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RISS 인기검색어
- 검색키워드
- 저자 : ( Brian Mcnabb ) (검색결과 2 건)
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( Alessio Aghemo ),( Alessandra Mangia ),( Eric Lawitz ),( Ed Gane ),( Brian Conway ),( Peter J. Ruane ),( Armando Abergel ),( Sooji Lee ),( Brian McNabb ),( Anu Osinusi ),( Frances Chen ),( Hadas Dvo 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Early results from registries and cohort studies have demonstrated that patients with cirrhosis who achieve SVR with DAA experience improvements in liver-related morbidity, HCC risk, and mortality. However, follow-up time for these studies is generally short. This analysis from the Gilead Cirrhosis Registry evaluates long-term outcomes in patients with cirrhosis who achieved SVR following treatment with a sofosbuvir-(SOF) based regimen. Methods: Patients with cirrhosis who achieved SVR after re ceiving a SOF-based regimen were eligible for enrollment. Patients enrolled within 60 weeks of completing a treatment study or transfer from another SVR registry study, or within 2 years of achieving SVR following treatment in a clinical practice setting. Patients return for visits every 24 weeks for 5 years for laboratory, clinical, and radiographic assessments of durability of SVR and clinical progression of liver disease. In this abstract we report the HCC incidence, CTP scores, and SVR durability. Results: As of 5 OCT 2017, 1564 patients have been enrolled in the cirrhosis registry. Mean age (range) is 59 (26-86) years, 68% are male, and 84% of patients had pretreatment CTP scores A. Median (range) of registry follow-up time was 53 (<1-144) weeks. Overall, there were 55 observed events of HCC in 3922 person-years (PYs) of follow-up since the start of DAA treatment (34 cases in 3292 PYs of follow-up for CTP-A patients and 21 in 601 PYs of follow-up for CTP B+C patients). Overall, patients with pretreatment CTP-A cirrhosis maintained CTP-A status while patients with pretreatment CTP B or C cir rhosis showed improvement. Conclusions: In this ongoing registry of patients with cirrhosis who achieved SVR after treatment with a SOF-based regimen, HCC was uncommon and occurred more often in patients with decompensated cirrhosis. The majority of patients main tained or improved their CTP category relative to pretreatment through up to week 96.
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( Lai Wei ),( Qing Xie ),( Jin Lin Hou ),( Hong Tang ),( Qin Ning ),( Jun Cheng ),( Yuemin Nan ),( Lunli Zhang ),( Jun Li ),( Jianning Jiang ),( Megan Kim ),( Brian Mcnabb ),( Fangqiu Zhang ),( Gregor 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Chronic hepatitis C virus (HCV) infection remains a major health threat in China, affecting at least 10 million people, with approximately 58% having genotype (GT) 1 infection. There is a critical need for simple, all oral, direct-acting antiviral regimens to treat GT1 HCV in this region. Treatment with ledipasvir (LDV)/sofosbuvir (SOF) results in high sustained virologic response rates 12 weeks after therapy (SVR12) in GT1 HCV infected patients in clinical trials and real-world settings. This study evaluated the efficacy and safety of LDV/SOF for 12 weeks in Chinese patients with chronic GT1 HCV infection. Methods: Treatment experienced and treatment naïve patients with chronic GT1 HCV infection with no cirrhosis or with compensated cirrhosis were eligible to enroll in a single-arm, openlabel trial to receive a fixed dosed combination of LDV/SOF 90/400 mg daily for 12 weeks. The primary efficacy endpoint was SVR12 using the CAP/CTM HCV 2.0 assay (LLOQ =15 IU/mL) and the primary safety endpoint was adverse events (AEs) leading to LDV/SOF discontinuation. Results: A total of 206 Chinese patients were enrolled and treated. Of these, 50% were male, 16% had compensated cirrhosis, 49% were treatment-experienced, 76% had IL28B CC genotype, and 100% had GT1b HCV infection. The mean (range) age and body mass index of enrolled subjects were 47 (21-72) years and 23 (14-34) kg/m2, respectively. The overall SVR12 rate is 100% (206/206). All 32 patients with cirrhosis (15 of whom were treatment-experienced), achieved SVR12. There were no discontinuations due to AEs. No serious or severe AEs were assessed by the investigator as related to study drug and there were no deaths. Conclusions: Treatment with the single tablet regimen of LDV/SOF for 12 weeks resulted in 100% SVR12 and was well tolerated in treatment experienced and treatment naïve GT1 HCVinfected Chinese patients with and without cirrhosis.
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