Intelence

etravirine

This document is a summary of the European public assessment report (EPAR) for Intelence. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Intelence.

What is Intelence?

Intelence is a medicine that contains the active substance etravirine. It is available as tablets (100 mg and 200 mg).

What is Intelence used for?

Intelence is used to treat adults (aged 18 years or over) who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Intelence is only used in patients who have been treated for their HIV infection before. Intelence must be used together with other antiviral medicines that include a ‘boosted protease inhibitor’.

The medicine can only be obtained with a prescription.

How is Intelence used?

Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.

The recommended dose of Intelence is two 100 mg tablets or one 200 mg tablet taken twice a day after a meal. For patients who are unable to swallow the tablets, Intelence tablets can be dispersed by stirring them in a glass of water to form a milky solution. This solution has to be drunk immediately.

How does Intelence work?

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 it to infect cells in the body and make more viruses. By blocking this enzyme, Intelence, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Intelence 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.

How has Intelence been studied?

Intelence has been studied in two main studies involving a total of 1,203 HIV-infected adults who had been taking anti-HIV therapy that was not working any longer and who had few or no treatment options remaining. Both studies compared Intelence with placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor) and at least two other antiviral medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood. The main measure of effectiveness was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ml after 24 weeks of treatment.

What benefit has Intelence shown during the studies?

Intelence was more effective than placebo at reducing viral load. Looking at the two studies taken together, the average viral load was 70,000 copies/ml at the start of the studies. After 24 weeks, 59% of the patients taking Intelence (353 out of 599) had a viral load below 50 copies/ml, compared with 41% of those taking placebo (248 out of 604). These findings were maintained at 48 weeks.

What is the risk associated with Intelence?

The most common side effect with Intelence (seen in more than 1 patient in 10) is rash. For the full list of all side effects reported with Intelence, see the package leaflet.

Intelence should not be used in people who may be hypersensitive (allergic) to etravirine or any of the other ingredients.

Severe skin reactions have been reported with Intelence (rash with blisters typically on the lips, mouth and eyes, sometimes with peeling skin). Treatment with Intelence should be stopped if a severe skin reaction develops. As with other anti-HIV medicines, patients taking Intelence may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system). Patients who have hepatitis B or C infection may be at an elevated risk of liver damage when taking Intelence.

Why has Intelence been approved?

The CHMP decided that Intelence’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Intelence has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular further information on its effectiveness and safety. Every year, the European Medicines Agency will review any new information that may become available, and this summary will be updated as necessary.

What information is still awaited for Intelence?

The company that makes Intelence will carry out a study to demonstrate that similar results to the two main studies are seen when Intelence is used in combination with protease inhibitors other than boosted darunavir.

Other information about Intelence

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Intelence on 28 August 2008.

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

This EPAR was last updated on 03/05/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

19/03/2012  Intelence -EMEA/H/C/000900 -II/0020

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

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Pharmacotherapeutic group

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.

This indication is based on week 48 analyses from 2 randomised, double-blind, placebo-controlled phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where Intelence was investigated in combination with an optimised background regimen which included darunavir/ritonavir.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents