Early virological response may predict treatment response in sofosbuvir-based combination therapy of chronic hepatitis c in a multi-center "real-life" cohort.

BACKGROUND: The combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a (peg-IFN-alfa-2a) as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials. However, there is only limited data concerning the efficacy and safety in a "real-life" cohort. METHODS: We analyzed a cohort of 119 patients with chronic HCV infection treated at four investigational sites in Germany. All patients received either a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV. RESULTS: The rates of SVR at 12 weeks after end of treatment (SVR 12) were as follows: Among 76 patients with genotype 1 infection the SVR 12 rate was 74% (n = 56), among 14 patients with genotype 2 infection the SVR 12 rate was 79% (n = 11), among 24 patients with genotype 3 infection the SVR 12 rate was 92% (n = 22) and among 5 patients with genotype 4 infection the SVR 12 rate was 80% (n = 4). Of all 26 patients with a relapse in our cohort, 69% (n = 18) of these patients presented with liver cirrhosis and 58% (n = 15) were treatment experienced. Notably, the level of HCV-RNA after 4 weeks of treatment was a significant predictor of treatment response in genotype 1 patients. Patients with HCV-RNA levels ≥ 12 IU ml-1 after 4 weeks of treatment achieved SVR 12 only in 30% (n = 17/56, p < 0.0001) of cases and treatment response was even lower with SVR 12 of 25% (n = 5/20, p = 0.0016) in the subgroup of patients with cirrhosis. CONCLUSION: We observed a high rate of SVR 12 with SOF-based treatment regimes, however probably due to the high number of patients with liver cirrhosis and prior treatment experience, treatment response rates were lower than in previously published trials. In genotype 1 patients the analysis of early virological response may predict treatment response in SOF-based combination therapies.

Impact of direct acting antiviral (DAA) treatment on glucose metabolism and reduction of pre-diabetes in patients with chronic hepatitis C.

BACKGROUND AND AIM: With the development of direct acting antiviral agents (DAA) chronic hepatitis C virus (HCV) infection has become curable in most patients. Since HCV infection is known to have direct and/or indirect effects on glucose metabolism, successful HCV treatment may have an impact in reducing glucose level, pre-diabetes, the need of treatment for diabetes, and ultimately diabetes-associated morbidity. We investigated the association of DAA treatment and glucose metabolism in the context of development or resolution of hepatic fibrosis in a large cohort of HCV- infected patients. METHODS: In this retrospective single-center observational study, we investigated 281 patients receiving all-oral DAA therapy for fasting plasma glucose, HbA1c, liver enzymes and general clinical chemistry, measured during a 52-week follow-up. In addition, elastography, FIB-4- and APRI-calculation were used to assess hepatic fibrosis non-invasively. RESULTS: Successful elimination of HCV through DAA treatment was associated with a significant drop in fasting glucose level and a reduced rate of impaired fasting plasma glucose (FPG). Interestingly, this metabolic change was BMI-independent. In addition, long-term glucose levels also decreased after successful DAA treatment. A significant APRI-score reduction was associated with a persistent improvement of FPG. However, DAA did not have an impact on glucose metabolism in patients suffering from liver cirrhosis. CONCLUSION: This study highlights the beneficial impact of successful HCV therapy on glucose metabolism and identifies patients with liver cirrhosis as a collective in need of intensified surveillance with regard to diabetes progression despite HCV eradication.

An empirical investigation of quality improvement initiatives in for-profit and not-for-profit hospitals: environmental, competitive and outcome concerns.

PURPOSE: The objective of this study is to shed some light on quality improvement practices of for-profit and not-for-profit hospitals DESIGN/METHODOLOGY/APPROACH: The scope and effectiveness of several quality improvement efforts are studied for a sample of 110 hospitals. Factor analysis was utilized to analyze the data collected. FINDINGS: The results of this study tended to suggest that for-profit and not-for-profit hospitals were more similar than different with the regard to the effective utilization of quality improvement initiatives, thus underscoring the utility of quality improvement efforts despite differences in operating characteristics, strategies and operating constraints. RESEARCH LIMITATIONS/IMPLICATIONS: The sample used in this study is limited. Thus, the results should be interpreted accordingly. PRACTICAL IMPLICATIONS: This study offers decision-makers in healthcare operational settings empirical evidence of the operational and strategic effectiveness of different quality improvement efforts, thus justifying investments related to the initiation and implementation of such quality improvement efforts. ORIGINALITY/VALUE: This study represents an important step toward understanding the effective implementation of quality improvement initiatives in different operational settings.

An empirical investigation of the effectiveness of contemporary managerial philosophies in a hospital operational setting.

The new realities of the healthcare marketplace are forcing healthcare decision makers to implement innovative operational philosophies, techniques, and tools that were proven in other industries to enhance the effectiveness of their organization. This study examines the acceptance and effectiveness of these philosophies, techniques, and tools in a hospital operational setting. The impact of implementation on operational and strategic outcomes is examined for 108 hospitals. Overall, the results of this study appear to indicate that certain quality improvement philosophies, techniques, and tools have been successful when applied in a hospital operational setting.