1Institute of Digestive Heath and Liver Diseases, Mercy Medical Center, Baltimore, MD, 21202, USA.
2University of Maryland School of Medicine, Baltimore, MD, USA.
3Institute of Digestive Heath and Liver Diseases, Mercy Medical Center, Baltimore, MD, 21202, USA. email@example.com.
4University of Maryland School of Medicine, Baltimore, MD, USA. firstname.lastname@example.org.
Background: The efficacy of the two-dose hepatitis B virus (HBV) vaccine (Heplisav-B®) in patients with chronic liver disease (CLD) is unknown.
Aims: To compare the immunogenicity achieved with Heplisav-B and the conventional three-dose vaccine (Engerix-B®) in patients with CLD, and to identify factors that predict seroconversion.
Methods: We retrospectively identified all adults who completed Heplisav-B or Engerix-B regimens from August 1, 2015, to January 31, 2019. Post-vaccination immunity was assessed by quantitative HBV surface antibody (HBsAb) measurement.
Results: We identified 166 patients (106 Engerix-B and 60 Heplisav-B) with chronic liver disease (mean age 59.0 ± 11.3 years, 52% male, 34% cirrhosis, mean MELD score of those with cirrhosis 10.1 ± 5.4) who had completed the vaccinations and had data available on post-vaccination HBsAb levels at least 2 months after completion of the vaccine regimen. Seroprotective HBsAb levels (> 10 mIU/ml) were achieved in 63% with Heplisav-B and in 45% with Engerix-B (p = 0.03). Univariable analysis showed that age (p = 0.01), insurance (p = 0.02), renal failure (p = 0.02), COPD (p = 0.05), and cirrhosis (p < 0.01) had a significant effect on achieving immunogenicity. On multivariable analysis, patients with cirrhosis (adjusted odds ratio [aOR]: 0.27, 95% CI 0.13-0.55), COPD (aOR: 0.06, 95% CI 0.01-0.56), or renal failure (aOR 0.36, 95% CI 0.14-0.93) had a lower likelihood of achieving immunity, and patients who received Heplisav-B® had a 2.7-fold greater likelihood of achieving immunity than those who received Engerix-B® (aOR: 2.74, 95% CI 1.31-5.71).
Conclusion: The two-dose recombinant hepatitis B vaccine resulted in better seroconversion than the three-dose vaccine. Cirrhosis, COPD, and renal failure were associated with a lower likelihood of achieving immunogenicity.