In a 2024 systematic review and meta analysis, efficacy and safety of baloxavir was compared against oseltamivir in patients with influenza virus. Two randomized trials (N= 1,624 outpatients) and two retrospective trials (N= 874 inpatients) were assessed for mortality, hospital length of stay, illness duration and viral load, and treatment adverse events. In outpatients, no deaths occurred with either baloxavir or oseltamivir, and illness duration was comparable between groups; however, baloxavir was superior in influenza virus titer reduction (p<0.001), viral RNA load reduction (p<0.001), and was more tolerable (p= 0.03) compared to oseltamivir. In inpatients, baloxavir patients had a lower hospitalization period (p= 0.01), though mortality outcomes were similar. Based on these findings, baloxavir use may be safer and more efficacious than oseltamivir for treatment of influenza, though more data is required to confirm these findings. [1]
A 2024 systematic review and network meta-analysis of 33 randomized trials evaluated the efficacy and safety of six antiviral agents, including zanamivir, oseltamivir, laninamivir, baloxavir, amantadine, and rimantadine for post-exposure prophylaxis of influenza. A total of 19,096 individuals, with a mean age ranging from 6.75 to 81.15 years, were included. The analysis incorporated trials comparing antivirals to placebo or standard care, with primary outcomes including symptomatic influenza, asymptomatic infection, hospital admission, all-cause mortality, and adverse events. Zanamivir, oseltamivir, laninamivir, and baloxavir probably reduce the risk of symptomatic seasonal influenza in high-risk individuals when administered within 48 hours of exposure, with relative risk reductions ranging from 0.35 to 0.43. However, these agents likely provide little to no benefit in low-risk populations. No trial directly assessed post-exposure prophylaxis against zoonotic influenza; however, indirect evidence suggested that neuraminidase inhibitors and baloxavir might reduce symptomatic zoonotic influenza following exposure to novel influenza A viruses. No significant effect was observed on hospital admissions (moderate certainty) or all-cause mortality (high to moderate certainty). Adverse events and serious adverse events did not significantly increase with any antiviral, though certainty varied. The findings underscore the potential clinical utility of these antivirals in targeted high-risk populations while highlighting the need for further data in vulnerable groups, including pregnant individuals and those with comorbidities. [2]
A 2021 systematic review and meta-analysis of randomized trials evaluated the clinical efficacy and safety of baloxavir marboxil in comparison to oseltamivir and placebo for the treatment of influenza. The analysis included data from three phase 3 randomized trials, encompassing 3,771 patients (baloxavir, n= 1,451; oseltamivir, n= 1,288; placebo, n= 1,032). In comparison to placebo, baloxavir significantly reduced the time to symptom alleviation by an average of 26.32 hours (95% confidence interval [CI] -33.78 to -18.86) with no observed heterogeneity (I²= 0%). The virological response was superior with baloxavir, demonstrating a greater reduction in influenza virus titers and viral RNA load by day 2 compared to both oseltamivir and placebo. Although the time to symptom resolution was similar between baloxavir and oseltamivir (mean difference -1.29 hours; 95% CI -6.80 to 4.21; I²= 0%), baloxavir was associated with fewer overall adverse events than oseltamivir (odds ratio [OR] 0.82; 95% CI 0.69 to 0.98; I²= 0%), particularly for nausea. These findings support baloxavir as a clinically effective and relatively safe antiviral option, with a distinct virological advantage over oseltamivir. [3]
A 2021 Bayesian network meta-analysis assessed the efficacy and safety of baloxavir marboxil compared to neuraminidase inhibitors, including oseltamivir, zanamivir, laninamivir, and peramivir, in the treatment of influenza among high-risk and uncomplicated patients. A systematic literature review identified 32 relevant randomized controlled trials, comprising 7 studies involving high-risk patients, 13 trials focused on otherwise healthy individuals, and 14 studies that included both populations. The primary outcome evaluated was the time to alleviation of all influenza symptoms, while secondary measures included the time to resolution of fever, changes in viral titer at 24 and 48 hours post-treatment, and adverse event profiles. The analysis demonstrated that baloxavir significantly reduced the time to symptom resolution compared to placebo in high-risk individuals, with comparable efficacy to neuraminidase inhibitors. Notably, baloxavir was associated with a significantly greater decline in viral titer at 24 and 48 hours post-treatment when compared to oseltamivir and peramivir. In terms of safety, baloxavir exhibited a similar adverse event profile to other antiviral agents and was associated with a lower incidence of drug-related adverse events than oseltamivir and laninamivir. The findings remained consistent when pooling data from all uncomplicated influenza patients, reinforcing baloxavir’s superior antiviral activity and comparable clinical efficacy and safety to neuraminidase inhibitors. [4]
A 2024 cost-effectiveness analysis evaluated baloxavir marboxil compared with oseltamivir or no antiviral treatment for influenza management in the United States. A decision tree cost-effectiveness model was developed utilizing a lifetime time horizon with a 3.0% discount rate for costs and quality-adjusted life-years (QALYs). The model incorporated patient data from the Merative™ MarketScan® Research Databases, which included US commercial claims, Medicare, and Medicaid Supplemental databases from the 2018-2020 influenza seasons. Complication rates, healthcare resource utilization, and costs were extrapolated from real-world administrative claims data. Outcomes were reported in terms of total QALYs, incremental cost-effectiveness ratios (ICERs), and net monetary benefit (NMB) based on a willingness-to-pay threshold of $100,000 per QALY. Findings demonstrated that baloxavir was cost-effective compared with oseltamivir ($6,813/QALY gained) and no antiviral treatment ($669/QALY gained). The NMB of baloxavir was projected at $1,180 compared with oseltamivir and $6,208 compared with no treatment, with greater cost savings observed in high-risk individuals. Sensitivity analyses confirmed the robustness of these results, with probabilistic modeling indicating that baloxavir remained cost-effective in 69.3% of simulations versus oseltamivir and 95.2% versus no treatment. Scenario analysis assessing the impact of viral transmission reduction revealed that a 5% reduction increased the NMB of baloxavir to $2,592 over oseltamivir and $7,621 over no treatment, with baloxavir becoming dominant (more effective and less costly) at viral transmission reductions of 12.0% and 6.0%, respectively. These findings emphasize the economic and potential public health benefits of baloxavir in influenza management, particularly when considering its effect on viral transmission. [5]