PROSPECTS AND PROBLEMS OF DEVELOPMENT, PRODUCTION, AND USE OF BACTERIOPHAGE-BASED MEDICINES

Abstract

The objective of the study was to investigate the current state of bacteriophages in the fight against multidrug-resistant infections based on international and national scientific publications and to identify the main problems with the use of bacteriophage therapy in medical practice.

Methods: In our research, we used general theoretical methods: historical, documentary, analytical, generalization, comparison, systematization and analytical data processing

Results: The global medical community has been raising the issue of rational use of antibiotics for more than 30 years and is looking for new ways to combat multidrug-resistant (multidrug-resistant) infections. In particular, the WHO report for 2022 “The burden of bacterial antimicrobial resistance in the WHO European region in 2019: a cross-country systematic analysis” indicates that 541 thousand deaths in the European region were caused by multidrug-resistant infections. These fatal infections were caused by Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium, Streptococcus pneumoniae and Acinetobacter baumannii and their combinations with S. aureus. In Ukraine, the problem of multidrug-resistant infections is particularly relevant in connection with the Russian aggression, during which many militaries and civilians were injured. One of the most effective and promising ways to combat multidrug-resistant infectious diseases is the “forgotten” bacteriophage therapy. The interest of the medical community in bacteriophage therapy is evidenced by the large number of scientific publications on this topic. Thus, in 2009 it was about 2600 publications, and in 2024 their number increased to 20800. During this period, a large number of clinical trials were conducted to prove the efficacy and safety of phage therapy against various infectious agents; in Europe and the United States alone, this number reached more than 200 phase 1 and phase 2 clinical trials.

The world's largest research center is the Giorgi Eliava Institute of Bacteriophages, Microbiology, and Virology (Tbilisi, Georgia), which has been researching bacteriophages for more than 100 years. These studies have resulted in a number of medicines with bacteriophage “cocktails” that are successfully used to treat wounds from postoperative interventions, injuries and burns. Today, the technologies for treating bacterial infections developed in Georgia are used in medical institutions in Europe (Belgium, England, Germany, France), as well as in Israel and the United States.

Conclusions: Bacteriophage-based medicines are a promising area for the treatment of multidrug-resistant infectious diseases of various etiologies, and are currently used only as a last resort. WHO is collecting evidence on the effectiveness and safety of bacteriophages for the treatment of infectious diseases of various etiologies.

The main problem on the way to the development, clinical trials and introduction of bacteriophage-based medicines into medical practice is the international and national good regulatory practices (GLP, GCP, GMP, etc.) that all researchers and manufacturers of medicines must follow. Such regulatory requirements for drug development are not applicable to drugs containing bacteriophages, and therefore new requirements need to be developed or adapted to ensure that new drugs that can save thousands of lives are finally available.