The latest clinical data shows that the domestic new crown oral drug azvudine is safe and effective

Recently, a preprint of a clinical trial of the domestic new crown oral drug azvudine in Brazil for patients with mild and moderate infection of the new crown virus has been released
.
The results of clinical studies have proved that azvudine can significantly shorten the nucleic acid conversion time, accelerate virus elimination, significantly reduce viral load, reduce symptoms and shorten the course of disease in patients with mild and moderate SARS-CoV-2 infection, and has good safety and no significant impact on liver and kidney function of patients, which is safe and effective
.
Here, the clinical trial results of this study are interpreted to further demonstrate the effectiveness and safety
of azvudine in the treatment of new coronavirus infection.

For the treatment of patients with mild and moderate new crown infection, azvudine has significant efficacy and good safety

Azvudine tablets are used in a prospective, randomized, double-blind, placebo-controlled safety and efficacy clinical trial for the treatment of patients with mild infection with the new coronavirus

Study Design: A total of 281 patients completed treatment in 312 patients to assess the clinical efficacy and safety
of azvudine 1 mg tablets compared with placebo in patients with mild SARS-CoV-2 infection.

Findings: WHO Clinical Progress Scale: there was no significant difference
between the two groups in initial score (p=0.
999) and final score (p=0.
700).
The proportion of azvudine participants with a score of 1 at clinical discharge was 2.
0%, and 98% of participants scored
0.
In the placebo group, 2.
2% of patients had 1 point at clinical discharge and 97.
8% had 0 points
.

Azvudine significantly shortened the time to negative for nucleic acids in patients with mild infection: time to first negative for nucleic acids: compared with placebo, the time to first negative for subjects treated with azvudine was significantly shortened by about one-third (5.
55 days vs.
8.
27 days; P<0.
001）； Second nucleic acid conversion time: the first nucleic acid conversion time was significantly shorter in subjects treated with azvudine compared with placebo (6.
70 days vs.
9.
40 days; P<0.
001).

The time required for discharge of azvudine individuals is significantly reduced
.

Comparison of the time to negative first and second nucleic acid tests for all subjects in the azvudine and placebo groups, the data were mean (SD) red bars: azvudine; Blue bar: placebo

Azvudine significantly reduces viral load in the body: compared to
placebo.
A significant reduction in viral load (p<0.
001)
was observed in the azvudine group at days D3, D5 and D7 after administration.

Azvudine and placebo groups with viral load analysis (ddPCR) red lines during treatment: azvudine; Blue line: placebo

Azvudine was well tolerated: the incidence of adverse events in the azvudine group was similar to that in the placebo group, and the adverse events were mainly related to headache (36 cases), dizziness (35 cases), elevated AST (21 cases), nausea (19 cases), increased ALT (14 cases), and increased D dimer (11 cases), and adverse events all returned to normal quickly and were maintained until the end of
treatment.

Azvudine had no significant effect on liver and kidney function in people with mild infection: renal function measures including creatinine and blood urea nitrogen did not differ significantly from
placebo during treatment.
Aspartate aminotransferase, alanine aminotransferase, glutamyl transpeptidase and total bilirubin values are within the normal range, and the drug is well tolerated to the liver
.

Dynamic changes in renal and liver markers in the azvudine group and placebo group during treatment, the data are the median (SD) red line: azvudine; Blue line: placebo

Azvudine tablets in a randomized, double-blind, placebo-controlled clinical trial of safety and efficacy in patients with moderate SARS-CoV-2 infection

Study Design: 180 patients were included and 172 completed treatment to assess the efficacy and safety
of azvudine versus placebo in patients with moderate SARS-CoV-2 infection.

Results of the study: Azvudine significantly improved the clinical status of patients with moderate infectionWHO Clinical Progress Scale: the score of azvudine group was 0.
02±0.
15 at discharge, and the score of control group was 0.
11±0.
31, and the difference between the two groups was statistically significant (P=0.
024)

Symptom improvement: on days 1, 2, and 3 post-medication, azvudine significantly improves temperature recovery time (< 37.
6°C axillary) and chills, and shortens the duration of<b10> fever.

Azvudine significantly shortened the time of nucleic acid conversion in patients with moderate infection: the time to first negative nucleic acid: compared with the placebo group, the time to first negative of nucleic acid in the azvudine group was significantly shortened (6.
24 Vs.
7.
94 days, P=0.
002); Second nucleic acid conversion time: the time to continuous negative conversion to negative in subjects treated with azvudine was significantly shorter (7.
73 days) compared with placebo-treated participants (8.
89 days; p=0.
028）
。

Comparison of the time to negative first and second nucleic acid tests for all subjects in the azvudine and placebo groups, the data were mean (SD) red bars: azvudine; Blue bar: placebo

Significant decrease in viral load after medication: viral load decreased significantly at 3 days, 5, 7, 9 and 11 days after medication compared with the control group
.

Azvudine and placebo groups with viral load analysis (ddPCR) red lines during treatment: azvudine; Blue line: placebo

Azvudine was well tolerated: there was no difference in the rate of adverse events between the azvudine group and the placebo group, and the adverse events mainly included 13 cases of elevated glutamyl transpeptidase (GGT), 45 cases of alanine aminotransferase (ALT), 10 cases of aspartate aminotransferase (AST), and 8 cases of grade 1 headache, and the adverse events all returned to normal quickly and were maintained until the end of
treatment.
The adverse effects observed in the studies were the same as those seen with other antiviral drugs, and no unexpected adverse effects
were observed.

Azvudine had no significant effect on liver and kidney function in moderately infected people: azvudine was well tolerated, and there was no significant difference
between the renal and hepatic impairment azvudine group and the control group.

Dynamic changes in renal and liver markers in the azvudine group and placebo group during treatment, the data are the median (SD) red line: azvudine; Blue line: placebo

The above results showed that azvudine could significantly shorten the nucleic acid conversion time, accelerate virus elimination, significantly reduce viral load, reduce symptoms and shorten the course of disease in patients with mild and moderate SARS-CoV-2 infection, and had good safety and no significant effect
on liver and kidney function.

A number of authoritative experts suggest that the sooner you take Azvudine, the better the effect

At the State Council Joint Prevention and Control Press Conference on December 20, Wang Guiqiang, director of the Department of Infectious Diseases at Peking University First Hospital, said that most of the current new crown virus infection is mild or asymptomatic, but there are still a small number of infected people who show pneumonia, especially the elderly with underlying diseases and the elderly who have not been vaccinated, which are at high risk of
severe disease 。 For early intervention in these people at high risk for severe disease, the ninth edition of the protocol recommends several antiviral drugs, including monoclonal antibodies, nimatevir, and later supplementation of azvudine, all of which may reduce the occurrence of severe disease, shorten the duration of the disease, and shorten the time
to detoxify the virus.
Azvudine is a small molecule antiviral drug that can shorten the course of the disease, reduce virus levels, improve symptoms during the new crown treatment, and is also approved for use in
the new crown treatment.
It should not be used during pregnancy and lactation, and patients with moderate and severe liver and kidney function impairment should also be used with caution, so it also needs to be used
under the guidance of a doctor.

Professor Shi Yi of Jinling Hospital affiliated to Nanjing University School of Medicine said: "The application of antiviral drugs such as azvudine is to reduce the trend of severe development while effectively treating mild and ordinary patients, thereby reducing the mortality rate and achieving better efficacy in early treatment.

”

Professor Lu Hongzhou, president of Shenzhen Third People's Hospital, said: "In theory, there is damage if there is a virus, and azvudine is a drug that suppresses the virus, so there is no damage after the virus is reduced, so as long as it is positive and has a new coronavirus in the body, early asymptomatic can develop into symptomatic, early asymptomatic can develop into severe disease or even death can predict early medication
.
" The range of antiviral drugs can be more extensive, as long as there is a virus, it can be used, without the virus, there is no infectiousness, and there is no body damage
.
”

Li Yueping, director of the ICU of the Infectious Disease Center of the Eighth Affiliated Hospital of Guangzhou Medical University, said: "The main function of anti-new coronavirus drugs is to inhibit virus replication, so the earlier it should be used, the sooner the better
.
The advantage of azvudine is that there is no interaction with other drugs, such as antihypertensive drugs, lipid-lowering drugs, anticoagulants, azvudine does not have much side effects, and there is no need to consider the problem
of stopping the drug when using it.
”

Professor Wu Chao, chief physician of the Department of Infectious Diseases, Gulou Hospital Affiliated to Nanjing University School of Medicine and director of the Institute of Virology and Infectious Diseases of Nanjing University, said: "From the indications, azvudine is suitable for the treatment of adult patients with common COVID-19
.
This also means that if there is a patient with an underlying medical condition, some azvudine
can be taken.
The so-called the sooner the better, that is, try to take
it within the third and fifth days after the onset of illness.
Especially in the elderly over 65 years old, with underlying diseases, everyone can take
this type of people.
It can not only prevent severe disease, but also promote the early clearance of the virus, which is essential
for the already weak immune response of the elderly.
Similarly, rapid clearance of the virus is valuable for interrupting transmission, especially for the protection of families and others
.
”