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 [anti-HBs] <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 after the first vaccination.
Results: Among 64 PWH included, median time to anti-HBs measurement after vaccination was 13 weeks. The 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 nonresponse. 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 with 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 nonresponders is needed.
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