Tybost

cobicistat

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

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

What is Tybost and what is it used for?

Tybost is a medicine that contains the active substance cobicistat. It is used in the treatment of adults infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS). Tybost does not treat HIV directly but is given to boost the effects of atazanavir or darunavir, which are used with other standard medicines to treat HIV-1.

How is Tybost used?

Tybost can only be obtained with a prescription. Treatment should be started by a doctor who is experienced in managing HIV infection.

Tybost is available as tablets (150 mg). The recommended dose is one tablet per day, taken with food. Tybost is given together with 300 mg atazanavir once per day or with 800 mg darunavir once per day. For further information, see the package leaflet.

How does Tybost work?

The active substance in Tybost, cobicistat, blocks the action of a group of liver enzymes called CYP3A, which are involved in breaking down medicines in the body. By blocking CYP3A, Tybost slows down the rate at which atazanavir and darunavir are broken down, thereby prolonging the length of time they act in the body.

Tybost is taken with atazanavir or darunavir, both of which are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of the HIV-1 virus. When the enzyme is blocked, the virus cannot reproduce normally, which slows down the spread of infection.

Treatment with Tybost and atazanavir or darunavir does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS, when combined with other standard HIV-1 medicines.

What benefits of Tybost have been shown in studies?

Tybost was compared with another medicine called ritonavir in one main study involving 698 patients infected with HIV-1. The study compared these two medicines when used to boost the effects of atazanavir, given in combination with another standard HIV-1 medicine containing emtricitabine and tenofovir. 

The main measure of effectiveness was based on the reduction in viral load (the amount of virus found in the blood): patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment. Tybost was shown to be as effective as ritonavir: around 85% of patients (293 out of 344 patients) given Tybost responded to treatment, compared with around 87% of patients (304 out of 348 patients) given ritonavir.

What are the risks associated with Tybost?

The most common side effects with Tybost (which may affect more than 1 in 10 people) when given with atazanavir are ocular icterus (yellowing of the whites of the eyes), nausea (feeling sick) and jaundice (yellowing of the skin and eyes). For the full list of all side effects reported with Tybost, see the package leaflet.

Tybost must not be taken together with a number of other medicines that affect the way Tybost is broken down or whose action is affected by Tybost:

  • alfuzosin (used to treat an enlarged prostate gland);
  • amiodarone or quinidine (used to correct irregular heartbeat);
  • carbamazepine, phenobarbital, or phenytoin (used to prevent seizures);
  • rifampicin (used to prevent and treat tuberculosis and other infections);
  • dihydroergotamine, ergometrine or ergotamine (used to treat migraine headache);
  • cisapride (used to relieve certain stomach problems);
  • St John’s wort (a herbal remedy used for depression and anxiety);
  • lovastatin or simvastatin (used to lower blood cholesterol);
  • pimozide (used to treat abnormal thoughts or feelings);
  • sildenafil (used to treat pulmonary arterial hypertension);
  • oral midazolam or triazolam (used to aid sleep or relieve anxiety).

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

Why is Tybost approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Tybost’s benefits are greater than its risks and recommended that it be approved for use in the EU. Studies showed that Tybost was as effective as ritonavir as a booster for atazanavir, and a similar effect is expected for darunavir based on data on the impact of Tybost on the darunavir levels in the body. The CHMP considered that there were no safety concerns preventing Tybost from being used together with atazanavir or darunavir.

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

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

Other information about Tybost

The European Commission granted a marketing authorisation valid throughout the European Union for Tybost on 19 September 2013.

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

Name Language First published Last updated
Tybost : EPAR - Summary for the public BG = bălgarski 2013-10-24  
Tybost : EPAR - Summary for the public ES = español 2013-10-24  
Tybost : EPAR - Summary for the public CS = čeština 2013-10-24  
Tybost : EPAR - Summary for the public DA = dansk 2013-10-24  
Tybost : EPAR - Summary for the public DE = Deutsch 2013-10-24  
Tybost : EPAR - Summary for the public ET = eesti keel 2013-10-24  
Tybost : EPAR - Summary for the public EL = elliniká 2013-10-24  
Tybost : EPAR - Summary for the public EN = English 2013-10-24  
Tybost : EPAR - Summary for the public FR = français 2013-10-24  
Tybost : EPAR - Summary for the public IT = italiano 2013-10-24  
Tybost : EPAR - Summary for the public LV = latviešu valoda 2013-10-24  
Tybost : EPAR - Summary for the public LT = lietuvių kalba 2013-10-24  
Tybost : EPAR - Summary for the public HU = magyar 2013-10-24  
Tybost : EPAR - Summary for the public MT = Malti 2013-10-24  
Tybost : EPAR - Summary for the public NL = Nederlands 2013-10-24  
Tybost : EPAR - Summary for the public PL = polski 2013-10-24  
Tybost : EPAR - Summary for the public PT = português 2013-10-24  
Tybost : EPAR - Summary for the public RO = română 2013-10-24  
Tybost : EPAR - Summary for the public SK = slovenčina 2013-10-24  
Tybost : EPAR - Summary for the public SL = slovenščina 2013-10-24  
Tybost : EPAR - Summary for the public FI = suomi 2013-10-24  
Tybost : EPAR - Summary for the public SV = svenska 2013-10-24  
Tybost : EPAR - Summary for the public HR = Hrvatski 2013-10-24  

This EPAR was last updated on 26/05/2016 .

Authorisation details

Product details

Product details for Tybost
NameTybost
Agency product numberEMEA/H/C/002572
Active substance

cobicistat on silicon dioxide

International non-proprietary name (INN) or common name

cobicistat

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code V03AX03
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 Tybost
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union19/09/2013

Contact address:

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

Product information

Product information

01/04/2016  Tybost -EMEA/H/C/002572 -WS/0837

Name Language First published Last updated
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26
Tybost : EPAR - Product Information HR = Hrvatski 2013-10-24 2016-05-26

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
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  
Tybost : EPAR - All Authorised presentations HR = Hrvatski 2013-10-24  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human-immunodeficiency-virus-1 (HIV-1)-infected adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Tybost : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-07-29 2016-05-26

Initial marketing-authorisation documents

Name Language First published Last updated
Tybost : EPAR - Public assessment report HR = Hrvatski 2013-10-24  
CHMP summary of positive opinion for Tybost HR = Hrvatski 2013-07-26  

Authorised

This medicine is approved for use in the European Union