What is Odefsey and what is it used for - Emtricitabine, Rilpivirine, Tenofovir?
Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes the acquired immunodeficiency syndrome (AIDS).
Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide. It is used only in patients in whom the virus has not developed a resistance to the class of anti-HIV drugs called non-nucleoside reverse transcriptase inhibitors, to tenofovir or to emtricitabine, and which 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 who is experienced in managing 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 ingredient tenofovir within the body. Tenofovir and emtricitabine are related antiviral agents, called reverse transcriptase inhibitors.
Rilpivirine is an antiviral agent called 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 reduced level.
Odefsey does not cure HIV-1 infection or AIDS, but it may delay the onset of damage to the immune system and the development of infections and diseases associated with AIDS.
What benefit has Odefsey shown - Emtricitabine, Rilpivirine, Tenofovir during the studies?
The combination of the active ingredients of 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 as tenofovir alafenamide.
To support the use of tenofovir alafenamide, the company provided data from studies showing that the combination of drugs comprising tenofovir alafenamide is as effective as containing tenofovir disoproxil in reducing the amount of HIV-1 in the blood.
Furthermore, in support of the application, the company carried out a "bioequivalence" study comparing Odefsey with two other anti-HIV drugs: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide). This study showed that Odefsey produces in the body the same levels of rilpivirine 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 other drugs.
What are the risks associated with Odefsey - Emtricitabine, Rilpivirine, Tenofovir?
The most common side effects seen with the active substance rilpivirine and with the combination 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 disorder) and increased levels of liver and pancreatic enzymes. For the full list of side effects, see the package leaflet. Odefsey should not be given in combination with the following medicines, as they can reduce the levels of rilpivirine in the blood 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 reduce gastric 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 vegetable preparation used against depression and anxiety).
For the full list of limitations, see the package leaflet.
Why has Odefsey been approved - Emtricitabine, Rilpivirine, Tenofovir?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odefsey is 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 can lead to a reduction in the undesirable effects on the kidneys and bones. Therefore, the CHMP considered that Odefsey's benefits are greater than 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?
Recommendations and precautions to be taken by health professionals and patients to ensure the safe and effective use of Odefsey have been added to the summary of product characteristics and the package leaflet.
More information on Odefsey - Emtricitabine, Rilpivirine, Tenofovir
For more information about treatment with Odefsey, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
