Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

Zhou, Yiling; Liu, Yi; Jiang, Li; Zhang, Renqing; Zhang, Huohuo; Shi, Qingyang; Yang, Zhirong; Mao, Yi; Liu, Sha; Yang, Zhibo; Ding, Jialin; Zhou, Yongzhao; Ren, Bi; He, Liping; Zhao, Xing; Li, Weimin; Li, Sheyu; Liu, Dan

doi:10.1002/jmv.29318

Cited by 3 publications

(1 citation statement)

References 32 publications

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“…In a multicenter retrospective randomized cohort study, azvudine demonstrated a signi cant reduction in overall mortality rates and a decrease in the need for tracheal intubation in moderate to severe patients with COVID-19. [14] In a cohort study comparing Nirmatrevir-Ritonavir and azvudine, the latter showed comparable e cacy in slowing disease progression and reducing all-cause mortality rates in hospitalized patients with COVID-19. [10] Although the results of the Phase III clinical trials have not been formally published, several studies have indicated that azvudine can signi cantly reduce the proportion of disease deterioration and effectively lower the overall mortality rates in real-world applications.…”

Section: Discussionmentioning

confidence: 98%

Azvudine reduces the mortality rate of patients with Coronavirus disease 2019: a single-center retrospective analysis study

Zhong,

Liu,

Zhou

et al. 2024

Preprint

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Background: Several therapeutic drugs have been authorized for the treatment of patients with Coronavirus disease 2019 (COVID-19). However, further research on the mechanisms of action, efficacy, and target populations of these novel therapeutic drugs are necessary. Hence, this study aimed to investigate the effectiveness of azvudine in hospitalized patients with COVID-19. Methods: We conducted a retrospective cohort study of patients with COVID-19 admitted to our hospital from December 1, 2022, to March 31, 2023. Patients were divided into retrospective cohorts receiving azvudine antiviral therapy and standard treatment, and were followed-up for up to 28 days. Results: Prior to data processing, azvudine treatment was associated with reduced mortality rates at 7 days (1.09/1000 persons vs.5.06/1000 persons, p<0.001)and 14 days (3.35/1000 persons vs. 5.65/1000 persons, p=0.001). After propensity score matching, a decrease in mortality rates at 7 days (0.08/1000 persons vs.6.29/1000 persons, p<0.001), 14 days (3.42/1000 persons vs. 7.26/1000 persons, p<0.001), and 28 days (4.33/1000 persons vs. 7.29/1000 persons, p=0.003) were observed following azvudine treatment. After inverse probability of treatment weighting adjustment, the results were consistent with propensity score matching. In the clinical subgroup analysis, for hospitalized severe and critical patients with COVID-19, azvudine treatment intervention significantly reduced patient mortality rates. Conclusions: The study suggests that in hospitalized patients with COVID-19, azvudine treatment significantly reduces patient mortality rates in hospitalized COVID-19 infections, wherein the effects are more pronounced in severe and critical patients.

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Section: Discussionmentioning

confidence: 98%

Azvudine reduces the mortality rate of patients with Coronavirus disease 2019: a single-center retrospective analysis study

Zhong,

Liu,

Zhou

et al. 2024

Preprint

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Azvudine versus Paxlovid in COVID‐19: A systematic review and meta‐analysis

Amani,

Amani

2024

Reviews in Medical Virology

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This systematic review and meta‐analysis aimed to compare the effectiveness and safety of azvudine versus nirmatrelvir/ritonavir (Paxlovid) in treating coronavirus disease 2019 (COVID‐19). The researchers conducted searches on PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar until January 2024. The Cochrane risk of bias tool was utilised to evaluate the quality of the included studies, and data analysis was performed using Comprehensive Meta‐Analysis software. Thirteen studies, including 4949 patients, were analysed. The meta‐analysis results showed no significant difference between the azvudine and Paxlovid groups in terms of mortality rate (odds rate [OR] = 0.84, 95% confidence interval [CI]: 0.59–1.21), negative polymerase chain reaction (PCR) conversion time (standard mean difference [SMD] = 1.52, 95% CI: −1.07–4.11), and hospital stay (SMD = −0.39, 95% CI: −1.12–0.33). However, a significant difference was observed between the two groups in terms of intensive care unit admission (OR = 0.42, 95% CI: 0.23–0.75) and the need for mechanical ventilation (OR = 0.61, 95% CI: 0.44–0.86) in favour of azvudine. The incidence of adverse events in the azvudine group was significantly lower (OR = 0.66, 95% CI: 0.43–0.99). The certainty of evidence was rated as low and moderate. Azvudine and Paxlovid demonstrated similar effectiveness in reducing mortality rates, negative PCR conversion time and hospital stay. However, azvudine showed better effectiveness in improving other outcomes. Regarding the level of certainty of evidence, further research is needed to validate or challenge these results.

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Efficacy and Safety of Azvudine in Patients With COVID‐19 in China: A Meta‐Analysis of Observational Studies

Dong,

Zhang,

et al. 2024

Clinical Respiratory J

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BackgroundAzvudine (FNC) is a novel small molecule antiviral drug for treating COVID‐19 that is available only on the Chinese market. Despite being recommended for treating COVID‐19 by the Chinese guidelines, its efficacy and safety are still unclear. This study aimed to evaluate the protective effect of FNC on COVID‐19 outcomes and its safety.MethodsWe followed the PRISMA 2020 guidelines and searched the PubMed, Embase, Web of Science, Scopus, and China National Knowledge Infrastructure (CNKI) databases to evaluate studies on the effectiveness of FNC in treating COVID‐19 in China, focusing on mortality and overall outcomes. Additionally, its impact on the length of hospital stay (LOHS), time to first nucleic acid negative conversion (T‐FNANC), and adverse events was evaluated. The inclusion criterion was that the studies were published from July 2021 to April 10, 2024. This study uses the ROBINS‐I tool to assess bias risk and employs the GRADE approach to evaluate the certainty of the evidence.ResultsThe meta‐analysis included 24 retrospective studies involving a total of 11 830 patients. Low‐certainty evidence revealed no significant difference in mortality (OR = 0.91, 95% CI: 0.76–1.08) or LOHS (WMD = −0.24, 95% CI: −0.83 to 0.35) between FNC and Paxlovid in COVID‐19 patients. Low‐certainty evidence shows that the T‐FNANC was longer (WMD = 1.95, 95% CI: 0.36–3.53). Compared with the Paxlovid group, low‐certainty evidence shows the FNC group exhibited a worse composite outcome (OR = 0.77, 95% CI: 0.63–0.95) and fewer adverse events (OR = 0.63, 95% CI: 0.46–0.85). Compared with supportive treatment, low certainty shows FNC significantly reduced the mortality rate in COVID‐19 patients (OR = 0.61, 95% CI: 0.51–0.74) and decreased the composite outcome (OR = 0.67, 95% CI: 0.50–0.91), and very low certainty evidence shows significantly decreased the T‐FNANC (WMD = −4.62, 95% CI: −8.08 to −1.15). However, in very low certainty, there was no significant difference in LOHS (WMD = −0.70, 95% CI: −3.32 to 1.91) or adverse events (OR = 1.97, 95% CI: 0.48–8.17).ConclusionsFNC appears to be a safe and potentially effective treatment for COVID‐19 in China, but further research with larger, high‐quality studies is necessary to confirm these findings. Due to the certainty of the evidence and the specific context of the studies conducted in China, caution should be exercised when considering whether the results are applicable worldwide.Trial RegistrationPROSPERO number: CRD42024520565

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Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

Cited by 3 publications

References 32 publications

Azvudine reduces the mortality rate of patients with Coronavirus disease 2019: a single-center retrospective analysis study

Azvudine reduces the mortality rate of patients with Coronavirus disease 2019: a single-center retrospective analysis study

Azvudine versus Paxlovid in COVID‐19: A systematic review and meta‐analysis

Efficacy and Safety of Azvudine in Patients With COVID‐19 in China: A Meta‐Analysis of Observational Studies

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