Attention! Expert Consensus on Antiviral Therapy of COVID-19 is Released, Calling for Early Use of Antiviral Drugs Such as Azvudine

Recently, in order to further promote the rational use of anti-SARS-CoV-2 drugs in clinical practice, the National Center for Infectious Diseases (Beijing Ditan Hospital Capital Medical University and First Affiliated Hospital of Zhejiang University School of Medicine) organized about 30 authoritative experts in the fields of infectious diseases, respiration, intensive care, and pharmacology in China to develop an Expert Consensus on Antiviral Therapy of COVID-19 (hereinafter referred to as "Expert Consensus") based on the Diagnosis and Treatment Guideline for COVID-19 (Tentative 10th Edition) and experiences in the diagnosis and treatment of COVID-19 in China. The Expert Consensus is concise, practical, and highly operable. Hopefully it will improve the understanding of antiviral therapy for clinicians and provide suggestions for standardized medication in treatment of COVID-19.

According to the general application principles in the Expert Consensus for antiviral medications for COVID-19 infection, inhibiting viral replication is crucial for controlling the progression of SARS-CoV-2 infection, and antiviral therapy is one of the main therapeutic approaches for SARS-CoV-2 infection. Antiviral medications for COVID-19 should be reasonably chosen in light of the patients' disease course. Attention should be paid to the adverse drug reactions and drug interactions, and in general, oral COVID-19 antiviral medications should be used as early as possible.

The Expert Consensus states that Azvudine is a broad-spectrum RNA virus inhibitor that can inhibit the RNA-dependent RNA polymerase (RdRp) of SARS-CoV-2, block RNA elongation by embedding itself into viral RNA during synthesis, and thereby terminate RNA strand synthesis as well as viral replication. Since Azvudine is enriched in the thymus and peripheral blood lymphocytes, it significantly reduces the viral load in the thymus, thereby enhancing the body's immune function to inhibit SARS-CoV-2.

Regarding the adverse reactions of Azvudine, the Expert Consensus clearly states, "According to clinical trials, the difference in the rate of adverse events between the Azvudine group and the placebo control group is not statistically significant, and the adverse events were mostly mild. The common adverse reactions of Azvudine for COVID-19 include gastrointestinal reactions, diarrhea, abnormal liver function, etc., with uncommon cases of blood glucose elevation and lymphocyte count reduction. Pancreatitis was reported with other comparable nucleoside analogues, and Azvudine should be used with caution in patients with a history of pancreatitis."

The Expert Consensus also discloses in detail the global multicenter phase III clinical study of Azvudine tablets, "A randomized, double-blind, and placebo-controlled phase III clinical study conducted in Russia enrolled 314 patients with moderate COVID-19 symptoms. The subjects were randomized (1:1) and received oral administration of Azvudine (5 mg) or placebo once daily for up to 14 consecutive days. The PPS data showed that in the Azvudine group, the proportion of WHO clinical symptom scores in patients with moderate symptoms was significantly improved 7 days after dosing (40.43% vs. 10.87%, P < 0.001), the median time to clinical status improvement in patients was significantly shorter (10 days vs.13 days, P < 0.001), and the overall safety and tolerability were good. In Brazil, phase III studies of Azvudine were conducted in the treatment of patients with mild and moderate symptoms, respectively, both with a multicenter, randomized, double-blind, and placebo-controlled design. The results of Azvudine treatment in patients with moderate COVID-19 infection showed a significantly shorter time to first negative conversion time in the Azvudine group than in placebo group (6.24 days vs. 7.94 days; P = 0.002). DD-PCR testing showed a sustained decrease in viral load from day 3 after administration, and a statistically significant difference in viral load on day 3, day 5, day 7, day 9, and day 11 compared with that of the control group, as well as significant improvement in WHO clinical symptom scores in discharged patients (P = 0.024). The results of Azvudine treatment in patients with mild COVID-19 infection showed a significantly shorter time to first negative conversion in the Azvudine group than that in placebo group (5.55 days vs. 8.27 days; P < 0.001), and DD-PCR testing showed significantly reduced viral load on day 3, day 5, and day 7 after administration compared with that of the control group."

For more information about the Expert Consensus on Antiviral Therapy of COVID-19, please go to:

https://mp.weixin.qq.com/s/NsiPE09dhUpOe6t5-vh9SA