COVID-19 and immunocompromised patients – a dangerous mix. Now a new combination of antibodies should help.
Immunosuppressed patients and patients with blood and cancer diseases are still high-risk patients for a severe to fatal course of Covid. Pre-exposure prophylaxis can – in combination with previous measures such as compliance with the rules of distance and vaccination – represent a valuable additional protective measure. Now there is an official one opinion of the scientific medical societies for the use of the new antibody combination Tixagevimab/Cilgavimab.
New drug – new hope
This antibody combination has now been approved for COVID-19 PrEP in immunocompromised patients. According to the assessment of the professional societies, it is currently the only sufficiently effective combination of antibodies against the predominant one Omikron-Subtyp BA.2. “The preventive administration of recombinant, neutralizing, monoclonal antibody against SARS-CoV-2 can significantly reduce the risk of a severe course in vulnerable people,” emphasizes Prof. Bernhard Wörmann, Medical Director of the DGHO and Chairman of the AWMF Commission “Benefit Assessment of Drugs”.
The carried out Study concludes that a dosage of 300 mg is appropriate. The tixagevimab/cilgavimab antibodies identified from the serum of Covid-recovery patients bind to two non-overlapping regions of the spike protein of SARS-CoV-2 and have a longer half-life – and thus a possible effectiveness of up to 6 months.
Efficacy confirmed at Omikron
Although there are currently no clinical studies on the effectiveness of the antibody combination against the omicron variant, in vitro studies and serological analyzes indicate an increased effectiveness of the tixagevimab/cilgavimab combination – compared to the previously approved antibodies Casirivimab/Imdevimab or Sotrovimab.
In a study of 29 immunosuppressed patients with various underlying diseases, neutralizing antibodies against both BA.1 and BA.2 were detected in 19 patients after administration of cilgavimab/tixagevimab.
A second, larger study examined its effectiveness in 416 kidney transplant patients. Despite pre-exposure prophylaxis with cilgavimab/tixagevimab, 39 (9.4%) of the treated patients developed COVID-19; 14 patients (35.4%) were hospitalized, 2 died. In serological investigations were only small antibody titer found, which is why a higher dose (of 600 mg) for the BA.1 subtype could also be considered. This could increase protection and is already recommended by the US Food and Drug Administration (FDA) for those at high risk of BA.1 infection. However, the recommendations for a higher dosage do not refer to the omicron subtype BA.2 – the original dosage would be sufficient here.
Not all antibodies are the same
Until now, the antibody detection was the decisive parameter of the vaccination response. In the case of immunocompromised people, however, a closer look must be taken: there is no fixed predictive limit for booster vaccinations or PrEPs. Protection against omicrons may require higher limit values than previously assumed – especially in vulnerable groups. Therefore, in order to decide whether a patient should receive PrEP or not, the determination and evaluation of the titer with regard to the patient’s individual history is crucial.
Due to the lack of study data, children are approved from the age of 12 and weighing more than 40 kg.
However, the specialist societies also expressly point this out once again thereuponthat medicinal prophylaxis is not a substitute for other protective measures such as active vaccination, but merely a supplement. “Therefore, we urgently advise those affected to continue to observe non-pharmacological protective measures such as wearing mouth and nose masks, hand disinfection and keeping their distance,” says Prof. Rolf-Detlef Treede, President of the AWMF.
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