Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Olga P. Nyssen; Dino Vaira; Ilaria Maria Saracino; Giulia Fiorini; María Caldas; Luis Bujanda; Rinaldo Pellicano; Alma Keco-Huerga; Manuel Pabón-Carrasco; Elida Oblitas Susanibar; Alfredo Di Leo; Giuseppe Losurdo; Ángeles Pérez-Aísa; Antonio Gasbarrini; Doron Boltin; Sinead Smith; Perminder Phull; Theodore Rokkas; Dominique Lamarque; Anna Cano-Català; Ignasi Puig; Francis Mégraud; Colm O’morain; Javier P. Gisbert

doi:10.3390/jcm11061658

Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Olga P. Nyssen, Dino Vaira, Ilaria Maria Saracino, Giulia Fiorini, María Caldas, Luis Bujanda, Rinaldo Pellicano, Alma Keco-Huerga, Manuel Pabón-Carrasco, Elida Oblitas Susanibar, Alfredo Di Leo, Giuseppe Losurdo, Ángeles Pérez-Aísa, Antonio Gasbarrini, Doron Boltin, Sinead Smith, Perminder Phull, Theodore Rokkas, Dominique Lamarque, Anna Cano-CatalàIgnasi Puig, Francis Mégraud, Colm O’morain, Javier P. Gisbert^*

^*Corresponding author for this work

Applied Medicine

Research output: Contribution to journal › Article › peer-review

13 Citations (Scopus)

2 Downloads (Pure)

Abstract

Background: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin. METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control. Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukope-nia and thrombocytopenia with fever requiring hospitalisation. Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment.

Original language	English
Article number	1658
Journal	Journal of Clinical Medicine
Volume	11
Issue number	6
DOIs	https://doi.org/10.3390/jcm11061658
Publication status	Published - 16 Mar 2022

Bibliographical note

Funding Information:
Conflicts of Interest: Gisbert has served as speaker, consultant, and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. Nyssen has received research funding from Mayoly and Allergan. Pérez-Aisa has received compensation from Allergan and Mylan for formative actions. A. Di Leo served as consultant for T.H.D. spa. The remaining authors declare no conflict of interest.

Funding Information:
Funding: This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd).

Funding Information:
This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigaci?n Biom?dica en Red de Enfermedades Hep?ticas y Digestivas (CIBERehd).

Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Data Availability Statement

The data that support the findings of this study are not publicly available given that containing information could compromise the privacy of research participants. However, previous published data on the Hp-EuReg study, or de-identified raw data referring to current study, as well as further information on the methods used to explore the data could be shared, with no particular time constraint. Individual participant data will not be shared.

Keywords

Bismuth
Culture
Eradication failure
H. pylori
Helicobacter pylori
Hp-EuReg
Rescue
Rifabutin
Treatment

Access to Document

10.3390/jcm11061658

Nyssen_etal_CM_Experience_with_Rifabutin-Containing_VOR
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Final published version, 1.46 MBLicence: CC BY

Cite this

Nyssen, O. P., Vaira, D., Saracino, I. M., Fiorini, G., Caldas, M., Bujanda, L., Pellicano, R., Keco-Huerga, A., Pabón-Carrasco, M., Susanibar, E. O., Di Leo, A., Losurdo, G., Pérez-Aísa, Á., Gasbarrini, A., Boltin, D., Smith, S., Phull, P., Rokkas, T., Lamarque, D., ... Gisbert, J. P. (2022). Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg). Journal of Clinical Medicine, 11(6), Article 1658. https://doi.org/10.3390/jcm11061658

Nyssen, OP, Vaira, D, Saracino, IM, Fiorini, G, Caldas, M, Bujanda, L, Pellicano, R, Keco-Huerga, A, Pabón-Carrasco, M, Susanibar, EO, Di Leo, A, Losurdo, G, Pérez-Aísa, Á, Gasbarrini, A, Boltin, D, Smith, S, Phull, P, Rokkas, T, Lamarque, D, Cano-Català, A, Puig, I, Mégraud, F, O’morain, C & Gisbert, JP 2022, 'Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)', Journal of Clinical Medicine, vol. 11, no. 6, 1658. https://doi.org/10.3390/jcm11061658

@article{8a14aa352c3249bda7e688629abf2d85,

title = "Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)",

abstract = "Background: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin. METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control. Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukope-nia and thrombocytopenia with fever requiring hospitalisation. Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment.",

keywords = "Bismuth, Culture, Eradication failure, H. pylori, Helicobacter pylori, Hp-EuReg, Rescue, Rifabutin, Treatment",

author = "Nyssen, {Olga P.} and Dino Vaira and Saracino, {Ilaria Maria} and Giulia Fiorini and Mar{\'i}a Caldas and Luis Bujanda and Rinaldo Pellicano and Alma Keco-Huerga and Manuel Pab{\'o}n-Carrasco and Susanibar, {Elida Oblitas} and {Di Leo}, Alfredo and Giuseppe Losurdo and {\'A}ngeles P{\'e}rez-A{\'i}sa and Antonio Gasbarrini and Doron Boltin and Sinead Smith and Perminder Phull and Theodore Rokkas and Dominique Lamarque and Anna Cano-Catal{\`a} and Ignasi Puig and Francis M{\'e}graud and Colm O{\textquoteright}morain and Gisbert, {Javier P.}",

note = "Funding Information: Conflicts of Interest: Gisbert has served as speaker, consultant, and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. Nyssen has received research funding from Mayoly and Allergan. P{\'e}rez-Aisa has received compensation from Allergan and Mylan for formative actions. A. Di Leo served as consultant for T.H.D. spa. The remaining authors declare no conflict of interest. Funding Information: Funding: This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigaci{\'o}n Biom{\'e}dica en Red de Enfermedades Hep{\'a}ticas y Digestivas (CIBERehd). Funding Information: This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigaci?n Biom?dica en Red de Enfermedades Hep?ticas y Digestivas (CIBERehd). Publisher Copyright: {\textcopyright} 2022 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2022",

month = mar,

day = "16",

doi = "10.3390/jcm11061658",

language = "English",

volume = "11",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

publisher = "MDPI AG",

number = "6",

}

TY - JOUR

T1 - Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)

AU - Nyssen, Olga P.

AU - Vaira, Dino

AU - Saracino, Ilaria Maria

AU - Fiorini, Giulia

AU - Caldas, María

AU - Bujanda, Luis

AU - Pellicano, Rinaldo

AU - Keco-Huerga, Alma

AU - Pabón-Carrasco, Manuel

AU - Susanibar, Elida Oblitas

AU - Di Leo, Alfredo

AU - Losurdo, Giuseppe

AU - Pérez-Aísa, Ángeles

AU - Gasbarrini, Antonio

AU - Boltin, Doron

AU - Smith, Sinead

AU - Phull, Perminder

AU - Rokkas, Theodore

AU - Lamarque, Dominique

AU - Cano-Català, Anna

AU - Puig, Ignasi

AU - Mégraud, Francis

AU - O’morain, Colm

AU - Gisbert, Javier P.

N1 - Funding Information: Conflicts of Interest: Gisbert has served as speaker, consultant, and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. Nyssen has received research funding from Mayoly and Allergan. Pérez-Aisa has received compensation from Allergan and Mylan for formative actions. A. Di Leo served as consultant for T.H.D. spa. The remaining authors declare no conflict of interest. Funding Information: Funding: This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd). Funding Information: This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigaci?n Biom?dica en Red de Enfermedades Hep?ticas y Digestivas (CIBERehd). Publisher Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

PY - 2022/3/16

Y1 - 2022/3/16

N2 - Background: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin. METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control. Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukope-nia and thrombocytopenia with fever requiring hospitalisation. Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment.

AB - Background: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin. METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control. Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukope-nia and thrombocytopenia with fever requiring hospitalisation. Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment.

KW - Bismuth

KW - Culture

KW - Eradication failure

KW - H. pylori

KW - Helicobacter pylori

KW - Hp-EuReg

KW - Rescue

KW - Rifabutin

KW - Treatment

UR - http://www.scopus.com/inward/record.url?scp=85126625869&partnerID=8YFLogxK

U2 - 10.3390/jcm11061658

DO - 10.3390/jcm11061658

M3 - Article

AN - SCOPUS:85126625869

SN - 2077-0383

VL - 11

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 6

M1 - 1658

ER -

Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

Other files and links

Fingerprint

Cite this