Hybrid therapy highly effective for H. pylori

For eradication of Helicobacter pylori infection, a 14-day hybrid therapy that combined sequential and concomitant drug treatments improved the eradication rate, compared with 14-day standard sequential therapy, the investigators reported at the annual Digestive Disease Week.

“Worldwide, the eradication rate with standard triple therapy is less than 80 percent in intention-to-treat analyses,” WHO presented the findings. Standard triple therapy that includes a proton pump inhibitor (PPI), clarithromycin, and either amoxicillin or metronidazole.

“The ideal antimicrobial therapy would have an eradication rate of at least 95 percent by per-protocol analysis,” which would earn it a grade A score. In a recent assessment of 15 trials, mean eradication rates were 93 percent with sequential therapy and less than 95 percent with concomitant therapy, both of which have grade B result.

“Questioned whether prolonging the treatment duration of sequential therapy or continuing the amoxicillin throughout the treatment course might increase the eradication rate,” the specific aim of the study was to investigate whether either extending the duration of sequential therapy to 14 days or a 14-day hybrid regimen that combined sequential and concomitant approaches might increase the eradication rate to at least 95 percent (grade A) in per-protocol analysis.

Subjects had H. pylori infection proven by at least two positive results for the urease test, histology, and urea breath test.

The study was done as two separate pilot studies where 240 patients were randomized to the sequential therapy group, which included esomeprazole 40 mg b.i.d plus amoxicillin 1g b.i.d, (EA) 7 days followed by esomeprazole, clarithromycin 500 mg b.i.d, and metronidazole 500 mg b.i.d for 7 days, or to hybrid therapy, which included EA for 7 days followed by EA plus clarithromycin and metronidazole for 7 days. Patients were followed to week 8, when they underwent endoscopy with urease testing and histology, or urea breath test.

After excluding patients that had lack of compliance or incomplete follow-up, the final analyses included 115 in the sequential (control) group and 109 in the hybrid therapy group. The groups were similar demographically except for a higher proportion of metronidazole-susceptible patients in the sequential group.

In both the intention-to-treat and per-protocol analysis, the outcomes were superior after hybrid therapy.

“The study also showed that simply prolonging the treatment duration of sequential therapy does not achieve a grade A result,” pointed out, since rate of 93 percent can be achieved with just 10 days of sequential therapy.

In a univariate analysis if clinical and bacterial factors associated with efficacy, no factors, analyzed affected efficacy in the hybrid arm, but the presence of resistant strains reduced the eradication rate in the control arm to 88 percent.

When patients are resistant to both clarithro-mycin and metronidazole, 10-day sequential therapy carries only a 33 percent cure rate and 14-day sequential therapy has a 75 percent cure rate; however, with hybrid therapy, amoxicillin administration is prolonged out to 14 days, which can result in a 100 percent cure rate, reported.

Hybrid therapy also can overcome the negative effect of non-ulcer dyspepsia, which has been associated with lower eradication rates. With 14-day hybrid therapy, the eradication rate in this subset was 98 percent compared with 97 percent in the peptic ulcer group, reported.