What is Odefsey and what is it used for - Emtricitabine, Rilpivirine, Tenofovir?
Odefsey is an antiviral medicine used to treat adults and adolescents (over 12 years of age and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide. It is used only in patients whose virus has not developed resistance to the class of anti-HIV drugs called non-nucleoside reverse transcriptase inhibitors, to tenofovir or emtricitabine, and who have levels of HIV in the blood (viral load) not exceeding 100. 000 copies / mL of HIV-1 RNA.
How is Odefsey used - Emtricitabine, Rilpivirine, Tenofovir?
The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of HIV infection. Odefsey is available as tablets, each containing 200 mg of emtricitabine, 25 mg of rilpivirine and 25 mg of tenofovir alafenamide The recommended dose is one tablet a day, taken with food.
How does Odefsey work - Emtricitabine, Rilpivirine, Tenofovir?
Odefsey contains three active ingredients. Tenofovir alafenamide is a 'prodrug' of tenofovir; this means that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Rilpivirine is an antiviral agent called a non-nucleoside reverse transcriptase inhibitor. All three active ingredients block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected. By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood, keeping it at a low level.
Odefsey does not cure HIV-1 infection or AIDS, but it can delay the onset of immune system damage and the development of AIDS-associated infections and diseases.
What benefit has Odefsey - Emtricitabine, Rilpivirine, Tenofovir shown during the studies?
The combination of the active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) has already been approved in the EU for Eviplera, used in the treatment of HIV-1 infection, but in Eviplera, tenofovir is present as tenofovir disoproxil while in Odefsey it is present. such as tenofovir alafenamide.
To support the use of tenofovir alafenamide, the company provided data from studies showing that the drug combination including tenofovir alafenamide is as effective as tenofovir disoproxil in reducing the amount of HIV-1 in the blood.
In addition, to support the claim, the company performed a 'bioequivalence' study comparing Odefsey with two other anti-HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide). This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant and the same levels of emtricitabine and tenofovir alafenamide as Genvoya. This means that the effects of these components in Odefsey should be similar to the effects they cause in others. medications.
What are the risks associated with Odefsey - Emtricitabine, Rilpivirine, Tenofovir?
The most common side effects seen with the active substance rilpivirine and the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick). Other very common side effects of rilpivirine include increased cholesterol levels (total cholesterol and LDL cholesterol), insomnia (sleep disturbance) and increased liver and pancreatic enzyme levels. For the full list of side effects, see the package leaflet. Odefsey must not be given in combination with the following medicines, as they may reduce the blood levels of rilpivirine and consequently, the effectiveness of Odefsey:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
- rifabutin, rifampicin, rifapentine (antibiotics);
- omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (drugs used to lower stomach acid);
- dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) except when treated with a single dose;
- St. John's wort (a herbal preparation used against depression and anxiety).
For the full list of restrictions, see the package leaflet.
Why has Odefsey - Emtricitabine, Rilpivirine, Tenofovir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odefsey represents an "alternative treatment option to Eviplera, having similar efficacy. In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir. disoproxil and may lead to a reduction in side effects affecting the kidneys and bones. Therefore, the CHMP considered that the benefits of Odefsey outweigh its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Odefsey - Emtricitabine, Rilpivirine, Tenofovir?
The recommendations and precautions that healthcare professionals and patients should take to ensure the safe and effective use of Odefsey have been added to the summary of product characteristics and package leaflet.
Other information about Odefsey - Emtricitabine, Rilpivirine, Tenofovir
For more information about Odefsey therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Odefsey - Emtricitabine, Rilpivirine, Tenofovir published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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