Fe2O3-based nanozyme synergistic with oseltamivir for broad-spectrum inhibition of influenza A virus.

Objective: To evaluate the antiviral effect, clinical efficacy, safety and tolerability of pixavir marboxil in adult patients with acute, uncomplicated influenza. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase Ⅱ clinical trial. Eligible participants were adults aged 18 to 64 years with acute, uncomplicated influenza, presenting within 48 hours of symptom onset with an axillary temperature ≥38.0 ℃ and ≥1 moderate-to-severe influenza symptom, who were neither severely ill nor at high risk for severe disease. Exclusion criteria included known hypersensitivity and recent antiviral use or vaccination. Participants were centrally randomized (1∶1∶1∶1) to oral pixavir marboxil (40 mg, 80 mg, or 40+40 mg) or placebo. Randomization was stratified by body weight (<80 kg vs.≥80 kg) and baseline influenza symptom score (<12 points vs.≥12 points). Rescue medications were permitted as clinically indicated during follow-up. The primary endpoint was the time to influenza virus RNA negativity by RT-PCR (time from first dose to the first RNA measurement below the lower limit of detection). Secondary endpoints included the time to relief of all influenza symptoms (severity scores of 0 or 1 for all 7 symptoms, sustained for ≥21.5 hours), time to cessation of infectious viral shedding by virus titer, time to resolution of fever, time to recovery to pre-influenza health status, changes from baseline in EQ-5D-5L scores, and the incidence of adverse events. Statistical analyses were performed using SAS 9.4. Efficacy was analyzed in the intention-to-treat infected (ITTI) and intention-to-treat (ITT) populations. Time-to-event data, including the primary endpoint, were estimated using the Kaplan-Meier method and compared between groups using the stratified Peto-Prentice generalized Wilcoxon test. Categorical data were analyzed using the Fisher's exact test or the Mantel-Haenszel test. Results: A total of 202 patients with influenza B were enrolled. In the ITTI population (107 cases), the median time to influenza virus RNA negativity was 28.2 h (95%CI: 19.73-43.88) in the 80 mg group, 35.5 h (95%CI: 23.43-45.05) in the 40 mg+40 mg group, and 42.4 h (95%CI: 22.60-57.53) in the 40 mg group, compared with 48.1 h (95%CI: 23.25-83.67) in the placebo group; between-group differences were not statistically significant (all P>0.05). The median times to cessation of infectious viral shedding by virus titer (TCID50) for the pixavir marboxil were [80 mg: 19.5 h (95%CI: 15.17-22.80); 40 mg: 22.6 h (95%CI: 14.72-44.85); 40 mg+40 mg: 23.1 h (95%CI: 18.63-26.98)] were versus the 45.8 h (95%CI: 20.20-68.57) in the placebo group; only the 80 mg group reached a statistically significant difference (P=0.027). In the ITT population (200 cases), pixavir marboxil 40 mg significantly shortened the median time to relief of all influenza symptoms compared to the placebo group [37.7 h (95%CI: 22.23-49.33) vs. 68.2 h (95%CI: 47.70-97.17), P=0.009], whereas the 80 mg group showed only a non-significant trend toward shortening 45.8 h [(95%CI: 34.50-62.67) vs. 68.2 h]. The median time to resolution of fever was significantly reduced in both the 40 mg [24.1 h (95%CI: 19.40-30.97)] and 80 mg [22.9 h (95%CI: 19.48-27.00)] groups compared with placebo [44.0 h (95%CI: 34.67-50.85)], with reductions of 19.9 h and 21.1 h, respectively (both P<0.001). The median time to recovery to pre-influenza health status was significantly shortened in the 80 mg [127.7 h (95%CI: 99.65-168.77)] and 40 mg [152.1 h (95%CI: 105.55-171.83)] groups compared with placebo [198.1 h (95%CI: 167.10-210.52)], with reductions of 70.4 h and 46.0 h, respectively (both P<0.05). The incidence of adverse events was comparable across groups: 13.5% (40 mg), 18.0% (80 mg), 20.4% (40 mg+40 mg), and 20.4% (placebo). No baseline or treatment-emergent resistance mutations were detected. Conclusion: Single-dose pixavir marboxil regimens demonstrated potential benefits in improving infectivity-related virologic measures and alleviating clinical symptoms in adults with uncomplicated influenza, with favorable overall tolerability. These findings provide a basis for subsequent confirmatory clinical trials.

Respiratory syncytial virus as an independent driver of a subsequent influenza epidemic in Berlin before and after the COVID-19 pandemic.

LTX-109 as a broad-spectrum antiviral: in vitro and in vivo efficacy against SARS-CoV-2 and influenza viruses.

Surveillance and cross-species transmission assessment of H3NX avian influenza viruses isolated in Guangdong province, China from 2023 to 2025.

BECC-adjuvanted hemagglutinin influenza vaccine promotes enhanced immunogenicity and protective efficacy.

When viruses meet cystic fibrosis: Insights into host-pathogen dynamics.

Comparative analysis of next-generation sequencing methods for whole-genome sequencing of seasonal influenza viruses.

The Respiratory Triple Pandemic in the Intensive Care Unit: Epidemiology, Clinical Features and Management of COVID-19, Influenza and Respiratory Syncytial Virus.

Development of a DC-targeting Salmonella- amplifying RNA vector platform co-delivering dual antigens and adjuvants for enhanced protection against H9N2 avian influenza.

Pixavir marboxil (Yilikang®; ®) is an oral cap-snatching endonuclease inhibitor being developed by TaiGen Biotechnology for the treatment of influenza virus infections. Pixavir marboxil recently received approval in China for the treatment of uncomplicated influenza A and B in previously healthy adults and adolescents aged ≥ 12 years. This article summarizes the milestones in the development of pixavir marboxil leading to this first approval for uncomplicated influenza A and B infections.

Discovery of rare cycloartane-type triterpenoid sulfates from Wrightia pubescens and their neuraminidase inhibition activity.

Influenza A and B viruses are the main agent of the seasonal flu outbreaks and their circulation in each area is important to control pandemic caused by this viruses. The aim of the present study was to identify the molecular and seasonal pattern of influenza virus subtypes to investigate circulating influenza A and B viruses in Tehran, Iran. A cross sectional study was conducted on 108 positive clinical samples in Tehran, Iran between 2023 and 2024. In order to determined mutations and antigenic changes in IAV, and IBV, a conventional PCR and then sequencing was performed on purified PCR products. Among these, 70 (64.81%), and 38 (35.18%) were IAV, and IBV, respectively. Of the 70 influenza A cases, 45 (64.28%) were subtype H3N2 and 25 (35.71%) were subtype H1N1pdm09. Of 38 influenza B cases, while, 20 was unsuitable and was excluded from study, 23 were further characterized as belonging to the B/Yamagata lineage. We detected 13 distinct amino acid substitutions in the HA1 subunit of H1N1, and 8 amino acid substitutions in HA1 among the H3N2 isolates. The current phylogenetic study and complete sequencing of the HA and NA gene fragments of influenza viruses A and B provide essential information for tracking viral evolution, guiding vaccine development, and ensuring public health preparedness against influenza outbreaks which will play an increasingly important role in global health initiatives.

Virucidal multipurpose aqueous solution containing quaternary ammonium cation and sulfobetaine is effective against highly pathogenic avian influenza viruses.

Respiratory viruses in adult community-acquired pneumonia identified by a multiplex PCR panel: a single-center retrospective study.

NS1-A53D enhances HA stability to coordinate viral entry with vRNP export and replication during adaptation of H1N1 canine influenza virus.

Respiratory viruses as key drivers of pulmonary fibrosis: integrated pathways from barrier injury to immune-fibrotic crosstalk.

Development of a recombinant chimeric Newcastle disease virus-vectored vaccine conferring single-dose, triple protection against genotype VII NDV, IBDV, and H9N2 AIV.

Development of an ELISA-based pulldown approach for functional analysis of antigen-specific antibodies.

Niclosamide inhibits the replication of highly pathogenic avian influenza A (H5Nx) viruses and antiviral-resistant mutants.