Helicobacter pylori gastritis rescue therapy

Helicobacter pylori gastritis rescue therapy


HELICOBACTER-PYLORI

 

What is Helicobacter pylori?

This is an ancient bacteria (germ) able to live in the acidic stomach lining. About 40% of Australians over 60 have it in their stomach lining. Other high risk groups include close family members with peptic ulcer or gastric cancer, migrants from high-prevalence areas and those institutions or lower socio-economics. Most are infected in childhood.

It is a harmless coloniser without symptoms in most and a friendly preventer of disease is some. It causes gastritis in most, gastric or duodenal ulcers in up to 20%, and gastric cancer in up to 2%. "Triple therapy" (amoxycillin+ clarithromycin+PPI eg. "Nexium HP7" or metronidazole if amoxycillin allergy) cures  up to 90% in clinical trials, and somewhat lower rates in Australian "real world" settings. Causes for failure include: non-adherence, resistance (chlarithromycin 8%, metronidazole 50%, amoxycillin rare). Drug interactions need consideration with chlarithromycin.

Rescue therapy is use as plan B or C and each have 60-80% cure success:

a) levofloxacin-based 10 day therapy: levofloxacin+amoxycillin+PPI

b) quadruple therapy 7-14 days: colloidal bismuth subcitrate (120mg qid) +tetracycline (500 mg qid) +metronidazole (400mg tds) +PPI*

c) rifabutin-based 10 day therapy: amoxycillin +rifabutin+ PPI**

*Adverse effects are common (eg nausea, loose or discoloured stools, taste disturbance) ; clear written instruction maximise adherence. This regimen is often used after failure of levofloxacin-based triple therapy, but may be used beforehand

**Rifabutin treatment is best left for those experienced in its use. First, this is expensive; second, severe leucopenia and thrombocytopenia can occur (unusual with short course under 500 mg/day); third, several drug interactions need consideration. Finally, multiresistant strains of Mycobacterium tuberculosis are on the rise and rifabutin is an important TB drug. So use needs to be limited to avoid further increases in resistance. Rifabutin should be used only as rescue therapy after amoxicillin, clarithromycin, metronidazole, tetracycline, and levofloxacin have failed.

A video about Helicobacter pylori:

Will levofloxacin rescue cure my H pylori?

After 30 years of research, there is no ideal H pylori cure without side effects. Even after two "triple therapy" failures (PPI plus amoxycillin plus clarithromycin or metronidazole), H. pylori can still be cured with "quadruple" or levofloxacin-based “rescue” therapy. In "rescue" studies this levofloxacin-regimen (esomeprazole 40mg, amoxicillin 1g and levofloxacin 500mg twice a day for 10 days) worked in over 80%. Our practice experience has been 90% successful cure. Traditional "quadruple" therapy has about 70% success. Unfortunately, resistance to quinolones is easily acquired, and in countries with a high consumption of these drugs, the resistance rate is already relatively high. Levofloxacin resistance will reduce the successful eradication rate.

What are the possible risks or side effects?

Any decision to treat Helicobacter pylori involves a balance of the risk of not treating against the risk of treating.

Levofloxacin: If you decide to treat with levofloxacin, one study described no side effects in 72% and only 3% had side effects severe enough to require stopping. The most frequent side effects include nausea, headache, diarrhoea, and rashes. There are reported cases of inflamed tendons and tendon rupture and Clostridium difficile diarrhoea.

As with all medications, there is the possibility of unknown risks and late side-effects. However, after more than 15 million prescriptions in the US, the rate seems very low - less than 4 in a million.

Why is levofloxacin, tetracycline, colloid bismuth or rifabutin difficult to find in most pharmacies?

These first three drugs are not registered in Australia. This means the "Therapeutic Goods Administration (TGA) has not evaluated them either for quality, safety and or efficacy” and rifabutin is not approved by the TGA for H pylori infection. In spite of this, levofloxacin does seem simpler to take than quadruple therapy with fewer side effects. Your doctor will need to seek special access from a special Compounding pharmacy or approval from the government TGA (tel: 6232 8111) to use for your conditio via a Category B form to Canberra. Levofloxacin cost is about $60-100 depending on health card status.

Suggested steps for TGA approval:

  1. Your doctor faxes Category B form to TGA with a request to send approval to your pharmacy*.
  2. Contact your pharmacist or Ramsay pharmacy (T:8425 3911, F: 8425 3910) or Cincotta (T:98971011, F:88414532) or Customcare (T: 9651 3547, F: 9651 5293, info@customcarepharmacy.com.au) after 2 weeks to confirm levofloxacin approveal. If there is a delay, call TGA direct (6232 8111) and request they fax to pharmacy
  3. On approval, provided you have delivered the script, you may collect the levofloxacin in person or, pay over the phone and the pharmacist will post it to you.
  4. For levofloxacin-base rescue therapy : take 3 medications morning and night for 10 days as directed. Levofloxacin (½ hr before, or if you forget 2 hours after food), Nexium (½ hour before food), amoxycillin (no special directions)
  5. Stop only if significant side effects and let your doctor know.
  6. Not less than 4 weeks after your last antibiotic taken and off any PPI mediation(omeprazole, Nexium, Somac, Pariet, Zoton, Losex etc) for 2 weeks , repeat the urea breath test. Then make an appointment to review the result with your doctor to confirm H pylori cure.
  7. To assist with our research and future patient care, we would appreciate if you would fill out the brief survey below (or send an email to Dr Samuel's rooms) indicating whether the levofloxacin therapy successfully cured your H pylori infection and whether you had any side effects.

*Dr Samuel has no financial interest in Ramsay, Customcare or Cincotta pharmacy. They are three pharmacies with expertise in dispensing this currently difficult to attain medicine.