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

Liu, D. and Van Belleghem, J. D. and de Vries, C. R. and Burgener, E. and Chen, Q. and Manasherob, R. and Aronson, J. R. and Amanatullah, D. F. and Tamma, P. D. and Suh, G. A.

Viruses (2021) 13:

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 optimize safety and toxicity monitoring with the therapeutic use of phage moving forward. In our systematic review of the literature, we found some adverse events associated with phage therapy, but serious events were extremely rare. 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.

Citation

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. (2021). The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses, 13(7). https://doi.org/10.3390/v13071268 *animal models, *phage therapy, *clinical trials, *immune activation, *safety and toxicity, Adaptive Phage Therapeutics (APT). The funders had no role in the design of the, manuscript, or in the decision to publish the results., study, in the collection, analyses, or interpretation of data, in the writing of the

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