Isn't the 8th wave of the new corona started?
The number of infected people is increasing, and new mutant viruses are also emerging.
Meanwhile, on the 22nd, Shionogi Pharmaceutical Co., Ltd.'s "Zokoba" was approved as an oral drug that can be taken by patients with a low risk of becoming severe at a mild stage.
We have summarized the latest situation of what kind of drugs are currently approved in Japan and what kind of effects they have.
(As of November 22, 2022)
As of November 2022, there are nine types of novel coronavirus drugs approved in Japan.
[Drugs that can be used in the mild stage]
Countries around the world have been developing an oral medicine that is effective shortly after being infected with the new corona, as it can reduce the number of severe cases and deaths.
There are currently two approved oral drugs that can be used from the mild stage: "Lagebrio" developed by the American pharmaceutical giant "Merck" and "Pakilovid Pack" developed by the American pharmaceutical giant "Pfizer".
"Lagebrio"
On December 24, 2021, “Lagebrio” (generic name: molnupiravir) was approved for the first time in Japan.
After the virus invades the cell, it suppresses the action of the enzyme necessary for copying "RNA", which is the blueprint of the virus, and prevents it from multiplying.
According to the package insert of the drug, it is targeted for administration to patients aged 18 and over with mild to moderate disease1 who are at risk of aggravation such as the elderly, obesity, and diabetes, and five days after the onset of symptoms. I plan to take it twice a day for 5 days within the same period.
Pregnant women and women who may become pregnant should not take this drug as it may affect the fetus.
It is said to have the effect of reducing the risk of hospitalization and death in patients at risk of severe disease by about 30%, and the rate of adverse events after taking the drug is the group who took the drug and the group who took the placebo. I'm assuming it hasn't changed.
According to the Ministry of Health, Labor and Welfare, 1.6 million people have been secured so far, and as of September 15, 2022, about 619,600 people have been administered.
From September 16, 2022, the drug production system is in place, and distribution through wholesale companies is being carried out in the same way as general drugs.
"Pakrobid Pack"
Following Laghebrio, special approval was granted on February 10, 2022 for the `` Pakilovid Pack '' developed by the American pharmaceutical giant `` Pfizer ''.
It is a drug that combines the antiviral drug 'nilmatrelvir' developed for the new corona and 'ritonavir', which is an existing drug used to treat AIDS and plays a role in enhancing the effect of the antiviral drug.
Like "Lagebrio", it is a type of drug that suppresses the proliferation of viruses that have invaded cells, but the mechanism of action is different. suppress proliferation.
According to the final analysis results of the clinical study published by the company in December 2021, the risk of hospitalization and death increased by 89 when treatment was started within 3 days of the onset of symptoms in patients at risk of severe disease. 88% reduction even when administration was started within 5 days of onset.
In addition, the rate of adverse events after taking the drug was the same for those who received the drug and those who received the placebo, and most of them were mild.
According to the package insert of the drug, it is to be administered to patients aged 12 years or older with mild to moderate disease 1 who are at high risk of exacerbation, and should be taken twice a day for 5 days.
Pakilovid packs are used because there are about 40 drugs that are prohibited to be taken together, and because doses need to be adjusted for patients with impaired kidney function. The number of cases remains relatively low.
According to the Ministry of Health, Labor and Welfare, 2 million people have been secured, but as of October 31, 2022, only about 50,000 people have been administered.
Both “Lagebrio” and “Pakilovidpak” are believed to have little effect even if the “spike protein”, which is a stepping stone for virus infection of cells, mutates, and the effect is maintained.
Visiting professor Tsuneo Morishima of Aichi Medical University, who is familiar with the treatment of the new corona, said, "There are many medicines that cannot be taken together with the ``Paikirovid Pack'', but you can ask for information in your medicine notebook or prescribe it at your family medical institution. If we can establish a mechanism for retrieving drugs, we may be able to prescribe more.”
[Antibody drugs that can be used for mild cases]
There are two types of "antibody medicines" developed for the new corona that can be administered by intravenous drip or injection, which can be used for people with mild symptoms.
"Antibody drug" is a type of drug that administers an artificially made antibody, and the antibody binds to the "spike protein", a protrusion on the surface of the new coronavirus, which prevents the virus from entering cells. To do.
Antibody cocktail therapy "Lonapreve"
In July 2021, special approval was granted as the first drug that can be used for patients with mild symptoms.
Administer by infusion or injection.
"Sotrovimab"
In addition, in September 2021, special approval was granted for Sotrovimab, brand name Zebudy, which administers one type of antibody.
Administer by drip.
Both are targeted for administration to patients with mild to moderate illness 1 who are at risk of becoming severe, such as the elderly and those with underlying diseases. Sotrovimab is administered once within 5 days of onset.
In clinical trials, Lonapreve reduced the risk of hospitalization and death by about 70% compared to those who did not receive it.
In addition, it is also approved to be administered for the purpose of preventing onset to close contacts who have weakened immunity and are at risk of becoming severe.
According to the Ministry of Health, Labor and Welfare, as of October 31, 2022, approximately 43,000 people have been administered.
In clinical trials, sotrovimab reduced the risk of hospitalization and death by approximately 85% compared to those who did not receive it.
According to the Ministry of Health, Labor and Welfare, as of October 31, 2022, more than 180,000 people have been administered the drug.
However, these antibody drugs have the weakness that if the shape of the "spike protein" changes due to mutation of the virus, it will become difficult to bind and the effect will be reduced.
Especially for Omicron strains, there were many reports that the effect was significantly reduced compared to conventional strains. Therefore, we will consider using it when other therapeutic agents cannot be used."
[Drugs that can be used to suppress the onset]
Some antibody drugs can be used to suppress the onset of infection by administering it before infection.
"Eva Sheld"
The antibody drug "Evasheld" developed by the British pharmaceutical giant "AstraZeneca" will be granted special treatment in August 2022 as it can be used to suppress the onset of the disease in people whose immune function is weakened and vaccination is ineffective. Approved.
This drug is given by injection of two types of antibodies.
According to the attached document, etc., in a clinical trial conducted on about 5,200 people, including those who were considered to be inadequately affected by the vaccine, the risk of developing the disease was reduced by 77% when administered before infection, and the effect lasted for half a year. increase.
In addition, it is said that administration to high-risk patients with mild to moderate symptoms was effective in reducing the risk of severe illness and death by 50%.
Since it is difficult to provide a stable supply of this drug, the Ministry of Health, Labor and Welfare distributes it free of charge only when it is used for the purpose of preventing the onset of symptoms.
On the other hand, for the Omicron strain, "Because there is a possibility that the efficacy may decrease, we will consider using it when other therapeutic agents cannot be used."
[Therapeutic drug developed for another disease also targets mild symptoms]
"Remdesivir"
Some drugs have been developed as therapeutic drugs for other diseases and are also used as effective against the new coronavirus, and some of them can be used from the mild stage.
In May 2020, the infusion antiviral drug Remdesivir, which was originally developed as a treatment for Ebola hemorrhagic fever, was approved for the first time as a treatment for the new coronavirus.
It has been used for severe hospitalized patients from the new corona moderate disease 1, but in March 2022, the Ministry of Health, Labor and Welfare expanded the indication to mild and moderate patients who are at risk of becoming severe.
[Drugs for patients with moderate or higher symptoms]
For moderately ill patients who developed pneumonia and required oxygen administration, and for severely ill patients with more severe symptoms, drugs that suppress the excessive action of the immune system are available to suppress inflammation in various parts of the body. used.
"Dexamethasone"
In July 2020, the Ministry of Health, Labor and Welfare recommended ``Dexamethasone'', a steroid that suppresses the excessive action of the immune system, as a treatment for the new corona.
It was originally used to treat severe pneumonia and rheumatism.
"Baricitinib"
Baricitinib, which was approved in April 2021, is also a drug that suppresses excessive immune activity and is administered to patients with moderate disease 2 or higher.
Originally, it was an oral tablet that was used for patients with rheumatoid arthritis, etc. In Japan, it is limited to use in combination with remdesivir.
"Actemra"
In January 2022, the rheumatoid arthritis drug Actemra, generic name Tocilizumab, developed by the Japanese pharmaceutical company Chugai Pharmaceutical, was also approved as a treatment for the novel coronavirus.
It is a drug that suppresses excessive immune function by intravenous drip, and it is said to be administered in combination with steroids to patients with moderate disease 2 or higher who need oxygen administration.