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Introduction Hepatitis C virus (HCV) is a major global health issue and successful treatment has been associated with a reduction of risk of all-cause mortality. Advancements have been made in HCV treatment through the use of interferon-free regimens. Most trials have been conducted in HCV genotype (GT) 1 and data for interferon-free regimens in GT4 patients are limited. The aim of this study was to evaluate the safety and efficacy of sofosbuvir plus simeprevir in a real-world cohort of HCV GT4 patients with advanced fibrosis. Patients and Methods Eighty-seven GT4 treatment-naïve or –Interferon (IFN) ribavirin (RBV) experienced patients treated with sofosbuvir and simeprevir +/- ribavirin (RBV) were enrolled in this cohort study (41% severe fibrosis, 59% cirrhosis). Results Patients were 51.7% male, 78.2% IFN/RBV treatment-experienced, and 37.9% received RBV treatment. The overall sustained virologic response at least 12 weeks after treatment (SVR12) rate was 87.4% while patients treated with and without RBV had rates of 87.9% and 87% (p = 0.593), respectively, and patients with advanced fibrosis (F3) and patients with cirrhosis had SVR12 rates of 94.4% and 82.4% (p = 0.087), respectively. SVR12 rates in treatment-naïve patients and in IFN/RBV -experienced patients were 78.9% and 89.7% (p = 0.191), respectively. Treatment failure occurred most commonly in patients with cirrhosis and severe disease. The treatment was well tolerated and no patient died or discontinued treatment due to adverse events. Conclusions Sofosbuvir in combination with simeprevir +/- ribavirin in GT 4 HCV patients with advanced fibrosis achieved high SVR12 rates and was well tolerated. RBV did not appear to increase the rate of SVR12.

Introduction: Hepatitis C virus (HCV) is a major global health issue and successful treatment has been associated with a reduction of risk of all-cause mortality. Advancements have been made in HCV treatment through the use of interferon-free regimens. Most trials have been conducted in HCV genotype (GT) 1 and data for interferon-free regimens in GT4 patients are limited. The aim of this study was to evaluate the safety and efficacy of sofosbuvir plus simeprevir in a real-world cohort of HCV GT4 patients with advanced fibrosis. Patients and Methods: Eighty-seven GT4 treatment-naïve or -Interferon (IFN) ribavirin (RBV) experienced patients treated with sofosbuvir and simeprevir +/- ribavirin (RBV) were enrolled in this cohort study (41% severe fibrosis, 59% cirrhosis). Results: Patients were 51.7% male, 78.2% IFN/RBV treatment-experienced, and 37.9% received RBV treatment. The overall sustained virologic response at least 12 weeks after treatment (SVR12) rate was 87.4% while patients treated with and without RBV had rates of 87.9% and 87% (p = 0.593), respectively, and patients with advanced fibrosis (F3) and patients with cirrhosis had SVR12 rates of 94.4% and 82.4% (p = 0.087), respectively. SVR12 rates in treatment-naïve patients and in IFN/RBV -experienced patients were 78.9% and 89.7% (p = 0.191), respectively. Treatment failure occurred most commonly in patients with cirrhosis and severe disease. The treatment was well tolerated and no patient died or discontinued treatment due to adverse events. Conclusions: Sofosbuvir in combination with simeprevir +/- ribavirin in GT 4 HCV patients with advanced fibrosis achieved high SVR12 rates and was well tolerated. RBV did not appear to increase the rate of SVR12., SCOPUS: ar.j, info:eu-repo/semantics/published

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Background and study aims: This was an observational, non-interventional, multicenter, phase IV study, in patients with genotype 1/4/5/6 chronic hepatitis C (CHC). The primary objectives were to evaluate SVR in patients with no or minimal fibrosis (METAVIR F0-F1) versus well established fibrosis (F2-F4), and to estimate response on Weeks 12, 24 and 48 on treatment in previously untreated patients with genotypes 1/4/5/6 CHC. Patients and methods: 538 patients treated with pegylated interferon alfa 2b 1.5 mcg/kg in combination with ribavirin 800- 1200 mg/day were enrolled in 55 sites in Belgium and Luxembourg, 505 being considered for the analysis. 40% of the patients were female and 60% male, the average age was 47.5 years, 10.5% were 65 or older. Results: SVR was observed in 35% of the patients, EVR in 68%, of which pEVR in 33% and cEVR in 35%. SVR was observed in 43% of the low fibrosis group (F0, F1) and 30% of the high fibrosis group (F2, F3, F4) (p = 0.005). SVR rates were 34% for genotype 1, 37% for genotype 4, and 47% for genotype 5 (NS). Multivariate analysis showed that EVR and baseline METAVIR score are independent prognostic factors for SVR. Conclusions: This trial confirms that fibrosis stage and early viral response are the most important key-factors to predict sustained response, suggesting that the earlier patients are treated, the better the outcome. Non-invasive techniques enable us to closely monitor progression of fibrosis, allowing a better selection of patients for antiviral treatment in the DAA-era., SCOPUS: ar.j, info:eu-repo/semantics/published

Nationwide studies comparing patients with hepatitis B and C virus (HBV and HCV) infections are mandatory for assessing changes in epidemiology., Comparative Study, Journal Article, SCOPUS: ar.j, info:eu-repo/semantics/published

Introduction: Nationwide studies are mandatory to assess changes in the epidemiology of HBV infection in Europe. Aim: To describe epidemiological characteristics of HBsAgpositive patients, especially inactive carriers, and to evaluate how practitioners manage HBV patients in real life. Methods: Belgian physicians were asked to report all chronically infected HBV patients during a one-year period. Results: Among 1,456 patients included, 1,035 (71%) were classified into one of four phases of chronic infection: immune tolerance (n = 10), HBeAg-positive hepatitis (n = 248), HBeAgnegative hepatitis (n = 420) and inactive carrier state (n = 357 HBeAg-negative patients with ALT < upper limit of normal (ULN) and HBV DNA < 2,000 IU/mL). Using less restrictive criteria for ALT (1-2 ULN) or HBV DNA (2,000-20,000 IU/mL), 93 unclassified patients were added to the group of inactive carriers. These 93 additional inactive carriers were younger, more frequently males, with similar risk factors for HBV infection and histological features compared to inactive carriers according to recent guidelines. Recent guidelines on management of HBV patients were generally followed, but systematic HBV DNA measurements and HDV coinfection screening should be reinforced. Conclusion: In Belgium, an inactive carrier state was a common form of chronic HBV infection. Using less restrictive criteria for classification of inactive carriers did not modify their main characteristics and seemed better adapted to clinical practice. Recent guidelines on management of HBV patients should be reinforced., SCOPUS: ar.j, info:eu-repo/semantics/published

Introduction: Non-alcoholic Fatty Liver Disease (NAFLD) is increasingly recognised as a source of liver related morbidity and mortality. Hard data on epidemiology and natural history are scarce. Aim: To study demographic and metabolic characteristics of the NAFLD patients seen by Belgian hepatologists. Methods: Belgian hepatologists filled in a questionnaire for every newly diagnosed NAFLD patient between January 1st and December 31st 2004. Liver biopsy was advised if ALT > 1.5 × ULN and if 3/5 of the criteria for the metabolic syndrome (MS) (ATPIII) were present, but was not mandatory. Biopsy was scored using the Brunt classification. Results: 230 patients were prospectively included in 9 centres; 54% were males; mean age was 49.4 ± 13.9 y; mean BMI was 30.6 ± 4.6 kg/m2. The MS was present in 53%. In 16% formerly undiagnosed diabetes was discovered. 51% had a liver biopsy: 25% met the criteria, 26% did not. Grading did not differ between patients with or without MS. Staging was significantly more severe in patients with MS (2.43 ± 1.25 vs. 1.73 ± 1.18, p < 0.001). A subgroup of patients with GGT > 5 × ULN were significantly older (55.9 vs. 47.64 y, p = 0.02), more frequently diabetic (53% vs. 23%, p = 0.01) and had more advanced fibrosis (3.42 vs. 1.08, p = 0.008). ALT levels were variable. Conclusions: The MS is highly prevalent in Belgian NAFLD patients and is associated with more severe disease. Mild to moderate fibrosis is frequent, and the proposed criteria for liver biopsy are not accurate in selecting these patients. Patients with elevated GGT constitute a subgroup with more advanced disease., SCOPUS: ar.j, info:eu-repo/semantics/published

Background The combination therapy of pegylated-interferon-α2a plus ribavirin is considered as the standard of care for patients with chronic hepatitis C. A sustained viral response is obtained in 40-50% of naïve patients with genotype 1 and in around 80% of naïve patients with genotype 2 or 3. Aim To assess whether amantadine, added to the conventional combination therapy, could improve the treatment efficacy. Methods In all, 630 patients (intent-to-treat population) with chronic hepatitis C were randomized into two groups: 316 patients (treatment group) received pegylated-interferon-α2a (180 μg once weekly) plus ribavirin (1000-1200 mg/daily) with amantadine (200 mg/daily); 314 patients (control group) received pegylated-interferon-α2a (180 μg once weekly) plus ribavirin (1000-1200 mg/daily) without amantadine. The duration of the treatment was 48 weeks for genotypes 1, 4, 5 and 6, and 24 weeks for genotypes 2 and 3. Results There was no statistically significant difference between treatments groups for any of the variables tested for. Subgroups of patients likely to take advantage of the addition of amantadine were not identified. Conclusions This large study definitely excludes the role of amantadine in addition of conventional combination therapy in the treatment of chronic hepatitis C patients. © 2009 Blackwell Publishing Ltd., SCOPUS: ar.j, FLWIN, info:eu-repo/semantics/published

Fifth Framework Programme of the European Commission.

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Background and study aims: The combination of Pegylated (PEG)interferon 2b and ribavirin is considered to be the standard treatment for naïve chronic hepatitis C patients. Study aims are to evaluate the differences between standard interferon and PEG-interferon by conducting a multi-centre, controlled randomized trial comparing 3 groups. Group A: daily interferon alfa-2b at a dose of 4 MIU + ribavirin, Group B: PEG-interferon alfa-2b at a dose of 100 mcg/week + ribavirin; Group C: interferon alfa-2b at a dose of 3 MIU TIW + ribavirin. Patients and methods: Multicentrer, open label study including naïve chronic Hepatitis C Virus patients randomised in three groups with a ratio of 2:2:1. Group A: daily interferon α-2b (4 MIU s.c. for patients >65 kg or 0.06 MIU/kg < 65 kg) and ribavirin, group B: PEG-interferon α-2b (100 μg s.c. weekly for patients > 65 kg or 1.5 μg/kg weekly for patients < 65 kg) and ribavirin and group C (reference arm): interferon α-2b (3MIU s.c. TWI) and ribavirin. The duration of the treatment was 48 weeks for all 3 groups, with a 6 month follow-up period. 336 patients were enrolled in the study and included in the intention-to-treat analysis; 78 never started treatment (35 in group A, 28 in group B and 15 in group C): 101 in group A, 98 in group B and 59 in group C. Results: Demographic data, PCR results and reasons for early withdrawal have been statistically analysed. At baseline, the 3 groups did not show any statistical difference regarding age, gender, race, genotypes and METAVIIR score. At week 24 on treatment, HCV ribonucleic acid RNA was undetectable in 87% in group A, in 79% in group B and in 69% in group C. At the end of treatment, 73% 74% and 58% respectively, had a negative PCR result. At week 24 of follow-up, these results were 71%, 64% and 48%, respectively. When comparing the efficacy of the daily interferon (+ ribavirin) and the PEG-interferon (+ ribavirin) regimen, no statistical difference was found (p = 0.32). In group A, 38%, SCOPUS: ar.j, info:eu-repo/semantics/published

Glomerulonephritis (GN) is an uncommon but well-described complication of chronic hepatitis B virus (HBV) infection. HBV-related membranous nephropathy (MN) may lead to renal failure in 1/3 of the patients and spontaneous remission is rare. There is no standard therapy for HBV-associated MN. We report a case of a 28-year-old man with HBV-associated MN due to pre-core HBV mutant with complete remission under an on-going 7-year lamivudine monotherapy. ©2008 Dustri-Verlag Dr. K. Feistle., SCOPUS: ar.j, info:eu-repo/semantics/published

Aim of the study: There is a lack of epidemiological data on hepatitis C (HCV) infected patients in Belgium. Therefore our purpose was to address this important question and to evaluate the feasibility of a national HCV observatory. Patients and methods: From November 2003 to November 2004, every new patient prospectively seen for HCV antibody positivity in 9 Belgian hospital centres was recorded and a standardised 10-items questionnaire was completed during the consultation, including a Quality of Live (QOL) visual analogue scale. Results: Three hundred and eighteen consecutive patients were recruited. Fifty five percent were male with a median age of 45 y (11-87 y). The main risk factors for infection were IV drug use (27%), blood transfusion (23%), and invasive medical procedure (11%). On the QOL scale, ranging from 0 and 100, mean value was 61 ± 31. Transaminases were abnormal in 66% with a median elevation 2 times above normal value. HCV RNA was positive in 87% with a viral load above 800 000 IU/ml in 42%. Genotype 1 was predominant (59%), followed by genotypes 3 (19%) and 4 (14%). A liver biopsy was performed in 190 patients, with minimal fibrosis (METAVIR F0-F1) in 43%, moderate fibrosis (F2) in 35% and advanced stages (F3-F4) in 22%. Antiviral treatment was not considered in 53% because of normal ALT (30%), old age (7%), minimal histological stage (6%) or patient refusal (4%). Conclusions: This study highlights the feasibility of a national HCV survey using a simple questionnaire. This pilot study could be generalised throughout Belgium, and, if repeated, could allow a regular assessment of the changes in epidemiology and management of HCV infection in our country., SCOPUS: ar.j, info:eu-repo/semantics/published

Pegylated interferon plus ribavirin is the standard treatment for chronic hepatitis C (HCV). Even if genotype 2 and 3 patients only request a treatment of 24 weeks, this treatment remains very costly and difficult to tolerate due to numerous side effects. Recently several studies focused on the possibility of further reducing treatment duration in chronic HCV genotype 2 and 3 patients without compromising sustained virological response (SVR). Based on the available data, patients presenting a negative PCR at week 4 named a rapid virological response (RVR) probably are the best candidates to benefit from shorter treatment duration. In contrast patients without RVR should at least be treated for 24 weeks and retrospective data suggest that a more intensive or prolonged therapy for 48 weeks could be necessary. However, at this moment it remains impossible to propose general recommendations for all patients with genotype 2 and 3. Therefore more randomized prospective trials are needed to clarify several issues that are discussed in this review article., SCOPUS: re.j, info:eu-repo/semantics/published

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To assess the efficacy of the combination of long-acting release (LAR) octreotide and tamoxifen (TMX) for the treatment of advanced hepatocellular carcinoma (HCC). A total of 109 patients with advanced HCC were randomised to receive octreotide LAR combined with TMX (n=56) (experimental treatment group) or TMX alone (n=53; control group). The clinical, biological and tumoural parameters were recorded every 3 months until death. Primary end point was patient survival; secondary end points were the impact of therapy on tumour response, quality of life and variceal bleeding episodes. Univariate and multivariate analyses were performed for assessment of specific prognostic factors. The median survival was 3 months (95% CI 1.4-4.6) for the experimental treatment group and 6 months (CI 95% 2-10) for the control group (P=0.609). There was no difference in terms of alpha-foetoprotein (alpha-FP) decrease, tumour regression, improvement of quality of life and prevention of variceal bleeding between the two groups. Variables associated with a better survival in the multivariate analysis were: presence of cirrhosis, alpha-FP level <400 ng ml(-1) and Okuda stage I. The combination of octreotide LAR and TMX does not influence survival, tumour progression or quality of life in patients with advanced HCC., Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

The presence of hyperferritinemia has to rule out acquired causes such as chronic inflammatory disorders, hemolytic anemia, liver diseases as hepatitis B or C, alcohol abuse and non alcoholic fatty liver disease, specially in patients with normal transferrine saturation. Genetic testing for hemochromatosis is systematically indicated in all patients with elevated transferrine saturation. When an iron overload is demonstrated in the absence of these classic causes, second-line genetic testing should be considered to exclude non HFE hemochromatosis. The aim of this paper is to propose a practical algorithm in the diagnosis of hyperferritinemia and to precise the diagnostic and therapeutic management of genetic hemochromatosis., SCOPUS: ar.j, info:eu-repo/semantics/published

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Chronic hepatitis C (VHC) is a worldwide public health issue. The mother-to-child transmission could be the main cause of hepatitis C infection in children. Despite the risk of histological injuries, chronic hepatitis C is not a contra-indication to pregnancy. In patients with VHC, there is no evidence that the outcome could be modified. In co-infected patients (VIH-VHC), a caesarean should be proposed taking into account the significant risk of mother-to-child transmission. Breast-feeding is not contra-indicated. Systematic screening of VHC, discussed in this article, could be proposed in woman planning a pregnancy., SCOPUS: re.j, info:eu-repo/semantics/published

Infection with the hepatitis C virus (HCV) represents an important public health problem and is a leading cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma. Chronic hepatitis C is a heterogeneous disease. Many patients have mild disease at presentation but not all of them will develop advanced liver disease. However, the identification of these patients with mild hepatitis C who will show progressive disease is difficult and is based on histological criteria and the assessment of co-factors (age, alcohol intake, steatosis). In addition, serum transaminases that are persistently normal on several occasions during 18 months may point to a more benign course. Patients with mild hepatitis C should not be excluded "a priori" from the possibility of being treated, as treatment with pegylated interferon and ribavirin is safe and effective in this group. Overall, the decision to initiate therapy should be individualized and based on the severity of the disease by liver biopsy, the potential of serious side effects, the probability of response and the motivation of the patient., SCOPUS: cp.j, info:eu-repo/semantics/published

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Public hospitals in Belgium are taking care of a disfavoured people such as drug addicts, alcoholics, patients with low income and people referred by refugee centres. Many of these patients are at risk of hepatitis C. The medical and paramedical staff is facing numerous problems in taking care of these patients. Requests of hepatologists from public hospitals are a more effective psychosocial management, an increase of the framing in these hospitals, and a more rapid process of reimbursement of medication for treatment of hepatitis C, allowing to treat the patients according to international standards., SCOPUS: cp.j, info:eu-repo/semantics/published

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A putative pathogenetic role has been ascribed to Helicobacter pylori in several extradigestive diseases, including vascular (atherosclerosis and ischaemic heart disease, primary Raynaud phenomenon, primary headache), autoimmune (Sjögren's syndrome, Henoch-Schönlein purpura, autoimmune thyroiditis, idiopathic arrythmias, Parkinson's disease, nonarterial anterior optic ischemic neuropathy), and skin diseases (chronic idiopathic urticaria, rosacea, alopecia areata), sideropenic anemia, growth retardation, late menarche, extragastric MALT lymphoma, diabetes mellitus, hepatic encephalopathy, sudden infant death syndrome, and anorexia of aging. We examine critically the strength of the evidence linking these diseases to Helicobacter pylori, using ischaemic heart disease as an example of epidemiological techniques, and skin diseases as an example of treatment studies. By the standards of evidence-based medicine, studies have been often of low quality. The best evidence usually is not indicative of a role for Helicobacter pylori in these diseases., SCOPUS: cp.j, info:eu-repo/semantics/published

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