
  • St. John’s wort (a herbal preparation used to treat depression and anxiety);
  • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy).

For the full list of restrictions, see the package leaflet.

Why is Sovaldi approved?

The European Medicines Agency decided that Sovaldi’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that adding Sovaldi to standard treatment is of benefit to patients. Sovaldi allows the virus to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which can cause serious side effects, including reduced growth in adolescents).

The Agency 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 Agency noted that, although there is limited information in some groups of patients 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 that occur are mainly due to combined treatment with ribavirin or interferons.

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

The company that markets Sovaldi will carry out a study in patients who have had liver cancer to evaluate the risk of the cancer returning after treatment with direct-acting antivirals such as Sovaldi. The study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sovaldi have also been included in the summary of product characteristics and the package leaflet.

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 (English only) 2014-02-05 2017-10-18

This EPAR was last updated on 18/10/2017 .

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 J05AX15
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 Sovaldi
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision12
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

14/09/2017  Sovaldi -EMEA/H/C/002798 -II/0036

Name Language First published Last updated
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18
Sovaldi : EPAR - Product Information EN = English 2014-02-05 2017-10-18

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 EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  
Sovaldi : EPAR - All Authorised presentations EN = English 2014-02-05  

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 and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Sovaldi : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2014-08-26 2017-10-18
Sovaldi-H-C-2798-II-0036 : EPAR - Assessment Report - Variation EN = English 2017-10-18  
Sovaldi-H-C-2798-A20-0029 : EPAR - Assessment Report - Variation EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion EN = English 2017-03-13  
Sovaldi-H-C-PSUSA-00010134-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation EN = English 2016-09-23  

Initial marketing-authorisation documents

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