Hepatitis: Michielsen P

Colle I, Adler M, Brenard R, Henrion J, Langlet P, Michielsen P, Orlent H, Reynaert H, Sprengers D, Stärkel P, Van Damme P, Verslype C, Delwaide J, Anonymous00199. · Department of Hepatology and Gastroenterology, Ghent University Hospital, Ghent, De Pintelaan 185, 9000 Gent, Belgium. · Acta Gastroenterol Belg. · Pubmed #18330099 No free full text.

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Robaeys G, Buntinx F, Bottieau E, Bourgeois S, Brenard R, Colle I, De Bie J, Matheï C, Mulkay JP, Van Damme P, Van Ranst M, Verrando R, Michielsen P, Bourgeois N, Brenard R, de Galocsy Ch, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Reynaert H, Robaeys G, Sprengers D, Anonymous00401. · Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Schiepse Bos, 6, B-3600 Genk, Belgium. · Acta Gastroenterol Belg. · Pubmed #15832586 No free full text.

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Robaeys G, Buntinx F, Bottieau E, Bourgeois S, Brenard R, Colle I, De Bie J, Matheï C, Mulkay JP, Van Damme P, Van Ranst M, Verrando R, Michielsen P, Bourgeois N, Brenard R, de Galocsy Ch, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Reynaert H, Robaeys G, Sprengers D, Anonymous00401. · Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Schiepse Bos, 6, B-3600 Genk, Belgium. · Acta Gastroenterol Belg. · Pubmed #15832586 No free full text.

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Michielsen P, Brenard R, Bourgeois N, De Galocsy Ch, Delwaide J, Henrion J, Horsmans Y, Nevens F, Reynaert H, Robaeys G, Sprengers D, Van Vlierberghe H, Anonymous00046. · Department of Hepatogastroenterology, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem. · Acta Gastroenterol Belg. · Pubmed #12812144 No free full text.

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Verslype C, Michielsen P, Adler M, Orlent H, Sprengers D, Delwaide J, D'heygere F, Langlet P, Brenard R, Colle I, Reynaert H, Stärkel P, Henrion J, Anonymous00136. · Department of Hepatology, University Hospital Gasthuisberg, Leuven, Belgium. · Acta Gastroenterol Belg. · Pubmed #16268417 No free full text.

Abstract: 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.

Michielsen P, Bottieau E. · University Hospital Antwerp, Wilrijkstraat 10, B-2650 Edegem. · Acta Gastroenterol Belg. · Pubmed #15832592 No free full text.

Abstract: Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infections are major health problems world-wide. As both viruses partially share routes of transmission, co-infection is common. This is especially the case in patients infected through intravenous drug use. It has been shown that HIV accelerates HCV progression to cirrhosis. The influence of HCV infection on the natural history of HIV disease remains highly controversial. It is also known that HCV co-infection increases the risk of hepatotoxicity of Highly Active Antiretroviral Therapy (HAART). These considerations as well as the improved survival of HIV patients due to HAART leads to increasing numbers of patients undergoing assessment and treatment of HCV infection. HCV treatment should be considered in stable HIV disease. Recent data indicate that HCV treatment schedules should be similar in co-infected and HCV mono-infected individuals, with pegylated interferon combined with ribavirin. For all treatment regimens published, coinfected patients had a lower sustained viral response rate compared to HCV mono-infected patients. Similar predictive factors determine the success rate. The effect of prolonging therapy to 12 months in genotype 2/3 and to 18 months in early viral responders with genotypes 1/4 needs to be assessed in further studies.

Michielsen P, Brenard R, Reynaert H. · Division of Gastroenterology and Hepatology, University Hospital of Antwerp, Wilrijkstraat 10, B-2650 Edegem, Belgium. · Acta Gastroenterol Belg. · Pubmed #12148446 No free full text.

Abstract: Results of treatment for chronic hepatitis C have improved substantially during the last decade. Combination treatment with interferon alpha 3 MU tiw and ribavirin 1000-1200 mg daily during 24 to 48 weeks leads to sustained virologic response (SVR) in approximately 40% of patients, two to three times more than interferon alpha monotherapy. It was considered standard therapy at the EASL Consensus Conference of February 1999. Recently, results have been published on treatment with pegylated interferons alone and in combination with ribavirin. Pegylated interferon treatment leads to almost doubling of SVR rate as compared with standard interferon monotherapy. Combination of pegylated interferon alpha with ribavirin is most promising, leading to a SVR rate of 54 to 56%. It is to be expected that this treatment will become the new standard. Selected patients with geno-type 2 or 3 have now a SVR rate of almost 80%. Response to treatment also leads to significant improvement of quality of life and survival, probably by reducing the risk of developing hepatocellular carcinoma. Recent data suggest that early interferon alpha treatment of patients with acute hepatitis C largely prevents the development of chronicity.

Van Vlierberghe H, Leroux-Roels G, Adler M, Bourgeois N, Nevens F, Horsmans Y, Brouwer J, Colle I, Delwaide J, Brenard R, Bastens B, Henrion J, de Vries RA, de Galocsy C, Michielsen P, Robaeys G, Bruckers L. · Department of Gastroenterology and Hepatology, Ghent University Hospital, Ghent, Belgium. hans.vanvlierberghe@rug,ac.be · J Viral Hepat. · Pubmed #14633181 No free full text.

Abstract: The standard treatment for patients with chronic hepatitis C is a 6-12-month combination therapy with interferon alpha and ribavirin. Induction treatment could result in a faster early decline of the hepatitis C virus (HCV) load and a better response rate. Naive chronically infected HCV patients (n = 454) were randomized into two arms to receive either induction treatment with interferon alpha 2b 5 million units (MU) subcutaneously (s.c.) daily during a period of 8 weeks (arm A); or treatment with interferon alpha 2b 5 MU s.c. three times a week (TIW) for a period of 8 weeks (arm B). After week 8, interferon treatment in both arms was 3 MU s.c. TIW for a total period of 12 months. In both arms, ribavirin (1000-1200 mg orally per day) was added at week 4. Induction treatment resulted in a higher virological response at week 8 of treatment (66%vs 47%; P < 0.01). However, response at the end of treatment and at 6 months follow-up was not different (53%vs 50%, 41%vs 33%). The occurrence of adverse events and the drop-out rate were similar in both arms. Although an early virological response is observed more frequently in the induction treatment, end of treatment response and sustained responses did not differ.

Veldt BJ, Brouwer JT, Adler M, Nevens F, Michielsen P, Delwaide J, Hansen BE, Schalm SW, Anonymous00368. · Department of Gastroenterology of the Erasmus Medical Center Rotterdam, The Netherlands. · BMC Gastroenterol. · Pubmed #12948399 links to  free full text

Abstract: BACKGROUND: Evidence based medicine depends on unbiased selection of completed randomized controlled trials. For completeness it is important to publish all trials. This report describes the first large randomised controlled trial where combination therapy was compared to placebo therapy and to ribavirin monotherapy, which has not been published until now. METHODS: One hundred and twenty one patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy, were included from 16 centers in Belgium, the Netherlands and Luxembourg between 1992 and 1996. Patient poor-response characteristics were: genotype 1 (69%), HCV RNA above 2 x 10(6) copies/ml (55%) and cirrhosis (38%). Patients were randomized to 6 months combination therapy with interferon alpha-2b (3 MU tiw) and ribavirin (1000-1200 mg/day), 6 months ribavirin monotherapy (1000-1200 mg/day) or 6 months ribavirin placebo. The study was double blinded for the ribavirin/placebo component. One patient did not fit the entry criteria, and 3 did not start. All 117 patients who received at least one dose of treatment were included in the intention to treat analysis. RESULTS: At the end of treatment, HCV RNA was undetectable in 35% of patients on combination therapy and in none of the patients treated with ribavirin monotherapy or placebo. The sustained virological response rate at 6 months after therapy was 15% for patients treated with interferon and ribavirin.During the 6 months treatment period 13% of patients on interferon ribavirin combination therapy, 13% of patients on ribavirin monotherapy and 11% of patients on placebo withdrew due to side effects or noncompliance. At 24 weeks of treatment the mean Hb level was 85% of the baseline value, which means a mean decrease from 9.1 mmol/l to 7.8 mmol/l. The Hb levels at the end of treatment were not significantly different from patients treated with ribavirin monotherapy (p = 0.76). End of treatment WBC was significantly lower in patients treated with combination therapy, compared to ribavirin (p < 0.01) as well as for patients treated with ribavirin monotherapy compared to placebo (p < 0.01). DISCUSSION: This belated report on the only placebo controlled study of interferon ribavirin combination therapy in non responders to standard doses of interferon monotherapy documents the effectiveness, be it limited, of this approach as well as the dynamics of the effects on blood counts.

Horsmans Y, Collez I, Van Vlierberghe H, Langlet P, Adler M, Bourgeois N, Brenard R, Michielsen P, Goossens A, Bruckers L, Anonymous00024. · Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. · Acta Gastroenterol Belg. · Pubmed #19198574 No free full text.

Abstract: BACKGROUND AND STUDY AIMS: The combination of Pegylated (PEG)interferon alpha-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 alpha-2b (4 MIU s.c. for patients > 65 kg or 0.06 MIU/kg < 65 kg) and ribavirin, group B: PEG-interferon alpha-2b (100 microg s.c. weekly for patients > 65 kg or 1.5 microg/kg weekly for patients < 65 kg) and ribavirin and group C (reference arm) : interferon alpha-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 METAVIR 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% of drop-outs were due to adverse events compared to 37% in group B and 58% in group C. No statistical differences were observed regarding safety. CONCLUSION: Daily weight based interferon alpha-2b dosing and PEG interferon alpha-2b weighed based dosing once weekly both in combination with Ribavirin offer the same efficacy and safety rates.

De Maeght S, Henrion J, Bourgeois N, de Galocsy C, Langlet P, Michielsen P, Reynaert H, Robaeys G, Sprengers D, Orlent H, Adler M. · CH Jolimont, Haine Saint Paul. · Acta Gastroenterol Belg. · Pubmed #18396742 No free full text.

Abstract: 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.

Robaeys G, De Bie J, Wichers MC, Bruckers L, Nevens F, Michielsen P, Van Ranst M, Buntinx F. · Ziekenhuis Oost Limburg, Department of Gastroenterology and Hepatology, Schiepse Bos 6, B 3600 Genk, Belgium. · World J Gastroenterol. · Pubmed #17963300 links to  free full text

Abstract: AIM: To study the predictive value of the vegetative-depressive symptoms of the Zung Depression Rating Scale for the occurrence of depression during treatment with peg-interferon alpha-2b of chronic hepatitis C (CHC) patients. METHODS: The predictive value of vegetative-depressive symptoms at 4 wk of treatment for the occurrence of a subsequent diagnosis of major depressive disorder (MDD) was studied in CHC patients infected after substance use in a prospective, multi-center treatment trial in Belgium. The presence of vegetative-depressive symptoms was assessed using the Zung Scale before and 4 wk after the start of antiviral treatment. RESULTS: Out of 49 eligible patients, 19 (39%) developed MDD. The area under the ROC curve of the vegetative Zung subscale was 0.73, P = 0.004. The sensitivity at a cut-point of > 15/35 was 95% (95% CI: 74-100). The positive predictive value equalled 44% (95% CI: 29-60). CONCLUSION: In this group of Belgian CHC patients infected after substance use, antiviral treatment caused a considerable risk of depression. Seven vegetative-depressive symptoms of the Zung scale at wk 4 of treatment predicted 95% of all emerging depressions, at a price of 56% false positive test results.

Hutse V, Verhaegen E, De Cock L, Quoilin S, Vandenberghe H, Horsmans Y, Michielsen P, Van Damme P, Van Vlierberghe H, Claeys F, Vranckx R, Van Oyen H. · Unit of Epidemiology, Scientific Institute of Public Health, Brussels, Belgium. · J Med Virol. · Pubmed #16032713 No free full text.

Abstract: Currently viral antigens and antibodies are detected by traditional serological tests. However, the introduction of oral fluid as an alternative medium would allow other alternatives. The collection of oral fluid is, in comparison with venepuncture, less invasive, less painful, less expensive (i.e., no trained personal required), and safe (prevention of needle stick injuries). Also large numbers of samples can be collected easily for epidemiological purposes. Forty-three HBsAg positive and seventy-three HBsAg negative paired serum/oral fluid samples were tested. They were collected from patients attending university hospitals. The oral fluid samples were collected using the Oracol collection device and they were subjected to an IgG quantification assay to ensure their quality and quantity. The detection of HBsAg in oral fluid was carried out using a modified ETI-MAK-4 ELISA. The validation of this oral fluid test gave a sensitivity and specificity of 90.7% and 100%, respectively. The modified ETI-MAK-4 ELISA is a suitable test for oral fluid samples collected by the Oracol collection device for epidemiological purposes.

Brenard R, Michielsen P, Anonymous00092. · No affiliation provided · Acta Gastroenterol Belg. · Pubmed #12148434 No free full text.

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Callens S, Bottieau E, Michielsen P, Colebunders R. · No affiliation provided · AIDS. · Pubmed #15090841 No free full text.

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