What are the recommendations for unvaccinated patients against Hepatitis B (HBV) who are considering or taking Vumerity (diroximel fumarate)?

Hepatitis B Vaccination for Unvaccinated Patients Taking Vumerity

Unvaccinated patients against Hepatitis B who are considering or taking Vumerity (diroximel fumarate) should be vaccinated against HBV before starting treatment, as immunocompromised patients are at higher risk for HBV reactivation and should receive prevaccination serologic testing. 1, 2

Risk Assessment and Vaccination Strategy

Initial Screening

• All unvaccinated patients considering Vumerity should undergo serologic testing for HBV markers:
  • Hepatitis B surface antigen (HBsAg)
  • Antibody to hepatitis B core antigen (anti-HBc)
  • Antibody to hepatitis B surface antigen (anti-HBs) 1

Interpretation of Results

• If negative for all three markers: Patient is susceptible and should receive complete vaccination series
• If HBsAg positive: Patient has chronic HBV infection and needs evaluation for antiviral treatment
• If anti-HBc positive and anti-HBs positive: Patient has resolved previous infection and is immune
• If isolated anti-HBc positive: Further assessment needed to rule out occult HBV infection 1

Vaccination Protocol for Unvaccinated Patients

Timing of Vaccination

• Ideally, complete HBV vaccination before initiating Vumerity
• If not possible, begin vaccination immediately with the first dose, even if concerns about completion exist 1
• Do not delay vaccination while waiting for serologic test results 2

Vaccination Schedule

• Standard schedule: 0,1, and 6 months 1, 2
• Alternative accelerated schedules may be considered:
  • 0,1, and 4 months
  • 0,2, and 4 months 1

Post-Vaccination Testing

When to Test

• For immunocompromised patients (including those on Vumerity), post-vaccination serologic testing is recommended 1
• Test anti-HBs levels 1-2 months after completing the vaccination series 1

Interpretation of Results

• Anti-HBs ≥10 mIU/mL: Considered immune with long-term protection 1
• Anti-HBs <10 mIU/mL: Non-responder, requires revaccination 1

Management of Non-Responders

• Administer a second complete 3-dose series
• Test for anti-HBs 1-2 months after final dose
• If still <10 mIU/mL after second series, test for HBsAg and anti-HBc
• If negative, consider patient susceptible and counsel about precautions and need for HBIG post-exposure prophylaxis for any known exposure 1

Special Considerations for Immunocompromised Patients

Monitoring

• Regular monitoring of anti-HBs levels may be required in immunocompromised patients 3
• Unlike immunocompetent individuals, immunocompromised patients may need booster doses to maintain anti-HBs ≥10 mIU/mL 3

Barriers to Address

• Common barriers to vaccination include:
  • Lack of healthcare provider recommendation (most significant factor)
  • Fear of side effects
  • Need for separate appointments
  • Lack of health insurance 4
• To improve vaccination rates:
  • Implement standing orders for vaccination
  • Provide clear recommendations
  • Ensure follow-up for completion of the series 4, 5

Importance of Vaccination Completion

• Complete the full vaccination series to ensure protection
• Assign a healthcare provider to monitor completion of the 3-dose vaccination 4
• Document vaccination status in medical records to avoid unnecessary revaccination 1

Post-Exposure Management

If an unvaccinated patient on Vumerity is exposed to HBV:

• Administer HBIG (0.06 mL/kg) as soon as possible (preferably ≤24 hours)
• Begin HBV vaccination series simultaneously at a separate anatomic site
• Complete the full vaccine series 1

By following these guidelines, clinicians can help protect patients taking Vumerity from HBV infection and potential reactivation, significantly reducing morbidity and mortality risks.