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Modified Sequential Therapy Containing Levofloxacin Versus Levofloxacin Triple Therapy in the Second Line Treatment of Helicobacter pylori: A Randomized Trial
1384 Abstracts
Clinical Gastroenterology and Hepatology Vol. 13, No. 7
a liver biopsy or fibroscan is needed with regular surveillance in all HCV cirrhotic patients.
Survival from diagnosis
Percent survival
100
Not screened Screened
80 60 40
p<0.0001 (Log-rank)
20 0
0
5
10
15
Survival Modified Sequential Therapy Containing Levofloxacin Versus Levofloxacin Triple Therapy in the Second Line Treatment of Helicobacter pylori: A Randomized Trial Jyh-ming Liou, Ming-Shiang Wu, C. C. Chen, C. Y. Chang, Y. J. Fang, and J. T. Lin OBJECTIVES: Levofloxacin triple therapy (LT) has been
recommended as one of the second line eradication regimen for Helicobacter pylori (H. pylori) according to the Maastricht Consensus Report. However, recent studies showed unsatisfactory efficacy (<80%) of this regimen. Our previous pilot study showed that the eradication rate of modified sequential therapy containing levofloxacin (MS) was higher than 90%. Therefore, we further conducted this randomized trial to compare the efficacy and tolerability of the two regimens. SUBJECTS AND METHODS: This open-label, randomized, multicenter trial was conducted in 9 hospitals and one community in Taiwan between 2012 and 2015. H. pylori infected subjects who failed from clarithromycin-based regimens (N¼600) were randomized (1:1) to receive MS (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or LT (lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. RESULTS: The prevalence of clarithromycin, levofloxacin, and metronidazole resistance in this study population were 60%, 17.6%, and 36.9%, respectively. The eradication rates of MS and LT were 84.1% (244/290) and 76% (219/288) in the ITT analysis (p¼0.015), respectively, and 86.5% (244/282) and 78.8% (219/278) in the PP analysis (p¼0.019), respectively. There were no differences in the compliance. The efficacies in strains susceptible and resistant to levofloxacin were 92.7%
(76/82) and 47.2% (9/19) for MS (p<0.001), respectively, and were 76.4% (55/72) and 19.2% (5/26) for LT, respectively (p<0.001). The efficacies in strains susceptible and resistant to metronidazole were 92.3% (55/59) and 83.3% (30/36) for MS, respectively. CONCLUSION: Modified sequential therapy containing levofloxacin was more effective than levofloxacin triple therapy in the second line treatment for H. pylori in populations with high clarithromycin resistance. TRIAL REGISTRATION: ClinicalTrials.gov NCT01537055
Personalized Therapy of Chronic Hepatitis C and B Dually Infected Patients With PEGylated Interferon Plus Ribavirin: A Randomized Study M. L. Yeh, C. F. Huang, C. I. Huang, M. Y. Hsieh, J. F. Huang, C. Y. Dai, W. L. Chuang, and M. L. Yu BACKGROUND: Current treatment strategy for active hepatitis C virus (HCV)/chronic hepatitis B virus (HBV) dually-infected patients is based on HCV genotypeguided therapy (GGT). We aimed to evaluate the efficacy of response-guided therapy (RGT) based on HCV genotype, baseline viral loads (VL) and rapid virological response (RVR, HCV RNA undetectable at treatment week 4) with peginterferon-alpha (Peg-IFN) plus ribavirin for HCV/HBV dually-infected patients. MATERIALS AND METHODS: Two hundred and three patients, seropositive of anti-HCV, HCV RNA and HBV surface antigen (HBsAg) and seronegative for HBV e antigen for > 6 months, were randomized to receive Peg-IFN/ribavirin by either GGT (n¼102: HCV genotype 1 (HCV-1), 48 weeks; HCV-2/3, 24 weeks) or RGT (n¼101: HCV-1, 48 weeks or 24 weeks if patients with baseline VL < 400,000 IU/ml and RVR; HCV-2/3, 24 weeks or 16 weeks if patients with RVR). The primary endpoint was HCV sustained virological response (SVR, HCV RNA undetectable 24 weeks after end-of-therapy). RESULTS: The HCV SVR rate was comparable between the GGT (77.5%, 79/102) and RGT groups (70.3%, 71/101, p¼0.267), either among HCV-1/HBV (69.4% [43/62] vs. 63.5% [40/63], p¼0.571) or among HCV-2/3/HBV (90.0% [36/40] vs. 81.6% [31/38], p ¼ 0.342) duallyinfected patients based on intention-to-treat analysis. In HCV-1/HBV dually-infected patients, RVR (odds ratio [OR]: 6.31; 95% confidence intervals [CI]: 2.228–17.85) and lower pretreatment blood glucose levels (OR: 0.97; CI: 0.945-0.989) were independent predictors of HCV SVR. While RVR (OR: 12.42; CI: 2.119–72.72) and high body mass index (OR: 1.31; CI: 1.008–1.704) were significant factors associated with HCV SVR in HCV-2/3/HBV dually-infected patients. HBsAg loss at one year post-treatment was observed in 17 of 185(9.2%) patients. The rates of discontinuation and adverse events were also similar between the two groups. CONCLUSION: RGT with Peg-IFN/RBV may be considered for HBeAg-negative HBV/HCV dually-infected patients.
Clinical Gastroenterology and Hepatology Vol. 13, No. 7
a liver biopsy or fibroscan is needed with regular surveillance in all HCV cirrhotic patients.
Survival from diagnosis
Percent survival
100
Not screened Screened
80 60 40
p<0.0001 (Log-rank)
20 0
0
5
10
15
Survival Modified Sequential Therapy Containing Levofloxacin Versus Levofloxacin Triple Therapy in the Second Line Treatment of Helicobacter pylori: A Randomized Trial Jyh-ming Liou, Ming-Shiang Wu, C. C. Chen, C. Y. Chang, Y. J. Fang, and J. T. Lin OBJECTIVES: Levofloxacin triple therapy (LT) has been
recommended as one of the second line eradication regimen for Helicobacter pylori (H. pylori) according to the Maastricht Consensus Report. However, recent studies showed unsatisfactory efficacy (<80%) of this regimen. Our previous pilot study showed that the eradication rate of modified sequential therapy containing levofloxacin (MS) was higher than 90%. Therefore, we further conducted this randomized trial to compare the efficacy and tolerability of the two regimens. SUBJECTS AND METHODS: This open-label, randomized, multicenter trial was conducted in 9 hospitals and one community in Taiwan between 2012 and 2015. H. pylori infected subjects who failed from clarithromycin-based regimens (N¼600) were randomized (1:1) to receive MS (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or LT (lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. RESULTS: The prevalence of clarithromycin, levofloxacin, and metronidazole resistance in this study population were 60%, 17.6%, and 36.9%, respectively. The eradication rates of MS and LT were 84.1% (244/290) and 76% (219/288) in the ITT analysis (p¼0.015), respectively, and 86.5% (244/282) and 78.8% (219/278) in the PP analysis (p¼0.019), respectively. There were no differences in the compliance. The efficacies in strains susceptible and resistant to levofloxacin were 92.7%
(76/82) and 47.2% (9/19) for MS (p<0.001), respectively, and were 76.4% (55/72) and 19.2% (5/26) for LT, respectively (p<0.001). The efficacies in strains susceptible and resistant to metronidazole were 92.3% (55/59) and 83.3% (30/36) for MS, respectively. CONCLUSION: Modified sequential therapy containing levofloxacin was more effective than levofloxacin triple therapy in the second line treatment for H. pylori in populations with high clarithromycin resistance. TRIAL REGISTRATION: ClinicalTrials.gov NCT01537055
Personalized Therapy of Chronic Hepatitis C and B Dually Infected Patients With PEGylated Interferon Plus Ribavirin: A Randomized Study M. L. Yeh, C. F. Huang, C. I. Huang, M. Y. Hsieh, J. F. Huang, C. Y. Dai, W. L. Chuang, and M. L. Yu BACKGROUND: Current treatment strategy for active hepatitis C virus (HCV)/chronic hepatitis B virus (HBV) dually-infected patients is based on HCV genotypeguided therapy (GGT). We aimed to evaluate the efficacy of response-guided therapy (RGT) based on HCV genotype, baseline viral loads (VL) and rapid virological response (RVR, HCV RNA undetectable at treatment week 4) with peginterferon-alpha (Peg-IFN) plus ribavirin for HCV/HBV dually-infected patients. MATERIALS AND METHODS: Two hundred and three patients, seropositive of anti-HCV, HCV RNA and HBV surface antigen (HBsAg) and seronegative for HBV e antigen for > 6 months, were randomized to receive Peg-IFN/ribavirin by either GGT (n¼102: HCV genotype 1 (HCV-1), 48 weeks; HCV-2/3, 24 weeks) or RGT (n¼101: HCV-1, 48 weeks or 24 weeks if patients with baseline VL < 400,000 IU/ml and RVR; HCV-2/3, 24 weeks or 16 weeks if patients with RVR). The primary endpoint was HCV sustained virological response (SVR, HCV RNA undetectable 24 weeks after end-of-therapy). RESULTS: The HCV SVR rate was comparable between the GGT (77.5%, 79/102) and RGT groups (70.3%, 71/101, p¼0.267), either among HCV-1/HBV (69.4% [43/62] vs. 63.5% [40/63], p¼0.571) or among HCV-2/3/HBV (90.0% [36/40] vs. 81.6% [31/38], p ¼ 0.342) duallyinfected patients based on intention-to-treat analysis. In HCV-1/HBV dually-infected patients, RVR (odds ratio [OR]: 6.31; 95% confidence intervals [CI]: 2.228–17.85) and lower pretreatment blood glucose levels (OR: 0.97; CI: 0.945-0.989) were independent predictors of HCV SVR. While RVR (OR: 12.42; CI: 2.119–72.72) and high body mass index (OR: 1.31; CI: 1.008–1.704) were significant factors associated with HCV SVR in HCV-2/3/HBV dually-infected patients. HBsAg loss at one year post-treatment was observed in 17 of 185(9.2%) patients. The rates of discontinuation and adverse events were also similar between the two groups. CONCLUSION: RGT with Peg-IFN/RBV may be considered for HBeAg-negative HBV/HCV dually-infected patients.