Vaccines:

Indications for: PREHEVBRIO

Hepatitis B immunization.

Clinical Trials:

The immunogenicity of Prehevbrio was evaluated in comparison with a US-licensed hepatitis B vaccine (Engerix-B) in 2 randomized, active controlled, double-blind, multi-center Phase 3 clinical trials in adults. Prehevbrio and Engerix-B were administered according to a 0-, 1- and 6-month schedule. The trials compared the seroprotection rates (SPR), defined as the proportion of participants with anti-HBs titers ≥10 mIU/mL, induced by Prehevbrio and Engerix-B. Non-inferiority was met if the lower bound of the 95% confidence interval (CI) of the difference in SPR (Prehevbrio minus Engerix-B) was greater than -5%.

Study 1 in adults ≥18 years of age

The immunogenicity population included patients who received Prehevbrio (n=718) and those who received Engerix-B (n=723). The mean age was 57 years in both groups. The primary analysis compared the SPR, 4 weeks after receiving the third dose of Prehevbrio or Engerix-B in patients ≥18 years of age. The SPR induced by Prehevbrio compared to Engerix-B was non-inferior in patients ≥18 years of age.

  • The results were:
    All adults (age 18+):
    • Prehevbrio: 91.4% (95% CI, 89.1-93.3); Engerix-B: 76.5% (95% CI, 73.2-79.5); Difference in SPR: 14.9% (95% CI, 11.2-18.6).
  • Age 45+ group:
    • Prehevbrio: 89.4% (95% CI, 86.8-91.7); Engerix-B: 73.1% (95% CI, 69.4-76.5); Difference in SPR: 16.4%; 95% CI, 12.2-20.7).

Study 2 in adults 18 through 45 years of age

The immunogenicity population included patients who received Prehevbrio (n=1753) and those who received Engerix-B (n=592). The mean age was 34 years in the Prehevbrio group and 33 years in the Engerix-B group. The study compared the SPR, 4 weeks after receiving the third dose of Prehevbrio or Engerix-B in all patients. The SPR induced by Prehevbrio compared to Engerix-B was non-inferior.

  • The results were:
    Age 18-45:
    • Prehevbrio: 99.3% (95% CI, 98.7-99.6); Engerix-B: 94.8% (95% CI, 92.7-96.4); Difference in SPR: 4.5% (95% CI, 2.9-6.6).

Adult Dosage:

Give IM inj in deltoid muscle. ≥18yrs: 10mcg (1mL) at elected date; repeat 1 and 6 months later.

Children Dosage:

<18yrs: not established.

PREHEVBRIO Contraindications:

Severe allergic reaction (including anaphylaxis) after a previous dose of any hepatitis B vaccine.

PREHEVBRIO Warnings/Precautions:

Immunocompromised. Have epinephrine inj available. Limited effectiveness due to unrecognized hepatitis B infection status at time of administration. Pregnancy. Nursing mothers.

PREHEVBRIO Classification:

HB.

PREHEVBRIO Interactions:

Concomitant immunosuppressants; may get sub-optimal response. Concomitant immune globulin; give separately using different syringes at different inj sites. May interfere with lab tests.

Adverse Reactions:

Inj site pain, tenderness, headache, fatigue, myalgia.

Note:

For the Pregnancy Exposure Registry: call (888) 421-8808.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials—1,10