Background: Information about co-morbidities of patients (pts) currently treated for chronic HCV genotype 1 (G1) infection in real-life is scarce. The present interim analysis of the NOVUS observational study was therefore aimed to investigate the frequency of pre-existing and ongoing co-morbidities of pts treated for chronic HCV G1 infection in German real-life and to determine the frequency of co-medications.

Background: The achievement of early virologic response (EVR) during triple therapy of chronic HCV genotype 1 infection with boceprevir (BOC) was identified as predictor of high SVR rates of up to 90% and as predictor to shorten treatment to 24 weeks. This interim analysis of the NOVUS observational study aimed to investigate EVR during BOC triple therapy in German real-life and to identify factors associated with EVR.

Background: Triple therapy with the HCV protease inhibitor boceprevir has been approved as new standard of care for patients with chronic HCV G1 infection. The NOVUS observational study was conducted to investigate the efficacy of this novel antiviral therapy in German real-life.

PurposeIn trials of pegylated interferons (PEG-IFNs), the lack of an early virological response (EVR) was associated with sustained virological response (SVR) rates of only 0-3%. The rates were similarly low when hepatitis C virus (HCV)-RNA was positive at week 24. Treatment guidelines therefore recommend stop rules' on the basis of HCV-RNA levels at weeks 12 and 24 of treatment. We analyzed the use of these rules under real-life' conditions.Patients and methodsThis was a prospective, community-based cohort study involving 467 physicians from institutions throughout Germany, including 4727 treatment-naive genotype-1 patients who received a full course of treatment with PEG-IFN -2a plus ribavirin between 2003 and 2009.ResultsThe overall SVR rate was 43.1%. Failure to determine EVR decreased from 20% in 2003-2004 to 10% in 2006-2007. Unexpectedly, treatment was continued in 86.1% of patients without an EVR and in those who had an EVR but were HCV-RNA positive at week 24 (67.5%), resulting in SVR rates of 15.7 and 40.9%, respectively. Between 77.5 and 95.3% of physicians did not follow prescribed recommendations to reduce PEG-IFN or ribavirin in cases of hematological abnormalities.ConclusionAlthough recommendations to assess EVR and HCV-RNA at week 24 were increasingly observed in daily practice, the corresponding stop rules' in nonresponders were neglected. The subsequent SVR was 5-10 times higher than that reported in controlled trials. This may partly be because of the fact that reductions in PEG-IFN or ribavirin dose were not performed despite recommendations. The issue of stop rules will gain even more interest since the first HCV protease inhibitors have been approved. Prolongation of treatment beyond the new stop rules is associated with risks of resistant HCV variants. Thus, the new stop rules are to be observed more strictly when compared with previous therapy with interferons and ribavirin. (C) 2013 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

Treatment of Chronic Hepatitis C Genotype 1 (G1) Infection With Boceprevir (Victrelis®) in German Real-Life: Impact of Hemoglobin Decline on Virologic Response Gerlinde Teuber, Peter Buggisch, Hanns Lohr, Hermann Steffens, Michael Kraus, Christine John, Peter Geyer, Bernd Weber, Thomas Witthoeft, Andreas Herrmann, Mark Hoesl, Uwe Naumann, Tarek Dahhan, Dagmar Hartmann, Bernd Dreher, Manfred Bilzer

Background: Triple therapy with the HCV protease inhibitor boceprevir has been approved as new standard of care for patients with chronic HCV G1 infection. The NOVUS observational study was conducted to investigate the efficacy of this novel antiviral therapy in German real-life.

Background: Data regarding the severity and impact of hemoglobin (Hb) decline caused by triple therapy with boceprevir (BOC) in real-life are still scarce and were evaluated in the present interim analysis of the German NOVUS observational study.

Background: Recently, renal impairment corresponding to renal insufficiency stage 3 has been reported in about 5% of patients treated for HCV genotype 1 infection with telaprevir or boceprevir (S Mauss et al., Hepatology 2014; 59:46 – 48). The present interim analysis of the NOVUS observational study was conducted to determine the frequency of stage 2 and stage 3 renal insufficiencies and to elucidate associated risk factors and mechanisms in patients (pts) undergoing boceprevir triple therapy in German real-life.

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: Triple therapy with the HCV protease inhibitor boceprevir (Victrelis®) combined with pegylated interferons (PegIFN) and ribavirin (RBV) has recently been approved as new standard of care for patients (pts) with chronic HCV genotype 1 (G1) infection. As a consequent next step we conducted a non-interventional observational study (NOVUS) to investigate the efficacy and safety of this novel and more complex therapeutic approach in the German real-life setting.

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.

912 LEUKOCYTE DECLINE PREDICTS SUSTAINED VIROLOGIC RESPONSE IN PATIENTS UNDERGOING PEGINTERFERON alfa-2b/RIBAVIRIN TREATMENT OF CHRONIC HCV GENOTYPE 1 INFECTION G. Teuber, S. Mauss, D. Huppe, E. Zehnter, M.P. Manns, T. Dahhan, U. Meyer, T. Witthoft, B. Moller, N. Dikopoulos, J. Brack, D. Hartmann, B. Dreher, M. Bilzer, Berufsverband Niedergelassener Gastroenterologen Deutschlands e.V.. Interdisziplinares Facharztzentrum Sachsenhausen, Frankfurt, Center for HIV and Hepatogastroenterology, Dusseldorf, Medical Group Practice, Herne, Gastroenterological Practice, Dortmund, Medical School of Hannover, Hannover, Medical Practice, Fellbach, Medical Practice, Berlin, Gastroenterological Practice, Stade, Gesundheitszentrum Langenau, Langenau, Hospital Nord Ochsenzoll, Hamburg, MSD Pharma GmbH, Haar, Germany E-mail: teuber@ifs-frankfurt.de

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.