What is it and what is it used for?
Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available as tablets.
Eviplera is used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
The medicine can only be obtained with a prescription.
How Eviplera is used
Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet once a day and it must be taken with food.
If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir disoproxil. If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
How Eviplera works
Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor.
All three active substances 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, Eviplera reduces the amount of HIV-1 in the blood and keeps it at a low level. Eviplera does not cure HIV-1 infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.
All three active substances are already available in separate medicines in the EU.
What are the benefits?
The CHMP concluded that Eviplera was as effective as combinations containing efavirenz. It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day. However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load. Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
What are main side effects?
The most common side effects with Eviplera in patients who had not received previous HIV treatment (seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams, headache, diarrhoea and insomnia. In patients who had received previous HIV treatment, the most common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and insomnia. Rarely, kidney problems may occur in patients taking tenofovir disoproxil. Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.
Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
- rifampicin, rifapentine (antibiotics);
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
- systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
- St John’s wort (a herbal medicine to treat depression and anxiety).
For the full list of side effects and restrictions with Eviplera, see the package leaflet.
What studies have been done?
The Eviplera combination compared well with combinations containing efavirenz. In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz. In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment. This compared with 83% of patients in the efavirenz group.
The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.
Eviplera was first approved for use in the EU in 2011. It is manufactured by Gilead.
European Medicines Agency website page for Eviplera (accessed 19/07/18)
Links available in External Resources