No “game changer”: CoV drugs are bare in Austria
In the foreseeable future, the first drugs in tablet form against Covid-19 will also be available in Austria. However, the availability will be extremely limited at the beginning, the application will be sustained and strict requirements will be attached. During a conversation with the general medicine initiative AM Plus in Vienna, leading experts stated that this was not a “game changer”. The Covid-19 vaccination remains the be-all and end-all of the fight against the pandemic.
“The most important thing is always the vaccination. After that, nothing comes for a long time, then nothing – and only then medication, ”said the Viennese infectiologist Florian Thalhammer from MedUni Vienna. Christa Wirthumer-Hoche, Head of the Medical Market Supervision of the Agency for Health and Food Safety (AGES), said: “None of these drugs are ‘game changers’.”
Should prevent a severe course
Nevertheless, the new drugs represent a step forward: They are molnupiravir, which is already approved in Great Britain and will also be available in Austria to a very limited extent in a special program (“compassionate use”) in the near future. The product comes from the manufacturers of Merck, Sharp and Dohme and received emergency approval for high-risk patients aged 18 and over in the USA on Thursday. The drug, also known in Europe under the name Lagevrio, is intended for the treatment of Covid-19 diseases with mild to moderate symptoms and is intended to prevent the disease from developing into a severe course.
The second candidate drug is Pfizer’s SARS-CoV-2 protease inhibitor combination therapy, nirmatrelvir / ritonavir, currently in the US for emergency approval. Both therapies are currently being assessed by the European Medicines Agency (EMA). Unlike monoclonal antibodies, which are primarily used in clinics, they are intended for use outside of hospitals.
Synthetically produced
The mechanisms of action: Molnupiravir works, it compensates with SARS-CoV-2-infected cells that produce new particles, subvert false RNA building blocks and thus lead to the termination of virus replication. Nirmatrelvir inhibits an important SARS-CoV-2 protease enzyme. The feeling of maturation and infectivity of the Covid-19 pathogen. The additional substance ritonavir, as a second protease inhibitor, is intended to delay the breakdown of nirmatrelvir.
The advantage: Both drugs are synthetically producible active ingredients. They will be available to be taken orally. This takes place over five days.
Effective, but “not a miracle cure”
But there are numerous restrictions: The phase III study published a few days ago in the “New England Journal of Medicine” on the efficacy and tolerability of molnupiravir such as a thirty percent reduction in the frequency of hospital admissions and patients in Covid 19 patients with mild to moderate Course of the disease and at least one risk factor (age over 60, obesity, chronic kidney disease, diabetes, cancer, etc.). There was no doubt a significant effect, but molnupiravir is not a “miracle cure”.
A positive aspect like Thalhammer shows: after three days it was only given in five percent of those treated, after five days in none of the decided. According to the available data, nirmatrelvir / ritonavir has the potency to an even 89 percent risk reduction (severe course, decisions).
Pregnant women and children are out of the question for these therapies. Serious causes can also occur with other drugs.
Monitored delivery system
Probably the biggest limitation: The production quantities of both drugs will initially be far too low to make them freely prescribable and available. This means that a system WILL be used in Austria that was already used for the formerly just as scarce Remdesivir or other first Covid-19 therapies: in every federal state with a hospital pharmacy as the central Covid-19 pharmacy.
The need for the drugs is recorded for each federal state; this also depends, for example, on the regional Covid-19 incidence rates. The hospital pharmacy ordered the necessary quantities. Then the distribution takes place from there. The data is sent back to the medical market regulator, where the activity is monitored. This is to ensure that the application is as fair and competent as possible.
It is expected that the first 12,000 packs of molnupiravir will be available in the compassionate use system from around December 28th. The individual federal states will probably – the city of Vienna is structured differently than “federal states” – will have to process the settlement according to their regional ones.
Waiting for approval
However, since both molnupiravir and nirmatrelvier / ritonavir are being assessed by the EMA, approvals in the EU can be expected in the near future, based on the models in Great Britain (molnupiravir) and the USA (combination therapy). Only then could the Covid-19 drugs become more freely prescribable, for example by general practitioners. However, there remains the limitation of the quantitative availability and the strict requirement in the selection of suitable patients. The corresponding rules for processing still have to be drawn up.
The first requirement: an acute SARS-CoV infection documented in a laboratory. “The sooner the drugs are taken, the better,” said Thalhammer. Similar to the specific acting influenza medication, it is best to assume that it is taken within two to three days of the onset of symptoms.
Quite a few hurdles
Erwin Rebhandl, President of AM Plus, who has been working as a family doctor in Upper Austria for decades and is now co-operator of a primary care center, summarizes the conditions as follows: Then we need a precise definition of who is at risk (risk of serious disease, note). We have to take the time factor into account. Financing has to be regulated – and we need the medication in the ordination software. “
When it comes to the two drug therapies, Austria is probably quite early on in an international comparison. For example, until a week ago, molnupiravir was not used anywhere outside of clinical studies, worldwide Wirthumer-Hoche. One should use the time now, optimally on these challenges to be optimally. The priority now is to use the time for an additional first vaccination and the third vaccination.