Fostemsavir (rukobia) in the case of hiv

Fostemsavir (trade name Rukobia) has been approved for adults with HIV type 1 infection in combination with other medications since February 2021. It is suitable for patients who are infected with a multidrug-resistant virus type and for whom no other sufficiently effective combination of drugs against HIV can be used.

The HI virus ("human immunodeficiency virus") multiplies in cells of the defense system and destroys them in the process. Without treatment, the immune system of most people with HIV infection will weaken over time to such an extent that they will become severely ill. This stage is then called "AIDS" (German: "Erworbenes Immunschwache-Syndrom").

HIV infection cannot be cured with the available drugs. However, treatment can permanently protect people with HIV infection from immunodeficiency. Different drugs against HIV are usually combined.

However, a drug may lose its effect over time in some people. The viruses become resistant and begin to multiply again more strongly. If it comes to the point that many drugs no longer work, this is called multidrug resistance.

Fostemsavir is designed to prevent HI viruses from entering cells of the immune system and thus inhibit the multiplication of HI viruses.

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Fostemsavir is available as a tablet in a dosage of 600 mg. The drug is taken 2 times a day. The active substance is combined with other drugs against HI viruses.

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Patients with multidrug-resistant HIV-1 infection usually receive individualized therapy for HIV. This takes into account what medications have already been tried and why they were discontinued. It is possible, for example, that the previous treatment did not work because the viruses have developed resistance or the treatment caused too many side effects.

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The Institute for Quality and Efficiency in Health Care (IQWiG) 2021 assessed whether fostemsavir has advantages or disadvantages for adults with HIV infection compared with individual therapies.

However, to answer this question, the manufacturer did not provide suitable data.

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This text summarizes the most important results of an expert opinion prepared by IQWiG on behalf of the Federal Joint Committee ( G-BA ) in the context of the early benefit assessment of drugs. The G-BA decides on the additional benefit of fostemsavir (Rukobia) on the basis of the expert opinion and comments received .

Institute for Quality and Efficiency in Health Care (IQWiG). Fostemsavir (HIV infection) – benefit assessment according to § 35a SGB V. Dossier evaluation; Order A21-33. 29.06.2021. (IQWiG reports; volume 1147).

IQWiG health information is intended to help people understand the advantages and disadvantages of important treatment options and health care offerings.

Whether one of the possibilities described by us is actually useful in individual cases can be clarified in a conversation with a doctor. Health can support, but not replace, discussions with physicians and other experts. We do not offer individual advice.

Our information is based on the results of high-quality studies. They are written by a team of authors from medicine, science and editorial staff and peer-reviewed by experts outside IQWiG. How we develop our texts and keep them up to date, we describe in detail in our methods .

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Created on 01. July 2021
Next planned update: 2024

Institute for Quality and Efficiency in Health Care (IQWiG)

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