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For medical professionals only
Early targeting of antiviral therapy can control virus transmission and disease progression
.
As the latest variants continue to emerge, global outbreaks have recurred and cases have surged
.
According to the latest data from the World Health Organization (WHO), as of January 9, 2023, the number of confirmed cases of novel coronavirus infection (COVID-19) in the world has reached 664.
19 million, and the number of deaths has exceeded 6.
7 million[1].
Nowadays, new strains are emerging one after another, and the Omicron variant has become the dominant variant due to its strong immune escape ability [2].
With the release of the "New Ten Rules", China's society has gradually opened up, and the whole country has also ushered in the peak
of new crown infection in recent days.
In the face of the unpredictable epidemic situation, there are more uncontrollable factors in the treatment of infected people, and when antiviral treatment is particularly important
.
Recently, Professor Zhang Wenhong appealed: "We must seize the 'golden 72 hours' of new crown infection patients and use antiviral drugs as soon as possible!" "So why the emphasis on early antiviral treatment?
Seizing the "golden 72" hours of antiviral treatment can bring more benefits to infected people
People with COVID-19 usually develop symptoms
soon after initial exposure.
After infection, SARS-CoV-2 binds to the host target cell receptor angiotensin-converting enzyme 2 (ACE2), and the active replication and release of the virus in the body leads to nonspecific symptoms such as fever, myalgia, headache, and respiratory symptoms [3].
It is important to emphasize that a peak SARS-CoV-2 load and a subsequent decrease in the respiratory tract can be observed at the onset of symptoms or during the first week of onset [4], suggesting that the virus has the highest infectious potential
before or during the first five days of symptom onset.
For viral infectious diseases, the therapeutic effect of antiviral drugs is mainly reflected in the early stage of the disease with high viral load and direct viral damage (mild/moderate stage), and the efficacy is very limited
in the severe stage dominated by immune response disorders, cytokine storms, and secondary immune damage.
Studies have shown [5] that SARS-CoV-2 viral load correlates with symptom severity, with mild symptoms generally beginning 1 day after peak and moderate to severe symptoms generally beginning 2 days after peak, and early use of antiviral drugs after diagnosis may affect peak viral load and alter the natural course of
the disease.
Drawing on experience with antiviral therapy for influenza, varicella, recurrent herpes, and cytomegalovirus (CMV) pneumonia, antiviral therapy for COVID-19 should be initiated early in the course of innate immunity, fever, or influenza-like symptoms to block transmission of the virus to the respiratory, endothelial, and neuronal tract to prevent pneumonia and other complications [6].
In general, early administration of antiviral therapy can not only control the spread of the virus and disease progression, but also prevent infected people from becoming more ill and reduce the burden on families and socio-economic issues
.
The Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10) [7] recommends that drugs
with potential antiviral effects should be used early in the course of the disease.
In addition, the newly released Expert Consensus on Antiviral Treatment for Patients with Novel Coronavirus Infection also states that oral COVID-19 antiviral drugs should be used
as soon as possible in principle.
Vaccines and oral antiviral drugs for COVID-19 are an important part of epidemic prevention and control, and are also the main means of
COVID-19 prevention and control.
With the increase in the number of patients with breakthrough infections caused by disease variants, people are more concerned about the progress of anti-novel coronavirus drugs in addition to the preventive effect of COVID-19
vaccines.
At this stage, with the deepening of scientific research on the life cycle and therapeutic drugs of the new coronavirus, a number of COVID-19 therapeutics have been approved and under research around the world [8], among which proteins such as RNA-dependent RNA polymerase (RdRp) that play a key role in the replication of the new coronavirus have received keen attention from the academic community and have become popular targets for "COVID-19 drugs"
.
At present, China has urgently authorized a number of neutralizing antibodies and small molecule compound drugs [9], and the mechanism of action of different types of drugs is different, and their advantages and disadvantages have certain differences
.
Table 1 Comparison of representative drugs for different COVID-19 treatments
Among them, azvudine, as China's first landmark oral small molecule anti-novel coronavirus drug with independent intellectual property rights, stands out among many COVID-19 treatment drugs with its unique advantages, and was conditionally approved in July this year, and has now been included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (10th Edition)" [7] for the treatment of medium-sized adult patients
with COVID-19.
From the clinical data, the results of the phase III Chinese study of azvudine from December 2020 to February 2022 [10] showed that subjects with log values ≥3 and log ≥4 had greater viral load decreases than those in the control group on the 5th day of using azvudine, which was statistically different
.
The results of the study [11] in patients with moderate COVID-19 also showed that after 7 days of azvudine, 36.
31% of subjects improved their clinical condition, which was clinically effective compared with placebo, and the median time to clinical improvement was significantly shortened (P<0.
001).
Fig.
1 Azvudine phase III clinical study: analysis results of viral load change from baseline
In addition, the latest preprint data to be released soon [12,13] were retrieved, showing that azvudine can accelerate viral clearance and shorten the time to negative nucleic acids in patients with moderate and mild COVID-19, shorten the time to clinical symptoms in patients with moderate COVID-19, thereby shortening the length of
treatment and hospital stay.
In terms of safety, the results also showed that there were no significant differences in kidney and liver damage and other adverse reactions in the azvudine group compared with the control group, all adverse events returned to normal relatively quickly and were maintained until the end of treatment, and the adverse reactions observed in the study were the same as those of other antiviral drugs, and no unexpected adverse reactions
were observed.
It is worth mentioning here that the negotiation of the 2022 national medical insurance drug catalogue has officially ended on January 8, 2023, and azvudine tablets have successfully entered the medical insurance catalog
.
According to the recent Notice on Optimizing the Relevant Policies for Medical Security for Patients with Novel Coronavirus Infection after the Implementation of "Class B and B Tube" (hereinafter referred to as the "Notice"), all therapeutic drugs in the "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)[7], including azvudine tablets, will be temporarily paid by medical insurance until March 31, 2023
.
During this period, insured COVID-19 patients will be eligible for reimbursement of these medicines
.
The new coronavirus is still mutating, the global epidemic is still in an epidemic situation, how to do a good job in prevention and early intervention is the top priority in fighting the epidemic, and is an important means
to achieve group protection and reduce the spread of the virus.
Whether it is neutralizing antibodies or small molecule oral drugs, in the battle with the new coronavirus, as long as it can bring benefits to patients, it is a "good medicine", and it is expected that there will be more clinical data to analyze
the effect of antiviral drugs in the future.
References:
[1]http://m.
ce.
cn/ttt/202212/22/t20221222_38301402.
shtml
[2]https://nextstrain.
org/ncov/gisaid/global/6m?p=grid
[3] NIH COVID-19 Treatment Guidelines
[4] Muge Cevik et al.
BMJ.
2020 Oct 23; 371:m3862.
[5] Helen C Stankiewicz Karita et al.
JAMA Netw Open.
2022 Jan 4; 5(1):e2142796.
[6] Shiraki K, Sato N, Sakai K, Matsumoto S, Kaszynski RH, Takemoto M.
Antiviral therapy for COVID-19: Derivation of optimal strategy based on past antiviral and favipiravir experiences.
Pharmacol Ther.
2022 Jul; 235:108121.
[7] Bai Jianfeng.
The 10th edition of the diagnosis and treatment plan for novel coronavirus infection was released[N].
People's Daily,2023-01-07(006).
[8] Joydeb Majumder et al.
The AAPS Journal (2021) 23: 14
[9] National Health Commission of the People's Republic of China.
Chinese Journal of Clinical Infectious Diseases,2022,15(2):81-89.
[10] Summary report of phase III clinical trial in China, the final results are subject to the literature published in phase III
[11] Azvudine tablet instructions
[12]https://doi.
org/10.
21203/rs.
3.
rs-2273657/v1
[13]https://doi.
org/10.
21203/rs.
3.
rs-2273694/v1
This information is for medical and scientific reference only and is not recommended for use in any manner inconsistent with the prescribed information approved in your country.
