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( Edward J. Gane ),( Marc Bourliere ),( Stuart C. Gordon ),( Alnoor Ramji ),( Natarajan Ravendhran ),( Tram T. Tran ),( Rob H. Hyland ),( Jie Zhang ),( Hadas Dvory-sobol ),( Luisa M. Stamm ),( Diana M 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: NS5A inhibitors are potent DAAs which are key components of HCV treatment regimens. In combination with other DAAs, NS5A inhibitors provide cure to over 90% of patients. For patients who have failed a regimen with an NS5A inhibitor, there is concern about long-lasting NS5A RASs and currently no approved retreatment option. Sofosbuvir (SOF) and velpatasvir (VEL) are pangenotypic inhibitors of the NS5B and NS5A proteins, respectively, and voxilaprevir (VOX) is a pangenotypic NS3/4A protease inhibitor. This study evaluates treatment with a SOF/VEL/VOX for 12 weeks in patients who previously received an NS5A inhibitor. Methods: Eligible patients received at least 4 weeks of a prior NS5A inhibitor-containing. Those with HCV GT1 were randomized 1:1 to receive SOF/VEL/VOX (400mg/100 mg/100 mg) or matching placebo daily for 12 weeks, stratified by the presence or absence of cirrhosis. Patients of all other GTs were assigned to receive SOF/VEL/VOX for 12 weeks. Those patients assigned to receive placebo were offered deferred treatment with SOF/VEL/VOX for 12 weeks. The primary endpoint evaluated the superiority of SVR12 to a performance goal of 85%. Results: Of 415 patients enrolled and treated with SOF/VEL/VOX, 76% were male, 80% were white, 46% had compensated cirrhosis, and 57% had GT 1infection. The majority of patients had DAA experience with an NS5A inhibitor given in combination with an NS5B inhibitor, and the most common prior NS5A inhibitor was ledipasvir (50%). Treatment with SOF/VEL/VOX was well tolerated. No serious adverse events attributed to study medication were reported. Overall, 253/263 (96%) of patients treated with SOF/VEL/VOX achieved SVR12, which was superior to the prespecified goal of 85% (p<0.001). High SVR12 was achieved across HCV GTs and regardless of selected baseline factors such as cirrhosisand RASs at any position. Conclusions: SOF/VEL/VOX for 12 weeks is a safe, well-tolerated and effective treatment for patients previously failed an NS5A inhibitor-containing DAA regimen, a group that currently has no retreatment option.
All-oral Dual Therapy with Daclatasvir and Asunaprevir in Patients with HCV Genotype 1B Infection
Michael Manns,Stanislas Pol,Ira M. Jacobson,Patrick Marcellin,Stuart C. Gordon,Cheng-Yuan Peng,Ting-Tsung Chang,Gregory T. Everson,Jeong Heo,Guido Gerken,Boris Yoffe,William J. Towner,Marc Bourliere,S 한국간담췌외과학회 2014 한국간담췌외과학회 학술대회지 Vol.2014 No.4
( Mindie H. Nguyen ),( Joseph Lim ),( A. Burak Ozbay ),( Jeremy Fraysse ),( Iris Liou ),( Laura Moore-schiltz ),( Geoffrey Dusheiko ),( Stuart Gordon ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Older patients and those of Asian descent are at higher risk for osteoporosis. In the U.S., most patients with chronic hepatitis B (CHB) are Asians. The aim of this study was to characterize the longitudinal trends in osteoporosis and bone fractures and to describe comorbidities and concomitant medications use in a large diverse population of U.S. CHB patients between 2006 and 2015. Methods: Adult patients diagnosed with CHB (without HDV) with continuous enrollment in the 6 months before and after CHB diagnosis were identified from the MarketScan® Commercial, Medicare, and Medicaid Databases during 7/1/2004- 6/30/2015. These CHB patients were matched to non-CHB controls by payer type, year, age, gender. The prevalence (per 1000 persons) and incidence (per 1000 person- years) of osteoporosis and bone fracture were calculated for each year during 2006-2015. Comorbidities and medication use which may influence bone mineralization were also evaluated. Results: Among the 44,026 CHB patients identified for the study, the prevalence of fracture and osteoporosis increased significantly between 2006 and 2015 by nearly 2-fold (91 to 177 per 1000) overall (Figure). This trend was observed for both males (76 to 133 per 1000) and females (109 to 228 per 1000). When compared to matched non-CHB controls, the prevalence and incidence were significantly higher in CHB patients during each study year period. In CHB patients, the prevalence of osteoporosis, osteoarthritis, or vitamin D deficiency also increased nearly 3-folds from 7% to 20%, (p<0.001). During the same period, the concomitant use of corticosteroids increased from 17% to 24%. Conclusions: : Between 2006-2015, the prevalence of bone fracture and osteoporosis increased significantly in U.S. patients with CHB, and was much higher in CHB patients than non-CHB controls. During the same period, comorbidities related to bone mineral loss also increased and should be considered in the management of CHB patients.
( Mindie H. Nguyen ),( Joseph Lim ),( A. Burak Ozbay ),( Jeremy Fraysse ),( Iris Liou ),( Laura Moore-schiltz ),( Geoffrey Dusheiko ),( Stuart Gordon ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Chronic kidney disease (CKD) is a significant comorbidity that may be more common among patients with chronic hepatitis B (CHB). Our goal was to characterize the prevalence and incidence of CKD over time during the period from 2006 to 2015 in a diverse population of CHB patients across the U.S. Methods: Using the Truven Health MarketScan<sup>®</sup> Commercial (general population), Medicare (mostly older than 65), and Medicaid (low income population) insurance databases, we identified a cohort of CHB cases (without HDV). We matched these to non-CHB controls by calendar year of diagnosis date, age, gender, and geographic region. Primary outcomes were CKD prevalence (per 1000 persons) and incidence (per 1000 person-years). We analyzed CKD outcomes by age group and by presence of diabetes and hypertension for CHB patients in 2015. Results: This study included 44,026 CHB patient cases and 121,568 non-CHB controls CKD prevalence increased significantly over time and was higher in CHB than non-CHB controls (Figure 1). CKD prevalence increased by nearly 3-fold from 44 to 114, p<0.001. CKD incidence increased by 56% (13 to 20, p=0.003). Between 2006 to 2015, the proportion of patients with comorbidities that may predispose patients to CKD increased: 12.2%-17.7% for diabetes, 22.0% -37.3% for hypertension. For CHB patients in 2015, CKD prevalence in patients with diabetes and hypertension was 10-fold higher than those without, and 6-fold higher in patients older than 60 compared to younger than 45. Conclusions: CKD prevalence in CHB patients has increased by almost 3-fold from 2006 to 2015 and is significantly higher than matched non-CHB controls and with similar trends observed for CKD incidence. CKD is particularly prevalent in older CHB patients and those with the comorbidities of diabetes and hypertension. Whether CHB has contributed to the prevalence of CKD in the cohort requires further analysis.
( Mindie H. Nguyen ),( Joseph Lim ),( A. Burak Ozbay ),( Jeremy Fraysse ),( Iris Liou ),( Laura Moore-schiltz ),( Geoffrey Dusheiko ),( Stuart Gordon ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Little is known about the age, prevalence of comorbidities, and co-medications among U.S. patients with chronic hepatitis B (CHB). Our aim was to characterize these longitudinal trends in a large diverse population of U.S. CHB patients, between 2006 and 2015. Methods: We conducted a study of CHB patients ≥ 18 years of age (without HDV) who were continuously enrolled for 6 months before and after CHB diagnosis, using de-identified and U.S. administrative healthcare claims extracted from the Truven Health MarketScan® Commercial (general population), Medicare (older than 65), and Multi-State Medicaid (low income population) databases between 7/1/2004 and 6/30/2015. Results: We identified a total of 44,026 U.S. CHB patients. The median age of CHB patients increased from 47 in 2006 to 52 in 2015 (p<0.001). Deyo-Charlson Comorbidity Index scores increased over time from a mean of 1.1 in 2006 to 1.4 in 2015 (p<0.001). The proportion of CHB patients with diabetes, hypertension, and hyperlipidemia also increased significantly between 2006 and 2015 (p<0.001) (Figure). Specifically, from 2006 to 2015, diabetes increased from 12.2% to 17.7%, renal impairment increased from 9.8% to 16.7%, hypertension increased by almost two-fold from 22.0% to 37.3%, hyperlipidemia increased by almost 3-fold from 8.1% to 24.0%, and non-alcoholic fatty liver disease (NAFLD) increased over 2-folds from 1.7% to 5.2% (p<0.001). From 2006 to 2015, use of cardiovascular medications increased from 27.0% to 37.1% and use of antidiabetic medications increased from 10.3% to 13.2% (p<0.001). Conclusions: Between 2006 and 2015, the median age of patients with CHB significantly increased with increasing prevalence of associated comorbidities and concomitant medication use, up to 3-fold increase in some major comorbidities. The contribution of hepatitis B to these comorbidities in an aging population merits further analysis but advancing age and comorbidities in this group require appropriate management.