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Antibiotics | Second-Line Levofloxacin-Based Quadruple Therapy for Helicobacter pylori: Real-World Efficacy in Vietnam

Antibiotics | Second-Line Levofloxacin-Based Quadruple Therapy for Helicobacter pylori: Real-World Efficacy in Vietnam
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This study reveals the real-world efficacy of second-line levofloxacin-based quadruple therapy for Helicobacter pylori eradication in Vietnam, demonstrating declining effectiveness but maintaining non-inferiority to the international guideline benchmark of 80% efficacy. It highlights treatment adherence as a critical modifiable factor influencing outcomes, providing evidence to optimize clinical treatment strategies.

 

Literature Overview
The article "Diminishing Efficacy of Second-Line Levofloxacin-Based Quadruple Therapy in Helicobacter pylori Eradication: A Prospective Real-World Study in Vietnam Amid Rising Antibiotic Resistance", published in *Antibiotics*, reviews and summarizes the real-world efficacy of levofloxacin-based quadruple therapy (PALB) for Helicobacter pylori eradication in Vietnam. It analyzes potential factors contributing to treatment failure, such as increasing antibiotic resistance and adherence issues. The study also notes the clinical utility of this regimen in resource-limited settings without antimicrobial susceptibility testing, while emphasizing the need for ongoing resistance monitoring.

Background Knowledge
Helicobacter pylori (H. pylori) infection is a leading global cause of chronic gastritis, peptic ulcer disease, and gastric cancer, with particularly high prevalence rates in Vietnam. Rising antibiotic resistance, especially to fluoroquinolones and amoxicillin, challenges the efficacy of standard regimens. The PALB second-line therapy (proton pump inhibitor + amoxicillin + levofloxacin + bismuth) was previously widely recommended but has shown declining real-world effectiveness. This study, based on a prospective real-world cohort, evaluates current eradication rates in Vietnamese populations and explores key factors affecting outcomes, including adherence and dosage adjustments, to inform updates to national treatment guidelines.

 

 

Research Methods and Experiments
This prospective cohort study was conducted at the Gastroenterology Department of Ho Chi Minh City Medical Center, enrolling 225 patients with H. pylori infections who failed first-line therapy. All participants received a 14-day PALB regimen, with eradication success assessed via 13C-urea breath test (UBT) or rapid urease test (RUT) 4–12 weeks post-treatment. Adherence was evaluated using pill counts and patient diaries, with ≥80% medication compliance defined as optimal adherence.

Key Conclusions and Perspectives

  • The PALB regimen achieved eradication rates of 78.2% in modified intention-to-treat (mITT) analysis and 78.6% in per-protocol (PP) analysis. Both 95% confidence intervals included the 80% benchmark, indicating no statistically significant difference.
  • Optimal adherence significantly improved eradication success (80.1%) with statistical significance (OR=2.93), identifying adherence as a modifiable determinant of therapeutic outcomes.
  • High-dose levofloxacin (>500 mg/day) showed higher eradication rates in PP analysis (87.1%), though the difference did not reach statistical significance (p=0.052).
  • The study highlights escalating antibiotic resistance in Vietnam, particularly to fluoroquinolones and amoxicillin, which may compromise second-line treatment efficacy.

Research Significance and Prospects
This research underscores the need for adherence-focused patient education and robust resistance monitoring systems in regions with increasing antibiotic resistance. Future studies should incorporate multi-center designs and genotype-based resistance testing to clarify the role of high-dose levofloxacin in second-line therapy, supporting data-driven personalization of treatment protocols.

 

 

Conclusion
This study provides updated real-world evidence on second-line levofloxacin-based quadruple therapy for H. pylori eradication in Vietnam, demonstrating slightly reduced efficacy that remains within acceptable clinical ranges. Treatment failure primarily correlates with poor patient adherence, while high-dose levofloxacin shows potential for improved outcomes requiring further validation. Findings recommend strengthening adherence education and resistance surveillance to guide clinical optimization. For research institutions and pharmaceutical companies, developing adherence-enhancing and resistance-targeted therapeutic strategies represents a critical future direction for H. pylori eradication.

 

Reference:
Thong Duy Vo, Thao Thu Ngan, and Thuy Thi Thanh Trinh. Diminishing Efficacy of Second-Line Levofloxacin-Based Quadruple Therapy in Helicobacter pylori Eradication: A Prospective Real-World Study in Vietnam Amid Rising Antibiotic Resistance. Antibiotics.