Volume 77 - 2014 - Fasc.4 - Original articles
A non-interventional phase IV Belgian survey to assess the antiviral effectiveness of pegylated interferon-alpha-2b and ribavirin treatment according to the stage of liver fibrosis in previously untreated patients with genotype 1-4-5-6 chronic hepatitis C (PRACTICE)
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 inter- feron 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 inde- pendent 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. (Acta gastroenterol. belg., 2014, 77, 393-400).
Pretreatment serum interferon gamma inducible protein-10 as biomarker of fibrosis and predictor of virological response in genotype 4 hepatitis C virus infection
Objective : Assess the value of baseline interferon-?-inducible protein-10 (IP-10) levels as a noninvasive maker of liver fibrosis and as a predictor of response to interferon therapy in HCV geno- type 4 infected patients.
Methods : Eighty-four HCV genotype 4 infected patients were enrolled in this study. Degrees of liver fibrosis were determined and baseline IP-10 was measured in serum samples collected prior to initiation of treatment using the enzyme-linked immunosorbent as- say. Patients were followed up for 1.5 year to assess their response to antiviral therapy.
Results : The baseline IP-10 levels were significantly correlated with the degree of fibrosis and had the ability to differentiate be- tween patients with mild, moderate and advanced stages of fibrosis (F0-1 : 95.24 ± 33.08 pg/ml, n = 25 ; F2 : 158.70 ± 52.74 pg/ml, n=37; F3-4: 357.45±162.18pg/ml, n=22; P<0.001). Baseline IP-10 levels were significantly lower in patients achieved Early vi- rological response (responders 134.80 ± 60.47 pg/ml, n = 60 ; non- responders 334.54 ± 168.94 pg/ml, n = 24, P < 0.001). Also baseline IP-10 levels were significantly lower in patients who became HCV RNA negative at 24 weeks of therapy (179.52±130.03pg/ml, n = 78) than non-responders (352.33 ± 132.58 pg/ml, n = 6, P = 0.002). SVR was achieved in 58/68 (85.3%) patients while 10 patients were relapsed. Baseline IP-10 levels differs significantly between patients who achieved SVR at week 24 post therapy and relapsed patients (IP10 level : SVR, 173.52 ± 125.20 pg/ml, n = 58 ; Relapsed, 216.20 ± 67.72 pg/ml, n = 10, P = 0.021).
Conclusion : Baseline IP-10 level independently predicts EVR, response at week 24 during therapy and SVR. It also differentiates patients with mild fibrosis from those with moderate and advanced fibrosis. (Acta gastroenterol. belg., 2014, 77, 401-407).
Investigation of risk factors predicting recurrence of colonic diverticular hemor- rhage and development of a recurrence risk score
Aim : Colonic diverticular hemorrhage often recurs. Several studies have identified risk factors for recurrence, but to our knowledge, none have focused on risk factors in the clinical situa- tion. The present study aimed to identify risk factors for the recur- rence of hemorrhage and to create a recurrence risk score.
Method: Hospitalized patients diagnosed with diverticular bleeding from 2008 to 2013 (N = 151) were included in a retrospec- tive cohort study. Risk factors predicting re-bleeding were identi- fied using multivariate analysis, and a risk score was developed using receiver operator characteristic (ROC) analysis.
Results : Recurrence was identified in 52 patients (34.4%) at a median interval of 11.5 months. A history of hypertension and hy- perlipidemia, a faster heart rate on admission, and longer hospital- ization period were significant risk factors for re-bleeding. We de- veloped a re-bleeding risk score by using these 4 factors ; the area under the curve of ROC curve was 0.8. With this risk score, if the cut-off point is 7, then the sensitivity is very high (94% ; specificity : 26%) ; if the cutoff point is 14, the specificity is very high (97% ; sensitivity : 40%). This enables the division of patients into 3 groups : high risk, intermediate risk, and low risk.
Conclusion : Colonic diverticular hemorrhage often recurs, and patients have high recurrence rates within short periods. Risk factors for re-bleeding include a history of hypertension and hyper- lipidemia, faster heart rate, and longer hospitalization period, and the risk score may supply useful information for clinicians to aid management. (Acta gastroenterol. belg., 2014, 77, 408-412).
Endoscopic findings in case of incidental colonic uptake in PET-CT How to improve PET-CT specificity ?
Unexpected colonic 18FDG focal uptakes (UCFU) in PET CT oc- cur in 1.3-3.3% of cases in retrospective study and are often associ- ated with significant colorectal findings in endoscopy, especially neoplastic lesions. The purpose of our prospective study was to evaluate the significance of UCFU and to assess criteria improving PET CT specificity for advanced adenoma and neoplasia. This study was conducted in a single institution from April 2012 to Sep- tember 2013. In the 2904 patients who benefit from PET CT, 52 had an UCFU and 43 were referred for colonoscopy. After endoscopy, 8 examinations showed no colonic abnormality (18.6%), 7 showed benign lesion (16.3%), 18 showed advanced adenoma (42.9%) and 10 showed carcinoma (23.3%).
There were more false positives results in the proximal colon compared to distal colon. Eighteen patients had UCFU and tomodensitometric abnormalities in the same colonic area. This pathological combination was strongly associated to the diagnosis of malignancy.
Diagnostic value of carcinoembryonic antigen in malignancy-related ascites : systematic review and meta-analysis
Background and study aims : There is a common misconception that malignant ascites is equivalent to peritoneal carcinomatosis. It seems that malignancy-related ascites is a more appropriate -description- of- malignant- ascites,- which- is- difficult- to- confirm. Carcinoembryonic antigen, a glycoprotein tumor marker shed by malignant cells, increases in a wide range of gastrointestinal malig- nancies. We carried out the current meta-analysis to determine carcinoembryonic antigen accuracy in the diagnosis of malignancy- related ascites.
Patients and methods: Pudmed/Medline and SCOPUS were searched using these search terms : malignan* AND ascites AND (CEA OR carcinoembryonic). The outcome of interest was carcino- embryonic antigen accuracy in the differentiation of malignancy- related ascites and nonmalignant ascites.
Results : Seven studies were included in this systematic review. Pooled diagnostic indices using random-effects model were as fol- lows-:- sensitivity- 43.1%- [381-48.3]-;- specificity- 95.5%- [93-97.3]-; LR+- (positive- likelihood- ratio)- 7.33- [4.58-11.73]-;- LR-- (negative likelihood- ratio)- 0.6- [0.54-0.68]-;- and- DOR- (diagnostic- odds- ratio) 12.93-[7.58-22].-
Conclusions :-Carcinoembryonic-antigen-of-the-ascitic-fluid-does not seem to be sensitive enough to diagnose malignancy-related -ascites.- However,- due- to- high- specificity,- the- positive- predictive value of this marker is high and the higher the level of carcino- embryonic antigen, the more likely it is to be malignancy-related. Nevertheless,- a- negative- test- result- cannot- definitely- rule- out- the malignancy. (Acta gastroenterol. belg., 2014, 77, 418-424).
Hematologic indices improve with eradication of HCV in patients with cirrhosis and predict decompensation
Background : Abnormal hematological indices (HI) are common in cirrhosis from hepatitis C virus (HCV). Eradication of HCV may ameliorate these abnormalities. The objectives of the current study were to assess whether HI improve with HCV eradication and whether they can predict prognosis in patients with cirrhosis dur- ing and after completion of antiviral therapy.
Methods : A retrospective cohort study of 153 patients with HCV cirrhosis treated with Peg-interferon and ribavirin was conducted. The primary endpoint was improvement in HI after successful antiviral therapy. The secondary outcome was clinical decompen- sation during and after completion of antiviral therapy and association with HI. A repeated measures 2-way ANOVA was performed to compare means. Multivariate analysis was used to identify predictors of clinical decompensation.
Results : One hundred fifty three patients met study criteria. The rate of sustained virological rate was 26%. Median follow-up was 55 months. Platelet and WBC counts improved with HCV eradication compared to those in whom treatment was unsuccess- ful (p < 0.05). On univariate analysis, the presence of thrombocyto- penia was associated clinical decompensation prior tO. on treat- ment and after completion of therapy. Thrombocytopenia (OR 14.8, p-value < 0.001) after completing treatment predicted clinical decompensation when controlled for albumin, MELD and age in multivariate analysis at 6 months after completion of therapy.
Conclusions : Platelet and leukocyte counts improve in patients with cirrhosis who respond to antiviral therapy against HCV. The presence of thrombocytopenia predicts decompensation on treat- ment and after completion of therapy. (Acta gastroenterol. belg., 2014, 77, 425-432).