by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
March 9, 2021
Schnittman SR, Zepf R, Cocohoba J, Sears D. Heplisav-B Seroprotection in People with HIV: A Single-Center Experience. J Acquir Immune Defic Syndr. 2021 April 1; 86(4): 445-449. doi: 10.1097/QAI.0000000000002573. PMID: 33196553.
Hepatitis B virus (HBV) vaccination for PWH is an important prevention intervention that decreases risk of developing chronic liver disease and related complications such as hepatocellular carcinoma. Among PWH, serologic response to primary vaccination with older HBV vaccines (e.g., Engerix-B, Recombivax HB) varies notably and has led to multiple vaccination studies and strategies. The purpose of this retrospective cohort study was to examine seroprotection rates (SPR) and predictors among adults without current HBV seroprotection (defined as anti-HBs < 10 mIU/mL) followed at a single quaternary care center HIV clinic who received at least one dose of Heplisav-B. Heplisav-B was approved in 2017 as a 2-dose vaccine and contains an immunostimulatory adjuvant; of note, PWH were not included in the trials which led to initial FDA approval. Among 64 PWH engaged in care at the study location, 63 received a complete 2-dose series, and 81% demonstrated post-vaccination seroprotection overall (defined as anti-HBs titers ≥ 10 mIU/mL); 63% achieved anti-HBs titers ≥ 100 mIU/mL. Seroprotection rate was 86% in patients without significant non-HIV immunosuppression, e.g. decompensated cirrhosis, solid organ transplantation, metastatic cancer, active chemotherapy, or asplenia. Seroprotection rates among PWH who underwent primary vaccination with Heplisav-B versus among PWH without a history of seroprotection after receiving older HBV vaccines (and subsequently received Heplisav-B) were 79% and 84%, respectively. Higher current and nadir CD4 cell counts were associated with seroprotection (p < 0.001 for both). There were no differences in pre- and post-immunization HIV viral load measurements; 90% of patients were virologically suppressed on ART.
This is the first published report describing immunogenicity and factors associated with seroprotection among PWH who underwent Heplisav-B vaccination. Research findings presented at CROI and other large scientific and clinical meetings will likely command HIV providers’ attention over the next few months, however this single-center analysis is informative and valuable. Despite a relatively small sample size, results suggest Heplisav-B associated seroprotection rates are high among PWH, especially persons with high CD4 counts and no significant immunosuppression. Favorable serologic response rates were also observed among persons who had not responded to older HBV vaccines. This may inform new revaccination strategies, which might be especially useful given ongoing differing approaches to revaccination. HIV providers will likely universally welcome future results from NIAID’s B-Enhancement of HBV Vaccination in Persons Living with HIV (Bee-HIVe) study,* which aims to evaluate response to and safety of Heplisav-B in populations with HIV (NCT04193189, ClinicalTrials.gov).
*Not yet recruiting
Disclaimer: Although employed at the same institution as study investigators, Dr. Chu was not involved in this research and has no financial relationship with its investigators.
The author has no conflicts of interest to disclose.
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