What is Intelence?
Intelence is a medicine that contains the active substance etravirine. It is available in white oval tablets (100 mg).
What is Intelence used for?
Intelence is an antiviral drug used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Intelence is only used in patients previously treated for HIV infection. The medicine should be used together with other antiviral medicines including an "enhanced 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 tablets twice a day after meals. In the event that the patient is unable to swallow the tablets, the latter can be dissolved in a glass of water, stirring until a milky solution is obtained. This solution must 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 the virus to infect cells and reproduce. By blocking this enzyme, Intelence taken in combination with other antiviral drugs reduces the amount of HIV in the blood, keeping it at a reduced 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.
What studies have been carried out on Intelence?
The effects of Intelence were first analyzed in experimental models before being studied in humans.
Intelence was analyzed in two main studies that brought together a total of 1 203 HIV-infected adults who had already undergone an anti-HIV therapy that had ceased to take effect and to which little or no treatment options remained. Both studies compared Intelence with a placebo (a dummy treatment) taken with boosted darunavir (a protease inhibitor) and at least two other antiviral drugs chosen for each patient as they had the best chances of reducing HIV levels in the blood. The main measure of effectiveness was the number of patients who had an HIV level in the blood (viral load) of less than 50 copies / ml after 24 weeks of treatment.
What benefit has Intelence shown during the studies?
Intelence was more effective than placebo in reducing viral load. Considering the two studies together, the average viral load was 70, 000 copies / ml at the beginning of the studies. After 24 weeks, 59% of patients taking Intelence in combination with other anti-HIV medicines (353 out of 599) had a viral load of less than 50 copies / ml, compared with 41% of patients taking placebo in combination with others anti-HIV medicines (248 out of 604). These results were maintained for 48 weeks.
What are the risks associated with Intelence?
The most common side effect of Intelence (seen in more than 1 patient in 10) is skin rashes. 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 components.
Serious skin reactions have been reported with Intelence (skin rash with blisters typically on the lips, mouth and eyes, sometimes with skin exfoliation). Treatment with Intelence should be discontinued in the event of severe skin reactions. As with other anti-HIV drugs, patients receiving Intelence may be at risk of lipodystrophy (changes in body fat distribution), osteonecrosis (death of bone tissue) or immune reactivation syndrome (infection symptoms caused by system reactivation). immune). Patients with hepatitis B or C may be exposed to a high risk of developing liver damage if treated with Intelence.
Why has Intelence been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Intelence's benefits were greater than its risks when taken in combination with an enhanced protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in the case of patients adults who had already undergone antiretroviral treatment. The committee recommended granting "marketing approval" for Intelence with "conditional approval". This means that further data is expected, in particular regarding the efficacy and safety of the medicine. The European Medicines Agency reviews each year the new information that may have become available and, if necessary, this summary will be updated.
What information is still awaited for Intelence?
The company that makes Intelence will carry out a study to show that results similar to those found in the two main studies can be found when Intelence is used in combination with protease inhibitors other than boosted darunavir.
More information on Intelence
On 28 August 2008, the European Commission issued a marketing authorization for Intelence, valid throughout the European Union, to Janssen-Cilag International NV.
The full EPAR for Intelence can be found here.
Last update of this summary: 06-2009
