Open Access Research article

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

Giorgio Antonucci1*, Francesco Mazzotta2, Claudio Angeletti3, Enrico Girardi3, Massimo Puoti4, Giulio De Stefano5, Paolo Grossi6, Nicola Petrosillo3, Gabriella Pagano7, Giovanni Cassola8, Anna Orani9, Caterina Sagnelli10, Orlando Armignacco11, Evangelista Sagnelli10 and Coorte Epatiti B SIMIT/COESI-B (HIV) Group

Author Affiliations

1 Italian Society of Infectious & Tropical Diseases (SIMIT), Florence, Italy

2 Department of Infectious Diseases, Santa Maria Annunziata Hospital, ASL Firenze, Florence, Italy

3 National Institute for Infectious Diseases L. Spallanzani, Rome, Italy

4 Institute of Infectious & Tropical Diseases, University of Brescia, Brescia, Italy

5 Infectious Diseases Unit, Madonna delle Grazie Hospital, Matera, Italy

6 Infectious Diseases Unit, Insubria University, Varese, Italy

7 Infectious Diseases Unit, San Martino Hospital, Genoa, Italy

8 Infectious Diseases Unit, Galliera Hospital, Genoa, Italy

9 Infectious Diseases Unit, Alessandro Manzoni Hospital, Lecco, Italy

10 Infectious Diseases Unit, Second University of Naples, Naples, Italy

11 Infectious Diseases Unit, Belcolle Hospital, Viterbo, Italy

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BMC Research Notes 2013, 6:153  doi:10.1186/1756-0500-6-153

Published: 17 April 2013



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.


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.


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 1x103 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).


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.

Cohort study; Hepatitis B chronic; HIV infections/complications; Antiviral agents/therapeutic use; Health Services accessibility; Guidelines adherence