Empirical vs Tailored Therapy for H. Pylori Infection

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

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Bismuth Containing Quadruple Therapy versus Tailored Therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area

10.21203/rs.2.13917/v2 ◽

2019 ◽

Author(s):

Byoung Wook Bang ◽

Jong Beom Shin ◽

Eun Jung Ko ◽

Kye Sook Kwon ◽

Yong Woon Shin ◽

...

Keyword(s):

Helicobacter Pylori ◽

Cost Effective ◽

Medical Costs ◽

Rapid Urease Test ◽

First Line ◽

Tailored Therapy ◽

Quadruple Therapy ◽

Clarithromycin Resistance ◽

Urease Test ◽

H Pylori

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

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Application of Visual Gene Clip-Based Tailored Therapy for the Eradication of Helicobacter pylori

BioMed Research International ◽

10.1155/2021/6150628 ◽

2021 ◽

Vol 2021 ◽

pp. 1-6

Author(s):

Lili Yang ◽

Ao Zou ◽

Huihua Wu ◽

Hai Guo ◽

Fangting Zhang ◽

...

Keyword(s):

Helicobacter Pylori ◽

Antibiotic Resistance ◽

Confidence Interval ◽

Acid Secretion ◽

Antimicrobial Agents ◽

Point Mutations ◽

Eradication Therapy ◽

23S Rrna ◽

Tailored Therapy ◽

H Pylori

Background. Helicobacter pylori eradication with therapies employing a proton pump inhibitor (PPI) and antimicrobial agents is mainly achieved via bacterial susceptibility to antimicrobial agents and the magnitude of acid secretion inhibition. However, annual eradication rates have greatly declined in Mainland China, and therefore, tailored H. pylori eradication regimens that inhibit acid secretion and employ optimal antimicrobial agents determined based on gene clip testing may improve eradication rates. This study was aimed at evaluating the efficacy of tailored H. pylori eradication therapy guided by visual gene clip testing for antibiotic resistance and PPI metabolism genotypes. Methods. This prospective study included 244 patients (141 men and 103 women aged 20–79 years) receiving initial treatment for H. pylori infection. Visual gene clip testing using gastric mucosal specimens was performed to detect antibiotic resistance to clarithromycin conferred by the A2142G and A2143G point mutations of the H. pylori 23S rRNA gene and to levofloxacin conferred by the Asn87 and Asp91 point mutations of the H. pylori gyrA gene. Patients received a 14-day bismuth quadruple therapy regimen guided by testing for antibiotic resistance and CYP2C19 polymorphisms, and primary H. pylori eradication was assessed at least 4 weeks after therapy. Results. H. pylori strains were successfully isolated from the gastric mucosa tissues of 244 patients. Antibiotic resistant isolates were identified in 63 patients, with clarithromycin resistance observed in 50 patients, levofloxacin resistance in 7 patients, and dual resistance in 6 patients. The PPI metabolic genotype of CYP2C19 was detected in 242 of 244 cases, and 97 cases were categorized as extensive metabolizers, 141 as intermediate metabolizers, and 4 as poor metabolizers. Among the 242 patients who received tailored therapy, the H. pylori eradication rate was 90.9% (95% confidence interval 87.3%~94.6%) in the intention-to-treat analysis and 96.9% (95% confidence interval 94.7%~99.2%) in the per protocol analysis. Conclusions. Tailored therapy for H. pylori infection guided by determination of antibiotic resistance and CYP2C19 polymorphism using visual gene chip technology may provide high clinical effectiveness as initial H. pylori eradication therapy.

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Bismuth Containing Quadruple Therapy versus Tailored Therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area

10.21203/rs.2.13917/v1 ◽

2019 ◽

Author(s):

Byoung Wook Bang ◽

Jong Beom Shin ◽

Eun Jung Ko ◽

Kye Sook Kwon ◽

Yong Woon Shin ◽

...

Keyword(s):

Helicobacter Pylori ◽

Cost Effective ◽

Medical Costs ◽

Rapid Urease Test ◽

First Line ◽

Tailored Therapy ◽

Quadruple Therapy ◽

Clarithromycin Resistance ◽

Urease Test ◽

H Pylori

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

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Randomized Clinical Trial Comparing Concomitant and Tailored Therapy for Eradication of Helicobacter pylori Infection

Journal of Personalized Medicine ◽

10.3390/jpm11060534 ◽

2021 ◽

Vol 11 (6) ◽

pp. 534

Author(s):

Nikola Perkovic ◽

Antonio Mestrovic ◽

Josko Bozic ◽

Mirela Pavicic Ivelja ◽

Jonatan Vukovic ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Primary Objective ◽

First Line ◽

Tailored Therapy ◽

Open Label ◽

Intention To Treat ◽

Clarithromycin Resistance ◽

Reasonable Choice ◽

H Pylori

As high clarithromycin resistance (>20%) in the Split-Dalmatia region of Croatia hinders the treatment of H. pylori infection, the primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori. In an open-label, randomized clinical trial, 80 patients with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p = 0.010) and per-protocol (87.5 vs. 100%, p = 0.030) analysis in the setting of increasing antibiotic resistance (clarithromycin 37.5%, metronidazole 17.5%, dual resistance 10%). Adverse effects were more frequent in the concomitant group (32.5 vs. 7.5%, p = 0.006). Tailored therapy achieves higher eradication with a lower adverse events rate. With the increasing resistance of H. pylori strains to antibiotic treatment, eradication regimes with such characteristics should be strongly considered as a reasonable choice for first-line treatment.

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Cost-Effectiveness, Efficacy, and Safety Analysis of Tailored Therapy in Patients with Helicobacter pylori Infection

Journal of Clinical Medicine ◽

10.3390/jcm10122619 ◽

2021 ◽

Vol 10 (12) ◽

pp. 2619

Author(s):

A Reum Choe ◽

Ki-Nam Shim ◽

Yehyun Park ◽

Eun-Mi Song ◽

Chung Hyun Tae ◽

...

Keyword(s):

Helicobacter Pylori ◽

Antibiotic Resistance ◽

Cost Effectiveness ◽

Eradication Rate ◽

Empirical Therapy ◽

Medical Costs ◽

First Line ◽

Tailored Therapy ◽

Total Treatment ◽

H Pylori

Recently in Korea, where triple therapy is accepted as the first-line Helicobacter pylori (H. pylori) eradication treatment, antibiotic resistance to clarithromycin has increased considerably, resulting in eradication rates of less than 80%. We investigated the efficacy of tailored therapy after a clarithromycin resistance test compared with empirical therapy for H. pylori eradication. The cost-effectiveness of H. pylori eradication success was evaluated according to the average medical cost per patient. A total of 364 patients were enrolled in the study. The first-line H. pylori eradication rate was significantly higher in patients who received tailored therapy than in those who received empirical therapy. The total medical costs for the tailored and empirical groups were 46,374 Won and 53,528 Won. The total treatment period for each ultimately successful eradication in the tailored group was 79.8 ± 2.8 days, which is shorter than that of the empirical group (99.2 ± 7.4 days). The rate of eradication-related adverse events for the tailored group and empirical group was 12.9% and 14.8%, respectively. Tailored therapy could be a useful option to achieve a higher successful eradication rate, shorter treatment periods, and lower medical costs than empirical therapy in the era of increasing antibiotic resistance.

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Vonoprazan-Based Triple-Therapy Could Improve Efficacy of the Tailored Therapy of Helicobacter pylori Infection

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld-222 ◽

2019 ◽

Vol 28 (4) ◽

pp. 389-395 ◽

Cited By ~ 3

Author(s):

Tetsuya Shinmura ◽

Kazunori Adachi ◽

Yoshiharu Yamaguchi ◽

Shinya Izawa ◽

Yasutaka Hijikata ◽

...

Keyword(s):

Helicobacter Pylori ◽

Multivariate Analysis ◽

Triple Therapy ◽

Conventional Therapy ◽

Eradication Therapy ◽

Resistant Bacteria ◽

Tailored Therapy ◽

Exact Test ◽

Therapy Regimen ◽

H Pylori

Background and Aims: The prevalence of clarithromycin resistant bacteria is increasing, and the effectiveness of Helicobacter pylori (H. pylori) triple therapy is gradually decreasing in Japan. Vonoprazan, a potassiumcompetitive acid blocker, has been reported for its effectiveness in eradicating H. pylori. We aimed to evaluate the efficacy of tailored vonoprazan-based triple therapy in patients with H. pylori. This study is the first to compare the efficacy of vonoprazan-based tailored triple therapy to that of vonoprazan-based conventional therapy. Method: This retrospective cohort study evaluated the treatment efficacy in 920 patients. Of these, 541 received conventional and 379 received tailored therapy. Successful eradication was confirmed by a negative 13C-urea breath test 6–8 weeks following completion of H. pylori eradication therapy, and the data were evaluated using the Chi-square test, or Fisher’s exact test, as appropriate. Results: The eradication rate of tailored therapy was 90% and 96.3% by intent-to-treat analysis and per protocol analysis, respectively, which was significantly higher than the 85% and 90.2% found for conventional therapy (p < 0.05 and p < 0.001, respectively). Amoxicillin- or clarithromycin-resistant bacteria did not affect treatment outcomes. By univariate and multivariate analysis, both amoxicillin- and clarithromycin-resistant bacteria and conventional therapy were detected as risk factors for eradication failure (odds ratio = 6.267, 95% CI [1.056–119.924], p < 0.05, and odd ratio =3.113, 95% confidence interval [1.688–6.160], p < 0.001, by multivariate analysis). Conclusion: Vonoprazan-based triple therapy could be a more effective treatment for H. pylori infection than conventional therapy when combined with a therapy regimen tailored according to bacterial antibiotic susceptibility.

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The rod-to-coccoid body transformation in cultures of Helicobacter pylori

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100160686 ◽

1990 ◽

Vol 48 (3) ◽

pp. 626-627

Author(s):

A. R. Crooker ◽

W. G. Kraft ◽

T. L. Beard ◽

M. C. Myers

Keyword(s):

Helicobacter Pylori ◽

Growth Cycle ◽

Negative Bacterium ◽

Body Formation ◽

Coccoid Form ◽

Spiral Form ◽

Prolonged Culture ◽

H Pylori ◽

Upper Gastrointestinal

Helicobacter pylori is a microaerophilic, gram-negative bacterium found in the upper gastrointestinal tract of humans. There is strong evidence that H. pylori is important in the etiology of gastritis; the bacterium may also be a major predisposing cause of peptic ulceration. On the gastric mucosa, the organism exists as a spiral form with one to seven sheathed flagella at one (usually) or both poles. Short spirals were seen in the first successful culture of the organism in 1983. In 1984, Marshall and Warren reported a coccoid form in older cultures. Since that time, other workers have observed rod and coccal forms in vitro; coccoid forms predominate in cultures 3-7 days old. We sought to examine the growth cycle of H. pylori in prolonged culture and the mode of coccoid body formation.

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Vacuoles Induced in Mammalian Cells by Helicobacter Cytotoxin are Acidic Organelles

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100158388 ◽

1990 ◽

Vol 48 (3) ◽

pp. 168-169

Author(s):

M. H. Chestnut ◽

C. E. Catrenich

Keyword(s):

Acridine Orange ◽

Mammalian Cells ◽

Laser Scanning ◽

Laser Scanning Microscopy ◽

Confocal Laser ◽

Ulcer Disease ◽

Gastroduodenal Disease ◽

H Pylori

Helicobacter pylori is a non-invasive, Gram-negative spiral bacterium first identified in 1983, and subsequently implicated in the pathogenesis of gastroduodenal disease including gastritis and peptic ulcer disease. Cytotoxic activity, manifested by intracytoplasmic vacuolation of mammalian cells in vitro, was identified in 55% of H. pylori strains examined. The vacuoles increase in number and size during extended incubation, resulting in vacuolar and cellular degeneration after 24 h to 48 h. Vacuolation of gastric epithelial cells is also observed in vivo during infection by H. pylori. A high molecular weight, heat labile protein is believed to be responsible for vacuolation and to significantly contribute to the development of gastroduodenal disease in humans. The mechanism by which the cytotoxin exerts its effect is unknown, as is the intracellular origin of the vacuolar membrane and contents. Acridine orange is a membrane-permeant weak base that initially accumulates in low-pH compartments. We have used acridine orange accumulation in conjunction with confocal laser scanning microscopy of toxin-treated cells to begin probing the nature and origin of these vacuoles.

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