Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19

Silva, Renato Martins da; Cabral, Paula Gebe Abreu; Souza, Sávio Bastos de; Arruda, Raul Ferraz; Cabral, Sheila Passos de Figueiredo; Assis, Arícia Leone Evangelista Monteiro de; Martins, Yolanda Porto Muniz; Tavares, Carlos Augusto de Araújo; Viana, Ana Carolina Cavalcante; Chang, Junbiao; Lei, Pingsheng

doi:10.3389/fmed.2023.1143485

Cited by 23 publications

(30 citation statements)

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“…5 The Phase III study of Azvudine, which included a total of 143 participants in the Azvudine group, showed that it could shorten the time to negative nucleic acid conversion and reduce viral load in mild to moderate patients. 13 However, these The results of this study showed that Azvudine could reduce overall mortality compared to the control group when using IPTW for data processing. However, when using propensity score matching for data processing, this outcome measure did not…”

Section: Discussionmentioning

confidence: 62%

“…In a single‐arm compassionate use trial ( n = 31), all COVID‐19 patients who received oral Azvudine achieved recovery, with a 100% viral NANC rate in 3.29 ± 2.22 days and a 100% hospital discharge rate in 9.00 ± 4.93 days 5 . The Phase III study of Azvudine, which included a total of 143 participants in the Azvudine group, showed that it could shorten the time to negative nucleic acid conversion and reduce viral load in mild to moderate patients 13 . However, these studies only measured outcomes based on the time to negative nucleic acid conversion or viral load levels, and there was a lack of research on clinically important outcomes, such as disease progression rate and all‐cause mortality.…”

Section: Discussionmentioning

confidence: 99%

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Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

Hui

Wang

Jiang

et al. 2023

Journal of Medical Virology

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Azvudine is recommended by Chinese health authorities for COVID-19 treatment but has not been tested in real-world clinical studies. This study aimed to evaluate the realworld effectiveness of Azvudine among COVID-19 nonhospitalized patients. This was a retrospective cohort study, looking at nonhospitalized patients who tested positive for SARS-CoV-2. Patients admitted between December 19, 2022 and January 5, 2023 were included. Those who received Azvudine treatment were in the Azvudine group, while those who received supportive treatment were the control group. The primary outcome was the disease progression rate by Day 28. Secondary outcomes were individual disease progression outcomes (death or COVID-19-related hospitalization) and duration of fever. The safety outcomes were assessed based on adverse events (AEs) overall, as well as AEs that were considered to be related to the drug. A total of 804 patients with high risk for progression were enrolled in our study. Among them, 317 (39.43%) received treatment with Azvudine. Our study found that Azvudine could reduce the rate of disease progression, as well as rate of COVID-19-related hospitalization in patients comparing the control group. Furthermore, if taken within 3 days of the onset of symptoms, it could also shorten the duration of fever. Despite a higher incidence of drug-related AEs compared to supportive treatment, the majority of these were mild. Azvudine has been found to be effective in reducing the rate of disease progression of COVID-19, albeit with a slight increase in AEs.

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Section: Discussionmentioning

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

Hui

Wang

Jiang

et al. 2023

Journal of Medical Virology

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“…As the rst launched Chinese oral anti-COVID-19 drug [8], Azvudine exhibited antiviral activity effectively against coronavirus in preliminary clinical trials [2,4,9,10,11]. Meanwhile, several retrospective cohort studies suggested that Azvudine showed more effectiveness in hospitalized COVID-19 patients compared with Nirmatrelvir-ritonavir and Paxlovid in terms of composite disease progression outcome [12,13].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A Multi-center Retrospective Study in Beijing, China

Han

Xiao

Wang

et al. 2023

Preprint

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Background: Clinical effectiveness of Azvudine against coronavirus infection and optimal time for initiation of Azvudine treatment to hospitalized COVID-19 patients are not fully understood. Methods: This is a multi-center retrospective cohort study, and five clinical centers of the Chinese People’s Liberation Army General Hospital participated. From omicron pandemics, 6218 hospitalized patients confirmed with COVID-19 from December 10, 2022, to February 20, 2023, were retrieved for this study. After exclusions and propensity score matching , 428 Azvudine recipients and 428 controls were included with a follow-up of 28 days. The primary outcome was all-cause mortality during 28 days of hospitalization, and the secondary outcome was the proportion of patients with clinical improvement up to day 28. Results: The Azvudine group had a lower crude all-cause death rate when compared to the control group (2.82 per 1000 person-days vs. 4.52 per 1000 person-days; HR: 0.63, 95%CI: 0.40-1.00; P=0.038). Notably, the incidence rate of clinical improvement outcome was significantly higher in patients who received Azvudine within 5 days from the onset of symptoms, compared to the control group (Median days: 9 vs. 10; P=0.007). Subgroup analyses showed that chronic lung disease and corticosteroid treatment acted as protective factors (P=0.010; P=0.050). Conclusions: Clinical effectiveness of Azvudine in improving all-cause mortality in COVID-19 patients was seen, and initiation of Azvudine treatment within 5 days of the onset of symptoms was found to be significant. Additionally, the findings revealed the protective effect of Azvudine in COVID-19 patients with chronic lung disease.

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“…In phase III clinical trial (trial number: NCT05033145), mild COVID‐19 patients who received Azvudine treatment experienced a shorter NANC by an average of 2.7 d compared to those in the placebo group. [ 34 ] Compared to placebo groups, Azvudine showed good safety. The adverse reactions included headache, dizziness, AST increase, nausea, ALT increase, and D Dimer increase and were the same as those related to antiviral drugs.…”

Section: Clinical Studiesmentioning

confidence: 99%

A Nearly 20‐Year Journey to Success of Azvudine for Antiviral Therapy

Chang

2023

Chin. J. Chem.

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Comprehensive SummaryModified nucleosides, particularly those with 4'‐modifications, are significant nucleosides used in antiviral treatments. The drug discovery campaign of Azvudine starts from 2′‐deoxynucleoside, followed by extensive modifications, such as introducing the 4’‐position substitutions, a 2’‐β‐fluoro atom, and changing the nucleobases. Azvudine acts potently toward various HIV‐1 strains by inhibiting HIV‐1 reverse transcription and preventing Vif‐induced A3G degradation, representing the first‐in‐class dual‐acting antiviral agent. In July 2021, NMPA conditionally approved Azvudine as an adjunct therapy for adult patients with high levels of HIV‐1 virus load when combined with NRTIs or NNRTIs. Azvudine is capable of inhibiting SARS‐CoV‐2, as well as its variants, including Alpha, Beta, Delta, and Omicron. Clinical trials reveal its real‐world effectiveness among hospitalized severely or critically ill COVID‐19 patients or those with pre‐existing conditions. On July 25th, 2022, the NMPA granted conditional authorization approving Azvudine as China's first domestic oral anti‐COVID‐19 agent. Generally, Azvudine at therapeutic doses is safe and well‐tolerated in clinical settings. Azvudine got approval from the National Health Commission and National Administration of Traditional Chinese Medicine on August 9th to be used in the "Diagnosis and Treatment Program for Novel Coronavirus Pneumonia (Ninth Edition)" for treating common COVID‐19 adult patients. On August 12th, 2022, it was also approved by the National Healthcare Security Administration to be added to the list of medical reimbursements. Of note, the achievements related to Azvudine were indexed in the China Basic Research Development Report in Thirty‐Five of 2022. Azvudine was also approved on January 5th, 2023, to be used in the "Diagnosis and Treatment Program for Novel Coronavirus Pneumonia (Tenth Edition)" for treating COVID‐19 patients. In February 2023, the Ministry of Health of the Russian Federation approved the usage of Azvudine among individuals infected with SARS‐CoV‐2.This article is protected by copyright. All rights reserved.

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Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19

Cited by 23 publications

References 40 publications

Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A Multi-center Retrospective Study in Beijing, China

A Nearly 20‐Year Journey to Success of Azvudine for Antiviral Therapy

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