Edurant - Rilpivirine

What is Edurant - Rilpivirine?

Edurant is a medicine that contains the active substance rilpivirine, available as tablets (25 mg).

What is Edurant - Rilpivirine used for?

Edurant is indicated in combination with other antiviral medicines for the treatment of adult patients infected with HIV-1 (human immunodeficiency virus type 1), a virus that causes acquired immune deficiency syndrome (AIDS). The medicine is only used in patients who have never been previously treated for HIV infection and who show HIV levels in the blood (viral load) not exceeding 100, 000 HIV-1 RNA copies / ml.

The medicine can only be obtained with a prescription.

How is Edurant - Rilpivirine used?

Edurant therapy should be started by a doctor who has experience in managing HIV infection. The recommended dose of Edurant is one tablet taken once a day. Edurant should be taken with a meal.

How does Edurant - Rilpivirine work?

Edurant is an antiviral drug. The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to infect cells and reproduce. By inhibiting the enzyme, Edurant, taken in combination with other antiviral drugs, reduces the amount of HIV in the blood, keeping it at a reduced level. Edurant 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 performed on Edurant - Rilpivirine?

The effects of Edurant were first tested in experimental models before being studied in humans.

Edurant has been studied in two main studies involving 1 368 patients with an untreated HIV-1 infection. In the first study, Edurant was compared to another NNRTI called efavirenz: both medicines were administered in combination with a fixed antiviral regimen consisting of tenofovir disoproxil and emtricitabine. In the second study, Edurant was compared with efavirenz: both medicines were given in combination with a fixed regimen of antiviral drugs consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.

In both studies, the main measure of effectiveness was the reduction in viral load. Patients with a viral load below 50 HIV-1 RNA copies / ml after treatment were considered to have responded to treatment.

What benefit has Edurant - Rilpivirine shown during the studies?

Edurant, taken in combination with other antiretroviral drugs, was as effective as the comparator in reducing the level of HIV-1 in the patient's blood. Considering both studies together, 84% of patients treated with Edurant responded to therapy after one year, compared with 82% of patients treated with efavirenz.

What is the risk associated with Edurant - Rilpivirine?

The most common side effects with Edurant (seen in more than 1 patient in 10) are headache, nausea and increase in total cholesterol, increase in LDL cholesterol (low density lipoprotein), increase in pancreatic amylase (an enzyme produced in pancreas that breaks starch into sugars) and increased transaminases (liver enzymes). For the full list of all side effects reported with Edurant, see the package leaflet.

Edurant must not be used in people who may be hypersensitive (allergic) to rilpivirine or any of the other ingredients. Edurant should not be given in combination with the following medicines, as they can reduce the level of rilpivirine in the blood and, consequently, decrease the effectiveness of Edurant:

carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat seizures)
rifabutin, rifampicin and rifapentine (antibiotics)
omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to reduce stomach acid)
systemic dexamethasone (an anti-inflammatory drug and steroid immunosuppressant), unless it is used as a single dose
products that contain St. John's Wort (a herbal product used to treat depression)

Why has Edurant - Rilpivirine been approved?

The CHMP concluded that Edurant, in combination with other antiretroviral medicinal products, has the same efficacy as the main NNRTI currently used in the first-line treatment of HIV-1 infected patients. The committee noted that Edurant produces fewer unwanted effects in the early stages of treatment and offers the advantage of being taken in a single tablet once a day. However, the CHMP noted a certain risk that HIV-1 may develop resistance to rilpivirine, which appears to be lower in patients with a lower viral load. Therefore, the CHMP decided that Edurant's benefits are greater than its risks in patients with a low HIV-1 viral load, and recommended that it be granted for this group of patients.