Which is the most expensive Covid drug that cured Trump, approved by the WHO and which Argentina does not use

The summer of Covid cases is good, but it should not distract us from the goal of improving access to new therapies that protect the most vulnerable population against the virus: the one that does not produce antibodies after vaccination. In line with this objective, the WHO on Thursday launched a request to laboratories to facilitate access to a monoclonal antibody very expensive: the regenerate.

This is exactly the one used by former US President Donald Trump when he had Covid, only today there are few experts who would recommend it to obese patients, if they do not have other conditions. and, above all, if they are vaccinated.

Proof of the usefulness of this monoclonal antibody (most recent, incorporated in an article by British medical journal this Thursday) confirms – as several publications had indicated last year – that the avoid moderate and severe Covid photos in the elderly and in adolescents from 12 years of age, young people and adults with some degree of immune compromise, either by transplantation, or by chemotherapy treatments or a rheumatological disease.

Weeks ago Bugle This is why regeneron is not used in Argentina. The question comes up again, now that the WHO has re-promoted its use, pointing out that the economic access to drugs.

And that makes sense. We are talking about a combination of two monoclonal antibodies, casirivimab and imdevimab, which is administered as a single dose. Around $ 2,000.

Cost-benefit

Unlike vaccines (which inject us with the virus – in whole or in part – to “simulate” the disease and our body shoots a battalion of antibodies), drugs like regeneron are given. once the person is positive for Covid.

“These are antibodies produced in the laboratory that go directly against a region of the S protein. By blocking it, the virus stops replicating because it does not adhere to human receptor cells,” he explained. Martin Stryjewski, head of international at Cemic, member of the board of directors of SADI and former researcher in infectious diseases and master’s degree in health sciences from Duke University, United States.

If the treatment is aimed at people with risk factors, it is because, while the majority of healthy people raise immunity through vaccination, this population has the categorical problem of almost do not raise antibodies, as if the effect of the vaccines were diluted.

“In the best case scenario, after a vaccination with a full schedule, a kidney transplant patient has a 50% chance of not having antibodies»Stryjewski illustrated.

At the same time, he said, “FDA figures for the last dose adjustment that was made in phase 3 showed that in the placebo group 3.2% progressed to moderate disease. . In those who took regeneron, it was 1%. The difference is not huge. Out of 45 patients, you would prevent 1 from progressing severely or dying”.

But nevertheless, he believes that the results are clear: “WHO is right to insist on access to monoclonal antibodies … these drugs are expensive, but their role is to target these patients in particular.”

As he suggested, “health centers that take care of this type of patient should have a few doses in stock. If they contract Covid, they could be treated quickly and prevent progression to worse photos. “

The agreements

At the end of this note, the Ministry of Health had not replied if it was considering authorizing the use of regeneron in the country.

Bugle was able to maintain a written exchange with Juan Pablo Solé, director of access for rock Argentina, the laboratory that produces one of the presentations of regeneron, trade name Ronapréve.

Solé clarified that the drug is available in 30 countries through bilateral purchasing agreements, and noted that it has obtained approval for emergency use from regulatory agencies FDA (US) and EMA (Europe).

Given that “to access this treatment, you must agreements with national governments“He pointed out that” from Roche, data from clinical studies have been shared with national health authorities. ”

However, he continued: “We are available for continue the dialogue when they deem it appropriate, depending on the local situation regarding the pandemic ”.

Of Cost of the drug, he said, “to support rapid and wide access around the world, they used international differentiated prices, in order to meet the challenges of affordability in low- and middle-income countries (as defined by the World Bank and the classification used by the WHO) ”.

Doubts and candidates

The latest recommendation from the WHO expert group states that it is “conditional“, And indicates” candidates “to receive the regeneration.

It is recommended in small pictures, when, for some reason, the patient has above the 10% chance of ending up hospitalized.

Also, in those who pass severe or critical images, if it has been proven that they are “seronegativeBoth because they weren’t vaccinated and because they didn’t raise antibodies.

So far, it seems that the local obstacle to the use of regeneron is fully economic and legal, due to the lack of authorization from Anmat.

However, there are two caveats to be made. One, which Stryjewski warned to take into account before sending out for purchase, is that the emergence of new variants (such as the famous Delta) could cause “this type of antibody” to lose its weight. efficiency.

The second, that there is no complete consensus on the use of this monoclonal antibody “like that”, echoing the words of the head of intensive care at Muñiz hospital, Eleonora Cunto.

As he pointed out, “just as the WHO does not recommend the use of ivermectin or hydroxychloroquine, the recommendation for the use of regeneron is currently ‘conditional’. There is no firm recommendation”.

Cautious, the doctor then concluded: “Also, it is for a very specific group of patients. In others, no benefit was found. And in some subgroups there was even an aggravation. Having a high cost and with a conditional recommendation, I would not indicate it for the moment”.

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