Viread

tenofovir disoproxil

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Viread is a medicine used to treat patients aged 2 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS). Viread is used in combination with other HIV medicines. In children and adolescents it is only used in patients who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI). For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood that the virus will respond to antiviral medicines.

Viread is also used to treat chronic (long-term) hepatitis B virus infection in adults and children aged 2 years and above with liver damage whose liver is still working properly (compensated liver disease). In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B infection).

Viread contains the active substance tenofovir disoproxil.

: Viread can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Viread, available as tablets and as granules, is taken once a day with food. The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function. For more information about using Viread, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Viread, tenofovir disoproxil, is a ‘prodrug’ that is converted into tenofovir in the body.

Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI). In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood

and keeps it at a low level. Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called DNA polymerase, which is involved in the formation of viral DNA. Viread stops the virus making DNA and prevents it from multiplying and spreading.

: HIV

For the treatment of HIV, Viread was more effective than placebo (a dummy treatment) when added to existing treatment. Two studies involving 741 HIV-infected adults showed that Viread resulted in a fall in the levels of HIV in the blood (viral load) of around 75% after 4 and after 24 weeks, compared with a small rise or fall in viral load of around 5% in the patients taking placebo. In a third study Viread was as effective as another medicine stavudine, when added to lamivudine and efavirenz. Similar numbers of patients in the Viread and stavudine groups had viral loads below 400 copies/ml after 48 weeks.

A study carried out in 87 adolescents (12 to 18 years of age) investigated the effects of adding Viread to existing treatment. Although it showed no benefit of adding Viread to existing treatment compared with adding placebo, Viread produced similar levels of the active substance in the body compared to adults, and it was judged that the results were influenced by the type of patients included in the Viread group.

A study in 97 children (aged 2 to 12 years) treated with stavudine or zidovudine, compared the effects of switching their treatment to Viread with continuing previous treatment. It showed that the majority of those who switched treatment from stavudine or zidovudine maintained their low HIV blood levels on Viread (83% of children in the Viread group and 92% of those on stavudine or zidovudine had viral loads below 400 copies/ml after 48 weeks).

Hepatitis B

For the treatment of hepatitis B, two studies involving 641 adult patients compared Viread with another medicine, adefovir dipivoxil. One of these studies involved patients with ‘HBeAg-negative’ hepatitis B, a type that is more difficult to treat, while the other involved the more common ‘HBeAg-positive’ hepatitis B. After 48 weeks, 71% of the HBeAg-negative and 67% of HBeAg-positive patients taking Viread had a complete response to treatment, compared with 49% and 12%, respectively, of the patients taking adefovir dipivoxil.

In a third study involving 112 adults whose liver had stopped working properly (decompensated liver disease) Viread was compared with entecavir and a combination treatment of Viread and emtricitabine. Overall, 70% of patients taking Viread or entecavir had a viral load below 400 copies/ml. The figure for the combination treatment of Viread and emtricitabine was 88%. A fourth study, involving 280 adults who had not responded to treatment with lamivudine, compared Viread alone with a combination treatment of Viread and emtricitabine. 89% of patients taking Viread had a viral load below 400 copies/ml after 96 weeks of treatment, compared with 86% of patients taking the combination treatment of Viread and emtricitabine.

A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo. In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo.

: The most common side effects with Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, hypophosphataemia (low levels of phosphate in the blood), rash and asthenia (weakness). Rare cases of severe kidney problems have also been seen in patients treated with Viread. Moreover, Viread may cause a reduction in bone density. For the full list of side effects and restrictions with Viread, see the package leaflet.

: The European Medicines Agency decided that Viread’s benefits are greater than its risks and it can be authorised for use in the EU.

: The company that makes Viread will ensure that all doctors who are expected to prescribe or use Viread in children are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.

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

As for all medicines, data on the use of Viread are continuously monitored. Side effects reported with Viread are carefully evaluated and any necessary action taken to protect patients.

: Viread received a marketing authorisation valid throughout the EU on 5 February 2002.

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Viread : EPAR - Medicine overview (PDF/84.26 KB)

First published: 10/06/2009
Last updated: 16/05/2019
EMA/184130/2019
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Viread : EPAR - Risk-management-plan summary (PDF/136.64 KB)

First published: 15/11/2018
Last updated: 22/03/2022

This EPAR was last updated on 04/01/2023

Authorisation details

Product details
Name	Viread
Agency product number	EMEA/H/C/000419
Active substance	tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name	tenofovir disoproxil
Therapeutic area (MeSH)	Hepatitis B, Chronic HIV Infections
Anatomical therapeutic chemical (ATC) code	J05AF07

Publication details
Marketing-authorisation holder	Gilead Sciences Ireland UC
Revision	58
Date of issue of marketing authorisation valid throughout the European Union	04/02/2002
Contact address	IDA Business & Technology Park Carrigtohill County Cork T45 DP77 Ireland

Product information

20/12/2022 Viread - EMEA/H/C/000419 - IB/0208

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Viread : EPAR - Product Information (PDF/2.06 MB)

First published: 03/08/2009
Last updated: 04/01/2023
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Viread : EPAR - All Authorised presentations (PDF/17.46 KB)

First published: 17/04/2008
Last updated: 11/02/2015
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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

HIV 1 infection

Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.

The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Viread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with

compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

HIV 1 infection

Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.

The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Viread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:

compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

HIV 1 infection

Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.

The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Viread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:

compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

HIV 1 infection

Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults.

In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).

Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.

The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with:

compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1).
evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1).
decompensated liver disease (see sections 4.4, 4.8 and 5.1).

Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:

compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

HIV 1 infection

Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.

Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate.

In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).

The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:

compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1).
evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1).
decompensated liver disease (see sections 4.4, 4.8 and 5.1).

Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:

compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

Viread

Table of contents

Overview

Viread : EPAR - Medicine overview (PDF/84.26 KB)

Viread : EPAR - Risk-management-plan summary (PDF/136.64 KB)

Authorisation details

Product information

Viread : EPAR - Product Information (PDF/2.06 MB)

Viread : EPAR - All Authorised presentations (PDF/17.46 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Viread : EPAR - Procedural steps taken and scientific information after authorisation (PDF/583.53 KB)

Viread-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/135.16 KB)

Viread-H-C-419-II-0191 : EPAR - Assessment Report - Variation (PDF/3.31 MB)

CHMP post-authorisation summary of positive opinion for Viread (II-191) (PDF/86.63 KB)

Viread-H-C-419-P46-0249 : EPAR - Assessment Report (PDF/98.43 KB)

Viread-H-C-419-II-0120 : EPAR - Assessment Report - Variation (PDF/1.92 MB)

Viread-H-C-419-P46-0243 : EPAR - Assessment Report (PDF/97.58 KB)

CHMP post-authorisation summary of positive opinion for Viread (PDF/81.93 KB)

Viread-H-C-419-II-0119 : EPAR - Assessment Report - Variation (PDF/385.87 KB)

Viread-H-C-419-II-0115 : EPAR - Assessment Report - Variation (PDF/1.48 MB)

Viread-H-C-419-X-0105-G : EPAR - Assessment Report - Extension (PDF/1.02 MB)

CHMP post-authorisation summary of positive opinion for Viread (PDF/61.99 KB)

Viread-H-C-419-II-0098 : EPAR - Assessment Report - Variation (PDF/394.75 KB)

Viread-H-C-419-II-0097 : EPAR - Assessment Report - Variation (PDF/549.47 KB)

CHMP post-authorisation summary of positive opinion for Viread (PDF/57.77 KB)

Viread-H-C-419-II-0075 : EPAR - Assessment Report - Variation (PDF/306.82 KB)

Viread : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/115.23 KB)

Initial marketing-authorisation documents

Committee for medicinal products for human use, summary of positive opinion for Viread (PDF/33.98 KB)

Viread : EPAR - Procedural steps taken before authorisation (PDF/91.04 KB)

Viread : EPAR - Scientific Discussion (PDF/459.76 KB)

News

More information on Viread

Public statement on efficacy and safety concerns regarding the co-administration of tenofovir disoproxil fumarate (TDF, Viread) and didanosine (ddI, Videx) (PDF/128.24 KB)

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