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      • A Randomized, Controlled Trial of Sofosbuvir/Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Experienced Patients with GT1-6 HCV Infection: The POLARIS-4 Study

        ( Paul Kwo ),( Stefan Zeuzem ),( Steven L. Flamm ),( Myron Tong ),( John M Vierling ),( Stephen Pianko ),( Peter Buggisch ),( Victor de Lédinghen ),( Robert H. Hyland ),( Xiaoru Wu ),( Evguenia S. Sva 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: DAAs provide safe and highly efficacious therapies for HCV infection. However, the small proportion of patients who do not achieve a sustained virologic response with DAA-based regimens represent a population with an unmet medical need. Sofosbuvir(SOF) and velpatasvir(VEL) are pangenotypic inhibitors of the HCV NS5B and NS5A proteins, respectively, and voxilaprevir(VOX) is a pangenotypic HCV NS3/4A protease inhibitor. This study evaluates treatment with a SOF/VEL/VOX for 12weeks and a SOF/VEL for 12weeks as salvage regimens in DAA-experienced patients who had not previously received an NS5A inhibitor. Methods: Patients with genotypes 1-3 were randomized 1:1 to receive open-label SOF/VEL/VOX or SOF/VEL for 12weeks, stratified according to genotype and cirrhosis status. Patients of all other genotypes were assigned to receive SOF/VEL/VOX for 12weeks. DAA-experienced patients who previously were treated with an NS5A inhibitor or with only an NS3/4A protease inhibitor in combination with ribavirin and Peg-IFN were excluded. The primary endpoint evaluates the superiority of the SVR12 of each treatment to a prespecified goal of 85%. Results: Of the 333 patients who were randomized and treated, 77% were male, 19% had the IL28B CC genotype, 46% had compensated cirrhosis and 43% had genotype 1 infection. Most patients had prior DAA experience with either an NS5B inhibitor alone(73%) or an N5SB inhibitor and an NS3/4A protease inhibitor(25%); the most common prior treatment regimens were SOF with ribavirin ±Peg-IFN and SOF combined with simeprevir. Treatment was well tolerated.No SAE was assessed to be attributable to study drug. Overall, SVR12 was achieved in 97%(177/182) of patients treated with SOF/VEL/VOX and 90%(136/151) patients treated with SOF/VEL. SOF/VEL/VOX met the prespecified 85% SVR12 performance goal(p<0.001); SOF/VEL did not. Conclusions: SOF/VEL/VOX for 12 weeks provides a safe, well tolerated and effective retreatment options for patients who did not previously achieve SVR following treatment with non-NS5A inhibitor-containing DAA regimens.

      • SCOPUSKCI등재

        Process Evaluation of a Mobile Weight Loss Intervention for Truck Drivers

        Wipfli, Brad,Hanson, Ginger,Anger, Kent,Elliot, Diane L.,Bodner, Todd,Stevens, Victor,Olson, Ryan Occupational Safety and Health Research Institute 2019 Safety and health at work Vol.10 No.1

        Background: In a cluster-randomized trial, the Safety and Health Involvement For Truck drivers intervention produced statistically significant and medically meaningful weight loss at 6 months (-3.31 kg between-group difference). The current manuscript evaluates the relative impact of intervention components on study outcomes among participants in the intervention condition who reported for a post-intervention health assessment (n = 134) to encourage the adoption of effective tactics and inform future replications, tailoring, and enhancements. Methods: The Safety and Health Involvement For Truck drivers intervention was implemented in a Web-based computer and smartphone-accessible format and included a group weight loss competition and body weight and behavioral self-monitoring with feedback, computer-based training, and motivational interviewing. Indices were calculated to reflect engagement patterns for these components, and generalized linear models quantified predictive relationships between participation in intervention components and outcomes. Results: Participants who completed the full program-defined dose of the intervention had significantly greater weight loss than those who did not. Behavioral self-monitoring, computer-based training, and health coaching were significant predictors of dietary changes, whereas behavioral and body weight self-monitoring was the only significant predictor of changes in physical activity. Behavioral and body weight self-monitoring was the strongest predictor of weight loss. Conclusion: Web-based self-monitoring of body weight and health behaviors was a particularly impactful tactic in our mobile health intervention. Findings advance the science of behavior change in mobile health intervention delivery and inform the development of health programs for dispersed populations.

      • KCI등재

        Process Evaluation of a Mobile Weight Loss Intervention for Truck Drivers

        Brad Wipfli,Ginger Hanson,Kent Anger,Diane L. Elliot,Todd Bodner,Victor Stevens,Ryan Olson 한국산업안전보건공단 산업안전보건연구원 2019 Safety and health at work Vol.10 No.1

        Background: In a cluster-randomized trial, the Safety and Health Involvement For Truck drivers intervention produced statistically significant and medically meaningful weight loss at 6 months (3.31 kg between-group difference). The current manuscript evaluates the relative impact of intervention components on study outcomes among participants in the intervention condition who reported for a postintervention health assessment (n ¼ 134) to encourage the adoption of effective tactics and inform future replications, tailoring, and enhancements. Methods: The Safety and Health Involvement For Truck drivers intervention was implemented in a Webbased computer and smartphone-accessible format and included a group weight loss competition and body weight and behavioral self-monitoring with feedback, computer-based training, and motivational interviewing. Indices were calculated to reflect engagement patterns for these components, and generalized linear models quantified predictive relationships between participation in intervention components and outcomes. Results: Participants who completed the full program-defined dose of the intervention had significantly greater weight loss than those who did not. Behavioral self-monitoring, computer-based training, and health coaching were significant predictors of dietary changes, whereas behavioral and body weight selfmonitoring was the only significant predictor of changes in physical activity. Behavioral and body weight self-monitoring was the strongest predictor of weight loss. Conclusion: Web-based self-monitoring of body weight and health behaviors was a particularly impactful tactic in our mobile health intervention. Findings advance the science of behavior change in mobile health intervention delivery and inform the development of health programs for dispersed populations.

      • KCI등재

        Urodynamic Mechanisms Underlying Overactive Bladder Symptoms in Patients With Parkinson Disease

        Gregory Vurture,Benoit Peyronnet,Jose-Alberto Palma,Rachael D. Sussman,Dominique R. Malacarne,Andrew Feigin,Ricardo Palmerola,Nirit Rosenblum,Steven Frucht,Horacio Kaufmann,Victor W. Nitti,Benjamin M. 대한배뇨장애요실금학회 2019 International Neurourology Journal Vol.23 No.3

        Purpose: To assess the urodynamic findings in patients with Parkinson disease (PD) with overactive bladder symptoms. Methods: We performed a retrospective chart review of all PD patients who were seen in an outpatient clinic for lower urinary tract symptoms (LUTS) between 2010 and 2017 in a single-institution. Only patients who complained of overactive bladder (OAB) symptoms and underwent a video-urodynamic study for these symptoms were included. We excluded patients with neurological disorders other than PD and patients with voiding LUTS but without OAB symptoms. Results: We included 42 patients (29 men, 13 women, 74.5±8.1 years old). Seven patients (16.7%) had a postvoid residual (PVR) bladder volume >100 mL and only one reported incomplete bladder emptying. Detrusor overactivity (DO) was found in all 42 patients (100%) and was terminal in 19 (45.2%) and phasic in 22 patients (52.4%). Eighteen patients had detrusor underactivity (DU) (42.3%). Later age of PD diagnosis was the only parameter associated with DU (P=0.02). Patients with bladder outlet obstruction (BOO) were younger than patients without BOO (70.1 years vs. 76.5 years, P=0.004), had later first sensation of bladder filling (173.5 mL vs. 120.3 mL, P=0.02) and first involuntary detrusor contraction (226.4 mL vs. 130.4 mL, P=0.009). Conclusions: DO is almost universal in all patients with PD complaining of OAB symptoms (97.1%). However, a significant percentage of patients also had BOO (36.8%), DU (47%), and increased PVR (16.7%) indicating that neurogenic DO may not be the only cause of OAB symptoms in PD patients.

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