Author: Janssen-Cilag International NV


Long information

What is it?

Intelence is a medicine that contains the active substance etravirine. It is available as white, oval tablets (100 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Intelence is an antiviral medicine. It is used to treat adults 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 which have to include a ?boosted protease inhibitor?.
The medicine can only be obtained with a prescription.

How is it 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 tablets twice a day taken 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 it 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 it been studied?

The effects of Intelence were first tested in experimental models before being studied in humans. 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 benefits has it 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 in combination with other anti-HIV medicines (353 out of 599) had a viral load below 50 copies/ml, compared with 41% of the patients taking placebo in combination with other anti-HIV medicines (248 out of 604). These findings were maintained at 48 weeks.

What is the risk associated?

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 it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Intelence?s benefits are greater than its risks when used in combination with a boosted protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients. The Committee recommended that Intelence 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.

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