Reimagining Phage Therapy for MDR Pathogens: From Biobanks to Health System Integration-A Review

Area of Science:

• Microbiology and Infectious Diseases
• Biotechnology and Pharmaceutical Sciences
• Global Health and Health Systems

Background:

• Multidrug-resistant (MDR) pathogens, like Klebsiella pneumoniae, represent a critical global health threat, particularly in low- and middle-income countries (LMICs) with limited treatment options.
• Bacteriophage (phage) therapy offers a specific, potentially low-cost alternative to antibiotics, with demonstrated efficacy in vitro and in personalized treatments.
• Significant barriers hinder clinical integration of phage therapy in LMICs, including the absence of local phage banks and unclear regulatory frameworks.

Purpose of the Study:

• To propose a structured implementation framework for bacteriophage therapy tailored to resource-limited health systems.
• To bridge the translational gap between laboratory efficacy and clinical application of phage therapy in LMICs.
• To provide an actionable blueprint for integrating phage therapy into national antimicrobial resistance strategies.

Main Methods:

• Synthesis of current evidence on bacteriophage therapy efficacy and implementation challenges.
• Development of the "5-P roadmap" framework: Phage-host biobanks, Preparations, Preclinical validation (including phage-antibiotic synergy), Policy and regulatory pathways, and Pilot clinical trials.
• Focus on strategies applicable to resource-limited settings and health system integration.

Main Results:

• The 5-P roadmap provides a cohesive strategy for advancing phage therapy implementation.
• The framework addresses key systemic barriers in LMICs, such as establishing integrated phage-host biobanks and developing context-appropriate phage preparations.
• It emphasizes rigorous preclinical validation, including phage-antibiotic synergy, and the parallel development of policy and regulatory pathways.

Conclusions:

• The proposed 5-P roadmap offers a viable blueprint for advancing bacteriophage therapy in LMICs.
• Simultaneous attention to the interconnected pillars of the roadmap is crucial for successful implementation.
• This framework can facilitate the scalable, equitable, and sustainable integration of phage therapy as an adjunct to combat antimicrobial resistance in LMICs.