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Reviews of "The Safety of Antivirals and Neutralising Monoclonal Antibodies Used in Prehospital Treatment of Covid-19"

Reviewers: P Htoo (Harvard University) | 📒📒📒◻️◻️ • C Zang (Cornell University) | 📒📒📒 ◻️◻️

Published onJun 13, 2024
Reviews of "The Safety of Antivirals and Neutralising Monoclonal Antibodies Used in Prehospital Treatment of Covid-19"
key-enterThis Pub is a Review of
The safety of antivirals and neutralising monoclonal antibodies used in prehospital treatment of Covid-19
The safety of antivirals and neutralising monoclonal antibodies used in prehospital treatment of Covid-19
Description

Abstract Objective This proof-of-principle pharmacovigilance study used Electronic Health Record (EHR) data to examine the safety of sotrovimab, paxlovid and molnupiravir in prehospital treatment of Covid-19.Method With NHS England approval, we conducted an observational cohort study using OpenSAFELY-TPP, a secure software-platform which executes analyses across EHRs for 24 million people in England. High-risk individuals with Covid-19 eligible for prehospital treatment were included. Adverse events (AEs) were categorised into events in the drug’s Summary of Product Characteristics (SmPC), drug-reactions and immune-mediated. Cox models compared risk across treatments. A pre-pandemic record analysis was performed for comparative purposes.Results Between 2021-2023, 37,449 patients received sotrovimab, paxlovid or molnupiravir whilst 109,647 patients made up an eligible-but-untreated population. The 29-day rates of AEs were low: SmPC 0.34 per 1000 patient-years (95%CI 0.32-0.36); drug-reactions 0.01(95% CI0.01-0.02) and immune-mediated 0.03(95%CI 0.03-0.04), and similar or lower than the pre-pandemic period. Compared with the eligible but untreated population, sotrovimab and paxlovid associated with a risk of SmPC AE [adjHR 1.36(95%CI 1.15-1.62) and 1.28(95%CI 1.05-1.55), respectively], whilst sotrovimab associated with a risk of drug-reactions [adjHR 2.95(95%CI 1.56-5.55)] and immune-mediated events [adjHR 3.22(95%CI 1.86-5.57)].Conclusion Sotrovimab, paxlovid and molnupiravir demonstrate acceptable safety profiles. Although the risk of AEs was greatest with sotrovimab, event rates were lower than comparative pre-pandemic period.

To read the original manuscript, click the link above.

Summary of Reviews: The reviewers find the study on the safety of antivirals and neutralizing monoclonal antibodies for prehospital COVID-19 treatment potentially informative but highlight several areas for improvement. They commend the analysis of adverse events using UK OpenSAFELY-TPP data but point out issues such as the need for more explicit trial emulation methods, addressing competing risks like acute mortality, and conducting sensitivity analyses considering variant concerns and long-term effects. Additionally, a reviewer notes that the reported "acceptable safety profile" contradicts the observed increased risks of adverse events and suggests more accurate interpretations of results. Reviewers emphasize addressing potential confounding factors and providing more comprehensive methodological details for stronger conclusions.

Reviewer 1 (Phyo H…) | 📒📒📒 ◻️◻️

Reviewer 2 (Chengxi Z…) | 📒📒📒 ◻️◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

To read the reviews, click the links below. 

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