H. pylori eradication: Efficacy of levofloxacin-based triple therapy as a second-line treatment after triple therapy failure

H. pylori is widely regarded as a significant risk factor for the development of PUD and gastric cancer.¹ Successful eradication of this organism is, therefore, essential for preventing these disorders. Notably, the eradication rate of standard triple therapy (ie, clarithromycin, amoxicillin/metronidazole plus a proton pump inhibitor [PPI]) has declined to <80% worldwide in recent years, primarily due to increasing rates of clarithromycin and metronidazole resistance.^2-5

Eradication strategies with higher efficacy are urgently needed to improve the H. pylori eradication rate.⁶ Although regimens containing fluoroquinolones have been used as second-line therapy for H. pylori eradication, there is a lack of trial data to support their use.⁷

Levofloxacin-based triple therapy:
A viable second-line treatment strategy
Professor Varocha Mahachai and colleagues at Chulalongkorn University and Bangkok Hospital, Thailand, recently led a study to determine the efficacy of levofloxacin-based triple therapy as a second-line treatment strategy in the eradication of H. pylori in patients who had previously failed standard first-line triple therapy.⁸

The investigators recruited a total of 70 patients (mean age, 53.3 years; 65 patients with gastritis and 5 patients with PUD) who had previously been treated with and had failed a 7.10 day regimen of standard triple therapy, as evaluated by the 13C-Urea Breath Test (UBT). Antral biopsy samples obtained from the subjects by gastroscopy were used for sensitivity tests standard E-test and HelicoDR molecular test⁹ towards antibiotics such as amoxicillin, clarithromycin and levofloxacin.

Patients were treated with a 10-day regimen of oral levofloxacin (500 mg once daily) plus lansoprazole and amoxicillin (30 mg and 1,000 mg bid, respectively). Eradication of H. pylori was evaluated at 4 weeks post-therapy by 13C-UBT.

Efficacy of levofloxacin-based second-line triple therapy
Approximately 10% of study subjects reported minor side effects but none dropped out. At 4 weeks, the levofloxacin-based triple therapy, as a second-line treatment, resulted in an eradication rate of 62.9% (Figure 1). Patients in this study were considered difficult to treat as they had previously failed first-line standard triple therapy and likely harboured high loads of multiple-drug-resistant organisms. Levofloxacin resistance by HelicoDR test was detected in 50% (18/36) of subjects, and the eradication rate in the levofloxacin-sensitive group was higher than in the levofloxacin-resistant group (66.7% vs 16.7%). The study found no correlation between age or gender and eradication rate.

Click on image to enlarge.

Given that 70% of patients originally achieved H. pylori eradication after first-line standard triple therapy, the 62.9% eradication rate of levofloxacin-based second-line triple therapy in the remaining 30% of patients (who have failed the first-line therapy) led to the cumulative eradication rate of ≈89% [70%+(30%*62.9/100), shown in Figure 2]. Patients who failed both first-and second-line therapies (≈11%) may be subjected to further treatments until permanent cure is achieved.

The investigators concluded that a simple levofloxacin-based triple regimen is effective as second-line therapy for the eradication of H. pylori, with good patient tolerability.

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Click on image to enlarge.

References

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3. Gisbert JP, et al. Helicobacter 2007;12 Suppl 2:50-58.
4. O’Connor A, et al. Helicobacter 2010;15 Suppl 1:46-52.
5. O’Connor A, et al. Helicobacter 2011;16 Suppl 1:53-58.
6. Gisbert JP, Calvet X. Aliment Pharmacol Ther 2011;34:1255-1268.
7. Li Y, et al. Wien Klin Wochenschr 2009;121:47-52.
8. Varocha M, et al. Efficacy of levofloxacin-based triple therapy as a second-line therapy after triple therapy failure. Poster session presented at: Gastro 2013 APDW/WCOG, 21.24 September 2013; Shanghai, China.
9. Cambau E, et al. J Clin Microbiol 2009 Nov;47(11):3600-3607.