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EASL 2018 FRI-321
A virological response to PEG-IFNa treatment of hepatitis D is
associated with an improved clinical long-term outcome: 10 years
follow-up of the HIDIT-1 study
A. Wranke1, C. Yurdaydin2, B. Heidrich1, Z. Kalliopi3, K. Yalcin4,
T. Fehmi5, U. Akarca6, F. Lammert7, D. Häussinger8, T. Müller9,
M. Wöbse1, M.P. Manns10, H. Wedemeyer11, S. Hardtke1,12. 1Hannover
Medical School, Department of Gastroenterology, Hepatology and
Endocrinology; 2Ankara University School of Medicine, Department of
Gastroenterology, Ankara, Turkey; 3University of Thessaly, Department of
Medicine and Research Laboratory of Internal Medicine, Larissa, Greece;
4Dicle University, Medical Faculty, Diyarbaki, Turkey; 5Cerrahpasa School
of Medicine, Istanbul University, Department of Infectious Diseases,
Istanbul, Turkey; 6Ege University School of Medicine, Department of
Gastroenterology, Izmir, Turkey; 7Saarland University Medical Center,
Department of Medicine Ii, Homburg, Germany; 8Heinrich Heine
University, Department of Gastroenterology, Hepatology and Infectious
Diseases, Düsseldorf, Germany; 9Charite- Universitätsmedizin,
Medizinische Klinik m. S. Hepatologie und Gastroenterologie, Berlin,
Germany; 10Dept. of Gastroenterology, Hepatology and Endocrinology,
Hannover Medical School, Hannover, Germany; 11Department of
Gastroenterology and Hepatology, University Clinic Essen, Essen,
Germany; 12German Center for Infection Research (DZIF), Partner Site
HepNet Study-House, Hannover, Germany
Email: [email protected]
Background and Aims: Hepatitis delta virus (HDV) infection causes
the most severe form of chronic viral hepatitis associated with
accelerated fibrosis progression and an increased risk for developing
liver-related clinical complications. PEG-interferon alpha results in
HDV RNA suppression in 25–30% of patients but late HDV RNA
relapses occur and the impact on the development of clinical
endpoints is unclear. The aim of this study was to investigate the
long-term outcome after a 48 weeks course of PEG-IFNa therapy.
Method: We performed a retrospective follow-up study of patients
included in the HIDIT1 trial (Wedemeyer H. et al., NEJM 2011).
Patients received 48 weeks of treatment with either peginterferon
alfa-2a plus adefovir dipivoxil (Group I), peginterferon alfa-2a alone
(Group II), or adefovir dipivoxil alone (Group III). Liver related
complications were defined as liver-related death, liver transplantation,
HCC and hepatic decompensation (Child Pugh B,C or an
increase in MELD of five or more points in relation to baseline values).
Patients were censored for further analysis when patients were (re-)
treated with PEG-IFNa.
Results: Follow-up data (at least 1 visit beyond post-treatment week
24)were available for 61 patients of the HIDIT 1 trial (Group I (n = 20),
Group II (n = 20), Group III (n = 21)). The median time of follow-up
was 6.0 (1.1–13.3) years. During follow up 25 patients were (re-)
treated with IFN-based therapy (57.1% in PEG-IFNa arms and 64.7% in
the adefovir only arm). At the last available visit, 13 (21.3%) patients
were HDV RNA negative. Late-HDV RNA relapses of patients being
negative at post-treatment week 24 were observed in 6/14 individuals.
HBsAg was negative in 2 patients at post-treatment week 24
and in 6 patients (9.8%) at the last available visit (all after PEG-IFNa
therapy). 11 patients (18.0%) developed clinical endpoints after a
median time of 3.6 (1.4–9.9) years. Most of the patients developed a
hepatic decompensation (n = 7) and four patients underwent liver
transplantation (including three subjects with an HCC). No significant
differences in clinical outcome could be observed between the three
treatment arms in Kaplan Meier analyses. Interestingly, only one of
the patients whowere HDV RNA negative at post-treatment week 24
developed a clinical endpoint and all patients who had undetectable
HDV RNA results throughout follow-up (n = 8) remained free of
hepatic events. None of the patients who were HBsAg negative at
posttreatment week 24 developed a clinical endpoint and but one
patient who lost HBsAg later during follow-up still experienced an
episode of hepatic decompensation.
Conclusion: This long-term follow-up study of a large randomized
clinical trial suggests that an off-treatment HDV RNA response to
PEG-IFNa treatment is associated with an improved clinical longterm
outcome of hepatitis delta.
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发表于 2018-4-6 08:44