What is the indication for Voquenza (unknown generic name) for outpatient Gastrointestinal (GI) care?

Vonoprazan (Voquenza) Indications for Outpatient Gastrointestinal Care

Vonoprazan (Voquenza) is FDA-approved for the treatment of Helicobacter pylori infection in outpatient GI care, specifically as part of dual therapy (with amoxicillin) or triple therapy (with amoxicillin and clarithromycin) regimens.

Background and Mechanism

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid and effective acid suppression in the stomach. Unlike traditional proton pump inhibitors (PPIs), vonoprazan:

• Works through a different mechanism by competitively inhibiting the potassium-binding site of gastric H+/K+-ATPase
• Achieves more rapid and potent acid suppression
• Maintains its efficacy regardless of food intake

FDA-Approved Indication

The primary indication for Voquenza (vonoprazan) in outpatient GI care is:

• Treatment of Helicobacter pylori infection as part of:
  • Vonoprazan triple therapy (20 mg vonoprazan twice daily + 1 g amoxicillin + 500 mg clarithromycin twice daily) for 14 days
  • Vonoprazan dual therapy (20 mg vonoprazan twice daily + 1 g amoxicillin three times daily) for 14 days

Clinical Evidence Supporting Use

The FDA approval was based on a randomized, controlled phase 3 trial conducted in the United States and Europe 1. This study demonstrated:

• In patients without clarithromycin and amoxicillin-resistant strains:

  • Vonoprazan triple therapy achieved 84.7% eradication rate
  • Vonoprazan dual therapy achieved 78.5% eradication rate
  • Both were noninferior to lansoprazole triple therapy (78.8%)

• In patients with clarithromycin-resistant infections:

  • Vonoprazan triple therapy achieved 65.8% eradication rate
  • Vonoprazan dual therapy achieved 69.6% eradication rate
  • Both were superior to lansoprazole triple therapy (31.9%)

• In the overall study population:

  • Both vonoprazan regimens were superior to PPI-based triple therapy

Potential Off-Label Uses

While not FDA-approved for these indications, research suggests vonoprazan may be effective for:

1. Gastroesophageal reflux disease (GERD) 2, 3:

   • Studies show improved symptom control and healing rates compared to some PPIs
   • Particularly effective for severe erosive esophagitis

2. Non-erosive reflux disease (NERD) 2:

   • One-month therapy improved symptoms in 89% of patients
   • Improvement maintained at one year in 82% without additional treatment

Dosing and Administration

For H. pylori eradication (FDA-approved indication):

• Triple therapy: 20 mg vonoprazan twice daily + 1 g amoxicillin + 500 mg clarithromycin twice daily for 14 days
• Dual therapy: 20 mg vonoprazan twice daily + 1 g amoxicillin three times daily for 14 days

Safety Considerations

• Overall frequency of treatment-emergent adverse events is similar between vonoprazan and lansoprazole regimens 1
• Common side effects include headache, diarrhea, and nausea
• Should be used with caution in patients with liver impairment

Clinical Practice Pearls

• Vonoprazan-based regimens are particularly valuable for patients with clarithromycin-resistant H. pylori strains
• Consider vonoprazan-based therapy in patients who have failed traditional PPI-based eradication regimens
• The medication can be taken without regard to meals, which may improve adherence compared to some PPIs

Conclusion

Vonoprazan (Voquenza) represents an important advancement in the treatment of H. pylori infection, particularly in areas with high clarithromycin resistance. Its FDA-approved indication is specifically for H. pylori eradication as part of dual or triple therapy regimens in outpatient GI care.