HEPLISAV Induces Higher Seroprotection Than Engerix-B in Immunocompromised Patients

SAN FRANCISCO, CAAccording to study results from a Phase 3 randomized, controlled trial, 3 doses of HEPLISAV induced significantly higher seroprotection and antibody concentration than 4 double doses of Engerix-B in a highly immunocompromised population, as presented at IDWeek 2013.

Patients with chronic kidney disease (CKD) exhibit a reduced response to hepatitis B vaccines, which is further weakened by those with diabetes.

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Robert Janssen, MD, from Dynavax Technologies Corporation, and colleagues conducted a pre-specified subgroup analysis on 521 patients with type 2 diabetes mellitus with CKD (defined by GFR <45mL/min/1.73m2).  The study compared 3 single doses of HEPLISAV (20mcg rHBsAg + 3000mcg 1018 ISS), an investigational hepatitis B vaccine, and 4 double doses of Engerix-B (4x40mcg rHBsAg + 500mcg aluminum hydroxide).

A total of 507 patients were included in the intent-to-treat population, with 168 patients receiving HEPLISAV at Weeks 0, 4, and 24 and 160 patients receiving Engerix-B at Weeks 0, 4, 8, and 24 (8 injections total).

At Week 28, the peak seroprotection rate (SPR; % with anti-HBs ≥10mIU/mL) in the HEPLISAV group was significantly higher than in the Engerix-B group (89.5% vs. 76.7%, respectively) with a difference in SPRs of 12.9% (95% CI: 4.4%, 21.2%).  Also, the geometric mean concentration (GMC) of anti-HBs in the HEPLISAV group was significantly higher than in the Engerix-B group (448.2mIU/mL vs. 109.3mIU/mL, respectively) with a ratio of GMCs of 4.1 (95% CI: 2.0, 8.6) at Week 28.

Local post-injection reactions were less frequent in the HEPLISAV treatment arm and systemic post-injection reactions had similar incidence in both groups.

“HEPLISAV was generally well tolerated among chronic kidney disease patients with type 2 diabetes and had a similar safety profile to Engerix-B,” added Dr. Janssen. The team noted that the rates of adverse events, serious adverse events, autoimmune adverse events, and deaths were similar in the two groups.