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Volume 73 - 2010 - Fasc.2 - Original articles

A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients

Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combi- nation with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommenda- tions for this patient population are not well defined. Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sus- tained virologic response in naïve patients (n = 348) and relapsers (n = 95). Results : Sustained virologic response rates were similar in naïve patients and relapsers, both for non-pegylated and pegylated inter- feron (respectively 27 and 26% and 54 and 43%). Pegylated inter- feron given for 48 weeks did not improved the relapse rate : 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naïve vs relapsers respectively. Stepwise logistic regres- sion analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively ; p = 0.02 ; odds ratio = 6.07). Conclusions : This trial confirms the value of using peginter- feron alfa-2a in both naïve and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response. (Acta gastroenterol. belg., 2010, 73, 223-228).


Hepatitis C genotype 4 response rate to pegylated interferon and ribavirin treatment in Belgium is similar to genotype 1

Background and aims : Patients with genotype 4 (G4) chronic hepatitis C from the Middle East respond better to treatment than genotype 1 (G1) patients. There are few data on the response rates to treatment of G4 patients living in Western Europe. Many G4 patients in Belgium originate from Central Africa, and their response to treatment seems lower. Methods : We analysed the data from 2 randomized phase III studies conducted in Belgium, BerNar-1 and BerNar-2, comparing the sustained virological response (SVR) to pegylated interferon and ribavirin of 78 G4 patients (34 Caucasians, 44 Blacks) and 477 G1 patients (455 Caucasians, 12 Blacks), and assessing the predic- tors of SVR. Results : Baseline characteristics of G4 and G1 patients were similar except mainly for race. Complete early virological response (cEVR) was similar in G4 (73.2%) and G1 (68.1%). cEVR was also similar between Black and Caucasian G4 and between Black and Caucasian G1 patients. Partial early virological response was similar for G4 and G1. SVR was similar for G4 (51.3%) and G1 (51.8%). There was a trend for a higher SVR in Caucasians than in Blacks. In multivariate analysis, the only predictors for SVR were the presence of cirrhosis, HCV viral load, age < 40 vs ?? 40 yrs, and treatment status (relapsers vs naïve). Conclusions : G4 patients in Belgium have the same SVR as G1 patients. It is lower than the SVR described in Arab countries, especially for Black G4 patients. (Acta gastroenterol. belg., 2010, 73, 229-234).


Helicobacter pylori virulence factors and their role in peptic ulcer diseases in Turkey

Background and study aims: The role of virulence factors present in Helicobacter pylori (H. pylori) strains and the character- ization of such factors being predictive of specific disease is still not clear. In this study, the cagA, vacA alleles and the recently charac- terized vacA i-region and dupA and their association with the severity of the disease was determined. Patients and methods : Antral biopsies from 91 patients with peptic ulcer (PU) (n = 41), gastritis (n = 48) and gastric cancer (GC) (n = 2) were analyzed for the presence of H. pylori by the CLO-test® and PCR. A 79/91 (86%) patients were positive for H. pylori by either PCR or by both PCR and CLO-test®. PCR- based typing of H. pylori isolates was performed on DNA extracted directly from biopsy samples. Results : The cagA+ strains were found more likely to be associ- ated with vacA s1 than s2. The vacA i1 allele detected in 16/23 (70%) of samples had significant association with duodenal ulcers than those 16/37 (44%) of gastritis (P < 0.04). No significant associ- ation was found between dupA and duodenal ulcer. This study pro- vided more evidence that the vacA i1 allele is one of the virulence factors of H. pylori that had significant association with severe out- come. (Acta gastroenterol. belg., 2010, 73, 235-238).