Background: Because of the current lack of direct antiviral drugs, improvement of HCV G3 treatment can be achieved only by optimization of dual therapy. Preliminary data suggest lower SVR rates for G3 infected elder patients. We therefore aimed to identify the contributing factors.

Aims: Peg2b in combination with RBV has been extensively explored for its efficacy in the treatment of chronic hepatitis C. Its use is accompanied by a variety of hematological side effects which may hamper reaching and maintaining the dose needed for maximal therapeutic effect. Data regarding the frequency of hematological side effects caused by Peg2b/RBV in real-life are still scarce and were therefore evaluated in the present analysis.

Background: It has been shown that anemia and the hemoglobin (Hb) decline during Peg2b/RBV treatment of genotype 1 (G1) infection predict favorable SVR rates (Sulkowski M, Gastroenterology 2010). However, approximately 50% of the patients with anemia received erythropoietin, which may have confounded the association between Hb decline and SVR. We here investigated whether the association between Hb decline and SVR can be confirmed for patients treated for HCV G1 and for HCV G2/3 infection in real-life without erythropoietin treatment for anemia.

International, Cambridge, MA).From the focus groups, there were 37 items (scale: 1= not important at all: 5 = extremely important) generated to assess dimensions believed to predict treatment satisfaction (TS).A separate and global measure of TS was developed using a tenpoint scale ranging from not satisfied at all to extremely satisfied.The 37 item instrument was pre-tested in 145 patients with a diagnosis of HCV (n =136 received past treatment; n=4 receiving current treatment for HCV) who were currently under the care of gastroenterologists and primary care physicians through Mayo Clinic, Rochester, MN.Subsequently, data collected through Harris Interactive, a web-based panel, were used to develop the confirmatory factor analysis (CFA) model.Structural equation modeling (SEM) was used to test the hypothesized relationships among three CFA dimensions and the global measure of TS.The panel included 333 patients with an HCV diagnosis (n=213 received past treatment; n=70 receiving current treatment for HCV).Results: Average age in the Harris Interactive panel was 51(SD = 12.1) years.Males comprised 55.0% of the sample and time since HCV diagnosis was approximately 12 (SD = 8.9) years.Principal components exploratory factor analysis (KMO = 0.97) reduced the 37-item domain to 12 items (Cronbach α = 0.95) explaining 75.0% of the variance.Cronbach α for three dimensions including Treatment Experience (TE), Side Effects (SE), and Social Aspects (SA) ranged from 0.70 to 0.90.Goodness of fit measures for the CFA measurement model (AMOS, Version 17) for 9 selected items were Chi squared = 20.9,df = 23, p = 0.59; CFI = 1.00,GFI = 0.99, TFI = 1.00,RMSEA = 0.001.All SEM estimates were significant (p < 0.05) as predictors of TE and TS and supported the relationship between the data and the hypothesized model.SE correlated positively with SA (0.85), SA was strongly and positively associated with TE (0.95).TE was positively associated with TS (0.12).Conclusion: The 10-item HCVTSAT demonstrated valid psychometric properties and was able to assess patient treatment satisfaction with HCV therapies.

International, Cambridge, MA).From the focus groups, there were 37 items (scale: 1= not important at all: 5 = extremely important) generated to assess dimensions believed to predict treatment satisfaction (TS).A separate and global measure of TS was developed using a tenpoint scale ranging from not satisfied at all to extremely satisfied.The 37 item instrument was pre-tested in 145 patients with a diagnosis of HCV (n =136 received past treatment; n=4 receiving current treatment for HCV) who were currently under the care of gastroenterologists and primary care physicians through Mayo Clinic, Rochester, MN.Subsequently, data collected through Harris Interactive, a web-based panel, were used to develop the confirmatory factor analysis (CFA) model.Structural equation modeling (SEM) was used to test the hypothesized relationships among three CFA dimensions and the global measure of TS.The panel included 333 patients with an HCV diagnosis (n=213 received past treatment; n=70 receiving current treatment for HCV).Results: Average age in the Harris Interactive panel was 51(SD = 12.1) years.Males comprised 55.0% of the sample and time since HCV diagnosis was approximately 12 (SD = 8.9) years.Principal components exploratory factor analysis (KMO = 0.97) reduced the 37-item domain to 12 items (Cronbach α = 0.95) explaining 75.0% of the variance.Cronbach α for three dimensions including Treatment Experience (TE), Side Effects (SE), and Social Aspects (SA) ranged from 0.70 to 0.90.Goodness of fit measures for the CFA measurement model (AMOS, Version 17) for 9 selected items were Chi squared = 20.9,df = 23, p = 0.59; CFI = 1.00,GFI = 0.99, TFI = 1.00,RMSEA = 0.001.All SEM estimates were significant (p < 0.05) as predictors of TE and TS and supported the relationship between the data and the hypothesized model.SE correlated positively with SA (0.85), SA was strongly and positively associated with TE (0.95).TE was positively associated with TS (0.12).Conclusion: The 10-item HCVTSAT demonstrated valid psychometric properties and was able to assess patient treatment satisfaction with HCV therapies.

Aims: Treatment of chronic hepatitis C with peginterferon/RBV is frequently complicated by anemia. Age older than 50 years and female gender are factors that increase the risk of anemia. We here investigated how these factors influence the incidence and onset of anemia.

Aim: Thrombocytopenia during treatment with interferon is a side effect which appears in up to 5% of patients.Moreover thrombocytopenia is directly correlated with reduced liver function, so that this side effect is seen more often in patients with liver cirrhosis.This analysis investigated risk factors predicting thrombocytopenia < 50,000 /μl pretreatment.Patients and methods: From 03/2003 until 08/2010, 9244 patients with platelets ≥ 90,000 at baseline were assessed in an observational cohort under real life conditions.For these patients descriptive, univariate and multivariate analyses (logistic regression model (LR), with 95% confidence intervals for the odds ratio (OR)) were performed to determine factors associated with thrombocytopenia < 50,000 /μl under therapy.Results: Overall 335/9244 patients (3.6%) suffered from thrombocytopenia.SVR in these patients was significantly lower (35.5% vs 51.7%, p<.001).In univariate analysis variables associated with thrombocytopenia were: age, duration of infection, sonographic, clinical or histological diagnosis of cirrhosis, AST, GGT, cholesterol, alkaline phosphatase, bilirubin and prothrombine time (PT).In multivariate analysis 1 including all significant parameters of univariate analysis incl.pts with biopsy results (n=757), PT was the strongest independent significant predictive factor [p<.001, OR=0.954 (CI95 0.929-0.979)]controlled for the effect of AST [p=0.031,OR= 1.006 (CI95 1.001-1.011)].In multivariate analysis 2 not restricted to patients with available liver histology (n=3019), PT again [p<.001,OR=0.972 (CI95 0.960-0.984)],cholesterol [p<.001,OR= 0.990 (CI95 0.985-0.995)]suspicion of cirrhosis in sonography [p<.001,OR=1.581 (CII95 1.277-1.957]and GGT [p=0.006,OR=1.002 (CI95 1.000-1.003)]were significant predictors.Mean baseline values in patients with/without thrombocytopenia were: PT 90.6% vs: 98.2; cholesterol 164.0 vs 178.4 mg/dl AST 89.6 vs 69.7 U/l and GGT 121.8 vs 80.8 U/l.Whereas in patients without thrombocytopenia mean AST and GOT values decreased continuously during treatment, in patients with thrombocytopenia both parameters in average increased during week 4 and 12 before they decreased rapidly.Conclusion: The best baseline risk factors associated with thrombocytopenia are lower PT and cholesterol, higher AST and GGT values, even in non-cirrhotic patients.

In randomized clinical trials, treatment with peginterferon plus ribavirin (RBV) results in a sustained virological response (SVR) in around half of hepatitis C virus genotype 1-infected and 80% of genotype 2/3-infected individuals. This study aimed to evaluate efficacy and tolerability of peginterferon alfa-2a plus RBV compared with peginterferon alfa-2b plus RBV for the treatment of chronic hepatitis C in routine clinical practice. The intent-to-treat cohort consisted of 3414 patients treated with either peginterferon alfa-2a plus RBV (Group A) or peginterferon alfa-2b plus RBV (Group B) in 23 centres participating in the large, multicentre, observational PRACTICE study. Collected data included baseline characteristics, treatment regimen, RBV dose and outcome. Rates of early virological response, end of treatment response and SVR were 76.6%, 75.7% and 52.9% in Group A, and 70.2%, 65.6% and 50.5% in Group B, respectively. In patients matched by baseline parameters, 59.9% of patients in Group A and 55.9% in Group B achieved an SVR (P < 0.051). In genotype 1-infected patients matched by baseline parameters and cumulative RBV dose, SVR rates were 49.6% and 43.7% for Group A and Group B, respectively (P < 0.047); when matched by baseline parameters and RBV starting dose, SVR rates were 49.9% and 44.6%, respectively (P = 0.068). Overall, 21.8% of group A and 29.6% of group B patients discontinued treatment (P < 0.0001). The efficacy and tolerability of peginterferon plus RBV in this large cohort of patients treated in routine daily practice was similar to that in randomized clinical trials. In matched pairs analyses, more patients achieved an SVR with peginterferon alfa-2a compared with peginterferon alfa-2b.

Aims: Late treatment failure in chronic hepatitis C (CHC), defined as relapse during follow-up after an end-of-treatment response, occurs in up to 30% of patients treated with a standard combination therapy of pegylated IFN-alfa and ribavirin (Caliceti P, Dig Liver Dis 2004; 36, Suppl. 3: 334–339). Thus far, only hcv-genotype, age, dose of ribavirin and duration of infection have been proposed as predictors of relapse. We sought to identify other potential predictors of relapse in genotype-1 patients who received weight-based PegIFN-alfa-2b and ribavirin within a large ongoing German multicentre observational study.

Summary. The likelihood of a sustained virological response (SVR) is the most important factor for physicians and patients in the decision to initiate and continue therapy for chronic hepatitis C (CHC) infection. This study identified predictive factors for SVR with peginterferon plus ribavirin (RBV) in patients with CHC treated under ‘real‐life’ conditions. The study cohort consisted of patients from a large, retrospective German multicentre, observational study who had been treated with peginterferon alfa‐2a plus RBV or peginterferon alfa‐2b plus RBV between the years 2000 and 2007. To ensure comparability regarding peginterferon therapies, patients were analysed in pairs matched by several baseline variables. Univariate and multivariate logistic regression analyses were used to determine the effect of nonmatched baseline variables and treatment modality on SVR. Among 2378 patients (1189 matched pairs), SVR rates were 57.9% overall, 46.5% in HCV genotype 1/4‐infected patients and 77.3% in genotype 2/3‐infected patients. In multivariate logistic regression analysis, positive predictors of SVR were HCV genotype 2 infection, HCV genotype 3 infection, low baseline viral load and treatment with peginterferon alfa‐2a. Negative predictors of SVR were higher age (≥40 years), elevated baseline gamma‐glutamyl transpeptidase (GGT) and low baseline platelet count (<150 000/μL). Among patients treated with peginterferon plus RBV in routine clinical practice, genotype, baseline viral load, age, GGT level and platelet levels all predict the likelihood of treatment success. In patients matched by baseline characteristics, treatment with peginterferon alfa‐2a may be a positive predictor of SVR when compared to peginterferon alfa‐2b.