- Email: [email protected]
769 Appropriateness of Repeating Helicobacter pylori Culture and Susceptibility Testing Following Failure of Individualized Antibiotic Therapy
AGA Abstracts
on testing, and duration of follow-up (p ‡0.17 for each comparison). Likelihood of typical symptoms was highest with strong reflux evidence and lowest with equivocal evidence (p= 0.046). Similarly, baseline symptom burden was highest with strong reflux evidence and lowest with equivocal evidence (DSI: p=0.021; GSS: p=0.043 across groups, Fig 1). ARS was highest with strong and good reflux evidence (p<0.01). On follow-up, likelihood of symptom improvement similarly followed strength of reflux evidence, highest with strong or good evidence, and lowest with equivocal evidence (DSI: p=0.051; GSS: p=0.006 across groups). GSS improvement ‡50% was seen in 72% with strong (76.0%) or good evidence (69.4%) of reflux, in contrast to 47.1% with equivocal evidence (p=0.015 across groups, Fig 2). Good or strong evidence was associated with an odds ratio of ‡50% GSS improvement of 2.91 (95% CI 1.21-7.00) compared to equivocal evidence. Conclusions: Strength of reflux evidence efficiently stratifies outcome in patients with reflux symptoms undergoing pH-impedance testing. Symptom reflux association allows identification of reflux cohorts with best likelihood of symptomatic improvement following antireflux therapy.
768 The Changing Profile of Helicobacter pylori Antibiotic Resistance: A 15-Year Study Tiing Leong Ang, Kwong Ming Fock, Daphne Ang, Subbiah Dhamodaran Background: Antibiotic resistance is an important cause of H pylori treatment failure. Pretreatment susceptibility testing is ideal but rarely performed. Empiric first-line therapy is the main treatment approach, guided by knowledge of local antibiotic resistance profiles. This study examined the change in H pylori antibiotic resistance profile in Singapore over the course of 15 years. Materials and methods: The study period was from January 2000 to November 2014. Gastric mucosal biopsies obtained from H pylori positive patients were cultured. Antibiotic susceptibility to metronidazole, clarithromycin, levofloxacin, tetracycline and amoxicillin was tested using the E-test on blood agar plates with 5 - 7% added sheep blood. Plates were incubated at 37°C for 72 hours in a microaerophillic atmosphere with 10% CO2. Thereafter the minimum inhibitory concentration (MIC) for each antibiotic was determined. H pylori reference strains ATCC 43504 and ATCC 43579 were used for quality control. The MIC breakpoints were: metronidazole: 8.0ug/mL; clarithromycin: 1.0ug/mL; levofloxacin: >1.0ug/mL; tetracycline: 1.0ug/mL; amoxicillin: ‡1.0ug/mL. Antibiotic resistant patterns were grouped into five 3-year intervals and analyzed using chi-square tests. Results: A total of 708 H. pylori isolates was cultured (2000 - 2002: 101; 2003 - 2005: 119; 2006 - 2008: 159; 2009 - 2011: 159; 2012 - 2014: 170). There was a significant trend of rising resistance rates for metronidazole (2000 - 2002: 24.8%; 2003 - 2005: 36.1%; 2006 - 2008: 41.5%; 2009 - 2011: 41.5%; 2012 - 2014: 48/2%; p <0.001), clarithromycin (2000 - 2002: 7.9%; 2003 - 2005: 10.9%; 2006 - 2008: 14.5%; 2009 - 2011: 15.1%; 2012 - 2014: 17.1%; p = 0.022) and levofloxacin (2000 - 2002: 5%; 2003 - 2005: 8.4%; 2006 - 2008: 10.7%; 2009 - 2011: 12.6%; 2012 - 2014: 14.7%; p = 0.007). There was no significant change in resistance rates for tetracycline (2000 - 2002: 5%; 2012 - 2014: 7.6%) and amoxicillin (2000 - 2002: 3%; 2012 - 2014: 4.4%). Common dual resistance patterns were metronidazole/ clarithromycin (4.4%), metronidazole/levofloxacin (2.3%) and metronidazole/tetracycline (2%). There was a significant increase in dual (2000 - 2002: 6.9%; 2012 - 2014: 9.4%; p < 0.001) and triple antibiotic resistance rates (2000 - 2002: 0; 2012 - 2014: 7.6%; p < 0.001). Conclusion: Over 15 years, there has been a significant increase in H pylori resistance rates to metronidazole, clarithromycin and levofloxacin. There is also increased resistance to multiple antibiotics. This change in antibiotic resistance profile has important implications for choice of empiric therapy.
769 Appropriateness of Repeating Helicobacter pylori Culture and Susceptibility Testing Following Failure of Individualized Antibiotic Therapy Doron Boltin, Haim Ben Zvi, Tsachi T. Perets, Rachel Gingold-Belfer, Zmira Samra, Ram Dickman, Yaron Niv Background: current guidelines recommend direct Helicobacter pylori culture and antibiotic susceptibility testing following two failed eradication attempts. If this process is followed yet subsequent treatment is unsuccessful, it is unclear whether susceptibility testing should be repeated. This is the first study to examine the appropriateness of repeated Helicobacter pylori culture and susceptibility testing following failure of individualized treatment. Methods: Between 2007 and 2014 consecutive patients who underwent at least two upper gastrointestinal endoscopies with H. pylori culture and susceptibility testing at our institution following several treatment failures, were retrospectively identified. Antibiotic susceptibility was recorded and linked to demographic data. Results: 68 cultures from 34 patients were included (12 (35.3%) males, aged 41.4±16.6 years). 20 (58.8%) cultures had a different antibiotic susceptibility profile on repeat testing (8 (23.5%) with new susceptibility and 13 (38.2%) with new resistance). Acquired resistance to clarithromycin, levofloxacin and metronidazole was observed in 9 (26.5%), 2 (5.9%) and 10 (29.4%) cultures, respectively. Subjects with resistance to £1 antibiotic at baseline were more likely to develop resistance to at least 1 antibiotic on subsequent culture, compared to subjects with resistance to ‡2 antibiotics at baseline (13 (100%) vs 5 (23.8%), p<0.01). Conclusion: Repeating H. pylori culture and susceptibility testing usually yields new antimicrobial susceptibility data. However, the clinical usefulness of this approach remains unclear.
Figure 1. 3D plots of acid exposure time (AET), symptom association probability (SAP) and global symptom severity (GSS) at baseline, demonstrating segregation of groups with varying strengths of reflux evidence (strong, good and equivocal) (p=0.012 across groups)
Figure 2. 3D plots of acid exposure time (AET), symptom association probability (SAP) and global symptom severity (GSS) after medical or surgical therapy, demonstrating good segregation of groups with varying strengths of reflux evidence (strong, good and equivocal) at follow up (p=0.045 across groups). Improvement of GSS in cohorts with strong and good reflux evidence is more marked that in those with equivocal evidence (p=0.003 for linear GSS change, p=0.015 for ‡50% GSS improvement across groups), compared to Figure 1.
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772 Helicobacter pylori Eradication Results in Mexico: Clarithromycin+Amoxicillin+Lanzoprazol vs. Azithromycin+Levofloxacin+Pantoprazol, An Open, Randomized IIIb Phase Clinical Trial A Laura Ladron-de-Guevara, Leticia Bornstein, Beatriz Castañeda-Romero, Fernando Costa, Mauricio Di Silvio, Maria Sarai Gonzalez-Huezo, Eduardo A. Vargas-Garcia Introduction: Helicobacter pylori (H pylori) is a highly prevalent infection in Mexico, where 70% of the population is infected. Gastric cancer and peptic ulcer bleeding are still among the top 20 causes of death in the general population. Eradication schemes have proven diminished efficacy however no antibiotic resistances have been studied in Mexico. Objective: to compare efficacy on H.pylori eradication with two different schemes treatments: pantoprazole 80 mg+ levofloxacin 500 mg+ azithromycin 500 mg OD (PLA) vs. Lanzoprazol 30 mg+ amoxicillin 1 g+ clarithromycin 500 mg TID (CLA), each 10 days, on biopsy proven H pylori positive, treatment naïve patients. Biopsies were required to identify resistance mutations on H pylori by fluorescence in situ hybridization (FISH). Methodology: Between June 2012 and March 2014 a randomized trial comparing PLA and CLA schemes was performed. One month after finishing the treatment, C13-urea breath testing (C13 UBT) was required to verify eradication. Biopsies were tested to FISH-Clarithromycin resistance (BACTFish Combikit Izinta Trading Co, Hungary). Demographics, eradication per protocol analysis, and clarithromycin resistance were evaluated using univariate and multivariate analysis. The protocol was approved and registered on COFEPRIS, Mexican health regulatory agency. Results: Prior signed informed consent, 227 biopsy proven H. pylori positive subjects were enrolled and randomized to either CLA group or PLA group; data on 22 subjects that did not completed C13 UBT and 8 not available-biopsies were not considered in the analysis, which included 105 subjects on PLA and 94 subjects on CLA. Average age was 42.47 ± 11.5 years. PLA eradication rate by C13 UBT was 62% while CLA eradication rate by C13UBT was 60.5%. FISH clarithromycin-resistant was found positive in 28.2% of the total samples. Subjects on the PLA group not resistant to clarithromycin had 83.5% eradication rate by C13-UBT compared to 59.3% of the CLA group not resistant to clarithromycin (p 0.013). Adverse effects were described on 75.1%; on the CLA group 86% while the PLA group reported 65.4% (p 0.001); all were minor and self-limited; dysgeusia was reported on 59% of CLA subjects while only on 8.7% of PLA (p 0.000). PLA most frequent AE was stool appearance changes in 24%, not different from 26% informed on the CLA group (p 0.74). Conclusions: H pylori eradication results in Mexico are suboptimal. Clarithromycin resistance average was 28.2%. PLA was not inferior to CLA regarding eradication. Levofloxacin-containing schemes are reported to have a higher eradication results, better tolerability and safety profile. Eradication results can be improved by knowing the pattern of resistance, particularly in countries with high antibiotic-resistance rates. Table 1: Participant characteristics by treatment group
Proposed algorithm for the management of resistant H. pylori following failure of individualized treatment
770 High Cumulative Eradication Rate in the First-Line and Rescue Therapies for Helicobacter pylori Infection by Repeated Optimized High Dose Dual Therapy Jyh-Chin Yang, Chun-Jung Lin, Jin-De Chen, Hong-Long Wang, John Y. Kao, Bor-Ru Lin, Ming Jium Shieh, Ming-Chu Chang, Yu-Ting Chang, Shu-Chen Wei, Chien-Chih Tung, Jau-Min Wong Background: The increased primary and acquired resistance rates of H. pylori to clarithromycin, metronidazole, and levofloxacin have resulted in a significant reduction in the efficacy of various anti-H. pylori regimens. We recently demonstrated that an optimized high-dose dual therapy (HDDT) is superior to the standard triple therapy (TT) or sequential therapy (ST) for H. pylori infection in a large-scale multi-hospital, randomized, comparative study (Clinical Gastro & Hepato, in press). Because the global prevalence of primary and acquired resistance to amoxicillin (AMO) is rare, we hypothesize that HDDT can be used repeatedly and empirically for H. pylori treatment without a reduction of eradication efficacy. Aim: To evaluated the cumulative efficacy of repeated HDDT treatment for first-line and rescue antiH. pylori therapy. Methods: A total of 618 patients with H. pylori infection diagnosed by endoscopy with biopsy for histology examination and bacterial culture were recruited in this multi-hospital study and were randomly allocated to receive HDDT, TT, or ST for therapy. As reported in our previous study, H. pylori was eradicated in 143 out of 150 (95.3%; 95% C.I. 92.9-97.8) treatment-naïve patients receiving the first course of HDDT (rabeprazole 20 mg + AMO 750 mg, qid for 14 days). Six patients who failed in the first HDDT treatment received the second course of HDDT. For treatment-experienced patients, 68 out of 84 patients failed in TT and 25 out of 45 patients failed in ST received the first course of HDDT. The second course of HDDT was used again if the first course failed. Four to eight weeks after termination of each treatment, H. pylori infection status was examined by the C13-urea breath test. The E-test was used to evaluate the antibiotics resistances of H. pylori strains before and after failed treatment of repeated HDDT. Results: Five out of 6 treatment-naïve patients had successfully H. pylori eradication by a second course of HDDT, resulting in a cumulative eradication rate of 98.7% (148/150; 95% C.I. 97.3-100.0) in the intention-to-treat (ITT) analysis, and 99.3% (148/149; 95% C.I. 98.4-100.3) in perprotocol (PP) analysis. For the treatment-experienced patients, H. pylori was successfully eradicated in 90.3% (84/93; 95% C.I. 85.9-94.7) of patients with first course of HDDT treatment. Seven out of 9 patients who failed in the first HDDT treatment achieved H. pylori eradication with a second course of HDDT. The cumulative eradication rate was 97.8% (91/ 93; 95% C.I. 95.7-100.0) in both ITT and PP analyses. The susceptibility of H. pylori to antibiotics did not significantly impact eradication rates. Conclusion: HDDT consisting of a PPI and AMO given four times daily is highly efficacious when it is used repeatedly for H. pylori eradication. Thus, H. pylori susceptibility testing may be avoided by using HDDT.
771 Seven-Day Rifabutin Containing Triple Therapy Versus Seven-Day Levofloxacin Containing Quadruple Therapy As Second-Line Treatment for Helicobacter pylori in Chinese Patients: An Open Label, Randomized Trial Ivan F. Hung, Sze Hang Kevin Liu, Victoria P. Tan, Axel Hsu, Wai-Kay Seto, Teresa Tong, Wai K. Leung Introduction: Rifabutin containing triple therapy (RIF) and levofloxacin containing quadruple therapy (QUAD) has been used as rescue therapy for resistant H. pylori infection. We compared the efficacy and tolerability of 7-day RIF with 7-day QUAD as second-line treatment for H. pylori infection. Levofloxacin was used instead of bismuth subcitrate for the quadruple therapy, as bismuth is no longer available in Hong Kong. Methods: Patients who have failed the triple therapy (esomeprazole, amoxicillin, and clarithromycin) and remained H. pyloripositive were randomly assigned to receive either 7-day RIF (esomeprazole, rifabutin and amoxicillin) or QUAD (esomeprazole, levofloxacin, tetracycline and metronidazole) treatments. H. pylori eradication was confirmed by urea breath test at 8 weeks. The primary outcome was the eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. Results: One hundred and fifty-one patients were randomized to receive either RIF or QUAD. The PP eradication rate of the RIF and QUAD groups were 89.3% and 95.6%, respectively (P = 0.16). Base on ITT analysis, the corresponding eradication rate was 88.2% and 90.7% (P = 0.62). One patient (1.3%) in the RIF and seven (9.3%) patients in the
Left: Gastric biopsy with H pylori (H&E 40X). Right: H pylori Clarithromycin resistant.( BactFish 40X).
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QUAD failed to complete the treatment regime. The overall incidences of adverse events were higher in the QUAD (30.7%) than in the RIF (15.8%) group (P = 0.03). Conclusion: Seven-day rifabutin containing triple therapy and levofloxacin containing quadruple therapy are both highly effective and should be considered as second-line treatment for resistant H. pylori infection.
on testing, and duration of follow-up (p ‡0.17 for each comparison). Likelihood of typical symptoms was highest with strong reflux evidence and lowest with equivocal evidence (p= 0.046). Similarly, baseline symptom burden was highest with strong reflux evidence and lowest with equivocal evidence (DSI: p=0.021; GSS: p=0.043 across groups, Fig 1). ARS was highest with strong and good reflux evidence (p<0.01). On follow-up, likelihood of symptom improvement similarly followed strength of reflux evidence, highest with strong or good evidence, and lowest with equivocal evidence (DSI: p=0.051; GSS: p=0.006 across groups). GSS improvement ‡50% was seen in 72% with strong (76.0%) or good evidence (69.4%) of reflux, in contrast to 47.1% with equivocal evidence (p=0.015 across groups, Fig 2). Good or strong evidence was associated with an odds ratio of ‡50% GSS improvement of 2.91 (95% CI 1.21-7.00) compared to equivocal evidence. Conclusions: Strength of reflux evidence efficiently stratifies outcome in patients with reflux symptoms undergoing pH-impedance testing. Symptom reflux association allows identification of reflux cohorts with best likelihood of symptomatic improvement following antireflux therapy.
768 The Changing Profile of Helicobacter pylori Antibiotic Resistance: A 15-Year Study Tiing Leong Ang, Kwong Ming Fock, Daphne Ang, Subbiah Dhamodaran Background: Antibiotic resistance is an important cause of H pylori treatment failure. Pretreatment susceptibility testing is ideal but rarely performed. Empiric first-line therapy is the main treatment approach, guided by knowledge of local antibiotic resistance profiles. This study examined the change in H pylori antibiotic resistance profile in Singapore over the course of 15 years. Materials and methods: The study period was from January 2000 to November 2014. Gastric mucosal biopsies obtained from H pylori positive patients were cultured. Antibiotic susceptibility to metronidazole, clarithromycin, levofloxacin, tetracycline and amoxicillin was tested using the E-test on blood agar plates with 5 - 7% added sheep blood. Plates were incubated at 37°C for 72 hours in a microaerophillic atmosphere with 10% CO2. Thereafter the minimum inhibitory concentration (MIC) for each antibiotic was determined. H pylori reference strains ATCC 43504 and ATCC 43579 were used for quality control. The MIC breakpoints were: metronidazole: 8.0ug/mL; clarithromycin: 1.0ug/mL; levofloxacin: >1.0ug/mL; tetracycline: 1.0ug/mL; amoxicillin: ‡1.0ug/mL. Antibiotic resistant patterns were grouped into five 3-year intervals and analyzed using chi-square tests. Results: A total of 708 H. pylori isolates was cultured (2000 - 2002: 101; 2003 - 2005: 119; 2006 - 2008: 159; 2009 - 2011: 159; 2012 - 2014: 170). There was a significant trend of rising resistance rates for metronidazole (2000 - 2002: 24.8%; 2003 - 2005: 36.1%; 2006 - 2008: 41.5%; 2009 - 2011: 41.5%; 2012 - 2014: 48/2%; p <0.001), clarithromycin (2000 - 2002: 7.9%; 2003 - 2005: 10.9%; 2006 - 2008: 14.5%; 2009 - 2011: 15.1%; 2012 - 2014: 17.1%; p = 0.022) and levofloxacin (2000 - 2002: 5%; 2003 - 2005: 8.4%; 2006 - 2008: 10.7%; 2009 - 2011: 12.6%; 2012 - 2014: 14.7%; p = 0.007). There was no significant change in resistance rates for tetracycline (2000 - 2002: 5%; 2012 - 2014: 7.6%) and amoxicillin (2000 - 2002: 3%; 2012 - 2014: 4.4%). Common dual resistance patterns were metronidazole/ clarithromycin (4.4%), metronidazole/levofloxacin (2.3%) and metronidazole/tetracycline (2%). There was a significant increase in dual (2000 - 2002: 6.9%; 2012 - 2014: 9.4%; p < 0.001) and triple antibiotic resistance rates (2000 - 2002: 0; 2012 - 2014: 7.6%; p < 0.001). Conclusion: Over 15 years, there has been a significant increase in H pylori resistance rates to metronidazole, clarithromycin and levofloxacin. There is also increased resistance to multiple antibiotics. This change in antibiotic resistance profile has important implications for choice of empiric therapy.
769 Appropriateness of Repeating Helicobacter pylori Culture and Susceptibility Testing Following Failure of Individualized Antibiotic Therapy Doron Boltin, Haim Ben Zvi, Tsachi T. Perets, Rachel Gingold-Belfer, Zmira Samra, Ram Dickman, Yaron Niv Background: current guidelines recommend direct Helicobacter pylori culture and antibiotic susceptibility testing following two failed eradication attempts. If this process is followed yet subsequent treatment is unsuccessful, it is unclear whether susceptibility testing should be repeated. This is the first study to examine the appropriateness of repeated Helicobacter pylori culture and susceptibility testing following failure of individualized treatment. Methods: Between 2007 and 2014 consecutive patients who underwent at least two upper gastrointestinal endoscopies with H. pylori culture and susceptibility testing at our institution following several treatment failures, were retrospectively identified. Antibiotic susceptibility was recorded and linked to demographic data. Results: 68 cultures from 34 patients were included (12 (35.3%) males, aged 41.4±16.6 years). 20 (58.8%) cultures had a different antibiotic susceptibility profile on repeat testing (8 (23.5%) with new susceptibility and 13 (38.2%) with new resistance). Acquired resistance to clarithromycin, levofloxacin and metronidazole was observed in 9 (26.5%), 2 (5.9%) and 10 (29.4%) cultures, respectively. Subjects with resistance to £1 antibiotic at baseline were more likely to develop resistance to at least 1 antibiotic on subsequent culture, compared to subjects with resistance to ‡2 antibiotics at baseline (13 (100%) vs 5 (23.8%), p<0.01). Conclusion: Repeating H. pylori culture and susceptibility testing usually yields new antimicrobial susceptibility data. However, the clinical usefulness of this approach remains unclear.
Figure 1. 3D plots of acid exposure time (AET), symptom association probability (SAP) and global symptom severity (GSS) at baseline, demonstrating segregation of groups with varying strengths of reflux evidence (strong, good and equivocal) (p=0.012 across groups)
Figure 2. 3D plots of acid exposure time (AET), symptom association probability (SAP) and global symptom severity (GSS) after medical or surgical therapy, demonstrating good segregation of groups with varying strengths of reflux evidence (strong, good and equivocal) at follow up (p=0.045 across groups). Improvement of GSS in cohorts with strong and good reflux evidence is more marked that in those with equivocal evidence (p=0.003 for linear GSS change, p=0.015 for ‡50% GSS improvement across groups), compared to Figure 1.
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772 Helicobacter pylori Eradication Results in Mexico: Clarithromycin+Amoxicillin+Lanzoprazol vs. Azithromycin+Levofloxacin+Pantoprazol, An Open, Randomized IIIb Phase Clinical Trial A Laura Ladron-de-Guevara, Leticia Bornstein, Beatriz Castañeda-Romero, Fernando Costa, Mauricio Di Silvio, Maria Sarai Gonzalez-Huezo, Eduardo A. Vargas-Garcia Introduction: Helicobacter pylori (H pylori) is a highly prevalent infection in Mexico, where 70% of the population is infected. Gastric cancer and peptic ulcer bleeding are still among the top 20 causes of death in the general population. Eradication schemes have proven diminished efficacy however no antibiotic resistances have been studied in Mexico. Objective: to compare efficacy on H.pylori eradication with two different schemes treatments: pantoprazole 80 mg+ levofloxacin 500 mg+ azithromycin 500 mg OD (PLA) vs. Lanzoprazol 30 mg+ amoxicillin 1 g+ clarithromycin 500 mg TID (CLA), each 10 days, on biopsy proven H pylori positive, treatment naïve patients. Biopsies were required to identify resistance mutations on H pylori by fluorescence in situ hybridization (FISH). Methodology: Between June 2012 and March 2014 a randomized trial comparing PLA and CLA schemes was performed. One month after finishing the treatment, C13-urea breath testing (C13 UBT) was required to verify eradication. Biopsies were tested to FISH-Clarithromycin resistance (BACTFish Combikit Izinta Trading Co, Hungary). Demographics, eradication per protocol analysis, and clarithromycin resistance were evaluated using univariate and multivariate analysis. The protocol was approved and registered on COFEPRIS, Mexican health regulatory agency. Results: Prior signed informed consent, 227 biopsy proven H. pylori positive subjects were enrolled and randomized to either CLA group or PLA group; data on 22 subjects that did not completed C13 UBT and 8 not available-biopsies were not considered in the analysis, which included 105 subjects on PLA and 94 subjects on CLA. Average age was 42.47 ± 11.5 years. PLA eradication rate by C13 UBT was 62% while CLA eradication rate by C13UBT was 60.5%. FISH clarithromycin-resistant was found positive in 28.2% of the total samples. Subjects on the PLA group not resistant to clarithromycin had 83.5% eradication rate by C13-UBT compared to 59.3% of the CLA group not resistant to clarithromycin (p 0.013). Adverse effects were described on 75.1%; on the CLA group 86% while the PLA group reported 65.4% (p 0.001); all were minor and self-limited; dysgeusia was reported on 59% of CLA subjects while only on 8.7% of PLA (p 0.000). PLA most frequent AE was stool appearance changes in 24%, not different from 26% informed on the CLA group (p 0.74). Conclusions: H pylori eradication results in Mexico are suboptimal. Clarithromycin resistance average was 28.2%. PLA was not inferior to CLA regarding eradication. Levofloxacin-containing schemes are reported to have a higher eradication results, better tolerability and safety profile. Eradication results can be improved by knowing the pattern of resistance, particularly in countries with high antibiotic-resistance rates. Table 1: Participant characteristics by treatment group
Proposed algorithm for the management of resistant H. pylori following failure of individualized treatment
770 High Cumulative Eradication Rate in the First-Line and Rescue Therapies for Helicobacter pylori Infection by Repeated Optimized High Dose Dual Therapy Jyh-Chin Yang, Chun-Jung Lin, Jin-De Chen, Hong-Long Wang, John Y. Kao, Bor-Ru Lin, Ming Jium Shieh, Ming-Chu Chang, Yu-Ting Chang, Shu-Chen Wei, Chien-Chih Tung, Jau-Min Wong Background: The increased primary and acquired resistance rates of H. pylori to clarithromycin, metronidazole, and levofloxacin have resulted in a significant reduction in the efficacy of various anti-H. pylori regimens. We recently demonstrated that an optimized high-dose dual therapy (HDDT) is superior to the standard triple therapy (TT) or sequential therapy (ST) for H. pylori infection in a large-scale multi-hospital, randomized, comparative study (Clinical Gastro & Hepato, in press). Because the global prevalence of primary and acquired resistance to amoxicillin (AMO) is rare, we hypothesize that HDDT can be used repeatedly and empirically for H. pylori treatment without a reduction of eradication efficacy. Aim: To evaluated the cumulative efficacy of repeated HDDT treatment for first-line and rescue antiH. pylori therapy. Methods: A total of 618 patients with H. pylori infection diagnosed by endoscopy with biopsy for histology examination and bacterial culture were recruited in this multi-hospital study and were randomly allocated to receive HDDT, TT, or ST for therapy. As reported in our previous study, H. pylori was eradicated in 143 out of 150 (95.3%; 95% C.I. 92.9-97.8) treatment-naïve patients receiving the first course of HDDT (rabeprazole 20 mg + AMO 750 mg, qid for 14 days). Six patients who failed in the first HDDT treatment received the second course of HDDT. For treatment-experienced patients, 68 out of 84 patients failed in TT and 25 out of 45 patients failed in ST received the first course of HDDT. The second course of HDDT was used again if the first course failed. Four to eight weeks after termination of each treatment, H. pylori infection status was examined by the C13-urea breath test. The E-test was used to evaluate the antibiotics resistances of H. pylori strains before and after failed treatment of repeated HDDT. Results: Five out of 6 treatment-naïve patients had successfully H. pylori eradication by a second course of HDDT, resulting in a cumulative eradication rate of 98.7% (148/150; 95% C.I. 97.3-100.0) in the intention-to-treat (ITT) analysis, and 99.3% (148/149; 95% C.I. 98.4-100.3) in perprotocol (PP) analysis. For the treatment-experienced patients, H. pylori was successfully eradicated in 90.3% (84/93; 95% C.I. 85.9-94.7) of patients with first course of HDDT treatment. Seven out of 9 patients who failed in the first HDDT treatment achieved H. pylori eradication with a second course of HDDT. The cumulative eradication rate was 97.8% (91/ 93; 95% C.I. 95.7-100.0) in both ITT and PP analyses. The susceptibility of H. pylori to antibiotics did not significantly impact eradication rates. Conclusion: HDDT consisting of a PPI and AMO given four times daily is highly efficacious when it is used repeatedly for H. pylori eradication. Thus, H. pylori susceptibility testing may be avoided by using HDDT.
771 Seven-Day Rifabutin Containing Triple Therapy Versus Seven-Day Levofloxacin Containing Quadruple Therapy As Second-Line Treatment for Helicobacter pylori in Chinese Patients: An Open Label, Randomized Trial Ivan F. Hung, Sze Hang Kevin Liu, Victoria P. Tan, Axel Hsu, Wai-Kay Seto, Teresa Tong, Wai K. Leung Introduction: Rifabutin containing triple therapy (RIF) and levofloxacin containing quadruple therapy (QUAD) has been used as rescue therapy for resistant H. pylori infection. We compared the efficacy and tolerability of 7-day RIF with 7-day QUAD as second-line treatment for H. pylori infection. Levofloxacin was used instead of bismuth subcitrate for the quadruple therapy, as bismuth is no longer available in Hong Kong. Methods: Patients who have failed the triple therapy (esomeprazole, amoxicillin, and clarithromycin) and remained H. pyloripositive were randomly assigned to receive either 7-day RIF (esomeprazole, rifabutin and amoxicillin) or QUAD (esomeprazole, levofloxacin, tetracycline and metronidazole) treatments. H. pylori eradication was confirmed by urea breath test at 8 weeks. The primary outcome was the eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. Results: One hundred and fifty-one patients were randomized to receive either RIF or QUAD. The PP eradication rate of the RIF and QUAD groups were 89.3% and 95.6%, respectively (P = 0.16). Base on ITT analysis, the corresponding eradication rate was 88.2% and 90.7% (P = 0.62). One patient (1.3%) in the RIF and seven (9.3%) patients in the
Left: Gastric biopsy with H pylori (H&E 40X). Right: H pylori Clarithromycin resistant.( BactFish 40X).
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QUAD failed to complete the treatment regime. The overall incidences of adverse events were higher in the QUAD (30.7%) than in the RIF (15.8%) group (P = 0.03). Conclusion: Seven-day rifabutin containing triple therapy and levofloxacin containing quadruple therapy are both highly effective and should be considered as second-line treatment for resistant H. pylori infection.