0
0
A groundbreaking clinical trial examining suraxavir marboxil, an antiviral drug, has revealed that a single 40-mg dose significantly shortened flu symptom resolution time in male patients but did not provide the same benefit to female participants. The study, led by the China-Japan Friendship Hospital and published in Nature Medicine, sheds light on the gender-dependent effects of this promising flu treatment.
Influenza remains a major global health concern, causing between 290,000 and 650,000 respiratory-related deaths annually. The study aimed to assess the efficacy of suraxavir marboxil, a polymerase subunit inhibitor developed to combat influenza viruses, especially as current treatments face challenges like resistance to neuraminidase inhibitors.
The trial, titled “Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents,” included 527 participants aged 5–65 who had confirmed influenza. Of these, 55.4% were male. Participants received either suraxavir (352 participants) or a placebo (175 participants). Exclusion criteria included severe pre-existing conditions, prior antiviral use, or a COVID-19 diagnosis.
The primary measure of success was the time to symptom alleviation, defined as the period from the initiation of treatment to the resolution of all flu symptoms for at least 21.5 hours. The results showed that suraxavir shortened symptom alleviation time by approximately 20 hours, with males benefiting the most. Men saw a median reduction of 42 hours compared to 63 hours for placebo recipients, whereas females did not experience the same improvement.
The study’s findings on gender differences were subtly referenced, with the primary endpoint for females failing to reach statistical significance. However, the data was not prominently featured in the study’s main text and was instead relegated to supplementary materials. This omission has sparked concern, as some media coverage failed to acknowledge that suraxavir’s efficacy was primarily observed in males.
Despite these disparities, the trial reported other positive outcomes for suraxavir, including a significantly faster viral load reduction and quicker viral clearance compared to the placebo group. The drug was generally well-tolerated, with mild to moderate side effects like diarrhea and transient irregular heartbeats being most common among children and adolescents.
However, questions remain about the trial’s combined data, particularly concerning the unreported outcomes for female patients. Further investigation is needed to explore the potential reasons for the gender disparity in treatment response and determine whether suraxavir’s effectiveness in males could be even greater than the trial suggests.
Virological endpoints were also promising, showing faster viral load reductions in the suraxavir group. Resistance monitoring revealed a slight occurrence of I38T mutations in H3N2 strains (0.9%), indicating a potential for developing resistance.
The study concludes that suraxavir marboxil is a promising treatment for uncomplicated influenza, particularly in males. Further research is needed to understand the gender-specific responses and to determine how these findings may influence future influenza treatment protocols.
For more information, the study is published in Nature Medicine (2025), DOI: 10.1038/s41591-024-03419-3.
Source: Yeming Wang et al, Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, Nature Medicine (2025).
