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    Anti-HDV immunoglobulin M testing in hepatitis delta revisited: correlations with disease activity and response to pegylated interferon-?2a treatment
    (Int Medical Press Ltd, 2012) Mederacke, Ingmar; Yurdaydin, Cihan; Dalekos, George N.; Bremer, Birgit; Erhardt, Andreas; Cakaloglu, Yilmaz; Yalcin, Kendal
    Background: The role of anti-HDV immunoglobulin M (IgM) testing in patients receiving pegylated interferon-alpha therapy for hepatitis delta is unknown. We performed anti-HDV IgM testing in a well defined cohort of HDVinfected patients who were treated with pegylated interferon-alpha 2a plus adefovir, or either drug alone. Methods: Sera from 33 HDV-RNA-positive patients from the international HIDIT-1 trial were available for anti-HDV IgM testing (ETI-DELTA-IGMK-2 assay, DiaSorin, Saluggia, Italy) before therapy, at treatment weeks 24 and 48, and at 24 weeks after the end of treatment. Results: Anti-HDV IgM tested positive in 31 out of the 33 patients (94%) prior to treatment. HDV IgM levels correlated with histological inflammatory activity (r= 0.51, P<0.01) and were higher in patients with alanine aminotransferase and gamma-glutamyl transpeptidase levels above the median (P<0.05). Quantitative anti-HDV IgM values declined in patients responding to antiviral therapy, however anti-HDV IgM remained positive after treatment in the majority of virological responders. Conclusions: We suggest that anti-HDV IgM testing might give additional useful information to determine disease activity in hepatitis delta and to predict treatment response to antiviral therapy with type I interferons. However, determination of anti-HDV IgM can not substitute HDV RNA testing, which remains the primary virological marker for response to therapy.
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    Can response to pegylated interferon treatment in chronic delta hepatitis be predicted with on-treatment parameters?
    (Wiley-Blackwell, 2012) Onder, Fatih Oguz; Erhardt, Andreas; Idilman, Ramazan; Keskin, Onur; Dalekos, George N.; Yalcin, Kendal; Manns, Michael P.
    [Abstract Not Available]
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    Pegylated interferon-based treatment in patients with advanced liver disease due to chronic delta hepatitis
    (Aves, 2012) Kabacam, Gokhan; Dalekos, George N.; Cakaloglu, Yilmaz; Zachou, Kalliopi; Bock, Thomas; Erhardt, Andreas; Zeuzem, Stefan
    Background/aims: The safety and efficacy of interferons in advanced delta hepatitis have not been explored. The aim of this subanalysis of a multi-center clinical trial was to compare the efficacy and safety of 48 weeks of pegylated interferon alpha-2a (180 mu g weekly) with or without adefouir (10 mg daily) in patients with chronic delta hepatitis-induced advanced liver disease and in those with non-advanced liver disease. Materials and Methods: Thirty-one patients with advanced and 27 patients with non-advanced liver disease were assessed. Patients were considered to have advanced liver disease when biopsy disclosed a fibrosis score of >= 4 according to Ishak or when imaging studies were indicative of cirrhosis. Virologic response, defined as achievement of undetectable hepatitis D virus RNA, was assessed at the end of treatment and end of 24 weeks of treatment-free follow-up. Results: Patients with advanced disease had lower hepatitis D virus RNA levels and platelet counts (p=0.014 and p=0.0015, respectively). End of treatment and end of follow-up virologic responses in patients with advanced vs. non-advanced liver disease were similar (29% vs. 19% and 32% vs 23%). Proportion of adverse events did not differ between groups except that thrombocytopenia was noted more often in the advanced liver disease group. Further, four cases of clinically important adverse events including two cases of hepatic decompensation and one case of tuberculosis reactivation occurred in the advanced liver disease group. Conclusions: Pegylated interferon is as effective in patients with advanced liver disease due to chronic delta hepatitis as in patients with non-advanced liver disease, but patients should be monitored closely for clinically important side effects.
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    Quantitative HBsAg and HDV-RNA levels in chronic delta hepatitis
    (Wiley, 2010) Zachou, Kalliopi; Yurdaydin, Cihan; Drebber, Uta; Dalekos, George N.; Erhardt, Andreas; Cakaloglu, Yilmaz; Degertekin, Halil
    Background: Hepatitis delta virus (HDV) causes severe liver disease. Aims: To investigate the quantitative HDV-RNA, HBsAg and hepatitis B virus (HBV)DNA levels in correlation to histological, biochemical and demographical parameters in patients with chronic HDV infection as similar data in a large series of HDV patients are missing. Methods: Eighty HDV patients were recruited in Germany, Turkey and Greece; quantitative determination of HDV-RNA, HBsAg and HBV-DNA was performed by real-time polymerase chain reaction, the Architect HBsAg assay and Cobas TaqMan HBV test respectively. Results: All patients were infected with HDV-genotype 1. Thirty-five patients (48%) had significant fibrosis (Ishak 3-4) and 15 (20.5%) had cirrhosis. HDV viraemia ranged from 1.1 x 10(3) to 8.4 x 10(7) copies/ml with 60% of patients showing HDV-RNA levels above 105 copies/ml accompanied by low HBV viraemia (<10(5) copies/ml). However, HDV-RNA and HBV-DNA levels showed no direct inverse correlation. HDV-RNA correlated positively with HBsAg and negatively with age. HBsAg correlated negatively with age and positively with histological grading. Only gamma-glutamyltranspeptidase was independently associated with cirrhosis (P=0.032), while no biochemical parameter was associated with grading. Conclusions: (i) HBsAg levels correlated with HDV viraemia in chronic HDV. (ii) Biochemical parameters did not accurately indicate the stage and grade of liver disease in chronic HDV and thus liver biopsy seems to remain the major tool for the evaluation of delta hepatitis patients.
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    Residual low HDV viraemia is associated HDV RNA relapse after PEG-IFNa-based antiviral treatment of hepatitis delta: Results from the HIDIT-II study
    (Wiley, 2020) Bremer, Birgit; Anastasiou, Olympia E.; Hardtke, Svenja; Caruntu, Florin Alexandru; Curescu, Manuela G.; Yalçın, Kendal; Akarca, Ulus S.; Gürel, Selim; Zeuzem, Stefan; Erhardt, Andreas; Luth, Stefan; Papatheodoridis, George, V.; Radu, Monica; Idilman, Ramazan; Manns, Michael P.; Cornberg, Markus; Yurdaydın, Cihan; Wedemeyer, Heiner
    The role of low levels of HDV-RNA during and after interferon therapy of hepatitis D is unknown. We re-analysed HDV RNA in 372 samples collected in the HIDIT-2 trial (Wedemeyer et al, Lancet Infectious Diseases 2019) with the Robogene assay (RA; Jena Analytics). Data were compared with the previously reported in-house assay (IA). We detected HDV-RNA in one-third of samples previously classified as undetectable using the highly sensitive RA. Low HDV viraemia detectable at week 48 or week 96 was associated with a high risk for post-treatment relapse, defined as HDV RNA positivity in both assays at week 120. HDV RNA relapses occurred in 10/15 (67%) patients with detectable low HDV RNA at week 48 and in 10/13 (77%) patients with low viraemia samples at week 96. In contrast, the post-treatment relapse rate was lower in patients with undetectable HDV RNA in both assays during treatment.
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    Role of immunohistochemistry for hepatitis D and hepatitis B virus in hepatitis delta
    (WILEY-BLACKWELL, 111 RIVER ST, HOBOKEN 07030-5774, NJ USA, 2014) Kabaçam, Gökhan; Wedemeyer, Heiner; Savaş, Berna; Dalekos, George; Tabak, Fehmi; İdilman, Ramazan; Erhardt, Andreas; Yalçın, Kendal; Bozdayı, Mithat A.; Bozkaya, Hakan; Manns, Michael; Dienes, Hans; Yurdaydın, Cihan; Keskin, Onur
    Background & Aims: Immunohistochemical assessment of liver tissue in chronic delta hepatitis (CDH) is underinvestigated. Aim of the study was (i) to assess variables associated with hepatitis D antigen (HDAg), hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) staining in the liver. Methods: Demographic, biochemical and virologic data collected from the HIDIT 1 study were used. HBsAg, HBcAg and HDAg immunohistochemical (IHC) staining was semiquantitatively assessed. Results: Hepatitis D antigen immunohistochemical staining displayed positive correlations with age and alanine aminotransferase (ALT) and negative correlations with serum HBsAg (P = 0.01 for all). HBsAg IHC displayed a negative correlation with gamma glutamyl transferase and positive correlations with serum HBV DNA, serum HBsAg levels and HBeAg serology (P < 0.001, P = 0.02 and P = 0.007 respectively). HBcAg staining was mainly nuclear and displayed negative correlations with serum HBsAg and histologic activity (P = 0.002 and P = 0.02 respectively). Pegylated IFN based treatment led to a decline of all IHC markers, however, these markers had no impact on treatment outcome. Conclusions: These data suggest an association of liver injury with HDAg expression in CDH whereas the negative correlation between HBcAg expression and liver injury and the overall nuclear localization of HBcAg suggest that HBcAg does not contribute to liver injury in CDH. HDV cases with high level of HBV replication, high serum HBsAg levels, HBeAg positivity, that are probably in the earlier stages of disease (low gamma-glutamyl transferase), had a more intense HBsAg staining profile. Overall, the data enforce the importance of HDAg and HBsAg in different phases of CDH infection.