Active Substance: etravirine
Common Name: etravirine
ATC Code: J05AG04
Marketing Authorisation Holder: Janssen-Cilag International NV
Active Substance: etravirine
Authorisation Date: 2008-08-28
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: Non-nucleoside reverse-transcriptase inhibitors
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.
What is Intelence and what is it used for?
Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV‑1) in adults and children from 6 years of age. HIV-1 is a virus that 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.
How is Intelence used?
Intelence 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 mg twice a day to 200 mg twice a day.
This medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection. For further information, see the package leaflet.
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 anti-HIV 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 damage to the immune system and the development of infections and diseases associated with AIDS.
What benefits of Intelence have been shown in studies?
Studies have shown that Intelence, in combination with other medicines, is effective at reducing the level of HIV in the blood (viral load) to undetectable levels (below 50 copies/ml) in many patients with HIV-1 infection.
In two main studies in a total of 1,203 adults, 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 of them 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.
What are the risks associated with Intelence?
The most common side effect with Intelence (seen in more than 1 patient in 10) is rash.
Intelence should not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C infection. For the full list of all side effects and restrictions with Intelence, see the package leaflet.
Why is Intelence approved?
Intelence is effective at reducing viral load to undetectable levels in both adults and children and its side effects are considered manageable. The European Medicines Agency therefore concluded that its benefits outweigh its risks and recommended that it be approved in the EU.
What measures are being taken to ensure the safe and effective use of Intelence?
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.
Other information about Intelence
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Intelence on 28 August 2008. This was switched to a full marketing authorisation on 20 November 2013.
For more information about treatment with Intelence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.