Merck announced the intermediate results of the "Mono Piravel" trial and applied for emergency use permit
US pharmaceutical giant Merck's candidate oral antiviral drug "Morphine Pirbil" made mild to moderate levels The risk of hospitalization for new coronavirus pneumonia patients is halved, and the risk of death is also greatly reduced.
On October 1, the US pharmaceutical giant Merck published the intermediate results of the final treatment trial (Phase 3 clinical trial) on the antiviral drug "morphine pyran" under development. Viral pneumonia, the risk of hospitalization and death will be greatly reduced. This is the first time that oral medication has been confirmed to be effective against new coronavirus .
For patients within 5 days of onset, take and cefepime 4 tablets twice a day for 5 days. Compared with patients taking placebo (counterfeit drugs), the hospitalization rate has increased from 14.1 % Changed to 7.3%, a decrease of about 50%. Regarding the proportion of deaths, 8 out of 377 patients who were given placebo died within 30 days after treatment, while the number of patients who took cefepime was zero.
“It’s great that there are drugs that can be taken easily at home.” Albert Shaw, an infectious disease expert at Yale University’s New Haven Hospital (, Connecticut), said: “If you can buy it in a pharmacy, The number of people who can buy it will also increase. "In addition, he did not participate in this study.
currently allowed to use , remdesivir and other antiviral drugs and monoclonal antibody drugs must be administered by drip in medical institutions. Monoclonal antibody drugs to The effectiveness of new crown is much higher, and can reduce the risk of hospitalization and death by up to 85%. However, the cost of treatment is almost three times that of monubivir.
antiviral drugs Why is it effective
antiviral drugs are used to treat a variety of viral infections such as herpes and influenza.Prevent the development of disease by preventing the replication of the virus in the infected person's cells.
Merck's 's new drug sends components similar to RNA into the viral genome, which can cause various errors when the virus replicates, thereby hindering proliferation.
Epidemiologist and Director of Infection Countermeasures at Mount Sayy Hospital Downtown Network (New York State) explained that it is important not to multiply the virus, because the virus increases, the more cells there are, Under normal circumstances, the condition will get worse. In addition, he did not participate in this research.
In addition, if the virus in the body exceeds a certain amount, the immune response will be over-reacted. "When the virus that has never been encountered before reaches a certain amount, the body will detect this and start a general attack. It is like dropping a tank on a small target." Jabeid said. Even if the virus can be ruled out, it may be implicated and cause serious damage to the body.
Monopiraville's clinical trials are implemented in many parts of the world. Merck explained that it ended early because of very promising results. It is said that the drug is also effective against mutant strains such as the Delta strain and Muir strain.
Based on this intermediate analysis of clinical trials of 775 people, in addition to applying for an emergency use permit (EUA) from the U.S. Food and Drug Administration (FDA), Merck also plans to make the same application in other countries. Although the approval date is not known, Merck announced that the US government has signed a contract to purchase 1.7 million treatments for US$700 (approximately 77,700 yen) per treatment. What kind of people can
use?
In the end, what kind of people can use Mono Piravel is not sure. Aaron Wynberg, who served as the doctor in charge of the clinical trial, explained that the subjects of the clinical trial are limited to those who have not received the new crown vaccine and have severe risk factors. Eligible risk factors include advanced age over 60 years old, obesity, low immunity due to chronic diseases, basic diseases such as heart disease and lung disease. In addition, pregnant women and breastfeeding women are excluded.
Jabeid said,When the FDA approves the drug, it may also restrict users to the same subjects as clinical trials.
Although this medicine is very promising, it is a therapeutic medicine after all, which is different from preventive medicines such as vaccines. Xiao reminded that it is not necessary to receive vaccination. Among the subjects taking the drug, there were also those who had worsened symptoms and were hospitalized.
In addition, according to Weinberg, no serious side effects were found in clinical trials. Even if there were, they were only symptoms of the digestive system. The incidence was similar in the treatment group and the placebo group. However, Xiao pointed out that in the future, when the usable objects expand, there may also be safety issues.
Despite this, the results of this trial are gratifying, "It is of great significance to save 8 lives. The same goes for halving the hospitalization." Jabed commented. Perhaps, among other candidate therapeutic drugs currently undergoing clinical trials, there will be more effective drugs that can reduce the risk of hospitalization by 80 to 100%. "However, judging from the current situation, there is no better oral antiviral drug than monubilaver. After all, there is no other drug."
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