Clinics and Research in Hepatology and Gastroenterology
Original articleHBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population
Section snippets
Abbreviations
- AEs
adverse events
- CAPD
continuous ambulatory peritoneal dialysis
- CDC
centers for disease control and prevention
- CI
confidence intervals
- CKD
chronic kidney disease
- CKD EPI
Chronic Kidney Disease Epidemiology Collaboration
- eGFR
estimated glomerular filtration rate
- ESRD
end-stage renal disease
- GI
gastrointestinal
- HBV
hepatitis B virus
- HCV
hepatitis C virus
- HIV
human immunodeficiency virus
- HD
haemodialysis
- IFN
interferon
- PD
peritoneal dialysis
- RT
renal transplant
- STROBE
Strengthening the Reporting of Observational studies in
Setting and study subjects
This was a prospective, cohort study in outpatients on regular follow-up at a metropolitan hospital (Milano city). There was a program-wide screening for hepatitis B virus infection susceptibility and immunization since early nineties at the unit. Hepatitis B virus susceptible patients with CKD were given an opportunity to participating in the study.
Inclusion criteria were receiving periodic follow-up at a inner city nephrology center, 18 years or older, serum HBsAg/anti-HBs negative at
Patient characteristics
We originally enrolled 107 patients, 102 of them completed the study, for which per-protocol analysis was done. Five patients did not complete the vaccine course – three patients were lost to follow-up, and two patients died or withdrew from the study on a voluntary basis, respectively.
The demographic, clinical and biochemical parameters of the patients at baseline are reported in Table 1. The majority of patients had Caucasian origin, none had detectable human immunodeficiency virus antibodies
Discussion
The evidence in the literature regarding the use of recombinant adjuvanted (HBV-AS04) vaccines in patients with CKD is extremely limited. In this prospective, cohort study aimed to assess immunogenicity and safety of HBV-AS04 in a large group of CKD patients not yet requiring dialysis we found a high immunization rate (97/102 = 95%); of note, this study concerns a real-life practice. As listed above, the study group presented several co-morbidities at baseline (such as arterial hypertension,
Conclusion
Our prospective cohort study conducted in a ‘real-life’ setting suggests a great immunogenicity and safety of HBV-AS04 among patients with CKD not requiring maintenance dialysis. Studies are under way to assess the persistence of anti-HBs antibodies in patients with CKD who have been subjected to active immunization successfully.
Disclosure of interest
The authors declare that they have no competing interest.
Acknowledgments
None.
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