Introduction

Rilpivirine (trade name: Edurant) has been approved in Germany for the treatment of HIV type 1 in adults since November 2011. The approval was expanded in November 2015 to include children and teenagers over the age of 12. Rilpivirine is taken in combination with other drugs for HIV, such as emtricitabine and tenofovir or zidovudine and lamivudine. It is an option for patients who have not yet taken any other medication to treat HIV.

Rilpivirine has been available as part of a fixed-dose combination of drugs together with emtricitabine and tenofovir (trade name: Eviplera) since November 2011. The fixed-dose combination with rilpivirine is an option for the following adult patients:

  • Those who have not taken any other medication for HIV.
  • Those who have taken other medication for HIV and who do not have a strain of the virus that has mutated and become resistant to the drugs in the rilpivirine combination.

The human immunodeficiency virus (HIV) multiplies in the cells of the immune system and destroys them. Without proper treatment, the immune system of most patients with an HIV infection weakens so much that they become seriously ill. This stage is called “AIDS” (acquired immunodeficiency syndrome). HIV can't be cured with medication, but the treatment seems to be able to protect people with HIV from developing immunodeficiency for many years. However, the medication can gradually become ineffective, allowing the viruses to multiply again.

The viral load shows how active HIV is: This value is a measure of the amount of viruses in a blood sample. Rilpivirine is approved for people who are beginning a treatment that aims to stop the multiplication of the virus for the first time and in whose blood no more than 100,000 viral components can be detected per milliliter. By combining medications with each other in certain ways, reproduction of the virus can be inhibited so much that it becomes undetectable.

A number of medications take advantage of the fact that HIV needs an enzyme called "reverse transcriptase" in order to multiply. Various drugs inhibit this enzyme by attacking it in various places. Rilpivirine also inhibits reverse transcriptase.

Application

Rilpivirine (Edurant) is taken once a day in tablet form with a meal. One tablet contains 25 milligrams of rilpivirine.

One tablet of the rilpivirine combination (Eviplera) contains 25 milligrams of rilpivirine, 200 milligrams of emtricitabine, and 245 milligrams of tenofovir.

Other treatments

One standard therapy option for adults starting HIV treatment for the first time is efavirenz combined with other drugs like emtricitabine and tenofovir. For children and teenagers above 12 years of age, a combination of efavirenz, abacavir and lamivudine is an option.

Patients who have already taken HIV drugs are given individual therapy. This involves looking at which treatments were tried before and why they were discontinued. For instance, the previous treatment may have been ineffective or caused side effects.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last assessed the advantages and disadvantages of rilpivirine in combination with various drugs for the treatment of HIV type 1 compared with conventional treatments. The institute considered the following groups of patients:

  • Initial treatment in adults: Rilpivirine (Edurant) in combination with other medications for adults who have not had previous treatment with other HIV drugs. Data on the advantages and disadvantages of rilpivirine in this group of patients was available.
  • Initial treatment in adults: Rilpivirine (Eviplera) as a fixed-dose combination with emtricitabine / tenofovir, for adults who have not had previous treatment with other HIV drugs. Data was available on the advantages and disadvantages for this group too.
  • Initial treatment in children and teenagers over 12 years of age: Rilpivirine (Edurant) in combination with various other medications for children and teenagers who haven't already had treatment with other drugs. The manufacturer didn't provide IQWiG with suitable data for this group of patients. So it isn't possible to determine whether rilpivirine has any advantages or disadvantages for children and teenagers over the age of 12 who haven't already had treatment.
  • Subsequent treatment in adults: Rilpivirine (Eviplera) as a fixed combination with emtricitabine / tenofovir for adults who have taken other medication for HIV and who do not have a strain of the virus that is mutated to be immune against the active ingredients. The manufacturer didn't provide IQWiG with suitable data for this group of patients. So it is unclear whether the fixed rilpivirine combination has any advantages or disadvantages for adults who have had treatment before.

Learn more

More information

This information summarizes the main results of several reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of rilpivirine (Edurant, Eviplera).

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