Heplisav-B Seroprotection in People with HIV: A Single-Center Experience.

Schnittman, Samuel R; Zepf, Roland; Cocohoba, Jennifer; Sears, David

BACKGROUND Heplisav-B, a hepatitis B virus (HBV) vaccine with an immunostimulatory adjuvant, was FDA-approved in 2017 for adults >18 years. In randomized controlled trials, Heplisav-B demonstrated seroprotection rates (SPR) of 90-95% versus 65-80% for Engerix-B. No studies have included people with HIV (PWH), and the SPR and its predictors in this population are unknown. SETTING Quaternary care center HIV clinic. METHODS This retrospective cohort study evaluated PWH aged >18 years without current HBV seroprotection (anti-HBV surface antibody level <10 mIU/mL) who were administered Heplisav-B. Patients without post-immunization titers were excluded. The primary outcome was the SPR, the proportion of participants with HBV seroprotection at any point following the first vaccination. RESULTS Among 64 PWH included, median time to anti-HBs measurement after vaccination was 13 weeks. Median age was 58 years, 81% were men, and 95% had a viral load <200. The SPR was 81% in the entire cohort (and 86% in those without significant non-HIV immunosuppression), 79% in those with no prior HBV vaccination and no anti-HBc positivity, and 84% in those with prior vaccine non-response. Lower current and nadir CD4+ counts were associated with progressively lower seroprotection. CONCLUSION In the first single-center retrospective study of Heplisav-B in PWH, the SPR compared favorably to the SPR seen among PWH from prior HBV vaccines across key subgroups. Given these findings, Heplisav-B should be considered for expanded use for HBV vaccination in PWH. Further research on the effectiveness of a repeat vaccination series or higher dosing in non-responders is needed.