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Last week, Merck and Company announced that an experimental pill they are working on to treat COVID-19 early in the disease to prevent patients from becoming seriously ill or dying is proving to be safe and effective. After discussion with the FDA, she and Merck felt the results were so good that they decided to shut down additional enrollment for the trial. They will complete the study around November, then present the results and seek approval for an emergency clearance. Production of the pills has already started in order to be ready for rapid distribution once approved.
This is the first easy-to-use treatment specifically for COVID. It is a pill that, when taken as prescribed at the onset of symptoms, will reduce the risk of hospitalization and death by approximately 50%.
The medicine is called malnupiravir. It comes in oral form and is easily taken at home. It should be started within five days of the onset of symptoms. It is therefore important for people with symptoms compatible with COVID-19 to get tested immediately (there is now a national backlog of tests, which slows the availability of results) and to see their doctor early on. The treatment is eight tablets a day for five days. It is a lot like the oral medications people use when the flu starts.
Along with the widespread use of vaccines and monoclonal antibodies, this can make COVID-19 a manageable disease. We would be able to go from pandemic to endemic. Merck has said it will license malnupiravir for the production of generics for use in low-income countries.
Currently, treatment for COVID-19, although much better than it was during the first few months of the pandemic, is somewhat limited to monoclonal antibodies in people with the disease who have not yet been hospitalized, dexamethasone for use in very ill hospital patients, respiratory support such as ventilators and oxygen, and supportive care for other manifestations of the disease.
Monoclonal antibodies are used in similar situations, but they are not as readily available, they require an intravenous infusion, and they are significantly more expensive than pills. Nevertheless, they have been found to be around 70% effective. The lack of availability of this treatment and its high cost prevent it from being widely used, and almost not used at all in low-income countries. Dexamethasone is used in very ill hospital patients to counteract the massive response of the body’s immune system which is actually the immediate cause of pneumonia. In fact, the body’s attempt to get rid of the virus causes the lungs to fill with fluid and inflammatory cells, blocking the ability to transfer oxygen.
In the Merck study, 1,400 high-risk unvaccinated patients were included. Some patients received malnupiravir and others received placebo. The active drug has so far shown a 50% lower rate of serious illness and death than placebo. After seeing this initial data, Merck, with the approval of the FDA, decided that it was not necessary to continue enrolling study participants and that it would be inappropriate to continue to give placebo to patients. people.
Other companies are also working on the development of a pill to treat COVID. The most promising so far have been produced by Pfizer and Roche. All drugs affect the ability of the virus to replicate in the host cell.
One potential downside to treatment is that people can use treatment as a reason for not getting the vaccine. It’s not a good idea. Vaccination studies show that it is very effective in preventing disease and that malnupiravir is only 50% effective. This is very good for oral antiviral drugs, but it would still allow the underlying virus to spread in the population.
Finally, we have real reason to celebrate and a way to reduce the risk of death in unvaccinated people.
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