It is called Tecovirimat and is currently the drug on which to place the greatest expectations for the treatment of monkeypox. Tecovirimat is the antiviral that, even in Italy, can be administered to people who have come into contact withOrthopoxvirusa virus similar to that which causes smallpox (from which it differs in less diffusivity and severity) and bovine smallpox.
An experimental drug against monkeypox
Its use, however, is still in an experimental phase. In fact, never before has it been used in people suffering from this infection. But only in animals. Let’s play, the ongoing epidemic is therefore allowing to carry out a “real life” experimentation. With encouraging results.
Tecovirimat effective in pain and perianal lesions
In fact, a study has been published in the journal “Annals of Internal Medicine” in these hours, which describes the treatment of two patients (two men aged 26 and 37) with what is currently the only drug authorized for the cure of the infection.
Both had developed severe proctitis (inflammation of the lining of the rectum, the last section of the intestine) due to the infection. With skin lesions that caused itching and pain, to the point of requiring in both cases the administration of opiate painkillers.
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Thus – following the indications of the Center for Disease Control and Prevention (CDC), which recommend its use in case of severe infection or with a significant risk of course towards more advanced forms – the infectious diseases of George Washington University have prescribed the ‘taking tecovirimat.
The results of the therapy were as expected: the pain subsided in 36-48 hours and the skin manifestations of the infection disappeared after a week of treatment. “Although the direct effect in bringing about symptom improvement cannot be determined, we believe that early use of this drug should be considered for patients with monkeypox and severe proctitis until studies can be performed. randomized and controlled “.
The drug “comes” from the treatment of cowpox
There are currently no active substances indicated for the treatment of monkeypox infection in humans. And in all likelihood there will not be any for several months, given the time required for the development of new antivirals and a need that is unlikely to become pressing as it did in the case of Covid-19. Hence the need to make a virtue of necessity, resorting to drugs already available on the market. Among these, Tecovirimat is the one that has so far given the most encouraging feedback.
The active ingredient – used for the first time on a bovine in 2018, is administered orally and inhibits the spread of the virus from one cell to another – has been shown to be able to reduce the time span in which infected people exhibited the symptoms of monkeypox and the period of contagiousness. An indicator, the latter, whose duration is still unknown.
“During previous monkeypox outbreaks, patients were considered contagious until the scabs had completely fallen off, while in these cases the spread was recorded for at least three weeks after diagnosis,” he says. Catherine Houlihanvirologist ofUniversity College London and among the authors of a treatment report of seven patients published in the journal “The Lancet Infectious Diseases” -. The data on contagiousness are still conflicting and need to be investigated through further studies “.
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There is a lack of efficacy data from human studies
The spread of this epidemic with different characteristics from the previous ones and in places rarely called to manage monkeypox has increased attention towards what until a few weeks ago could be considered a neglected disease in all respects. With consequences that also fall on the front of possible therapies.
Safe but only in the veterinary field
Tecovirimat – it should be specified – is in fact currently used only on the basis of the indications of efficacy and safety that have emerged from studies and from application in the veterinary field. Although it is a less serious disease than that caused by HIV, with which it most likely shares the prevalent sexual transmission, the current emergency is increasing its use in humans. But caution is needed – as three US researchers write in an analysis published in the “New England Journal of Medicine” – to both guarantee patients’ right to access treatment and support their safety and efficacy. Aspects so far guaranteed only by studies conducted in vitro and on animals – experimental and non-experimental: treated to treat smallpox, monkeypox and bovine pox – from which it emerged that Tecovirimat is able to guarantee higher survival rates compared to placebo.
Tecovirimat: different dosages based on body weight
The eradication of smallpox and the limited spread of monkeypox have made it impossible so far to evaluate its efficacy in humans. A limit that the National Institute of Health (NIH) is now aiming to outdo once the results of the first human randomized trial are obtained, which will start in the coming weeks. And from which the regulatory agencies of other countries will also draw fundamental information.
For the moment we will go on considering the data obtained on animals and the safety profile determined by evaluating the adverse reactions recorded in healthy men called to take Tecovirimat.
Dosages of the drug
Combining these two parameters, it was possible to arrive at the indications regarding the dosages of the drug, which the European Agency (EMA) recommends prescribing “as soon as possible, after diagnosis”. Children (from 13 kilos and up) will eventually be able to take one capsule (200 milligrams) every 12 hours for 14 days. Double dosage (two capsules, 400 milligrams) for children and adolescents weighing between 25 and 40 kilograms. Triple (three capsules), on the other hand, for adults.
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Interest also in two other antivirals
Considering that the course of monkeypox is rarely severe, at the moment the most indicated therapy is that based on the containment of symptoms with antipyretics. The growing numbers and the unknowns linked to this pandemic suggest, however, to keep the attention high and work on the development of effective treatments to manage the most serious cases of infection.
Therapies which, as indicated in an analysis published in the journal “Drugs” and also signed by Giuseppe Lippi (full professor of clinical biochemistry and molecular biology at the University of Verona), should be taken into consideration in the most serious cases of infection and when dealing with a child or an immunocompromised patient.
In the experimental field, the potential use of two other antivirals is also looked at with interest: cidofovir e brincidofovir. Their effectiveness in treating animals has so far been lower. But it cannot be ruled out that earlier administration or at a different dose may cause a different course of the infection. As for the second molecule, also tested in the study published in “The Lancet Infectious Disesaes”, in all seven patients the most serious symptoms of the infection were not recorded: pneumonia and sepsis. “But further studies are needed to verify the effectiveness of these or other antivirals against what is a neglected infectious disease – the researchers warn -. What we have described and the current outbreak underline the need to maintain a close collaboration between the centers for manage the spread of cases of infection “.