Wiegand, Birgit Bremer, Andreas Geipel, Corinna M. Bremer, Anika Wranke, Dieter Glebe Introduction: Hepatitis delta is the most severe

form of viral hepatitis with a fast progression of fibrosis to cirrhosis. Treatment options are still very limited as PEG-interferon alfa is effective only in a minority of patients. Therefore, appropriate determination of stage of liver disease is desired. Non-invasive fibrosis scores used for other liver diseases including APRI-score, AST/ALT ratios or FIB-4 index do not perform well in hepatitis delta. We here aimed to develop novel non-invasive fibrosis scores optimized for patients with hepatitis delta. Methods: In the ongoing HIDIT-2 treatment trial check details 120 patients with chronic hepatitis delta were recruited. Liver biopsies were evaluated centrally by two independent pathologists. Additionally, HSP inhibitor 50 cytokines, chemokines, growth factors and angiogenic factors were measured in sera of 100 of the 120 patients using multiplex technology (Bio-Plex System). Anti-HDV-IgM-testing was performed in all patients by the ETI-DELTA-IGMK-2

assay (Diasorin). T-test was used to identify factors associated with cirrhosis or fibrosis. SPTLC1 With ROC curve analysis and calculation of the Youden index cut offs were determined differentiating cirrhosis and non-cirrhosis as well as fibrosis and non-fibrosis for each factor. In a last step logistic regression was used to identify the most important factors differentiating fibrosis and cirrhosis

in order to create the new score. Results: Four factors were identified differentiating between cirrhosis and Ishak scores <5 (MIF, AST/ALT ratio, age, HGF). Defined cut-offs were determined for each factor (MIF >3400 ng/ml, AST/ALT >0.8, age >35 and HGF >370 ng/ml) which were then included in the following equitation (1 point × the indicated factor for each variable if above the cut-off): 5*MIF+2*(AST/ALT)+AGE+HGF. The AUC of the new score was 0.84; >2 points predicted cirrhosis with a sensitivity of 85%, a specificity of 69%, a PPV of 72% and a NPV of 83%. In order to differentiate between fibrosis (Ishak-score >2) and non-fibrosis, another score was similarly determined based on 6 variables: 0.