Intelence
Authorised
This medicine is authorised for use in the European Union
etravirine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 2 years of age. HIV-1 causes acquired immune deficiency syndrome (AIDS).
Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor’.
It contains the active substance etravirine.
Intelence can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
It is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water. Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately. In adults, the recommended dose of Intelence is 200 mg twice a day after a meal, while in children the dose depends on body weight and ranges from 100 to 200 mg twice a day.
For further information about using Intelence, see the package leaflet or contact your doctor or pharmacist.
The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to make more copies of itself in the cells it has infected and so spread in the body. By blocking this enzyme, Intelence, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Intelence does not cure HIV infection, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.
Studies have shown that Intelence, in combination with other medicines, could reduce the HIV-level (viral load) to low (below 400 copies/ml) or undetectable levels (below 50 copies/ml) in many patients
with HIV-1 infection. This was considered to show that the virus was no longer able to make new copies of itself in the body (a viral load above 1000 copies/ml indicated that the virus was actively reproducing).
In two main studies in a total of 1,203 adults whose infection had not responded fully to previous treatment, the average viral load was 70,000 copies/ml at the start of treatment. After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo (a dummy treatment) plus the other HIV medicines. These findings were maintained at 48 weeks.
In a main study of 101 children aged between 6 and 17 years, about half the children had undetectable levels of HIV after 24 weeks of taking Intelence in combination with other medicines, and the proportion of children with undetectable levels of HIV increased slightly after 48 weeks.
Another study involved 20 children aged between 2 and 5 years whose HIV infection had not responded fully to previous treatment. The average viral load was more than 1,000 copies/ml at the start of treatment. After 48 weeks of taking Intelence together with other HIV medicines, 80% of the children had a viral load below 400 copies/ml.
The most common side effects with Intelence (which may affect more than 1 in 10 people) are rash, diarrhoea, nausea (feeling sick) and headache.
Intelence must not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C. For the full list of side effects and restrictions with Intelence, see the package leaflet.
The European Medicines Agency decided that the benefits of Intelence are greater than its risks and that it can be authorised for use in the EU.
The Agency concluded that Intelence is effective at reducing viral load to very low or undetectable levels in both adults and children and that its side effects are considered manageable.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intelence have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Intelence are continuously monitored. Side effects reported with Intelence are carefully evaluated and any necessary action taken to protect patients.
Intelence received a marketing authorisation valid throughout the EU on 28 August 2008.
Product information
Latest procedure affecting product information:
N/0070
08/08/2024
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).
Product details
- Name of medicine
- Intelence
- Active substance
- Etravirine
- International non-proprietary name (INN) or common name
- etravirine
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AG04
Pharmacotherapeutic group
- Non-nucleoside reverse transcriptase inhibitors
- Antivirals for systemic use
Therapeutic indication
Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.
This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
News on Intelence
Topics
This page was last updated on