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Study of iron status in patients with chronic hepatitis C with and without schistosomal hepatic fibrosis
Category 6: Viral hepatitis: clinical aspects ~-]
EFFICACY AND SAFETY OF INTERFERON alfa-2b AND RIBAVIRIN COMBINATION THERAPY IN CHRONIC HEPATITIS C PATIENTS: A CZECH MULTICENTER STUDY
Petr Husa 1, Vladislav Krtek 2, Jiri Svejda 3, Jaroslav Stransky 4, Blanka Cieslarova 4, Vit Nadvornik 5, Jiri Ehrmann 6, Petr Urbanek 7, Miroslava Volfovas. 1TeachingHospital, Brno; 2Teaching Hospital Krc;
3Privat Doctors Association, Usti nad Labem; 4TeachingHospital Kralovske Vinohrady, Praha; 5Military Hospital, Praha; 6Teaching Hospital, Olomouc; 7TeachingHospital Praha 2, Praha; STeaching Hospital, Hradec Kralove, Czech Republic Background: In this multicenter study we assessed the efficacy and changes of hematological parameters during combination therapy with of interferon alpha (IFN) and ribavirin (RBV). Methods: 173 chronic hepatitis C patients (51 naive, 47 relapsers, 85 nonresponders were treated with IFN alpha-2b (3 MU TIW) and RBV (1.0 or 1.2 g daily) for 48 weeks. There were no statistically significant differences in the distribution of age and sex. Results: Relapsers and naive patients had a higher rate of virological ETR (33/74, 70% and 24/41,59%) than non-responders (41/85, 48%, p < 0.05). The similar results were achieved in virological SR (21/47, 45% and 17/41, 41% versus 21/85, 25%, p < 0.05). Mean values of hemoglobin (HGB), white blood cells (WBC) and platelets (PLT) decreased significantly (p < 0.001, Wilcoxon matched pair test) during therapy and returned back to baseline values by week 24 of follow-up.
Baseline During treatment After follow-up
HGB [g/L] 14.7 12.0 14.7
WBC [GI/L] 5.7 3.7 5.9
PLT [GI/LI 185 163 195
The dose of IFN was reduced in 14 patients (8%) due to leucopenia; the dose of RBV was reduced in 37 (22%) patients due to anemia. Contusions: A 48-week treatment course of IFN alpha-2b and RBV is effective and safe therapy not only for naive patients and relapsers but also for previous IFN non-responders. The changes of hematological parameters are completely reversible.
J-~
STUDY OF IRON STATUS IN PATIENTS WITH CHRONIC HEPATITIS C WITH AND WITHOUT SCHISTOSOMAL HEPATIC FIBROSIS
Gamal Amin I , Mohamed El Biali ] , Yousry Ismail 2, E1 Said Ibrahim 5, Ali Nagy 3, Geylan Fadaii 3, Adel Zaki 4. JDepartmentof Medicine,
Medical Research Institute, University of Alexandria; 2Departmentof Chemical Pathology, Medical Research Institute, University of Alexandria; 3Departmentof Pathology, Medical Research Institute, University of Alexandria; 4Departmentof Medical Statistics, Medical Research Institute, University of Alexandria; SDepartment of Medicine (Hepatobiliary Unit), Faculty of Medicine, University of Alexandria, Egypt Objectives: The aim of the present study was to assess the iron status both in the serum and liver tissue in patients having chronic hepatitis C with or without schistosomal hepatic fibrosis (SHF)and its correlation with hepatic histopathological findings. Material: Thirty male patients (15 patients with pure chronic hepatitis C and 15 patients with combined chronic hepatitis C and SHF) were included in the study. All patients were subjected to: thorough clinical examination, laboratory investigation including: parasitological examination for schistosomal infection, serum bilirubin, serum transaminases, serum alkaline phosphatase, serological test for schistosomiasis and virological markers; all patients were negative for hepatitis B infection and positive for hepatitis C antibodies and HCV-RNA. Also, serum iron, total iron binding capacity and serum ferritin were measured in all patients. Liver biopsies were taken
237
from all patients to assess the degree of fibrosis, histological activity index, and hepatic iron content. Results: It was found that serum ferritin and hepatic iron content were significantly higher in patients with pure chronic hepatitis C than in those with combined chronic hepatitis C and SHE The degree of fibrosis was significantly higher in patients with combined infection than in those with pure chronic hepatitis C while there was no significant difference between both groups as regards histological activity index. In patients with pure chronic hepatitis C, the hepatic iron content was significantly correlated with serum ferritin level and the degree of fibrosis. In conclusion, hepatic iron deposition is associated with progression of liver disease and development of fibrosis in patients with chronic hepatitis C. The presence of associated SHF in these patients increases the degree of hepatic fibrosis.
- ~ LIVER FIBROSIS PROGRESSION IN HEPATITIS C VIRAL INFECTION: A CROSS-SECTIONAL STUDY Irina Ivanova I , Ivan Krasnaliev 2, lskren Kotzev l , Bogomila Manevska.
1Department of Internal Medicine, Clinic of Hepatogastroenterology, Medical University of Varna; 2Departmentof Pathology, Medical University of Varna, Bulgaria The study aimed to assess the rate of liver fibrosis progression and its determinants in 125 previously untreated patients referred to clinic for hepatitis C viral infection. The duration of infection in enrolled patients was known and fibrosis was evaluated according to METAVIR scoring system, so the estimated (indirect) fibrosis progression rate was able to calculate. The influence of sex, age at infection, age at biopsy, BMI, a history of blood transfusion, alcohol consumption, previous heroin addiction, HBV co-infection, ALT level, necroinflammatory activity and grade of steatosis on fibrosis progression was tested by correlation and chi-square analysis. Factors strongly related to fibrosis stage were age at infection and age at biopsy. Median FPR was 0.19 METAVIR units per year, less than the mean, 0.2967 (0.245 to 0.349). The significant higher FPR was estimated among patients with male gender, age at infection above 40, daily alcohol intake more than 50 grams and heroin addicts: 0.24; 0.266; 0.33 and 0.4 METAVIR units per year. Although expected time to cirrhosis was more than 50 years in 20 percent of patients, in 22 percent the median time to cirrhosis was less than 12 years. Further longitudinal studies on community-based cohorts are necessary to assess the fibrosis progression course in Bulgarian population infected with HCV.
•T]
COMPARATIVE ANALYSIS OF Peg-INTERFERON alpha-2b AND LAMIVUDINE IN THE TREATMENT OF CHRONIC HEPATITIS B PATIENTS: PRELIMINARY RESULTS
D. Koliouskas, I. Sidiropoulos, M. Masmanidou, S. Dokas, A. Ziakas.
AHEPA General Hospital, Thessaloniki, Greece Aim: To evaluate the safety and efficacy of Peg-Interferon alpha-2b and Lamivudine and to compare it with Interferon alpha-2b and Lamivudine or Lamivudine alone as treatment for previously untreated (naive) chronic hepatitis B HBV-DNA(+) patients. Patients & Methods: 30 patients (14 male, 16 female) of mean age 54 4- 16 years, with elevated transaminase levels, HBV-DNA(+) and without cirrhosis were randomized into one of three groups: (A) Peg-Interferon alpha-2b 1.5 mcg/kg QW plus Lamivudine 100 mg QD for 12 months (n = 14); (B) Interferon alpha-2b 5 M1U TIW plus Lamivudine 100 mg QD for 12 months (n = 8); or (C) Lamivudine 100 mg QD for 12 months (n = 8). Patients were subjected to monthly clinical and laboratory monitoring during therapy, and 6 months thereafter. Results: All patients exhibited normalization of ALT levels within 2 months of therapy. Virologic response (negative HBV-DNA) was observed in 12/14 patients of group A (75%), 5/8 patients of group B (62.5%) and in 0/8 patients of group C (0%). No major adverse events leading to the interruption of therapy were observed, although patients receiving either
EFFICACY AND SAFETY OF INTERFERON alfa-2b AND RIBAVIRIN COMBINATION THERAPY IN CHRONIC HEPATITIS C PATIENTS: A CZECH MULTICENTER STUDY
Petr Husa 1, Vladislav Krtek 2, Jiri Svejda 3, Jaroslav Stransky 4, Blanka Cieslarova 4, Vit Nadvornik 5, Jiri Ehrmann 6, Petr Urbanek 7, Miroslava Volfovas. 1TeachingHospital, Brno; 2Teaching Hospital Krc;
3Privat Doctors Association, Usti nad Labem; 4TeachingHospital Kralovske Vinohrady, Praha; 5Military Hospital, Praha; 6Teaching Hospital, Olomouc; 7TeachingHospital Praha 2, Praha; STeaching Hospital, Hradec Kralove, Czech Republic Background: In this multicenter study we assessed the efficacy and changes of hematological parameters during combination therapy with of interferon alpha (IFN) and ribavirin (RBV). Methods: 173 chronic hepatitis C patients (51 naive, 47 relapsers, 85 nonresponders were treated with IFN alpha-2b (3 MU TIW) and RBV (1.0 or 1.2 g daily) for 48 weeks. There were no statistically significant differences in the distribution of age and sex. Results: Relapsers and naive patients had a higher rate of virological ETR (33/74, 70% and 24/41,59%) than non-responders (41/85, 48%, p < 0.05). The similar results were achieved in virological SR (21/47, 45% and 17/41, 41% versus 21/85, 25%, p < 0.05). Mean values of hemoglobin (HGB), white blood cells (WBC) and platelets (PLT) decreased significantly (p < 0.001, Wilcoxon matched pair test) during therapy and returned back to baseline values by week 24 of follow-up.
Baseline During treatment After follow-up
HGB [g/L] 14.7 12.0 14.7
WBC [GI/L] 5.7 3.7 5.9
PLT [GI/LI 185 163 195
The dose of IFN was reduced in 14 patients (8%) due to leucopenia; the dose of RBV was reduced in 37 (22%) patients due to anemia. Contusions: A 48-week treatment course of IFN alpha-2b and RBV is effective and safe therapy not only for naive patients and relapsers but also for previous IFN non-responders. The changes of hematological parameters are completely reversible.
J-~
STUDY OF IRON STATUS IN PATIENTS WITH CHRONIC HEPATITIS C WITH AND WITHOUT SCHISTOSOMAL HEPATIC FIBROSIS
Gamal Amin I , Mohamed El Biali ] , Yousry Ismail 2, E1 Said Ibrahim 5, Ali Nagy 3, Geylan Fadaii 3, Adel Zaki 4. JDepartmentof Medicine,
Medical Research Institute, University of Alexandria; 2Departmentof Chemical Pathology, Medical Research Institute, University of Alexandria; 3Departmentof Pathology, Medical Research Institute, University of Alexandria; 4Departmentof Medical Statistics, Medical Research Institute, University of Alexandria; SDepartment of Medicine (Hepatobiliary Unit), Faculty of Medicine, University of Alexandria, Egypt Objectives: The aim of the present study was to assess the iron status both in the serum and liver tissue in patients having chronic hepatitis C with or without schistosomal hepatic fibrosis (SHF)and its correlation with hepatic histopathological findings. Material: Thirty male patients (15 patients with pure chronic hepatitis C and 15 patients with combined chronic hepatitis C and SHF) were included in the study. All patients were subjected to: thorough clinical examination, laboratory investigation including: parasitological examination for schistosomal infection, serum bilirubin, serum transaminases, serum alkaline phosphatase, serological test for schistosomiasis and virological markers; all patients were negative for hepatitis B infection and positive for hepatitis C antibodies and HCV-RNA. Also, serum iron, total iron binding capacity and serum ferritin were measured in all patients. Liver biopsies were taken
237
from all patients to assess the degree of fibrosis, histological activity index, and hepatic iron content. Results: It was found that serum ferritin and hepatic iron content were significantly higher in patients with pure chronic hepatitis C than in those with combined chronic hepatitis C and SHE The degree of fibrosis was significantly higher in patients with combined infection than in those with pure chronic hepatitis C while there was no significant difference between both groups as regards histological activity index. In patients with pure chronic hepatitis C, the hepatic iron content was significantly correlated with serum ferritin level and the degree of fibrosis. In conclusion, hepatic iron deposition is associated with progression of liver disease and development of fibrosis in patients with chronic hepatitis C. The presence of associated SHF in these patients increases the degree of hepatic fibrosis.
- ~ LIVER FIBROSIS PROGRESSION IN HEPATITIS C VIRAL INFECTION: A CROSS-SECTIONAL STUDY Irina Ivanova I , Ivan Krasnaliev 2, lskren Kotzev l , Bogomila Manevska.
1Department of Internal Medicine, Clinic of Hepatogastroenterology, Medical University of Varna; 2Departmentof Pathology, Medical University of Varna, Bulgaria The study aimed to assess the rate of liver fibrosis progression and its determinants in 125 previously untreated patients referred to clinic for hepatitis C viral infection. The duration of infection in enrolled patients was known and fibrosis was evaluated according to METAVIR scoring system, so the estimated (indirect) fibrosis progression rate was able to calculate. The influence of sex, age at infection, age at biopsy, BMI, a history of blood transfusion, alcohol consumption, previous heroin addiction, HBV co-infection, ALT level, necroinflammatory activity and grade of steatosis on fibrosis progression was tested by correlation and chi-square analysis. Factors strongly related to fibrosis stage were age at infection and age at biopsy. Median FPR was 0.19 METAVIR units per year, less than the mean, 0.2967 (0.245 to 0.349). The significant higher FPR was estimated among patients with male gender, age at infection above 40, daily alcohol intake more than 50 grams and heroin addicts: 0.24; 0.266; 0.33 and 0.4 METAVIR units per year. Although expected time to cirrhosis was more than 50 years in 20 percent of patients, in 22 percent the median time to cirrhosis was less than 12 years. Further longitudinal studies on community-based cohorts are necessary to assess the fibrosis progression course in Bulgarian population infected with HCV.
•T]
COMPARATIVE ANALYSIS OF Peg-INTERFERON alpha-2b AND LAMIVUDINE IN THE TREATMENT OF CHRONIC HEPATITIS B PATIENTS: PRELIMINARY RESULTS
D. Koliouskas, I. Sidiropoulos, M. Masmanidou, S. Dokas, A. Ziakas.
AHEPA General Hospital, Thessaloniki, Greece Aim: To evaluate the safety and efficacy of Peg-Interferon alpha-2b and Lamivudine and to compare it with Interferon alpha-2b and Lamivudine or Lamivudine alone as treatment for previously untreated (naive) chronic hepatitis B HBV-DNA(+) patients. Patients & Methods: 30 patients (14 male, 16 female) of mean age 54 4- 16 years, with elevated transaminase levels, HBV-DNA(+) and without cirrhosis were randomized into one of three groups: (A) Peg-Interferon alpha-2b 1.5 mcg/kg QW plus Lamivudine 100 mg QD for 12 months (n = 14); (B) Interferon alpha-2b 5 M1U TIW plus Lamivudine 100 mg QD for 12 months (n = 8); or (C) Lamivudine 100 mg QD for 12 months (n = 8). Patients were subjected to monthly clinical and laboratory monitoring during therapy, and 6 months thereafter. Results: All patients exhibited normalization of ALT levels within 2 months of therapy. Virologic response (negative HBV-DNA) was observed in 12/14 patients of group A (75%), 5/8 patients of group B (62.5%) and in 0/8 patients of group C (0%). No major adverse events leading to the interruption of therapy were observed, although patients receiving either