title: Spanish multicentre PIBHE study: Prevalence and immunization of chronic hepatitis B in haemodialysis patients in Spain.
abstract: BACKGROUND
  The PIBHE study, promoted by the Spanish Liver and Kidney Association and the Dialysis Virus Group of the Spanish Society of Nephrology, is the first study to determine the status of haemodialysis patients with chronic HBV infection and the immunisation against the vaccine.
  
  
  METHODS
  The study has a national multicentre, observational, cross-sectional design and was carried out between January 2013 and 2014. A data collection folder was sent to all the nephrology departments and outpatient haemodialysis units in Spain, to be completed based on patient medical files after informed consent. The data were recorded in a central database.
  
  
  RESULTS
  A total of 215 centres participated (15,645 patients), with an HBV prevalence of 1.03%. HCV or HIV was present in 7.2% of the HBV(+) patients. Viral load was below 2,000 IU/ml in 80%. GOT and GPT levels were 19.1±10.1 and 15.9±9.6 IU/ml, respectively. Liver biopsy was performed in 7.1%. Antiviral treatment was prescribed in 30% and suspended in 12.5%: entecavir (13.3%), lamivudine (10%), adefovir and tenofovir (6.7%), and interferon (3.3%). A total of 34.5% were candidates for renal transplantation and 6.9% had not been evaluated; 64.3% were followed up by a gastroenterologist; 27.2% of HBV(-) patients without immunisation had not been vaccinated. Fourteen different immunisation schedules had been used, with an immunisation rate of 58.8%. Mean anti-HBs stood at 165.7±297.8mIU/ml. A total of 72.7% of patients had received a vaccination course; 26.4%, 2 cycles; 1.0%, 3 cycles; and 11.6%, a booster dose. A total of 28.3% had a poor response (anti-HBs 10-99mIU/ml); 22.4%, an optimal response (anti-HBs 100-999mIU/ml); and 7.9%, an excellent response (anti-HBs ≥ 1,000mIU/ml). Age was significantly associated with response to vaccination; the mean age of nonresponders was significantly higher than patients who had a response of any kind (P<.05). The highest probability of an immune response was achieved with 4 doses of 40 mcg of adjuvanted vaccine (OR: 7.3; 95% CI 3.4 to 15.7), for the same age and number of cycles and boosters. Age, adjuvanted vaccine, dose and vaccination schedule influenced the immune response and the anti-HBs titres reached (P<.05).
  
  
  CONCLUSIONS
  The prevalence of chronic HBV infection in haemodialysis in Spain is low and so are the rates of immunisation against the virus. The vaccination schedules used are very diverse and have been observed to correlate with the immune response. It would therefore be necessary to establish a protocol for the most effective vaccination schedule to increase immunisation in these patients.
authors.affiliation: Unidad Hepatorrenal, Servicio de Nefrología, Hospital La Mancha-Centro, Alcázar de San Juan (Ciudad Real), España. Electronic address: rgarciaagudo@hotmail.com.
authors.forename: Rebeca
authors.initials: R
authors.lastname: García Agudo
authors.affiliation: Unidad Hepatorrenal, Servicio de Aparato Digestivo, Hospital La Mancha-Centro, Alcázar de San Juan (Ciudad Real), España.
authors.forename: Sami
authors.initials: S
authors.lastname: Aoufi Rabih
authors.affiliation: Servicio de Nefrología, Hospital Universitario La Princesa, Madrid, España.
authors.forename: Guillermina
authors.initials: G
authors.lastname: Barril Cuadrado
authors.affiliation: Grupo de Investigación de la Asociación Española de Hígado y Riñón, Alcázar de San Juan (Ciudad Real), España.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Proy Vega
authors.affiliation: Unidad de Apoyo a la Investigación, Hospital La Mancha-Centro, Alcázar de San Juan (Ciudad Real), España.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Arias Arias
authors.affiliation: Clínicas Asyter, Alcázar de San Juan (Ciudad Real), España.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Herruzo Gallego
mesh_terms: D003430:Cross-Sectional Studies; D006509:Hepatitis B; D017325:Hepatitis B Vaccines; D019694:Hepatitis B, Chronic / Q000453:epidemiology*; D006801:Humans; D015995:Prevalence; D006435:Renal Dialysis; D013030:Spain / Q000453:epidemiology
chemical_list: D017325:Hepatitis B Vaccines
keywords: Chronic kidney disease; Enfermedad renal crónica; Haemodialysis; Hemodiálisis; Hepatitis B; Hepatitis B virus; Vaccination; Vacunación