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See detailSofosbuvir in combination with simeprevir +/- ribavirin in genotype 4 hepatitis C patients with advanced fibrosis or cirrhosis: a real-life experience from Belgium
Moreno, C; Lasser, L; DELWAIDE, Jean ULg et al

in Hepatology (Baltimore, Md.) (2015, October), 62(1), 746

Background: All-oral, interferon-free regimens that combine direct-acting antiviral drugs have significantly advanced the treatment of hepatitis C (HCV), especially for genotype 1(G1) patients. However ... [more ▼]

Background: All-oral, interferon-free regimens that combine direct-acting antiviral drugs have significantly advanced the treatment of hepatitis C (HCV), especially for genotype 1(G1) patients. However, efficacy and safety data of interferon-free regimens in HCV genotype 4 (G4) patients are scarce. In Belgium, Sofosbuvir (SOF) and Simeprevir (SMV) treatment is available since January 2015 for G4 patients with advanced fibrosis (F3-F4 METAVIR) for 12 weeks. Methods: analysis of HCV G4 patients receiving SOF and SMV treatment in Belgium. The aim of the study was to evaluate the safety and efficacy of the treatment. Results: 73 G4 patients were enrolled in this data collection including 32 (43.8%) patients with severe fibrosis F3 and 41(56.2%) cirrhotic patients. The study population comprised 58.9% male, 77.8% treatment experienced patients. Median age was 59 [51-66] years and 5 patients were HCV/HIV co-infected. 24 patients received the treatment associated with ribavirin, 11/32 (34.37%) of patients with advanced fibrosis and 13/41 (31.71%) of cirrhotic patients. In cirrhotic patients, median MELD and Child-Pugh score were 9 [7-12.5] and 5 [5-6], 46.2% had platelet below 100.000/mm and 28.6% had albumin below 35 g/L. W4 HCV RNA was undetectable in 31.25% (15/48). 9 of the 15 patients with undetectable W4 HCV RNA received RBV. At W12, 100% (23/23) had HCV RNA below the limit of quantification, with 6/23 still detectable. All SVR12 data will be available at the time of presentation. No patient experienced serious adverse event. Conclusions: these preliminary results in difficult-to-treat G4 HCV patients show that SOF/SIM +/- RBV treatment is safe and seems promising, in line with that was observed in G1 HCV patients. [less ▲]

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See detailEthnic epidemiological profiles and antiviral therapy among patients infected with hepatitis C virus genotype 4: a multicenter study from Belgium.
Nkuize, M; Mulkay, JP; Moreno, C et al

in Acta Gastro-Enterologica Belgica (2015), 78(4), 365-372

Background: Hepatitis C virus genotype 4 (HCV-4) is the most prevalent genotype in Central Africa. A large population of Black African individuals, among whom HCV-4 infection is widespread, resides in ... [more ▼]

Background: Hepatitis C virus genotype 4 (HCV-4) is the most prevalent genotype in Central Africa. A large population of Black African individuals, among whom HCV-4 infection is widespread, resides in Belgium. Aim: To compare epidemiology, clinical characteristics and any differences in receipt of HCV therapy in two populations of HCV-4 patients residing in Belgium. Methods: This retrospective multicenter study selected 473 patients from seven hospital databases and compared them according to ethnic origin, i.e., Black African (n=331) or not (n=142), for epidemiological, clinical, biological and histological characteristics. Interleukin 28B polymorphism (CC-genotype) was evaluated in a second cohort of 69 Black African and 30 non-Black African patients. Results: Compared to other patients, the Black African patients were more likely to be female and were older, more commonly overweight, more frequently had abnormal glucose metabolism and arterial hypertension; they were less likely to have dyslipidemia, a history of alcohol consumption or ALT elevation. The route of infection was more frequently unknown in Black African than in other patients. Black African patients had more HCV-4 subtypes, were less frequently of IL28B CC-genotype and had less severe liver fibrosis. The proportion of patients who received antiviral treatment was similar in the two groups. Conclusion: In this Belgian cohort, patients with HCV-4 infection were more frequently of Black African origin than of other origin. Infected Black African patients were more commonly female, older at diagnosis, and had more co-morbidities than other patients; they also had less advanced liver fibrosis than infected non-Black African patients and fewer had a CC genotype. The number of patients treated with antiviral therapy was similar in the two groups. [less ▲]

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See detailResponse of Black African patients with hepatitis C virus genotype 4 to treatment with peg-interferon and ribavirin
Nkuize, M; Mulkay, JP; Adler, M et al

in Acta Gastro-Enterologica Belgica (2013), 76

Aim : To compare responses to therapy of Black African (BA) and non-Black African (non- BA) patients with hepatitis C virus genotype 4 (HCV-4) residing in Belgium. Methods : In this retrospective ... [more ▼]

Aim : To compare responses to therapy of Black African (BA) and non-Black African (non- BA) patients with hepatitis C virus genotype 4 (HCV-4) residing in Belgium. Methods : In this retrospective multicenter study, 473 patients with HCV-4 were selected from databases at 7 Belgian centers ; 209 treatment-naïve patients (154 BA) had received treatment with peg-interferon (peg-IFN) plus ribavirin (RBV) and were included in the study. Results : There was a greater percentage of female patients in the BA group than in the non- BA group ; BA patients were also older, had a greater body mass index, and more frequently had abnormal glucose metabolism. The route of contamination was more frequently unknown in BA than in non-BA patients and BA patients had more HCV-4 subtypes. There were no differences in other demographic factors between the groups. Sustained viral response (SVR) and complete early viral response rates were significantly lower and relapse rates significantly higher in BA than in non-BA patients. There were no differences between groups in rates of dose modification or in drug tolerance. Conclusion : In our cohort, treatment-naïve BA patients with HCV-4 who were treated with peg-IFN and ribavirin had a much lower SVR rate than treatment-naïve non-BA patients with HCV- 4 who were treated with peg-IFN and ribavirin, and a higher relapse rate, possibly related to a weaker response to interferonbased therapy. Treatment may need to be adapted in this population. [less ▲]

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See detailHepatitis B virus and hepatitis C virus infection in Belgium: similarities and differences in epidemic and initial management
De Vroey, B; Moreno, C; Laleman, W et al

in European Journal of Gastroenterology & Hepatology (2013), 25(5), 613-619

Introduction Nationwide studies comparing patients with hepatitis B and C virus (HBV and HCV) infections are mandatory for assessing changes in epidemiology. Aim The aim of this study was to compare ... [more ▼]

Introduction Nationwide studies comparing patients with hepatitis B and C virus (HBV and HCV) infections are mandatory for assessing changes in epidemiology. Aim The aim of this study was to compare epidemiological data and initial management of newly diagnosed patients with persistent HBV (HBsAg positive) or HCV (detectable HCV RNA) infection in Belgium. Patients and methods Data were extracted from two Belgian observational databases. Results A total of 655 patients (387 HBV and 268 HCV) were included. Compared with HCV patients, HBV patients were younger, more frequently men, more often of Asian or African origin (43 vs. 10%, P < 0.0001), and less frequently contaminated by transfusion or intravenous drug use (9 and 6% vs. 34 and 44%, P< 0.0001). Viral replication was assessed in 89% of HBV patients. Compared with HCV patients, HBV patients more frequently had normal alanine aminotransferase (ALT) levels (65 vs. 29%, P < 0.0001), less frequently underwent liver biopsy (29 vs. 67%, P < 0.0001), and were less often considered for antiviral therapy (25 vs. 54%, P < 0.0001). When taking only HBV patients with detectable viral replication into consideration, results remained unchanged. During the multivariate analysis, ALT was a major factor for performing liver biopsy or considering antiviral therapy in both groups. Conclusion HBV and HCV screening policies should be targeted toward immigrants and intravenous drug users, respectively. Guidelines recommending systematic search for viral replication should be reinforced in HBV patients. HBV patients less frequently underwent liver biopsy and were less often considered for antiviral therapy compared with HCV patients. Despite the lack of sensitivity and specificity, ALT remains a pivotal decision-making tool for liver biopsy and antiviral therapy in both infections. [less ▲]

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See detailHBV infection in Belgium: results of the BASL observatory of 1456 HBsAg carriers.
Deltenre, P.; Laleman, W.; Van Gossum, M. et al

in Acta Gastro-Enterologica Belgica (2012), 75(1), 35-41

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 ... [more ▼]

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. [less ▲]

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