title: Access to treatment for HBV infection and its consistency with 2008 European guidelines in a multicentre cross-sectional study of HIV/HBV co-infected patients in Italy.
abstract: BACKGROUND
  A survey was performed in 2008 to evaluate the profiles of patients with chronic hepatitis B cared for by Italian Infectious Diseases Centers (IDCs). This analysis describes: i) factors associated with access to the anti-HBV treatment in a cohort of HIV/HBV co-infected patients cared for in tertiary centers of a developed country with comprehensive coverage under the National Health System (NHS); ii) consistency of current anti-HBV regimens with specific European guidelines in force at the time of the study and factors associated with the receipt of sub-optimal regimens.
  
  
  METHODS
  The study focuses on 374 (87.6%) treated patients at some point in their life out of the 427 tested HIV/HBV positive. It is multicentre, cross-sectional in the design. To account for missing values, a Multiple Imputation method is used.
  
  
  RESULTS
  Three hundred and thirty-four (89.3%) patients were currently treated. The most common current regimen was combination therapy of tenofovir (TDF) plus LAM/FTC (lamivudine/emtricitabine) (n = 235, 70.4%), as part of antiretroviral treatment. In the multivariate analysis, an increased chance of getting treated was independently associated with increasing years since HBV diagnosis (2-10 years, p <0.001; >10 years, p <0.001). Patients consistently treated with European AIDS Clinical Society (EACS) 2008 guidelines were 255 (76.6%), of whom 202 (79.2%) with an indication to an anti-HIV treatment, 30 (11.8%)without an indication, and 21 (8.2%) with cirrhosis. Among the 78 not-consistent patients, LAM mono-therapy (n = 60, 76.9%) was the most common regimen, 34 (56.7%) of them showing HBV DNA load below 1x10(3) IU/mL. Previous anti-HBV treatment (p = 0.01) and a triple HDV co-infection (p = 0.03) reduced the chance of not-consistent regimens. Conversely, HCV co-infection was independently associated with an increased odds ratio of being inconsistently treated (p = 0.004).
  
  
  CONCLUSIONS
  Our study shows that Italian IDCs treat for HBV infection the vast majority of HIV/HBV co-infected patients with no disparities limiting access to antiviral therapy. In approximately two-thirds of the patients on treatment, anti-HBV regimens are consistent with 2008 EACS guidelines. Finally, our study identifies scenarios in which clinical practice deviates from recommendations, as in case of sub-optimal regimens with effective anti-HBV response.
authors.affiliation: Italian Society of Infectious & Tropical Diseases, Florence, Italy. giorgio.antonucci@fastwebnet.it
authors.forename: Giorgio
authors.initials: G
authors.lastname: Antonucci
authors.forename: Francesco
authors.initials: F
authors.lastname: Mazzotta
authors.forename: Claudio
authors.initials: C
authors.lastname: Angeletti
authors.forename: Enrico
authors.initials: E
authors.lastname: Girardi
authors.forename: Massimo
authors.initials: M
authors.lastname: Puoti
authors.forename: Giulio
authors.initials: G
authors.lastname: De Stefano
authors.forename: Paolo
authors.initials: P
authors.lastname: Grossi
authors.forename: Nicola
authors.initials: N
authors.lastname: Petrosillo
authors.forename: Gabriella
authors.initials: G
authors.lastname: Pagano
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cassola
authors.forename: Anna
authors.initials: A
authors.lastname: Orani
authors.forename: Caterina
authors.initials: C
authors.lastname: Sagnelli
authors.forename: Orlando
authors.initials: O
authors.lastname: Armignacco
authors.forename: Evangelista
authors.initials: E
authors.lastname: Sagnelli
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D060085:Coinfection / Q000821:virology; D003430:Cross-Sectional Studies; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068679:Emtricitabine; D005060:Europe; D005260:Female; D019983:Guideline Adherence; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006297:Health Services Accessibility; D006509:Hepatitis B / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D055552:Infectious Disease Medicine / Q000379:methods / Q000592:standards*; D007558:Italy; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D015999:Multivariate Analysis; D063065:Organophosphonates / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D012044:Regression Analysis; D000068698:Tenofovir; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D019259:Lamivudine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine