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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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    BASELINE ALT LEVELS BUT NOT HDV-RNA LEVELS ARE ASSOCIATED WITH RESPONSE TO PEGYLATED INTERFERON ALFA-2A TREATMENT OF DELTA HEPATITIS: DATA FROM THE HIDIT-1 TRIAL
    (John Wiley & Sons Inc, 2008) Wedemeyer, Heiner; Yurdaydin, Cihan; Zachou, Kalliopi; Erhardi, Annette; Cakaloglu, Yilmaz; Yalcin, Kendal; Gurel, Selim
    [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.