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RISS 인기검색어
- 검색키워드
- 저자 : ( Steven L. Flamm ) (검색결과 3 건)
- 무료
- 기관 내 무료
- 유료
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( 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.
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( Steven L. Flamm ),( Cheng-yuan Peng ),( Oren Shibolet ),( Ronald Nahass ),( Peggy Hwang ),( Eliav Barr ),( Michael Robertson ),( Barbara Haber ),( Eungeol Sim ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Safety and efficacy of HCV therapy in older individuals is of growing importance as the population with HCV infection ages. The objectives of this study were to compare the safety and efficacy of elbasvir (EBR)/grazoprevir (GZR) in participants aged ≥65 and <65 years. Methods: Safety and efficacy data from participants with HCV genotype (GT)1 or 4 infection receiving EBR (50 mg/day)/GZR (100 mg/day) for 12 weeks in 12 clinical trials were pooled and analyzed according to age (≥65 years vs <65 years). Sustained virologic response (SVR) 12 was defined as HCV RNA <lower limit of quantification 12 weeks after end of treatment (COBAS ® AmpliPrep/COBAS® Taqman® v2.0). Results: In participants aged ≥65 years (n=339), mean age was 70 years (range, 65-82) versus 49 years (range, 18-64) in those <65 years (n=2139). Demographic parameters in participants aged ≥65 years versus <65 years were noncirrhotic (85% vs 83%), treatment-naive (72% vs 85%), HCV GT1 infection (99% vs 95%), male (44% vs 61%), and white (26% vs 59%), black (12% vs 13%), and Asian (61% vs. 26%) race, respectively. SVR12 rates were 323/339 (95.3%) and 2041/2139 (95.4%) in participants with HCV GT1 or 4 infection aged ≥65 and < 65 years, respectively (Table). Rates of serious adverse events (SAEs), discontinuations due to adverse events (AEs), drug-related SAEs, and deaths were similar in both age groups (Table). AEs (occurring in >5% of either age group) in participants aged ≥ 65 versus <65 years were headache (7.1% vs 13.0%), fatigue (6.8% vs 11.3%), nasopharyngitis (6.5% vs 4.9%), nausea (4.1% vs 7.2%), and diarrhea (3.5% vs 5.8%), respectively. Conclusions: The efficacy of EBR/GZR for 12 weeks was similar in participants aged ≥65 years versus those <65 years. Treatment was well tolerated in both age groups, with low rates of SAEs, discontinuations due to AEs, drug-related SAEs, and deaths.
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( Eungeol Sim ),( Chizoba Nwankwo ),( Bruce Bacon ),( Michael P. Curry ),( Douglas T. Dieterich ),( Steven L. Flamm ),( Kris V. Kowdley ),( Scott Milligan ),( Naoky C. Tsai ),( Zobair M. Younossi ),( 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Lengthening treatment with elbasvir/grazoprevir (EBR/ GZR) to 16 weeks and/or adding ribavirin (RBV) is recommended for select patients with HCV GT1 infection. However, realworld data (J Hepatol 2017;66:S295) suggest that utilization of this regimen is low. This study examined the use of 12- and 16- week EBR/GZR ±RBV regimens in different patient subgroups. Methods: Data were collected from providers and specialty pharmacies through Trio Health’s disease management program. Patients (n=442) with HCV GT1 infection who initiated EBR/GZR therapy between Jan 28, 2016 (FDA approval) to Dec 31, 2016 were included. Results: 401 (91%) patients received EBR/GZR for 12 weeks, 12 (3%) received EBR/GZR+RBV for 12 weeks, 11 (2%) received EBR/GZR for 16 weeks, and 18 (4%) received EBR/GZR+RBV for 16 weeks. Possible baseline NS5A resistance was identified in 13/285 patients with GT1a infection: 3 (23%) received EBR/ GZR for 12 weeks, 1 (8%) received EBR/GZR+RBV for 12 weeks, 2 (15%) received EBR/GZR for 16 weeks, and 7 (54%) received EBR/GZR+RBV for 16 weeks. Across all patients, the +RBV subgroup had a higher proportion of treatment-experienced patients (43%, 13/30) than the -RBV group (17%, 69/412); and the 16-week subgroup had a higher proportion of GT1A subtype (93%, 27/29) than the 12-week group (62%, 258/413). Other characteristics including gender, age, baseline viral load, and cirrhosis were similar between regimens and between groups defined by RBV addition or therapy duration. SVR12 results at time of abstract submission were available for 262/442 patients. Overall per protocol (PP) SVR12 was 97% (253/262). Across GT1 subgroups (defined by subtype, prior treatment experience, and fibrosis) that received EBR/GZR for 12 weeks without RBV, the PP SVR12 was ≥94% (TABLE). Conclusions: In real-world practice, EBR/GZR was highly effective, with the majority of patients treated for 12 weeks without RBV. Full SVR12 data will be presented at the conference.
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