Publications by authors named "F Mentre"
Background: The global mpox outbreak which started in May 2022 was caused by a novel clade IIb variant of the mpox virus (MPXV). It differed from the traditional Western and Central Africa disease in transmission patterns and clinical presentation.
Methods: To address the need for detailed clinical and virologic data, we conducted an observational cohort study (MOSAIC) during May 2022-July 2023 in individuals with confirmed MPXV infection enrolled in six European Countries.
Article Synopsis
- Degenerative cerebellar ataxias are a group of rare genetic diseases with potential new treatments on the horizon, but effective trial designs and analyses are currently inadequate.
- This study used item response theory (IRT) modeling to analyze disease progression in various ataxias using data from the autosomal recessive cerebellar ataxia (ARCA) registry, specifically assessing changes with the Scale for Assessment and Rating of Ataxia (SARA).
- Findings indicated that disease progression rates differ by genotype, impacting trial design; faster progression in disorders like POLG requires smaller trial sizes and shorter timeframes for effective results compared to slower-progressing conditions like COQ8A.
Antiviral effect of Evusheld in COVID-19 hospitalized patients infected with pre-Omicron or Omicron variants: a modelling analysis of the randomized DisCoVeRy trial.
J Antimicrob Chemother
November 2024
Background: The antiviral efficacy of Evusheld (AZD7442) in patients hospitalized for SARS-CoV-2 is unknown.
Methods: We analysed the evolution of both the nasopharyngeal viral load and the serum neutralization activity against the variant of infection in 199 hospitalized patients (109 treated with Evusheld, 90 treated with placebo) infected with the SARS-CoV-2 virus and included in the randomized, double-blind, trial DisCoVeRy (NCT04315948). Using a mechanistic mathematical model, we reconstructed the trajectories of viral kinetics and how they are modulated by the increase in serum neutralization activity during Evusheld treatment.
Article Synopsis
- Therapeutic monoclonal antibodies have been effective against SARS-CoV-2 in at-risk groups, but their effectiveness is declining due to new variants.
- Health authorities are using in vitro tests to guide treatment recommendations, but these tests may not accurately reflect clinical efficacy in real-world situations.
- A study using hamsters shows that while AZD7442 retains some effectiveness against specific variants like BA.1 and BA.2, its reliability drops significantly against BA.5, underscoring the need for animal studies to enhance understanding of antibody performance in humans.
Conventional pharmacokinetic (PK) bioequivalence (BE) studies aim to compare the rate and extent of drug absorption from a test (T) and reference (R) product using non-compartmental analysis (NCA) and the two one-sided test (TOST). Recently published regulatory guidance recommends alternative model-based (MB) approaches for BE assessment when NCA is challenging, as for long-acting injectables and products which require sparse PK sampling. However, our previous research on MB-TOST approaches showed that model misspecification can lead to inflated type I error.
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