Efficacy of levofloxacin-doxycycline-based rescue therapy for Helicobacter pylori eradication: A prospective open-label trial in Saudi Arabia

Background: Helicobacter pylori eradication is achieved in 60%–80% with first-line therapy. Different second-line therapeutic options are available. However, the success of second-line therapy has not been addressed or reported from Saudi Arabia. Objectives: The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included were symptoms' response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment. Patients and Methods: A prospective, open-label, single-arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for 10 days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily and esomeprazole 20 mg twice daily. Urea breath test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Results: From 55 patients recruited, 32 had failed to respond to previous standard triple therapy, 15 patients failed to respond to sequential therapy and 8 patients failed to both regimens. Persistent H. pylori infection was confirmed by rapid urease test, histology or UBT. H. pylori eradication was achieved in 20 out of 51 patients (39.22%, per protocol analysis, 36.36% by intention to treat analysis). Therapy was well tolerated and side effects were generally mild. Conclusion: Rescue treatment with levofloxacin and doxycycline-based therapy for 10 days was well tolerated but effective only in 39.22% of patients infected with H. pylori in Saudi Arabia. More trials to determine the most efficacious rescue therapy in Saudi Arabia are needed.