Biktarvy

bictegravir / emtricitabine / tenofovir alafenamide

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An overview of Biktarvy and why it is authorised in the EU

Biktarvy is an antiviral medicine used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide. It is only used in patients where the virus has not developed resistance to a class of HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.

 

How is Biktarvy used?

Biktarvy can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.

Biktarvy is available as tablets, each containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide. The recommended dose is one tablet a day.

For more information about using Biktarvy, see the package leaflet or contact your doctor or pharmacist.

How does Biktarvy work?

Biktarvy contains three active substances which work in different ways against HIV:

  • Bictegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
  • Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
  • Emtricitabine is another type of NRTI (a nucleoside reverse transcriptase inhibitor) and it works in the same way as tenofovir.

Biktarvy does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Biktarvy have been shown in studies?

The benefits of Biktarvy in the treatment of HIV infection were investigated in four main studies.

Two studies involved adults infected with HIV-1 who had not been treated previously, and looked at the numbers whose viral load (the amount of HIV-1 in the blood) was reduced to less than 50 copies per ml after 48 weeks of treatment. In the first study, Biktarvy was compared with another antiviral medicine containing abacavir, dolutegravir and lamivudine in 629 patients. Overall, 92% of patients taking Biktarvy (290 out of 314) achieved viral load reduction, compared with 93% (293 out of 315) of patients who achieved it with the comparator.

The second study compared Biktarvy with dolutegravir plus emtricitabine/tenofovir alafenamide in 645 patients: 89% (286 out of 320) of patients taking Biktarvy achieved satisfactory viral load reduction, compared with 93% (302 out of 325) of patients on the comparator.

Two other studies involved previously treated patients in whom the viral load was already lower than 50 copies per ml, and looked at whether it increased above this level 48 weeks after patients were switched from their previous HIV treatment to Biktarvy. In one study, the percentage of patients with viral load greater than or equal to 50 copies/ml was 1% (3 out of 282) of patients who switched to Biktarvy, compared with 0.5% (1 out of 281) of patients who stayed on their previous treatment (dolutegravir, abacavir, lamivudine). In the second study, the viral load went above the threshold in 2% (5 out of 290) of patients switched to Biktarvy, and in 2% (5 out of 287) of patients who stayed on their previous treatment (‘boosted’ atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine).

What are the risks associated with Biktarvy?

The most common side effects with Biktarvy (which may affect around 1 in 20 people) are headache, diarrhoea and nausea (feeling sick). For the full list of side effects of Biktarvy, see the package leaflet.

Biktarvy must not be used together with rifampicin (an antibiotic) or with St. John’s wort (a herbal medicine used for treating depression). For the full list of restrictions, see the package leaflet.

Why is Biktarvy authorised in the EU?

Biktarvy was shown to be as effective as comparator antiviral medicines. Side effects were similar to those of medicines of the same class. The European Medicines Agency therefore decided that Biktarvy’s benefits are greater than its risks and it can be authorised for use in the EU.

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

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

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

Other information about Biktarvy

Biktarvy received a marketing authorisation valid throughout the EU on 21-06-2018.

Name Language First published Last updated
Biktarvy : EPAR - Medicine overview BG = bălgarski 2018-06-22  
Biktarvy : EPAR - Medicine overview ES = español 2018-06-22  
Biktarvy : EPAR - Medicine overview CS = čeština 2018-06-22  
Biktarvy : EPAR - Medicine overview DA = dansk 2018-06-22  
Biktarvy : EPAR - Medicine overview DE = Deutsch 2018-06-22  
Biktarvy : EPAR - Medicine overview ET = eesti keel 2018-06-22  
Biktarvy : EPAR - Medicine overview EL = elliniká 2018-06-22  
Biktarvy : EPAR - Medicine overview EN = English 2018-06-22  
Biktarvy : EPAR - Medicine overview FR = français 2018-06-22  
Biktarvy : EPAR - Medicine overview IT = italiano 2018-06-22  
Biktarvy : EPAR - Medicine overview LV = latviešu valoda 2018-06-22  
Biktarvy : EPAR - Medicine overview LT = lietuvių kalba 2018-06-22  
Biktarvy : EPAR - Medicine overview HU = magyar 2018-06-22  
Biktarvy : EPAR - Medicine overview MT = Malti 2018-06-22  
Biktarvy : EPAR - Medicine overview NL = Nederlands 2018-06-22  
Biktarvy : EPAR - Medicine overview PL = polski 2018-06-22  
Biktarvy : EPAR - Medicine overview PT = português 2018-06-22  
Biktarvy : EPAR - Medicine overview RO = română 2018-06-22  
Biktarvy : EPAR - Medicine overview SK = slovenčina 2018-06-22  
Biktarvy : EPAR - Medicine overview SL = slovenščina 2018-06-22  
Biktarvy : EPAR - Medicine overview FI = suomi 2018-06-22  
Biktarvy : EPAR - Medicine overview SV = svenska 2018-06-22  
Biktarvy : EPAR - Medicine overview HR = Hrvatski 2018-06-22  

This EPAR was last updated on 22/06/2018 .

Authorisation details

Product details

Product details for Biktarvy
NameBiktarvy
Agency product numberEMEA/H/C/004449
Active substance

bictegravir / emtricitabine / tenofovir alafenamide / fumarate

International non-proprietary name (INN) or common name

bictegravir / emtricitabine / tenofovir alafenamide

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR

Publication details

Publication details for Biktarvy
Marketing-authorisation holder

Gilead Sciences International Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/06/2018

Contact address:

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

Product information

Product information

21/06/2018  Biktarvy -EMEA/H/C/004449

Name Language First published Last updated
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - Product Information HR = Hrvatski 2018-06-22  

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
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  
Biktarvy : EPAR - All Authorised presentations HR = Hrvatski 2018-06-22  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (HIV 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Biktarvy : EPAR - Public assessment report HR = Hrvatski 2018-06-22  
CHMP summary of positive opinion for Biktarvy HR = Hrvatski 2018-04-27  

Authorised

This medicine is approved for use in the European Union