What is Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil?
Eviplera is a medicine containing the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available as tablets.
What is Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil used for?
Eviplera is indicated 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 Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil used?
Eviplera therapy should be started by a doctor with experience in the field of HIV infection. The recommended dose is one tablet a day. Eviplera should be taken with a meal.
If interruption of therapy with one of the active ingredients is indicated or if it is necessary to modify the dose, separate formulations of emtricitabine, rilpivirine and tenofovir disoproxil are available.
How does Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil work?
Eviplera contains three active substances: emtricitabine, a nucleoside reverse transcriptase inhibitor; rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI); tenofovir disoproxil, a tenofovir "prodrug", which is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Nucleoside inhibitors and nucleotide reverse transcriptase inhibitors are known as NRTIs.
All three active ingredients block the activity of reverse transcriptase, an enzyme produced by the HIV virus that allows it to infect cells and reproduce. By inhibiting the enzyme, Eviplera reduces the amount of HIV in the blood, keeping it at a reduced level. Eviplera does not cure HIV infection or AIDS, but it can slow down the damage to the immune system and the development of infections and diseases associated with AIDS.
All three active substances are already available as individual medicines in the EU.
What studies have been performed on Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil?
The effects of Eviplera were first tested in experimental models before being studied in humans.
In a main study involving 690 HIV-1 infected patients, the combination of Eviplera was compared to a similar combination in which rilpivirine was replaced by efavirenz. A second main study involving 678 patients compared rilpivirine with efavirenz: both medicines were given in combination with emtricitabine and tenofovir disoproxil or with two other nucleotide reverse transcriptase inhibitors.
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.
The company also presented studies showing that the tablet containing all three active ingredients is absorbed into the body in the same way as the two separate tablets, administered in parallel under similar conditions.
What benefit has Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil shown during the studies?
Eviplera showed an efficacy similar to the combinations containing efavirenz. In the first study, 83% of patients treated with the combination of Eviplera responded to treatment compared to 84% of patients who took the combination with efavirenz.
In the second study, 87% of patients in the rilpivirine-treated group (where patients treated with the Eviplera combination were present) responded to treatment, compared with 83% of patients treated with efavirenz.
What is the risk associated with Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil?
The most common side effects of the combination of Eviplera observed in the studies are: nausea, dizziness, abnormal dreams, headache, diarrhea and insomnia. For the full list of side effects, see the package leaflet. Rarely, kidney problems may occur in patients treated with tenofovir disoproxil, whereas the intake of tenofovir disoproxil and emtricitabine has been associated with lactic acidosis (accumulation of lactic acid in the body) and severe hepatomegaly (increased liver volume).
The CHMP noted that patients already taking the two active substances as separate tablets may be more likely to follow the treatment if Onduarp is prescribed. Furthermore, studies have shown that the medicine is effective in patients whose blood pressure is not adequately controlled with amlodipine alone. The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given marketing authorization. In patients with HIV and hepatitis B discontinuation of Eviplera may be associated with a worsening of liver disorders.
Eviplera should not be used in people who may be hypersensitive (allergic) to rilpivirine, emtricitabine, tenofovir disoproxil or any of the other ingredients. Eviplera 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 Eviplera:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines 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 Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil been approved?
The CHMP concluded that Eviplera has the same efficacy as the combinations containing efavirenz. It also 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 rilpivirine resistance, a risk that appears to be lower in patients with a lower viral load. Therefore, the CHMP decided that Eviplera'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.
Other information on Eviplera - emtricitabine / rilpivirine / tenofovir disoproxil
On 28/11/2011 the European Commission issued a marketing authorization for Eviplera, valid throughout the European Union.
For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
