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Authors

  • Paolo De Simone M.D.,

    1. Department of General Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy
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  • Lucio Caccamo M.D., Ph.D.,

    1. Department of General Surgery and Liver Transplantation, Ca' Granda-Maggiore Polyclinic Hospital, Scientific Institute for Research, Hospitalization, and Health Care, Milan, Italy
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  • Vincenzo Scuderi M.D.,

    1. Department of Hepatobiliary Surgery and Liver Transplantation, A. Cardarelli Hospital for National Relief, Naples, Italy
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  • Patrizia Burra M.D., Ph.D.,

    1. Multivisceral Transplant Unit (Gastroenterology), Department of Surgical and Gastroenterological Sciences, Padua University Hospital, Padua, Italy
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  • Monica Franciosi M.Sc.

    Corresponding author
    1. Department of Clinical Pharmacology and Epidemiology, Mario Negri Sud Consortium, Santa Maria Imbaro, Italy
    • Department of Clinical Pharmacology and Epidemiology, Mario Negri Sud Consortium, Via Nazionale 8/A, Santa Maria Imbaro, Italy 66030
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    • Telephone: +39 0872 570260; FAX: +39 0872 570263


  • This reply was written on behalf of the TWo evaluations about the HBV ImmunoglobuliNS (TWINS 1) study group.

Reply

TO THE EDITORS:

We are grateful to Yoshida et al. for their interest in our recent work on the development and validation of a questionnaire examining the quality of life (QOL) of liver transplantation (LT) recipients given long-term intravenous (IV) or intramuscular (IM) prophylaxis against hepatitis B virus.1 We share with these authors the view that the prevention of the posttransplant recurrence of hepatitis B virus should be based on a combination therapy using antiviral agents and hepatitis B immune globulins (HBIGs), and this strategy is almost universally used in our country. The questionnaire has been developed to capture patients' feelings, needs, and perceived QOL when they are receiving HBIG because no specific instrument was previously available and because such issues are seldom taken into account when the route of HBIG administration is being chosen.

However, we are especially appreciative of Yoshida et al.'s focus on the recent introduction of subcutaneous (SC) HBIG, which may further help to rekindle the issue of patients' centeredness in the post-LT management algorithm. In their previous experience with switching from the IM route to the SC route, LT patients preferred the latter, mainly because there was less pain.2 However, this is only 1 element of the dimensions of primary relevance composing the QOL spectrum in patients receiving long-term treatment. Recently, a European experience using a specifically designed SC HBIG formulation was reported.3 Yahyazadeh et al.3 switched stable LT recipients from IV HBIG to SC HBIG with the primary goal of defining the efficacy and safety of the proposed innovative treatment. Interestingly, the authors reported that the majority of the patients were progressively able to self-administer SC HBIG, and despite the lack of specific measurements, they speculated that self-administration was pivotal to improving QOL. Similarly, previous studies exploring the impact of the conversion from IV immune globulin to SC immune globulin in patients affected by primary immunodeficiency syndrome have shown relevant advantages in both QOL and costs.4, 5

To better capture the complex interplay of treatment-related pain, self-management, the disruption of daily routines, and patient preferences, we felt that there was a need to design and validate a specific questionnaire for LT patients on HBIG. Our results show that the route of HBIG administration has a significant impact on specific QOL domains.1 We compared the IV route with the IM route because SC HBIG was not yet commercially available in our country at that time. However, with the completion of a national, multicenter, single-arm study of the feasibility and safety of switching from IV or IM HBIG to SC HBIG6 and with its recent approval for commercial use after LT, we are currently applying and validating the questionnaire in patients converted to SC HBIG in order to shed more light on the impact of the SC route on QOL domains.

Paolo De Simone M.D.*, Lucio Caccamo M.D., Ph.D.†, Vincenzo Scuderi M.D.‡, Patrizia Burra M.D., Ph.D.§, Monica Franciosi M.Sc.,¶, * Department of General Surgery and Liver Transplantation University of Pisa Medical School Hospital Pisa, Italy, † Department of General Surgery and Liver Transplantation Ca' Granda-Maggiore Polyclinic Hospital Scientific Institute for Research Hospitalization, and Health Care, Milan, Italy, ‡ Department of Hepatobiliary Surgery and Liver Transplantation A. Cardarelli Hospital for National Relief Naples, Italy, § Multivisceral Transplant Unit (Gastroenterology) Department of Surgical and Gastroenterological Sciences Padua University Hospital, Padua, Italy, ¶ Department of Clinical Pharmacology and Epidemiology, Mario Negri Sud Consortium Santa Maria Imbaro, Italy.

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