Non-interventional study AI463-12 of real-world chronic HBV infection management--baseline characteristics and treatment patterns of Polish patients kohort.

AIM: This longitudinal non-interventional study aims to describe the demographics data disease characteristics and clinical management of a cross-sectional CHB patient population in Poland treated in regional medical centers. MATERIAL AND METHODS: [corrected] Between March 2008 and December 2010 we observed patients with HBV related liver disease from 5 medical centers in Poland, both sexes, > 18 years old. At baseline, we used a case report form to extract data from patient charts, comprising: sociodemographic data; disease characteristics, HBeAg/ antiHBeAg status, genotype HBV; co-morbidities; viral load, liver biopsy and ALT levels in previous 12 months; treatment history in previous 12 months; current CHB treatment; changes in disease characteristics and CHB management; time from diagnosis to the therapy and resource utilization and any reasons for termination of follow-up. Written informed consent was obtained from all participants RESULTS: The analysis population included 253 patients (94 treated and 159 non-treated at baseline) mostly male (69.1 vs. 56.6). Patients in treated group compared with untreated group were: significantly older (mean 42.6 vs. 37.5 years respectively, p < 0.001), observed longer since diagnosis(3.9 vs.2.9 years), with higher rate of HBeAg(+)(42.6% vs.5.1%), lower ALT activity, and higher VL HBV DNA PCR. Of the 53% of treated patients, the most frequently prescribed anti-HBV drugs were: Lamivudine (53%), Entecavir (23.7%), Pegylated IFN-alfa2a (23.7%), Adefovir (11.1%). During 24 months of follow-up in treated group 13(36.1%) patients underwent a treatment switch to another nucleosi(-ti)de analogue, in one (2.8%) patient another analogue was added, and in 25 (69.4%)patients the therapy was stopped. The proportion of all patients treated with monotherapy at the end of follow-up was 99.4%, unfortunately mostly with Lamivudine-49.3%. SUMMARY: 1. Despite the several methodological limitations usually associated with this type of observation, the collected data does characterize the demographics of polish patients chronically infected with HBV well, provides some insights into the determinants of treatment initiation and the clinical management of patients in real-word settings. 2. These results indicate that in clinical practice in 5 medical non-academic centers in Poland, European guidelines regarding the qualification to HBV treatment were followed, but there were discrepancies between the initial treatment decisions in real-life current clinical practice and guideline recommendations

Hepatocyte steatosis in HCV patients promotes fibrosis by enhancing TGF-beta liver expression.

AIM: The objective of this study was to examine the relationship between TGF-beta expression in steatotic liver and the stage and yearly progression rate of fibrosis in chronic hepatitis C (CHC) patients. METHODS: We examined 44 CHC fatty liver patients, using 76 non-steatotic CHC patients as controls. The stage of hepatic fibrosis was assessed on a score scale. TGF-beta expression was determined with the use of monoclonal serum and the ABC three-step method. RESULTS: We demonstrated a positive correlation of steatosis with the stage of fibrosis (P < 0.05). No relationship of thiskind was found with the yearly progression rate of fibrosis (P > 0.09). In steatotic biopsies, TGF-beta expression index in portal spaces and lobules was found to be higher as compared to TGF-beta expression in biopsies without steatosis (P < 0.05). CONCLUSION: In CHC patients steatosis induces the development of fibrosis by elevating the hepatic expression of TGF-beta.

[Pegylated interferon-alfa 2a with ribavirin in chronic viral hepatitis C (final report)]. / Pegylowany interferon alpha-2a z rybawiryna w leczeniu przewleklego wirusowego zapalenia watroby typu C (raport koncowy z badan).

UNLABELLED: We evaluated the efficacy and safety of peginterferon alfa-2a [40KD] (Peg-IFNalpha-2a) plus ribavirin in patients with chronic hepatitis C in an open-label programme in a routine clinical setting in Poland. Patients received Peg-IFNalpha-2a 180mg/week plus ribavirin 800-1200 mg/d for 48 weeks. Sustained virological response (SVR) was defined as undetectable HCV RNA (<50IU/mL) at the end of follow-up (week 72). 466 adults were enrolled. Most patients (87.3%) had genotype 1 infection. 440 subjects (94,4%) completed treatment. The overall SVR rate was 55.7%. A higher SVR rate was obtained in treatment-naïve patients (58.7%) than in relapsers (47.8%; p=0,048). SVR rates in genotype 1 and non-1 patients were 51.1% and 88.5%, respectively (p<0.001). There were significant higher SVR rates in patients with lower baseline fibrosis (p=0,01). There were no differences in SVRs by gender or viral load. Hemoglobin, leukocyte and neutrophil levels decreased significantly during treatment, but returned to baseline after the end of treatment. ALT levels decreased significantly during treatment in patients with and without an SVR. 38.4% of patients experienced adverse events like neutropenia, anemia, thrombocytopenia, and other. There was one death (severe thrombocytopenia). CONCLUSIONS: The overall SVR achieved in this predominantly genotype 1 population was 55.7%. SVR rates were significantly higher in treatment-naïve patients, those with non-1 genotypes, and in patients with lower baseline fibrosis scores.

[Oxidative stress evaluation in chronic hepatitis C pathogenesis]. / Ocena stresu oksydacyjnego w patogenezie przewleklego wirusowego zapalenia watroby typu C.

UNLABELLED: The aim of this study was oxidative stress evaluation as reflected by antioxidant status and lipid peroxidation products levels in plasma and erythrocytes from CHC patients (chronic hepatitis C patients). Antioxidant status, markers of lipid peroxidation and liver function were measured in erythrocytes and plasma from 29 CHC patients and from 26 matched healthy controls. Plasma and erythrocytes MDA (malondialdehyde) levels were statistically decreased in CHC patients as compared with healthy controls while erythrocytes CuZnSOD (superoxide dismutase--cytoplasmic enzyme contains copper and zinc) activity was statistically increased in CHC patients as compared to healthy subjects. Plasma MDA levels correlated positively with AST (aspartate aminotransferase), ALT (alanine aminotransferase), aldolase and LDH (lactate dehydrogenase) activity. GPX (glutathione peroxidase) activity correlated negatively with erythrocytes and plasma MDA levels and CuZnSOD activity correlated negatively with LDH, aldolase, AST activity and with plasma MDA levels. CONCLUSIONS: Results of antioxidant status in CHC patients indicate oxidative stress development and efficient function of intracellular antioxidants.

[Serum intercellular adhesion molecule ICAM-1 concentration in interferon alpha treated patients with chronic viral C hepatitis]. / Stezenie rozpuszczalnej formy czastki adhezyjnej ICAM-1 w surowicy chorych na przewlekle wirusowe zapalenie watroby typu C leczonych interferonem alpha.

Intercellular adhesion molecule is a protein regulating the inflammatory cells movement. An increase of ICAM-1 expression on hepatocytes and in serum has been observed in patients with chronic viral hepatitis. Interferon alpha treatment should lead to inflammatory response diminution and serum ICAM-1 concentration decrease. The aim of the study was the estimation of interferon alpha treatment influence on serum ICAM-1 concentration in patients with chronic viral C hepatitis. A group of 19 interferon alpha treated patients with chronic viral C hepatitis has been observed. ALT activity, the presence of HCV antibody and HCV-RNAas well as histological examination has been estimated in every patient. Patients have got 144 doses of interferon alpha in a schedule 5 MU three times a week. After three months of treatment control estimations have been conducted for initial evoluation of treatment efficacy. Differences in ALT activity have been observed between I and III trials. ICAM-1 serum concentration has decreased significantly from 1322 to 369 pg/ml, and differences in ICAM-1 serum concentration have been observed in all trials. Estimation of serum ICAM-1 concentration is an indirect parameter of attenuation of inflammatory reaction after interferon alpha treatment.

[Cases of ineffective anti-hepatitis B vaccination--own observations]. / Przypadki nieskutecznego szczepienia przeciw wirusowemu zapaleniu watroby typu B--obserwacje wlasne.

Between 1999-2001 there were 6 patients with acute hepatitis B, previously vaccinated according to the recommended schedule of anti-hepatitis B immunization for adults, hospitalized in the Department of Infectious Diseases (Bytom, Silesian University Medical School). The study presents epidemiological and clinical analysis of these cases. Special attention is paid to possibility of immune response failure in spite of anti-hepatitis B vaccination. It is emphasized, that efficiency of active hepatitis B prophylaxis should be verified by estimation of serum anti-HBs antibodies, especially in patients with planned surgery.