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Rilpivirine for HIV: Added benefit for single agent proven
Date:12/7/2012

Since the start of 2012, a new drug called rilpivirine has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1). It is marketed by two different pharmaceutical companies, by one as a single agent (trade name Edurant) and by the other as a fixed combination with other HIV drugs (trade name Eviplera). In two early benefit assessments pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has investigated whether the two new drugs have advantages over current standard therapies.

According to IQWiG, there is proof that rilpivirine as a single agent offers a considerable added benefit to men infected with HIV-1. For women, the available studies provide corresponding "indications" of considerable added benefit.

On the other hand, no added benefit can be derived from the manufacturer's dossier for the fixed combination - although precisely the same studies were available to the two pharmaceutical companies. This is because, unlike the manufacturer of the single agent, the company making the fixed combination product did not analyse the study data in a suitable way. Hence the contents of its dossier are incomplete.

G-BA specifies efavirenz as the appropriate comparator therapy

Two pharmaceutical companies introduced the new drug onto the market in Germany at the same time; one as a single agent and one in a fixed combination with emtricitabine and tenofovir. Both products are approved for adults who are beginning a treatment directed at stopping the multiplication of the virus for the first time and in whom not more than 100,000 viral components can be detected per millilitre of blood.

The Federal Joint Committee (G-BA) has in each case specified efavirenz-based therapy in combination with other drugs as the appropriate comparator therapy.

Studies on the single agent als
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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