Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

The Safety and Toxicity of Phage Therapy: A Review of Pre-Clinical and Clinical Studies

Version 1 : Received: 10 May 2021 / Approved: 11 May 2021 / Online: 11 May 2021 (10:30:59 CEST)

A peer-reviewed article of this Preprint also exists.

Liu, D.; Van Belleghem, J.D.; de Vries, C.R.; Burgener, E.; Chen, Q.; Manasherob, R.; Aronson, J.R.; Amanatullah, D.F.; Tamma, P.D.; Suh, G.A. The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses 2021, 13, 1268. Liu, D.; Van Belleghem, J.D.; de Vries, C.R.; Burgener, E.; Chen, Q.; Manasherob, R.; Aronson, J.R.; Amanatullah, D.F.; Tamma, P.D.; Suh, G.A. The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses 2021, 13, 1268.

Journal reference: Viruses 2021, 13, 1268
DOI: 10.3390/v13071268

Abstract

Increasing rates of infection by antibiotic resistant bacteria have led to a resurgence of interest in bacteriophage (phage) therapy. Several phage therapy studies in animals and humans have been completed over the last two decades. We conducted a systematic review of safety and toxicity data associated with phage therapy in both animals and humans reported in English-language publications from 2008 – 2021. Overall, 69 publications met our eligibility criteria including 20 animal studies, 35 clinical case reports or case series, and 14 clinical trials. After summarizing safety and toxicity data from these publications, we discuss potential approaches to optimizing safety and toxicity monitoring with the therapeutic use of phage moving forward. In our systematic review of the literature, we found few, but no serious, adverse events associated with phage therapy. Comprehensive and standardized reporting of potential toxicities associated with phage therapy has generally been lacking in the published literature. Structured safety and tolerability endpoints are necessary when phages are administered as anti-infective therapeutics.

Keywords

Phage therapy; clinical trials; animal models; safety and toxicity; immune activation

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