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Coronavirus disease 2019 (COVID‐19) has spread worldwide. To date, no specific drug for COVID‐19 has been developed. Thus, this randomized, open‐label, controlled clinical trial (ChiCTR2000029853) was performed in China. A total of 20 mild and common COVID‐19 patients were enrolled and randomly assigned to receive azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatment (control group). The mean times of the first nucleic acid negative conversion (NANC) of ten patients in the FNC group and ten patients in the control group are 2.60 (SD 0.97; range 1–4) d and 5.60 (SD 3.06; range 2–13) d, respectively (p = 0.008). The mean times of the first NANC of four newly diagnosed subjects in the FNC group and ten subjects in the control group are 2.50 (SD 1.00; range 2–4) d and 9.80 (SD 4.73; range 3–19) d, respectively (starting from the initial treatment) (p = 0.01). No adverse events occur in the FNC group, while three adverse events occur in the control group (p = 0.06). The preliminary results show that FNC treatment in the mild and common COVID‐19 may shorten the NANC time versus standard antiviral treatment. Therefore, clinical trials of FNC treating COVID‐19 with larger sample size are warranted. Azvudine treatment in the persistently mild and common COVID‐19 patients may shorten the nucleic acid negative conversion time versus standard antiviral treatment, regardless of whether the patients are newly diagnosed or have previously received routine treatment. Azvudine treatment could improve the lung function of patients. Moreover, the adverse events are not observed in patients receiving azvudine.

Azvudine has been recommended as a potential treatment for the recently discovered Coronavirus disease (COVID-19) in 2019. However, the effectiveness of Azvudine in individuals who have both COVID-19 and pre-existing cancer remains uncertain. Consequently, we undertook a retrospective analysis to evaluate the clinical efficacy of Azvudine therapy in hospitalized patients with COVID-19 and pre-existing cancer. This is a single-center retrospective analysis of patients diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, selected from patients admitted to a specialist oncology hospital between June 1, 2022 to June 31, 2023 with positive RT-PCR and pre-existing cancer. After exclusion and propensity score matching, patients in the test group treated with Azvudine and control patients treated with standard antiviral therapy were included. The primary outcome is the interval time from the first dose of Azvudine to the attainment of the first negative result for nucleic acid. Secondary outcomes included the rate of nucleic acid conversion, the duration of hospitalization, and the admission to the intensive care unit (ICU). Cox proportional hazards models were used to analyze the hazard ratio (HR) of event outcomes and to assess whether cancer types and Azvudine treatment will affect the course of COVID-19, specifically the time it takes for primary symptoms to alleviate. In this study, a total of 84 patients were included for analysis. Among them, 42 patients received Azvudine treatment after hospitalization, and the rest were treated with standard antiviral therapy. The results expressed that the time taken for the first negative nucleic acid test was significantly shorter in the Azvudine group compared to the control group [5 (IQR3-7) d vs 12 (IQR9-15) d], 0.0001. This difference was statistically significant. Furthermore, a multivariate COX analysis indicated that Azvudine treatment could effectively reduce the time required for nucleic acid conversion in cancer patients (HR 1.994, 95% CI 1.064-3.736, =0.031). And the type of cancer also had an impact on the course of COVID-19 in patients. (HR 3.442, 95%CI 1.214-9.756, =0.020; HR 3.246, 95% CI 1.925-7.209, =0.036). Azvudine was correlated with a reduced duration for achieving nucleic acid conversion in individuals diagnosed with cancer. And different types of cancer have a certain impact on the course of COVID-19 for patients.

This study aimed to explore the effectiveness and safety of azvudine, nirmatrelvir/ritonavir, and molnupiravir in adult patients with mild-to-moderate COVID-19. This retrospective cohort study included patients with mild-to-moderate COVID-19 (asymptomatic, mild, and common types) at the First Hospital of Changsha (Hunan Province, China) between March and November 2022. Eligible patients were classified into the azvudine, nirmatrelvir/ritonavir, or molnupiravir groups according to the antiviral agents they received. The outcomes were the times to nucleic acid negative conversion (NANC). This study included 157 patients treated with azvudine (n = 66), molnupiravir (n = 66), or nirmatrelvir/ritonavir (n = 25). There were no statistically significant differences in the time from diagnosis to NANC among the azvudine, molnupiravir, and nirmatrelvir/ritonavir groups [median, 9 (95% CI 9–11) vs. 11 (95% CI 10–12) vs. 9 (95% CI 8–12) days, P  = 0.15], time from administration to NANC [median, 9 (95% CI 8–10) vs. 10 (95% CI 9.48–11) vs. 8.708 (95% CI 7.51–11) days, P  = 0.50], or hospital stay [median, 11 (95% CI 11–13) vs. 13 (95% CI 12–14) vs. 12 (95% CI 10–14) days, P  = 0.14], even after adjustment for sex, age, COVID-19 type, comorbidities, Ct level, time from diagnosis to antiviral treatment, and number of symptoms. The cumulative NANC rates in the azvudine, molnupiravir, and nirmatrelvir/ritonavir groups were 15.2%/12.3%/16.0% at day 5 ( P  = 0.858), 34.8%/21.5%/32.0% at day 7 ( P  = 0.226), 66.7%/52.3%/60.0% at 10 days ( P  = 0.246), and 86.4%/86.2%/80.0% at day 14 ( P  = 0.721). No serious adverse events were reported. Azvudine may be comparable to nirmatrelvir/ritonavir and molnupiravir in adult patients with mild-to-moderate COVID-19 regarding time to NANC, hospital stay, and AEs.

Azvudine is recommended for patients with coronavirus disease 19 (COVID-19); however, its optimum therapeutic time window and its impact on mortality of patients are unclear. This single-centre, retrospective study from 1 November 2022 to 27 February 2023 conducted at the Peking Union Medical College Hospital was to discuss the dosing window of azvudine and compare the prognostic impact on COVID-19 patients of azvudine use within and after the defined time window. Therapeutic time window referred to the time interval between the onset of the disease and the drug administration. 28-day all-cause mortality and the incidence of 28-day disease progression were assessed using univariate logistic regression and adjusted for covariates through multivariate logistic regression analysis. A total of 421 COVID-19 patients using azvudine and 720 patients not using any anti-SARS-CoV-2 drugs were enrolled. After propensity score matching, 302 patients treated with azvudine and 302 patients without antiviral drugs were included. Multivariate logistic regression analysis showed that the use of azvudine was significantly protective until 8 days of symptom onset for COVID-19 patients. Compared with the latter, treatment with azvudine reduced the all-cause mortality rate (OR 0.55, 95% CI 0.30–1.00) and disease progression rate (OR 0.52, 95% CI 0.29–0.93) to 28 days. The study indicated that the benefit of azvudine seemed more significant within 8 days of symptoms onset and the administration of azvudine reduced the risk of death in adult COVID-19 patients. In the future, large randomized controlled trials (RCT) studies are needed to confirm our conclusions because of the inherent limitation of single-centre, retrospective study.

•Azvudine for the treatment of mild-to-moderate coronavirus disease 2019 was cost-effective.•Azvudine could reduce the mortality rate in high-risk outpatients with coronavirus disease 2019.•Azvudine could reduce the cost compared with the control group. This study aimed to evaluate the cost-effectiveness of Azvudine for the treatment of mild-to-moderate coronavirus disease 2019 in high-risk outpatients using real-world data and relevant references. In the decision-tree model, 2 cohorts were organized in a single center to compare the cost-effectiveness between the Azvudine plus symptomatic treatment group and the symptomatic treatment group. We calculated the cost and mortality rate for both groups. The incremental cost-effectiveness ratio was used to illustrate the cost-effectiveness. To assess the uncertainty of the model parameters, we conducted 1-way and probabilistic sensitivity analyses. In total, there were 804 outpatients included in the model. Among these, 317 patients received Azvudine plus symptomatic treatment, whereas the remaining 487 participants were treated with symptomatic treatment alone. The costs in the Azvudine and control groups were 1055.48 yuan and 2466.97 yuan and the survival rates were 100.00% and 98.70%, respectively. After calculation, the incremental cost-effectiveness ratio was determined to be −108,817.48 yuan per person. In the section of 1-way and probabilistic sensitivity analyses, Azvudine was still proven to be cost-effective. Our results support the usage of Azvudine for the treatment of high-risk outpatients with mild-to-moderate coronavirus disease 2019 from economic perspective.

Background: Nirmatrelvir/ritonavir and azvudine have been approved for the early treatment of COVID-19 in China, however, limited real-world data exists regarding their effectiveness and safety. Methods: We conducted a retrospective cohort study involving the hospitalized COVID-19 patients in China between December 2022 and January 2023. Demographic, clinical, and safety variables were recorded. Results: Among the 6,616 hospitalized COVID-19 patients, we included a total of 725 patients including azvudine recipients (N = 461) and nirmatrelvir/ritonavir (N = 264) recipients after exclusions and propensity score matching (1:2). There was no significant difference in the composite disease progression events between azvudine (98, 21.26%) and nirmatrelvir/ritonavir (72, 27.27%) groups ( p = 0.066). Azvudine was associated with a significant reduction in secondary outcomes, including the percentage of intensive care unit admission ( p = 0.038) and the need for invasive mechanical ventilation ( p = 0.035), while the in-hospital death event did not significantly differ ( p = 0.991). As for safety outcomes, 33 out of 461 patients (7.16%) in azvudine group and 22 out of 264 patients (8.33%) in nirmatrelvir/ritonavir group experienced drug-related adverse events between the day of admission ( p = 0.565). Conclusion: In our real-world setting, azvudine treatment demonstrated similar safety compared to nirmatrelvir/ritonavir in hospitalized COVID-19 patients. Additionally, it showed slightly better clinical benefits in this population. However, further confirmation through additional clinical trials is necessary.

Background: Nirmatrelvir-ritonavir, also known as paxlovid, is a widely used antiviral drug against coronavirus disease 2019 (COVID-19). Azvudine, a drug previously used to treat human immunodeficiency virus-1, has also been used to treat COVID-19 in China. However, only a few clinical studies have evaluated the effects of azvudine. Additionally, studies comparing nirmatrelvir-ritonavir with azvudine have been limited in number. Methods: We carried out a retrospective case-control analysis at the Third People's Hospital of the Tibet Autonomous Region. Eighty-two eligible patients with COVID-19 who received azvudine treatment were included. A total of 145 control patients who received nirmatrelvir-ritonavir treatment were selected by propensity score matching for age, sex, the severity of disease, and initial cycle threshold values. A comparison of the nucleic acid test negative conversion time, the length of hospitalization, and mortality rate was conducted. Results: Overall, the mean nucleic acid test negative conversion time was comparable between the nirmatrelvir- ritonavir and azvudine groups (7.0 [11.0, 15.0] vs 9.0 [6.0, 12.0] days, P=0.064). However, for patients with mild COVID-19, the nucleic acid test negative conversion time was significantly shorter in the nirmatrelvir-ritonavir group than in the azvudine group (6.0 [5.0, 8.0] vs 8.0 [6.0, 11.0] days, P=0.029). The nirmatrelvir-ritonavir group and the azvudine group did not differ significantly in length of hospitalization (8.0 [5.5,10.5] vs 8.0 [5.0,10.0] days, P=0.378). Regarding the mortality rate, there were 4 (2.8%) deaths in the nirmatrelvir-ritonavir group and 3 (3.7%) in the azvudine group (P=0.706). Conclusion: Azvudine is generally as effective as nirmatrelvir-ritonavir, but for patients with mild COVID-19, nirmatrelvir-ritonavir could suppress the virus more rapidly. For those who cannot be treated with nirmatrelvir-ritonavir, azvudine might be an effective therapy for COVID-19. Keywords: nirmatrelvir-ritonavir, azvudine, COVID-19, clinical outcome, high altitude

Background Azvudine has been approved for the treatment of coronavirus disease 2019 (COVID-19) patients in China, and this meta-analysis aims to illustrate the safety of azvudine and its effectiveness in reducing mortality. Methods PubMed, Embase, Web of science, Cochrane Library and the Epistemonikos COVID-19 Living Overview of Evidence database (L.OVE) were searched to aggregate currently published studies. Cochrane risk of bias tool and ROBINS-I tool were used to assess the risk of bias of randomized controlled study and cohort study respectively. Odds radios (ORs) with 95% confidence interval (CIs) were combined for dichotomous variables. Publication bias was assessed by Egger’s test and funnel plots. Results A total of 184 articles were retrieved from the included databases and 17 studies were included into the final analysis. Pooled analysis showed that azvudine significantly reduced mortality risk in COVID-19 patients compared with controls (OR: 0.41, 95%CI 0.31–0.54, p  < 0.001). Besides, either mild to moderate or severe COVID-19 patients could benefit from azvudine administration. There was no significant difference in the incidence of ICU admission (OR: 0.90, 95%CI 0.47–1.72, p  = 0.74) and invasive ventilation (OR: 0.94, 95%CI 0.54–1.62, p  = 0.82) between azvudine and control group. The incidence of adverse events was similar between azvudine and control (OR: 1.26, 95%CI 0.59–2.70, p  = 0.56). Conclusions This meta-analysis suggests that azvudine could reduce the mortality risk of COVID-19 patients, and the safety of administration is acceptable. Trial registration PROSPERO; No.: CRD42023462988; URL: https://www.crd.york.ac.uk/prospero/ .

Cancer significantly contributes to the unfavorable prognosis of coronavirus disease 2019 (COVID-19) patients. The efficacy and safety of azvudine and nirmatrelvir/ritonavir (Paxlovid) in cancer patients with COVID-19 remain uncertain. Therefore, we designed a comprehensive retrospective study encompassing clinical data of 32,864 hospitalized COVID-19 patients, 691 of whom were cancer patients treated with azvudine and 200 were cancer patients treated with Paxlovid. After 2:1 propensity score matching, 397 patients in the azvudine group and 199 patients in the Paxlovid group were enrolled. Cox regression analysis revealed the risk of all-cause death (HR: 1.84, 95% CI: 1.059–3.182, P  = 0.030) and composite disease progression (HR: 1.70, 95% CI: 1.043–2.757, P  = 0.033) were greater in the Paxlovid group than in the azvudine group. Two sensitivity analyses confirmed the robustness of our findings. The safety analysis of adverse events revealed no statistically significant differences between the two groups. In conclusion, we carried out the first analysis to compare the efficacy and safety of azvudine and Paxlovid in cancer patients with COVID-19 and demonstrated that azvudine significantly reduced the risk of all-cause death and composite disease progression among cancer patients with COVID-19 compared with Paxlovid.

Background and aim Two oral antivirals (Nirmatrelvir- ritonavir and Azvudine) are widely used in China practice during the Omicron wave of the pandemic. However, little evidence regarding the real-world effectiveness of these two oral antivirals in in-hospital patients. We aimed to evaluate the clinical effectiveness of nirmatrelvir-ritonavir versus azvudine among adult hospitalized patients with COVID-19. Methods This retrospective cohort study used data from three Chinese PLA General Hospital medical centres. Hospitalized patients with COVID-19 treated with azvudine or nirmatrelvir-ritonavir from Dec 10, 2022, to February 20, 2023, and did not require invasive ventilation support on admission were eligible for inclusion. Results After exclusions and propensity-score matching, the final analysis included 486 azvudine recipients and 486 nirmatrelvir-ritonavir recipients. By 28 days of initiation of the antivirus treatment, the crude incidence rate of all-cause death was similar in both types of antivirus treatment (nirmatrelvir-ritonavir group 2.8 events 1000 person-days [95% CI, 2.1–3.6] vs azvudine group 3.4 events/1000 person-days [95% CI, 2.6–4.3], P  = 0.38). Landmark analysis showed that all-cause death was lower in the nirmatrelvir-ritonavir (3.5%) group than the azvudine (6.8%, P  = 0.029) within the initial 10-day admission period, while no significant difference was observed for results between 10 and 28 days follow-up. There was no significant difference between the nirmatrelvir-ritonavir group and the azvudine group in cumulative incidence of the composite disease progression event (8.6% with nirmatrelvir-ritonavir vs. 10.1% with azvudine, HR, 1.22; 95% CI 0.80–1.86, P  = 0.43). Conclusion Among patients hospitalized with COVID-19 during the omicron wave in Beijing, similar in-hospital clinical outcomes on 28 days were observed between patients receiving nirmatrelvir-ritonavir and azvudine. However, it is worth noticing that nirmatrelvir-ritonavir appears to hold an advantage over azvudine in reducing early mortality. Further randomized controlled trials are needed to verify the efficacy of those two antivirus medications especially in early treatment.