Z Gastroenterol 2016; 54 - KV214
DOI: 10.1055/s-0036-1586990

Does response to antiviral therapy affect the clinical long-term outcome of hepatitis delta?

A Wranke 1, B Calle Serrano 1, B Heidrich 1, J Kirschner 1, B Bremer 1, S Hardtke 1, K Deterding 1, K Port 1, M Cornberg 1, MP Manns 1, H Wedemeyer 1, 2
  • 1Medizinische Hochschule Hannover, Gastroenterologie, Hepatologie und Endokrinologie, Hannover, Deutschland
  • 2Deutsches Zentrum für Infektionsforschung (DZIF), Hannover, Deutschland

Background: Hepatitis delta is the most severe form of viral hepatitis. Pegylated interferon alpha (PEG-IFNa) is effective in only 25 – 30% of patients and associated with frequent side effects. The aim of this study was to analyze the outcome of hepatitis delta according to different management strategies (no treatment, nucleos(t)ide therapies, interferon-based therapies).

Methods: Out of more than 350 anti-HDV-positive patients with chronic hepatitis delta, we selected 136 individuals who were followed for at least 6 months. The median time of follow up was 5.2 years (range 0.6 – 18.8 years). The mean age was 38 years and 67% were male. Cirrhosis was present in 62 patients at first presentation. Clinical endpoints defined as hepatic decompensation (ascites, encephalopathy, variceal bleeding), hepatocellular carcinoma, orthotropic liver transplantation or death occurred in 55 patients (40%). During follow up, 29% of patients did not receive any antiviral treatment, 38% were treated with IFNa-based therapies, and 33% received HBV polymerase inhibitors (NUCS) only.

Results: An HDV RNA loss during follow up defined as negative HDV RNA at the last available visit occurred in 33 patients which was associated with IFNa-based therapy in 58% of cases. HDV RNA loss was associated with a beneficial clinical long-term outcome (p < 0.01 in Chi-Square and Kaplan Meier analysis). Of note, patients with only transient HDV RNA negativation followed by subsequent re-appearance of HDV RNA showed a similar clinical course than untreated or NUC-treated patients patients. Comparing IFNa-treated patients only with or without a post-treatment HDV RNA response to therapy, did not reveal significant difference between the groups neither in Chi-square (p = 0.4) nor in Kaplan Meier analysis (p = 0.5) However, patients who responded to therapy had a more beneficial outcome than untreated patients or patients treated with NUCS (p < 0.01), which was not the case for IFNa-nonresponding patients (p = 0.1) in Kaplan Meier analysis.

Conclusion: IFN-based therapy should be recommended particularly with the aim of HDV RNA loss and responds to therapy. HDV RNA loss should be the primary endpoint of future clinical trials.