Pradefovir mesylate and tenofovir amibufenamide for chronic hepatitis B: a systematic review and pragmatic treatment algorithm
Frontiers in Pharmacology·
- DOI
- 10.3389/fphar.2026.1862886
- PMID
- —
- PMCID
- —
- OpenAlex
- —
- Study type
- Systematic review
- Publisher
- Frontiers Media SA
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The manuscript consolidates comparative safety and efficacy data to inform clinical guidelines regarding newly approved nucleotide prodrugs for chronic hepatitis B management.
Structured evidence summary
Research question
How do the antiviral efficacy, renal and bone safety profiles, and drug interaction potentials of pradefovir mesylate and tenofovir amibufenamide compare with established tenofovir formulations in chronic hepatitis B management?
Study design
The authors performed a systematic narrative review that evaluated phase two and three randomized controlled trials alongside observational cohort studies featuring extended follow-up durations.
Population and setting
The analysis centered on adult patients diagnosed with chronic hepatitis B, utilizing data primarily sourced from clinical trials and real-world cohorts conducted within China.
Main findings
Tenofovir amibufenamide achieved viral suppression comparable to tenofovir disoproxil fumarate over ninety-six weeks while demonstrating improved kidney and bone health markers. Retrospective observations suggested similar effectiveness to tenofovir alafenamide, though direct prospective validation remains absent. Pradefovir mesylate matched tenofovir disoproxil fumarate in early viral control and maintained sustained benefits through ninety-six weeks, but its metabolic activation pathway introduces notable drug interaction risks.
Public-health relevance
The manuscript consolidates comparative safety and efficacy data to inform clinical guidelines regarding newly approved nucleotide prodrugs for chronic hepatitis B management.
Important limitations
The review depends on retrospective real-world comparisons rather than direct prospective head-to-head randomized trials. Several long-term outcomes, including durability, resistance development, and comprehensive interaction profiles, remain insufficiently characterized.
GIDS interpretation
This systematic review documents recent regulatory approvals and comparative pharmacological profiles of novel antiviral compounds, offering searchable context for tracking evolving treatment standards in hepatology.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 8 auditable classifier relationships to diseases, places, topics, and study design.