The efficiency and safety of anti-Helicobacter pylori therapy in patients with concomitant chronic hepatitis C

Abstract

Aim. To evaluate the efficiency and safety of two eradication therapy (ET) regimens for Helicobacter pylori infection in patients with concomitant chronic hepatitis C (CHC) in relation to the stage of liver fibrosis (LF). Subjects and methods. A prospective clinical trial was conducted in parallel groups. Group 1 included 50 HCV-negative patients with H. pylori-associated peptic ulcer of the stomach or duodenum; Group 2 consisted of 50 HCV-positive patients with H. pylori-associated peptic ulcer of the stomach or duodenum concurrent with CHC. Each group was divided in 2 subgroups according to the used triple ET (a proton pump inhibitor (PPI) in a standard dose + amoxicillin 1000 mg twice daily + clarithromycin 500 mg twice daily for 10 days) or sequential therapy (PPI in a standard dose + amoxicillin 1000 mg twice daily within the first 5 days and then PPI in a standard dose + clarithromycin 500 mg twice daily + metronidazole 500 mg twice daily for the next 5 days). LF was assessed using indirect elastometry. The efficiency of ET was evaluated by a breath test (after 4 weeks) and an analysis depending on intention-to-treat (ITT) and per-protocol (PP) treatments. A patients recorded adverse events in specially developed diaries. Results. The efficiency of ET was 74% (ITT) and 80.4% (PP) in Group 1 and 76 (ITT) and 79.1% (PP) in Group 2. Both groups displayed a tendency towards an 11.9—12.4% increase in the efficiency of the sequential therapy versus the classical triple (PP) one. The rate of totally found side effects was 20% in Group 1 and 28% in Group 2. During sequential therapy, the rate of side effects was lower than that during the classical one. The efficiency of ET did not significantly depend on the stage of LF. Only the presence of concomitant type 2 diabetes mellitus and the use of macrolides (12 months before treatment) significantly lowered the efficiency of ET (OR 0,21; 95% CI 0,06—0,69, p=0,0102 and OR 0,27 95% CI 0,08—0,9, p=0,0342). LF regardless of its magnitude significantly determined the risk of adverse events during ET (OR 3,33 95% CI 1,19—9,31, p=0,0217). A group at the highest risk of adverse events included patients with liver cirrhosis (OR 4,87; 95% CI 1,01—23,5, p=0,0492). Conclusion. It is appropriate to prescribe a sequential ET regimen as more effective and safe for patients with concomitant CHC during therapy for H. pylori infection-associated diseases. LF increases the risk of adverse events during ET.

References

  1. Маев И.В., Самсонов А.А., Андреев Д.Н. Болезни желудка. М.: ГЭОТАР-Медиа; 2015.
  2. Маев И.В., Самсонов А.А., Андреев Д.Н., Гречушников В.Б., Коровина Т.И. Клиническое значение инфекции Helicobacter pylori. Клиническая медицина. 2013;8:4-12.
  3. Malfertheiner P, Link A, Selgrad M. Helicobacter pylori: perspectives and time trends. Nat Rev Gastroenterol Hepatol. 2014;11(10):628-638. doi: 10.1038/nrgastro.2014.99.
  4. Morgan DR, Crowe SE. Helicobacter pylori infection. In.: Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. Ed. by Mark Feldman, Lawrence S Friedman, Laurence J Brandt. 10th ed. 2015.
  5. Negro F. Epidemiology of hepatitis C in Europe. Dig Liver Dis. 2014;46 Suppl 5:S158-164. doi: 10.1016/j.dld.2014.09.023.
  6. Wedemeyer H. Hepatitis C. In: Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. Ed. by Mark Feldman, Lawrence S Friedman, Laurence J Brandt. 10th ed. 2015.
  7. El-Masry S, El-Shahat M, Badra G, Aboel-Nour MF, Lotfy M. Helicobacter pylori and Hepatitis C Virus Coinfection in Egyptian Patients. J Glob Infect Dis. 2010;2(1):4-9. doi: 10.4103/0974-777X.59244.
  8. Furusyo N, Walaa AH, Eiraku K, Toyoda K, Ogawa E, Ikezaki H, Ihara T, Hayashi T, Kainuma M, Murata M, Hayashi J. Treatment for Eradication of Helicobacter pylori Infection among Chronic Hepatitis C Patients. Gut Liver. 2011;5(4):447-453. doi: 10.5009/gnl.2011.5.4.447.
  9. Ponzetto A, Pellicano R, Redaelli A, Rizzetto M, Roffi L. Helicobacter pylori infection in patients with Hepatitis C Virus positive chronic liver diseases. New Microbiol. 2003;26(4):321-328. doi: 10.1034/j.1600-0641.2000.033004648.x.
  10. de Boer WA, Thys JC, Borody TJ, Graham DY, O’Morain C, Tytgat GN. Proposal for use of a standard side effect scoring system in studies exploring Helicobacter pylori treatment regimens. Eur J Gastroenterol Hepatol. 1996;8(7):641-643.
  11. Gatta L, Vakil N, Vaira D, Scarpignato C. Global eradication rates for Helicobacter pylori infection: systematic review and meta-analysis of sequential therapy. BMJ. 2013;347:f4587. doi: 10.1136/bmj.f4587.
  12. Feng L, Wen MY, Zhu YJ, Men RT, Yang L. Sequential Therapy or Standard Triple Therapy for Helicobacter pylori Infection: An Updated Systematic Review. Am J Ther. 2015 Jan 7. [Epub ahead of print]
  13. Li BZ, Threapleton DE, Wang JY, Xu JM, Yuan JQ, Zhang C, Li P, Ye QL, Guo B, Mao C, Ye DQ. Comparative effectiveness and tolerance of treatments for Helicobacter pylori: systematic review and network meta-analysis. BMJ. 2015;351:h4052. doi: 10.1136/bmj.h4052.
  14. Frye RF, Zgheib NK, Matzke GR, Chaves-Gnecco D, Rabinovitz M, Shaikh OS, Branch RA. Liver disease selectively modulates cytochrome P450-mediated metabolism. Clin Pharmacol Ther. 2006;80(3):235-245. doi: 10.1016/j.clpt.2006.05.006.
  15. Rodighiero V. Effects of liver disease on pharmacokinetics. An update. Clin Pharmacokinet. 1999;37(5):399-431. doi: 10.2165/00003088-199937050-00004.
  16. Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl AM, Andersen LP, Goossens H, Glupczynski Y; Study Group participants. Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut. 2013;62(1):34-42. doi: 10.1136/gutjnl-2012-302254.
  17. Maev IV, Andreev DN, Kucheryavyi YuA, Dicheva DT. Host factors influencing the eradication rate of Helicobacter pylori. World Applied Sci J. 2014;30:134-140. doi: 10.5829/idosi.wasj.2014.30.mett.61.
  18. Sargýn M, Uygur-Bayramicli O, Sargýn H, Orbay E, Yavuzer D, Yayla A. Type 2 diabetes mellitus affects eradication rate of Helicobacter pylori. World J Gastroenterol. 2003;9(5):1126-1128. doi: 10.3748/wjg.v9.i5.1126.
  19. Маев И.В., Кучерявый Ю.А., Андреев Д.Н., Баркалова Е.В. Эрадикационная терапия инфекции Helicobacter pylori: обзор мировых тенденций. Терапевтический архив. 2014;3:94-99.
  20. Маев И.В., Кучерявый Ю.А., Андреев Д.Н. Актуальные возможности оптимизации антихеликобактерной терапии. Лечащий врач. 2014;4:73-79.
  21. Delcò F, Tchambaz L, Schlienger R, Drewe J, Krähenbühl S. Dose adjustment in patients with liver disease. Drug Saf. 2005;28(6):529-545. doi: 10.2165/00002018-200528060-00005.
  22. Franz CC, Hildbrand C, Born C, Egger S, Rätz Bravo AE, Krähenbühl S. Dose adjustment in patients with liver cirrhosis: impact on adverse drug reactions and hospitalizations. Eur J Clin Pharmacol. 2013;69(8):1565-1573. doi: 10.1007/s00228-013-1502-z.
  23. Naranjo CA, Busto U, Mardones R. Adverse drug reactions in liver cirrhosis. Eur J Clin Pharmacol. 1978;13(6):429-434. doi: 10.1007/BF00566321.
  24. Halilovic J, Heintz BH. Antibiotic dosing in cirrhosis. Am J Health Syst Pharm. 2014;71(19):1621-1634. doi: 10.2146/ajhp140031.

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