We analyzed the prevalence, positions, and various characteristics of complex SVs in HBV. We further investigated clinical significance of complex SVs in HBV. Results: From the international database and published articles, we found six strains

of HBV with complex SVs. HBV genotype distribution was genotype A in two, genotype B in one, genotype D in one, and genotype E in two. All the complex SVs in HBV were observed in the region containing X open reading frame (ORF) and BCP. Patterns of complex SVs were deletion and duplication in two, deletion, insertion, and duplication in three, and deletion and insertion in one. Median deletion nucleotide length was 21 bases (range 8 -847 bases). In four strains with insertion, the median insertion nucleotide length was 23 bases (range 12-36 bases). In five strains with duplication, the median duplication nucleotide length was 31 NVP-BGJ398 mw bases (range 20-67 bases). Two were found in patients with hepato-cellular carcinoma, and other

two EPZ-6438 were found in severe liver disease patients with post-renal transplantation. Conclusion: Novel genetic variants, complex SVs, were observed in six HBV strains. Complex SVs were observed in the region between X ORF and BCP. Complex SV in HBV was combination of canonical mutations. Though the cause and detailed mechanism still are not clear, it seems that this genetic variation is associated with severe liver disease, such as hepatocellular carcinoma or hepatic failure. (1) Fujiwara K, J Virology, 2005, 79(22), 14404. Disclosures: The following people have nothing to disclose: Kei Fujiwara, Noboru Shinkai, Shunsuke Nojiri, Mio Endo, Etsuko Iio, Takashi Joh Background and aim In clinical practice, serum HDV RNA level is used as a marker of viral replication. However, knowledge about its relationship to intrahepatic HDV markers is scant and there is no available data on the stability of HDV RNA in formalin-fixed paraffin-embedded liver samples (FFPE-LS). The aim of this

study was to Non-specific serine/threonine protein kinase determine HDV RNA in FFPE-LS using a new technique and to compare the findings with HDV RNA levels in serum. Material and Methods Among 40 untreated CHD patients, 13 had FFPE-LS and a simultaneous serum sample testing positive for HDV RNA by qualitative assays. A patient with anti-HDV who tested negative for serum HDV RNA was also included. FFPE-LS were obtained between 1999 and 2012. Serum and liver HDV RNA were analyzed by quantitative realtime PCR. A new HDV RNA standard was used, and the sensitivity of the method was 10E3 to 10E6 copies HDV/uL. Results Liver HDV RNA was detected in 13/13 CHD patients (Table). The median liver HDV RNA level was 1.1×10E7 copies/mg (range 3.85×10E4-9.2×10E8). Retested serum HDV RNA yielded a median of 3.5×10E6 copies/uL (range 3.85×1 0E4-9.2×10E8). Serum and liver HDV RNA presented a good correlation (R2=0.89).

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