Limited availability of monkeypox drug Tecovirimat in Germany | Health City Berlin

Wednesday August 10, 2022 – Author: ham

To date, the only drug approved in Europe for the treatment of monkeypox infection is Tecovirimat. According to the Robert Koch Institute, it has limited availability in Germany. This is not the only reason why it is recommended to use the antiviral sparingly.

Monkeypox usually heals on its own. And the vast majority of patients recover at home – without having to go to the hospital. However, there are patients in whom the disease takes a severe course. According to the Robert Koch Institute, people with a relevant immunodeficiency, for example after organ or stem cell transplantation or who have not (sufficiently) treated HIV infection with a CD4 cell count < 200, are considered high-risk patients.

strict indication

It is these patients who fulfill the indication for a specific therapy against monkeypox, writes the standing working group of the competence and treatment centers for diseases caused by highly pathogenic pathogens at the RKI (STAKOB). This specific therapy is tecovirimat. To date, it is the only drug approved in Europe for the treatment of monkeypox infection. Even children from a weight of 13 kilograms can be treated with it. According to STAKOB, Tecovirimat is currently available in “limited quantities” for the treatment of monkeypox infections in Germany.

Evidence of rapid development of resistance

In its notes on monkeypox of July 29, the expert group points out a possible reduced effectiveness of the specific therapy in immune insufficiency, for which there are indications from animal models, it is said. Furthermore, in some cases an indication for therapy can also be useful for immunocompetent patients, for example depending on the clinical picture, the lesions or the social situation.

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The group of experts recommends that the indication should be strict, and the preparation should primarily be offered to people who are at risk of developing a severe course of the disease. The reason for this is indications of a possible rapid development of resistance. Data on the efficacy of tecovirimat in humans are not yet available.

Other medicines in reserve

In the case of very severe courses or contraindications for tecovirimat, the experts recommend the use of human vaccinia immunoglobulins. According to the recommendations of the American CDC, this drug can also be given prophylactically if there are severe T-cell defects and vaccination is contraindicated. However, vaccinia immunoglobulins are only available to a very limited extent in Germany.

Another drug approved in the US for the treatment of smallpox is brincidofovir, a lipid conjugate of cidofovir. Due to the increased toxicity, especially hepatotoxicity, the indication should be strictly defined, for example in the case of fulminant courses and a lack of availability of tecovirimat, advises STAKOB. However, the drug is currently not freely available in Germany. It is therefore advisable to involve the treatment centers of the STAKOB and the centers of the DGI and DPGI for advice and case discussions.



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