Efficacy of a Nitazoxanide Based Regimen for Helicobacter pylori (HP) EradicationCampitelli E1, Paszkiewich A1, Ibarra D1, Zanotti B1, Peré F1, Ronchetti R1, Lago N1, Corti R2, Améndola R2,

Doweck J2, Chaar E3, Perissé E3, Di Risio C3, Barcia T4, Pignataro S4, Rubio H4, Díaz M5

BACKGROUND: Claritromycin and metronidazole are widely utilized as the basis of HP therapy. Unfortunately, increasing drug resistance to these drugs is one of the most prevalent reasons for HP treatment failures. Nitazoxanide is an anti-infective drug with demonstrated activity against protozoa and anaerobic bacteria including HP. Nitazoxanide exerts its clinical efficacy on HP by interfering with anaerobic energy metabolism at the PFOR enzyme. In vitro data indicates nitazoxanide and tizoxanide (an active metabolite) are highly active against HP including metronidazole resistant strains. Other studies have demonstrated that nitazoxanide does not possess mutagenic activity, cause DNA fragmentation, or promote cross-resistance with metronidazole.

AIM:This study evaluates the efficacy and safety of nitazoxanide in conjunction with lansoprazole and amoxicillin in a 7-day regimen for the eradication of HP in previously untreated patients. METHODS: An open label study to evaluate the safety and efficacy of a one-week triple drug regimen of nitazoxanide, lansoprazole and amoxicillin in adult patients with treatment naïve HP. All patients had Active Superficial Gastritis (ASG) and active HP infection. The diagnosis of HP was confirmed by both 14C-Urea Breath Test (14C-UBT) and endoscopic biopsy, overall 100 patients were enrolled in the study. Patients received nitazoxanide 500 mg BID, lansoprazole 30 mg BID and amoxicillin 1000 mg BID for 7 days. Proton pump inhibitors were discontinued post treatment and therapeutic efficacy was assessed by 14C-UBT performed between the 6th and 8th week after the completion of therapy. Eradication was defined as a negative 14C-UBT, and failure as a positive 14C-UBT at the 6 to 8 week follow-up assessment. Evaluations for safety and tolerability of the regimen were made via interview and physical examination.

Table 1: Scheme of Treatment

RESULTS:Figure 1: Patients flowchart

Figure 2: Endoscopic biopsy

Figure 3: Treatment outcome

CONCLUSIONS A 7-day regimen of nitazoxanide , lansooprazole , and amoxicillin twice daily is effective for the eradication of HP infection in treatment naïve patients In addition, the regimen was well-tolerated and associated with good patient compliance Due to increasing patterns observed with claritromycin and metronidazole, nitazoxanide may offer a valuable alternative to these medications as a foundation for HP therapy.

REFERENCES1. Hemphill A, Mueller J, Esposito thiazolide anti-infective agent for the treatment of gastrointestinal infections. Exp Opinion. Pharmacotherapy 2006 May; 7: 953-62. Megraud F., Occhialini A., Rossignol J.F. 1998. Nitazoxanide, a Potential Drug for Eradication of Helicobacter pylori with No Cross-Resistance to Metronidazole. 42: 2836-2840.3. Sisson G, Goodwing A, Raudonikiene A, Birks N, Mukhopadhayay A.K, Berg D, & Hoffman, P. 2002. Identification of Enzymes Associated with Reductive Activation and Action of Nitazoxanide, Nitrofurans, and Metronidazole in Helicobacter pylori. 46: 2116-21234. Hoffman P., Sisson G., Croxen M., Welch K., Harman W., Cremades N., Morash M. 2007. Antiparasitic Drug Nitazoxanide Inhibits the Pyruvate Oxidoreductases of Helicobacter pylori, Selected Anaerobic Bacteria and Parasites, and Campylobacter jejuni. 51;3: 868-876

AKNOWLEDGEMENT:This study was supported by a grantfrom Roemmers-Argentina

1Hospital Aeronáutico, Buenos Aires, Argentina; 2Hospital Udaondo, Buenos Aires, Argentina; 3Hospital Penna, Buenos Aires, Argentina; 4CEED, Buenos Aires, Argentina;5Hospital Británico, Buenos Aires, Argentina

Histology of endoscopic biopsy samples by three different methods. A. Warting Starring specific Stain for HP B. Giemsa stain to improve SP vision. C. Hematoxilin-eosin stain from antrum mucosae.

Presented at American College of Gastroenterology Annual Scientific Meeting • October 3-8, 2008; Orlando, Florida

A B C