Helicobacter pylori
            first‐line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on
            H pylori
            management (Hp‐EuReg)

Background and Objectives: The prevalence of H. pylori in Eastern Europe remains quite high; however, there is insufficient data on the eradication regimens and their effectiveness. Therefore, the objective of the study was to evaluate the diagnostic methods and treatment of H. pylori infection as well as their adherence to Maastricht V/Florence consensus during the years 2013–2020 in Lithuania. Materials and Methods: Sub-study of the “European Registry on H. pylori Management” (Hp-EuReg), international multicenter prospective non-interventional registry of the routine clinical practice. Lithuanian data from the years 2013–2020 were analyzed for effectiveness on a modified intention-to-treat (mITT) basis. 2000 adult patients, diagnosed with H. pylori infection, were included. Data were compared to the European Maastricht V guidelines. Results: Triple-therapy was used in 90% of the cases. In 91% of the first-line prescriptions, standard triple therapy (STT) was used. The most common second-line treatment was a combination of PPI, amoxicillin and levofloxacin (PPI+A+L) (47%). The overall effectiveness in 552 cases valid for analysis was 90% by mITT. In first-line treatment, the STT effectiveness was 90% and second-line treatment with PPI+A+L achieved 92% by mITT. Increasing overall H. pylori eradication rates were observed: from 72% in 2013 to more than 90% in 2018–2020, as well as a shift from 7 to 10–14 days treatments duration throughout 2013–2020. Conclusions: In Lithuania, the prescribed eradication regimens for H. pylori were in accordance with the international guidelines but diagnostic methods and treatment duration only partially met Maastricht V/Florence guidelines. The eradication effectiveness was improved progressively during the years 2018–2020, reaching ≥90% cure rates.

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European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain

Antibiotics ◽

10.3390/antibiotics10010013 ◽

2020 ◽

Vol 10 (1) ◽

pp. 13

Author(s):

María Caldas ◽

Ángeles Pérez-Aisa ◽

Manuel Castro-Fernández ◽

Luis Bujanda ◽

Alfredo Lucendo ◽

...

Keyword(s):

Helicobacter Pylori ◽

Second Line ◽

Cure Rate ◽

Management Effectiveness ◽

First Line ◽

Intention To Treat ◽

First Line Therapy ◽

Line Therapy ◽

H Pylori ◽

European Registry

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. “Optimized” H. pylori therapies achieve over 90% success in Spain.

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Helicobacter pylori eradication rates in Slovenia in the period from 2017 to 2019 – data from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Digestive Diseases ◽

10.1159/000512506 ◽

2020 ◽

Author(s):

Bojan Tepes ◽

Natasa Brglez Jurecic ◽

Katja Tepes ◽

Marta Espada Sanchez ◽

Olga Perez Nyssen ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

Intention To Treat ◽

Line Therapy ◽

Medical Institutions ◽

H Pylori ◽

European Registry

Abstract Background. Helicobacter pylori (H pylori) is the most common chronic bacterial infection in the world, affecting over 50% of the world’s population. H pylori is a grade I carcinogen, responsible for the development of 89% of non-cardia gastric cancers. In the present study, we analyzed the data for H pylori eradication treatments in Slovenia after the 3rd National recommendations were implemented. Patients and methods. Slovenia is part of the European Registry on H pylori Management (Hp-EuReg) since the study was launched in 2013. Data were collected at AEG-REDCap e-CRF from September 2017 to December 2019. H pylori eradication treatment was assessed by modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results. Overall, 823 patients from 3 medical institutions were included. Effectiveness with first line 14-day triple therapy with a proton-pomp-inhibitor (PPI), clarithromycin 500 mg, amoxicillin 1000 mg, all BID, was 93% by mITT (714 patients). In patients allergic to penicillin, first line 14-day triple therapy with PPI-clarithromycin-metronidazole achieved 83% effectiveness by mITT (35 patients). Second-line 14-day triple therapy with a PPI-amoxicillin-levofloxacin achieved 89% mITT eradication rate (51 patients). Second-line therapy with the 10-day three-in-one single capsule containing bismuth-tetracycline- metronidazole achieved optimal effectiveness (100% mITT) in 10 patients ( p=0.02). Conclusions. Slovenia is a country with < 15% H pylori resistance to clarithromycin. Triple therapy with a PPI plus two antibiotics during 14 days reported optimal effectiveness (over 90%). Ten-day quadruple bismuth second-line therapy had better results than 14-day triple therapy with levofloxacin).

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Antibiotic Resistance Prevalence and Trends in Patients Infected with Helicobacter pylori in the Period 2013–2020: Results of the European Registry on H. pylori Management (Hp-EuReg)

Antibiotics ◽

10.3390/antibiotics10091058 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1058

Author(s):

Luis Bujanda ◽

Olga P. Nyssen ◽

Dino Vaira ◽

Ilaria M. Saracino ◽

Giulia Fiorini ◽

...

Keyword(s):

Helicobacter Pylori ◽

Antibiotic Resistance ◽

Antimicrobial Susceptibility ◽

Susceptibility Testing ◽

Resistance Rate ◽

Antimicrobial Susceptibility Testing ◽

Metronidazole Resistance ◽

Infected Adult ◽

H Pylori ◽

European Registry

Background: Bacterial antibiotic resistance changes over time depending on multiple factors; therefore, it is essential to monitor the susceptibility trends to reduce the resistance impact on the effectiveness of various treatments. Objective: To conduct a time-trend analysis of Helicobacter pylori resistance to antibiotics in Europe. Methods: The international prospective European Registry on Helicobacter pylori Management (Hp-EuReg) collected data on all infected adult patients diagnosed with culture and antimicrobial susceptibility testing positive results that were registered at AEG-REDCap e-CRF until December 2020. Results: Overall, 41,562 patients were included in the Hp-EuReg. Culture and antimicrobial susceptibility testing were performed on gastric biopsies of 3974 (9.5%) patients, of whom 2852 (7%) were naive cases included for analysis. The number of positive cultures decreased by 35% from the period 2013–2016 to 2017–2020. Concerning naïve patients, no antibiotic resistance was found in 48% of the cases. The most frequent resistances were reported against metronidazole (30%), clarithromycin (25%), and levofloxacin (20%), whereas resistances to tetracycline and amoxicillin were below 1%. Dual and triple resistances were found in 13% and 6% of the cases, respectively. A decrease (p < 0.001) in the metronidazole resistance rate was observed between the 2013–2016 (33%) and 2017–2020 (24%) periods. Conclusion: Culture and antimicrobial susceptibility testing for Helicobacter pylori are scarcely performed (<10%) in Europe. In naïve patients, Helicobacter pylori resistance to clarithromycin remained above 15% throughout the period 2013–2020 and resistance to levofloxacin, as well as dual or triple resistances, were high. A progressive decrease in metronidazole resistance was observed.

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European Registry on Helicobacter pylori Management: single-capsule bismuth quadruple therapy is effective in real-world clinical practice

United European Gastroenterology Journal ◽

10.1177/2050640620972615 ◽

2020 ◽

pp. 205064062097261

Author(s):

Olga P Nyssen ◽

Angeles Perez-Aisa ◽

Manuel Castro-Fernandez ◽

Rinaldo Pellicano ◽

Jose M. Huguet ◽

...

Keyword(s):

Helicobacter Pylori ◽

Clinical Practice ◽

Proton Pump Inhibitor ◽

Proton Pump ◽

Real World ◽

Case Report Form ◽

First Line ◽

Quadruple Therapy ◽

Intention To Treat ◽

H Pylori

Background There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterología REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e. three capsules every 6 hours for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

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Empirical or susceptibility-guided treatment for Helicobacter pylori infection? A comprehensive review

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820968736 ◽

2020 ◽

Vol 13 ◽

pp. 175628482096873

Author(s):

Javier P. Gisbert

Keyword(s):

Helicobacter Pylori ◽

Clinical Practice ◽

Helicobacter Pylori Infection ◽

Alternative Methods ◽

First Line ◽

Time Saving ◽

Line Therapy ◽

H Pylori ◽

Guided Therapy

Although susceptibility-guided therapy is frequently recommended for Helicobacter pylori infection, the evidence available to date supporting this strategy is limited. The aim of the present article is to review the advantages and limitations of the susceptibility-guided and the empirical strategies to treat this infection. We performed a bibliographic search to identify studies investigating H. pylori susceptibility-guided therapy. Culture is not the only way to assess antibiotic resistance, as different polymerase chain reaction-based approaches have been developed as alternative methods. For detecting H. pylori antimicrobial resistance, a molecular approach based on a stool sample might enable more convenient, time-saving methods. Unfortunately, the antimicrobial susceptibility cannot be obtained in all cases. Furthermore, antibiotic susceptibility testing in clinical practice yields useful information only for a few antibiotics: clarithromycin, metronidazole, and quinolones. In addition, susceptibility towards clarithromycin and metronidazole in vitro does not necessarily lead to eradication in vivo. In the case of H. pylori therapy failure, we should not re-administer any of the antibiotics against which H. pylori has probably become resistant. Our updated meta-analysis showed that susceptibility-guided treatment is not better than empirical treatment of H. pylori infection in first-line therapy if the most updated quadruple regimens are empirically prescribed, and similar efficacy results were also demonstrated with the two strategies for second-line therapy. Cumulative H. pylori eradication rate with several successive rescue therapies empirically prescribed reaches almost 100%. Finally, the studies that have evaluated the cost-effectiveness of the susceptibility-guided treatment have achieved contradictory results. In summary, we can conclude that the evidence is too limited to support the generalized use of susceptibility-guided therapy for H. pylori treatment in routine clinical practice, either as first-line or as rescue treatment. Nevertheless, it would be recommended that susceptibility tests are performed routinely, even before prescribing first-line treatment, in specialized centers with an interest in H. pylori management.

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Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicentre randomised trial in Japan

Gut ◽

10.1136/gutjnl-2019-319954 ◽

2020 ◽

Vol 69 (6) ◽

pp. 1019-1026 ◽

Cited By ~ 20

Author(s):

Sho Suzuki ◽

Takuji Gotoda ◽

Chika Kusano ◽

Hisatomo Ikehara ◽

Ryoji Ichijima ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Low Dose ◽

Protocol Analysis ◽

Randomised Trial ◽

Positive Culture ◽

Dual Therapy ◽

Randomised Clinical Trial ◽

First Line ◽

H Pylori

ObjectiveTo date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for Helicobacter pylori treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line H. pylori treatment, and compared this with vonoprazan-based triple therapy.DesignThis prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with H. pylori–positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, H. pylori antimicrobial resistance and institution. Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.ResultsBetween October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups.ConclusionThe 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance.Trial registration numberUMIN000034140.

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RESISTANCE TO AMOXICILLIN, CLARITHROMYCIN AND CIPROFLOXACIN OF Helicobacter pylori ISOLATED FROM SOUTHERN BRAZIL PATIENTS

Revista do Instituto de Medicina Tropical de São Paulo ◽

10.1590/s0036-46652014000300003 ◽

2014 ◽

Vol 56 (3) ◽

pp. 197-200 ◽

Cited By ~ 16

Author(s):

Simone Ulrich Picoli ◽

Luiz Edmundo Mazzoleni ◽

Heriberto Fernández ◽

Laura Renata De Bona ◽

Erli Neuhauss ◽

...

Keyword(s):

Helicobacter Pylori ◽

Eradication Therapy ◽

Empirical Therapy ◽

British Society ◽

World Population ◽

Southern Brazil ◽

First Line ◽

The World ◽

Antibiotics Susceptibility ◽

H Pylori

Introduction: Helicobacter pylori is a bacteria which infects half the world population and is an important cause of gastric cancer. The eradication therapy is not always effective because resistance to antimicrobials may occur. The aim of this study was to determine the susceptibility profile of H. pylori to amoxicillin, clarithromycin and ciprofloxacin in the population of Southern Brazil. Material and methods: Fifty four samples of H. pylori were evaluated. The antibiotics susceptibility was determined according to the guidelines of the British Society for Antimicrobial Chemotherapy and the Comité de l'Antibiogramme de la Société Française de Microbiologie. Results: Six (11.1%) H. pylori isolates were resistant to clarithromycin, one (1.9%) to amoxicillin and three (5.5%) to ciprofloxacin. These indices of resistance are considered satisfactory and show that all of these antibiotics can be used in the empirical therapy. Conclusion: The antibiotics amoxicillin and clarithromycin are still a good option for first line anti-H. pylori treatment in the population of Southern Brazil.

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Clinical Features and Effects of Eradication on Helicobacter Pylori Positive 207 ITP Cases in Japan.

Blood ◽

10.1182/blood.v104.11.2071.2071 ◽

2004 ◽

Vol 104 (11) ◽

pp. 2071-2071

Author(s):

Kingo Fujimura ◽

Masataka Kuwana ◽

Yoshiyuki Kurata ◽

Masahiro Imamura ◽

Hiroshi Harada ◽

...

Keyword(s):

Helicobacter Pylori ◽

Platelet Count ◽

Eradication Therapy ◽

The Other ◽

First Line ◽

Platelet Counts ◽

Count Response ◽

Successful Group ◽

H Pylori ◽

Over 40 Years

Abstract In 1998, Gasbarrini et al reported that in ITP cases with Helicobacter pylori (H.pylori) infection, elevation of platelet counts was observed by eradication of this bacterium. Since then, several reports from Italy and Japan confirmed the elevation of platelet counts after eradication. However, the characteristic background in the H.pylori positive ITP and eradication effects on platelet counts is unclear. On the other hand, reports from Spain, North Europe and USA could not show the evidence that eradication is effective on elevating platelet counts in H.pylori positive ITP. Therefore, we designed a nationwide retrospective study in Japan to evaluate the incidence of H.pylori positive ITP cases and the effects of eradication on platelet counts and to clear above problems. Four hundred and thirty-five ITP cases were enrolled over a period of one and half years (2002. 7~2003.12) from 12 hospitals. H. pylori infection was found in 300 cases(65%), who were significantly (P<0.005) older and showed hyperplastic megakaryocyte in bone marrow (P=0.011) comparison with negative cases. Eradication to H. pylori was performed in 207 H. pylori positive ITP cases and as a whole, the platelet count response was observed in 63% of eradication succeeded group. In the successful group, CR and PR rate were 23% and 42% respectively at 12 months after eradication. The platelet count response was significant in the successfully eradicated group (P<0.005) and the increased platelet count was maintained without ITP treatment for over 12 months. In conclusion, H. pylori infection was involved in most ITP patients over 40 years old in Japan and eradication therapy proved effective for increasing platelet counts even in splenectomy non-responsive cases and the platelet count response appeared one month after eradication. This evidence suggests that eradication therapy is the first line of treatment in H. pylori positive ITP patients.

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Best Helicobacter pylori Eradication Strategy in the Era of Antibiotic Resistance

Antibiotics ◽

10.3390/antibiotics9080436 ◽

2020 ◽

Vol 9 (8) ◽

pp. 436 ◽

Cited By ~ 1

Author(s):

Su Young Kim ◽

Jun-Won Chung

Keyword(s):

Helicobacter Pylori ◽

Antibiotic Resistance ◽

Resistance Rate ◽

First Line ◽

Helicobacter Pylori Eradication ◽

First Line Therapy ◽

Standard Triple Therapy ◽

Eradication Strategy ◽

Helicobacter Pylori Treatment ◽

H Pylori

Antibiotic resistance is the major reason for Helicobacter pylori treatment failure, and the increasing frequency of antibiotic resistance is a challenge for clinicians. Resistance to clarithromycin and metronidazole is a particular problem. The standard triple therapy (proton pump inhibitor, amoxicillin, and clarithromycin) is no longer appropriate as the first-line treatment in most areas. Recent guidelines for the treatment of H. pylori infection recommend a quadruple regimen (bismuth or non-bismuth) as the first-line therapy. This treatment strategy is effective for areas with high resistance to clarithromycin or metronidazole, but the resistance rate inevitably increases as a result of prolonged therapy with multiple antibiotics. Novel potassium-competitive acid blocker-based therapy may be effective, but the data are limited. Tailored therapy based on antimicrobial susceptibility test results is ideal. This review discussed the current important regimens for H. pylori treatment and the optimum H. pylori eradication strategy.

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