[The revised version of standard terminology in gastroenterological endoscopy - result of a consensus project of the german society for gastroenterology, digestive and metabolic diseases]. / Neufassung der Standard-Terminologie in der gastroenterologischen Endoskopie ­ Ergebnis eines Konsensusprojekts der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten.

A uniform and comprehensive terminology is essential in the correct documentation of diagnostic or therapeutic endoscopic procedure. In the German-speaking world, the standard terminology available so far is based on a previous version published in 1999. Therefore, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has undergone a comprehensive revision and re-structuring of the terminology. This appeared mandatory due to various changes, new diagnoses and new endoscopic procedures. The suggestions drawn up by individual working groups were approved by consensus and are now available as an online document (https://doi.org/10.1055/s-0043-121167) for modifying current software systems. In order to ensure an up-to-date documentation in the future, it was decided that annual updates will be performed by the DGVS to check respective software packages for modifications and new contents.

Colon Capsule Endoscopy: Indications, Findings, and Complications - Data from a Prospective German Colon Capsule Registry Trial (DEKOR).

BACKGROUND/AIMS: Reliable and especially widely accepted preventive measures are crucial to further reduce the incidence of colorectal cancer (CRC). Colon capsule endoscopy (CCE) might increase the screening numbers among patients unable or unwilling to undergo conventional colonoscopy. This registry trial aimed to document and determine the CCE indications, findings, complications, and adverse events in outpatient practices and clinics throughout Germany. METHODS: Patients undergoing CCE between 2010 and 2015 were enrolled in this prospective multicenter registry trial at six German centers. Patient demographics, outcomes, and complications were evaluated. RESULTS: A total of 161 patients were included. Of the CCE evaluations, 111 (68.9%) were considered successful. Pathological findings in the colon (n=92, 60.1%) and in the remaining gastrointestinal tract (n=38, 24.8%) were recorded. The main finding was the presence of polyps (n=52, 32.3%). Furthermore, five carcinomas (3.1%) were detected and histologically confirmed later. Adequate bowel cleanliness was more likely to be achieved in the outpatient setting (p<0.0001). Interestingly, 85 patients (55.6%) chose to undergo CCE based on personal motivation. CONCLUSION: CCE seems to be a reliable and safe endoscopic tool for screening for CRC and detecting other diseases. Its patient acceptance and feasibility seems to be high, especially in the outpatient setting.

Hepatitis C virus: Current steps toward elimination in Germany and barriers to reaching the 2030 goal.

Hepatitis C virus (HCV) affects over 70 million people globally, with an estimated 399 000 HCV-related deaths in 2016. The World Health Organization (WHO) has set a goal to eliminate HCV by 2030. Despite the availability of direct-acting antivirals-highly effective and well-tolerated therapies for HCV-many patients infected with HCV in Germany have not initiated treatment, including a majority of those who are aware of their positive diagnosis. Barriers to screening, diagnosis, and treatment are major factors taking many countries off track for HCV elimination by 2030. Identifying country-specific barriers and challenges, particularly in at-risk populations such as people who inject drugs or men who have sex with men, has the potential to create tailored programs and strategies to increase access to screening or treatment and engage at-risk populations. This review aims to report the current steps toward HCV elimination in Germany, the country-specific barriers and challenges that will potentially prevent reaching the 2030 HCV elimination goal and describe good practice examples to overcome these barriers.

Combination Therapy of Simeprevir and Sofosbuvir in Recurrent HCV Genotype 4 After Liver Retransplantation: Case Report.

BACKGROUND: The treatment of hepatitis C virus (HCV) infection is evolving rapidly. Many studies have been completed during the last 2 years, with more studies still in progress. The management of recurring HCV infection following liver organ transplantation remains very challenging, especially for HCV genotype 4 (GT-4). More research is needed in this area. CASE REPORT: We report on a patient with a recurring HCV infection and fibrosing cholestatic hepatitis following liver retransplantation, who was successfully treated with a combination therapy of simeprevir and sofosbuvir without interferon/ribavirin. As far as we know, this is the first reported case of this kind. CONCLUSIONS: This information may be of importance and inform future management of patients with recurrent HCV infections following liver transplantation.

Benefit of Treatment Individualization in Patients with Chronic Hepatitis C Receiving Peginterferon Alfa-2a and Ribavirin in a Large Noninterventional Cohort Study.

BACKGROUND AND AIMS: Individualization of treatment with peginterferon alfa and ribavirin in patients with chronic hepatitis C showed benefit in controlled trials and was implemented in treatment guidelines to increase response rates and to reduce side effects and costs. However, it is unknown whether individualization was adopted in routine daily practice and whether it translated into improved outcomes. METHODS: From a large noninterventional cohort study, clinical and virologic response data of 10,262 HCV patients who received peginterferon alfa-2a and ribavirin between 2003-2007 and 2008-2011 were analyzed. To account for treatment individualization, a matched-pair analysis (2,997 matched pairs) was performed. Variation in treatment duration and dosing of ribavirin were analyzed as indicators for individualization. RESULTS: Sustained virological response (SVR) rates were similar between 2003-2007 and 2008-2011 (62.0% vs. 63.7%). Patients with comorbidities were more abundant in the later period, (44.3% vs. 57.1%). The subsequent matched-pair analysis demonstrated higher SVR rates in the 2008-2011 period (64.3%) than in the 2003-2007 period (61.2%, p=0.008). More patients received abbreviated or extended treatment regimens in the later than the earlier period as an indicator of treatment individualization. To the same end, ribavirin doses were higher in the later period (12.6 versus 11.6 mg/kg/day). Factors independently associated with SVR included HCV genotype, low baseline viral load, younger age, route of infection, absence of concomitant diseases, lower APRI score, normal gamma-GT, higher ribavirin doses, no substitution for drug abuse, treatment duration, and treatment in the 2008-2011 period. CONCLUSIONS: Treatment individualization with peginterferon alfa and ribavirin was implemented in daily routine between 2003-2007 and 2008-2011, SVR rates improved in the same period. These findings may be most relevant in resource-limited settings.

Noncompliance with guidelines for the treatment of hepatitis C is frequent in daily practice.

PURPOSE: In 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 METHODS: This 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 α-2a plus ribavirin between 2003 and 2009. RESULTS: The 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. CONCLUSION: Although 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.

Predictive factors for sustained virological response after treatment with pegylated interferon α-2a and ribavirin in patients infected with HCV genotypes 2 and 3.

BACKGROUND: Previous trials have often defined genotype 2 and 3 patients as an "easy to treat" group and guidelines recommend similar management. AIMS: The present study looks for differences between the two genotypes and analyzes predictive factors for SVR. METHODS: Prospective, community-based cohort study involving 421 physicians throughout Germany. The analysis includes 2,347 patients with untreated chronic HCV genotype 2 (n = 391) and 3 (n = 1,956) infection treated with PEG-IFN α-2a plus ribavirin between August 2007 and July 2012. RESULTS: When compared with genotype 2 patients, those with genotype 3 were younger, had a shorter duration of infection, lower values of total cholesterol, LDL cholesterol and BMI, a higher frequency of drug use as infection mode and male gender (p<0.0001, respectively), and a higher APRI score (p<0.005). SVR was higher in genotype 2 when compared with genotype 3 (64.7% vs. 56.9%, p = 0.004). By multivariate analysis of genotype 2 patients, low baseline γ -GT and RVR predicted SVR. In genotype 3 age ≤45 years, cholesterol>130 mg/dl, a low APRI score, and a γ-GT ≥3-times ULN, RVR, and RBV starting dose were associated with SVR by multivariate analysis. CONCLUSIONS: The present study corroborates that liver fibrosis is more pronounced in genotype 3 vs. 2. SVR is higher in genotype 2 versus genotype 3 partly because of follow-up problems in genotype 3 patients, in particular in those infected by drug use. Thus, subgroups of genotype 3 patients have adherence problems and need special attention also because they often have significant liver fibrosis. TRIAL REGISTRATION: Verband Forschender Arzneimittelhersteller e.V., Berlin, Germany ML21645 ClinicalTrials.gov NCT02106156.