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Hepatitis D virus (HDV) infection represents the most serious form of chronic hepatitis. Turkey is among the countries with high HDV and intermediate hepatitis B virus prevalence. In Turkey, hepatitis B virus (HBV) vaccine series was included in the routine vaccination program in 1998. There have been regional differences in prevalence of HBV and HDV. Although a decline in HDV prevalence is estimated, there are uncertainties about the epidemic patterns of it. HDV prevalence was studied in varying groups and geographic regions. In this study, we aimed to analyse hepatitis D epidemiology in all groups and geographic regions in recent 35 years. During the study period of 35 years, 111 publications were noted. The analysis was done on the basis of three periods: 1999 and before (Period 1), 2000–2009 (Period 2), and 2010 and after (Period 3). The groups studied included inactive carrier state, chronic hepatitis B, all HBsAg‐positive individuals and special groups. Among inactive HBV carriers, HDV prevalence did not change significantly over three decades. Among patients with chronic hepatitis, studies reported decreasing (from Period 1 to Period 2) and then increasing (from Period 2 to period 3) HDV prevalence. The studies including all HBsAg‐positive patients reported decreasing (from Period 1 to Period 2) and then increasing (from Period 2 to period 3) HDV prevalence. Cumulative data of these 3 groups were taken to reveal HDV prevalence in HBV‐infected patients, and it showed decreasing (from Period 1 to Period 2) and then increasing (from Period 2 to period 3) HDV prevalence. Cumulative data of these 3 groups analysed according to the geographic regions of the country showed that Eastern and Southeastern Anatolia regions still have a high burden of HDV. The study showed that although HDV prevalence decreased from 8.3% in Period 1 to 4.8% in Period 2, it tended to increase 5.5% in Period 3. HDV infection is still a healthcare problem in Turkey. [ABSTRACT FROM AUTHOR]

Serum Hepatitis B core‐related antigen (HBcrAg) level moderately correlates with cccDNA. We examined whether HBcrAg can add value in monitoring the effect of peginterferon (PEG‐IFN) therapy for HBeAg‐negative chronic hepatitis B (CHB) infection. Thus, serum HBcrAg level was measured in 133 HBeAg‐negative, mainly Caucasian CHB patients, treated with 48 weeks of PEG‐IFN alfa‐2a. We assessed its association with response (ALT normalization & HBV DNA < 2000 IU/mL) at week 72. HBcrAg level strongly correlated with HBV DNA level (r = 0.8, P < 0.001) and weakly with qHBsAg and ALT (both r = 0.2, P = 0.01). At week 48, mean HBcrAg decline was −3.3 log U/mL. Baseline levels were comparable for patients with and without response at week 72 (5.0 vs 4.9 log U/mL, P = 0.59). HBcrAg decline at week 72 differed between patients with and without response (−2.4 vs −1.0 log U/mL, P = 0.001), but no cut‐off could be determined. The pattern of decline in responders resembled that of HBV DNA, but HBcrAg decline was weaker (HBcrAg −2.5 log U/mL; HBV DNA: −4.0 log IU/mL, P < 0.001). For early identification of nonresponse, diagnostic accuracy of HBV DNA and qHBsAg decline at week 12 (AUC 0.742, CI‐95% [0.0.629‐0.855], P < 0.001) did not improve by adding HBcrAg decline (AUC 0.747, CI‐95% [0.629‐0.855] P < 0.001), nor by replacing HBV DNA decline by HBcrAg decline (AUC 0.754, CI‐95% [0.641‐0.867], P < 0.001). In conclusion, in Caucasian patients with HBeAg‐negative CHB, decline of HBcrAg during PEG‐IFN treatment was stronger in patients with treatment response. However, HBcrAg was not superior to HBV DNA and qHBsAg in predicting response during PEG‐IFN treatment. [ABSTRACT FROM AUTHOR]

Background In patients with chronic hepatitis B, tenofovir disoproxil fumarate ( TDF) plus pegylated interferon ( PEG- IFN) for 48-weeks results in higher rates of hepatitis B surface antigen ( HBsAg) loss than either monotherapy. Aim To identify baseline and on-treatment factors associated with HBsAg loss at Week 72 and provide a model for predicting HBsAg loss in patients receiving combination therapy for 48 weeks. Methods A secondary analysis of data from an open-label study where patients were randomised to TDF (300 mg/day, oral) plus PEG- IFN (PI, 180 μg/week, subcutaneous) for 48 weeks ( TDF/ PI-48w); TDF plus PEG- IFN for 16 weeks, TDF for 32 weeks ( TDF/ PI-16w+ TDF-32w); TDF for 120 weeks ( TDF-120w) or PEG- IFN for 48 weeks ( PI-48w). Logistic regression methods were used to identify models that best predicted HBsAg loss at Week 72. Results Rates of HBsAg loss at Week 72 were significantly higher in the TDF/ PI-48w group (6.5%) than in the TDF/PI-16w+TDF-32w (0.5%), TDF-120w (0%) and PI-48w (2.2%) groups ( P = 0.09). The only baseline factor associated with response was genotype A. HBsAg decline at Week 12 or 24 of treatment was associated with HBsAg loss at Week 72 ( P < 0.001). HBsAg decline >3.5 log10 IU/mL at Week 24 in the TDF/ PI-48w group resulted in a positive predictive value of 85% and a negative predictive value of 99% for HBsAg loss at Week 72. Conclusions HBsAg decline at Week 24 of TDF plus PEG- IFN combination therapy may identify patients who, after completing 48 weeks of treatment, have a better chance of achieving HBsAg loss at Week 72. [ABSTRACT FROM AUTHOR]

There is a lack of knowledge regarding the effect of peginterferon ( PEG- IFN) on the expression of intrahepatic hepatitis B core and surface antigen ( HBc Ag and HBs Ag) in chronic hepatitis B ( CHB) and its relation with response to therapy. Fifty-two HBe Ag-positive and 67 HBe Ag-negative CHB patients with paired liver biopsies taken at baseline and after 1 year of PEG- IFN therapy were studied. After PEG- IFN therapy, HBe Ag-negative patients showed a significant reduction in both intrahepatic HBc Ag ( P = 0.04) and HBs Ag expression ( P < 0.001). In contrast, a reduction in intrahepatic HBc Ag expression was not observed in HBe Ag-positive patients, while a trend in reduction of intrahepatic HBs Ag staining was found ( P = 0.09). Post-treatment, 7 (13%) HBe Ag-positive and 9 (14%) HBe Ag-negative patients had no expression of intrahepatic HBs Ag. Patients without any intrahepatic HBs Ag expression post-treatment were more likely to achieve a combined response ( HBe Ag loss with hepatitis B virus ( HBV) DNA <2000 IU/mL for HBe Ag -positive and HBV DNA <2000 IU/mL and normal alanine aminotransferase for HBe Ag-negative CHB): 71% vs 5% for HBe Ag-positive ( P < 0.001) and 60% vs 16% for HBe Ag-negative patients ( P = 0.004), respectively. Moreover, a more profound decline of serum HBs Ag was observed in patients with absence of intrahepatic HBs Ag staining (3.1 vs 0.4 log IU/mL, P < 0.001 and 1.7 vs 0.4 log IU/mL, P = 0.005 for HBe Ag-positive and HBe Ag-negative CHB, respectively). In conclusion, PEG- IFN reduces expression of intrahepatic HBs Ag. Loss of HBs Ag as assessed by immunohistochemistry from the liver predicts a sustained response and is reflected in a pronounced serum HBs Ag decline. [ABSTRACT FROM AUTHOR]

Abstract Aims: The aim was to test the efficacy of a pre-S2-containing vaccine (Genhevac-B) in chronic hepatitis B (CHB). Twenty-five naive patients (22 male, three female; median age 35; range: 6–69 years) with CHB were recruited. The inclusion criteria were: hepatitis B e antigen (HBeAg) positive or HBV-DNA detectable with liquid hybridization; alanine aminotransferase (ALT) is at least 1.5-fold the upper normal limit and histological evidence of chronic hepatitis. Methods: In the first period, all patients received monthly injections of 20, 40 and 60 μg of the vaccine. One month after the last injection, patients who still had HBV-DNA were divided into two randomly assigned groups. While the patients in the first group and the patients who lost HBV-DNA in the first period continued to receive monthly injections of 20 μg vaccine for a further 6 months, the patients in the second group received 9 MU interferon α-2b (Roferon-A), three times per week using the same method as for the first group. Patients were followed up after 12 months without treatment. Response was defined as the loss of HBV-DNA and normalization of ALT. Results: Six of the 25 patients lost HBV-DNA after 3 months. Nine of the remainder were randomly placed in the first group (vaccine-only) and 10 were placed in the second group (vaccine + interferon). End-of-treatment response was achieved, overall, 8/15 from the vaccine group and 6/10 from the combination. One patient from each group relapsed during the follow up. Overall, the sustained response (SR) rate was 46% (7/15) in the vaccine group, and 50% (5/10) in the combination group. Histological improvement was achieved in 6/7 SR with vaccine-only and all five with combination treatment, while 1/8 of failures of vaccine and 2/5 of failures of combination improved. Conclusions: It was concluded that Genhevac-B decreases serum HBV-DNA levels in the majority of patients with CHB and sustained clearance was achieved in some... [ABSTRACT FROM AUTHOR]