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- 검색키워드
- 저자 : ( Eliav Barr ) (검색결과 3 건)
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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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Concomitant Proton Pump Inhibitor Use Does Not Reduce the Efficacy of Elbasvir/Grazoprevir
( Nancy Reau ),( Michael Robertson ),( Hwa-ping Feng ),( Luzelena Caro ),( Wendy W. Yeh ),( Bach-yen T. Nguyen ),( Janice Wahl ),( Eliav Barr ),( Peggy Hwang ),( Stephanie O. Klopfer ),( Youngmi Eun ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: It is estimated that up to one-third of hepatitis-C virus (HCV)-infected patients use proton pump inhibitors (PPIs) and other acid reducing agents. Concomitant PPI use with some NS5A inhibitors impacts the pharmacokinetics (PK) of direct-acting antiviral agents (DAAs), potentially reducing efficacy. Phase I study results demonstrated no effect of PPI use on the PK of the fixed-dose combination of elbasvir/grazoprevir (EBR/GZR) in healthy volunteers. This post hoc analysis of studies in the Phase 3 clinical program of EBR/GZR assessed the 12-week sustained viral response (SVR12) in subjects with self-reported PPI use and the PK of EBR/GZR in these patients. Methods: Data were derived from six Phase 3 EBR/GZR trials with treatment-naïve or treatment experienced GT1/4-infected subjects, with or without cirrhosis. Analyses were done in the modified Full Analysis Set population (excludes administrative discontinuations). Self-reported baseline PPI use was defined as ≥7 consecutive days of use between Day -7 and Day 7. Bivariate analyses assessed PPI use and other factors associated with SVR, with gender, age (continuous and dichotomous), cirrhosis status, prior treatment status, baseline HCV RNA (continuous and dichotomous), HCV genotype, and baseline resistance associated variants as variables in the models. Results: Overall, 12% (162/1322) of EBR/GZR-treated subjects reported baseline use of PPIs. Of those, 155/162 (96%) achieved SVR12. In patients without PPI use, 1129/1160 (97%) achieved SVR12. PPI use was not a predictive factor in achieving SVR12 based on a univariate analysis (p = 0.188). In the bivariate models, none of the interaction terms was statistically significant, indicating that any potential effects of PPI were consistent across the factors considered. In addition, PPI usage was not a statistically significant effect, regardless of adjustment for the factors considered. From 3 of the 6 studies for which population PK data were available, the estimated AUC and Cmax values for EBR were comparable among patients with and without reported PPI use (table). Conclusions: These results demonstrate that PPIs use with EBR/GZR has no clinically significant effect on SVR12 rates in GT1/4-infected patients with and without cirrhosis.
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( K. Rajender Reddy ),( David Roth ),( Annette Bruchfeld ),( Peggy Hwang ),( Barbara Haber ),( Bach-yen T. Nguyen ),( Eliav Barr ),( Janice Wahl ),( Wayne Greaves ),( Youngmi Eun ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Decreased estimated glomerular filtration rate (eGFR) has been reported in patients with HCV infection receiving direct-acting antiviral agents. EBR/GZR was safe and efficacious in patients with chronic kidney disease stage 4/5 (CKD 4/5) in the C-SURFER study. The aim of this analysis was to evaluate the impact of EBR/GZR on eGFR in patients with less severe CKD. Methods: We analyzed a pooled dataset of 1689 patients who received EBR/GZR (50 mg/100 mg) with or without ribavirin (RBV) for 8 (n=91, 5%), 12 (n=1238, 73%), 16 (n=211, 12%), or 18 (n=149, 9%) weeks (656 patients [39%] received RBV). Patients were treatment-naïve or treatment-experienced, and included cirrhotics and those with HIV co-infection. Creatinine values were assessed at baseline and ≥1 post-baseline timepoint. eGFR was calculated using the Modified Diet in Renal Disease equation at baseline, end of treatment, and 12 weeks post-therapy. Results: Of the 1689 patients evaluated, 32 had CKD 3 (eGFR < 60 mL/min/1.73 m2 to ≥30 mL/min/1.73 m2) and 1657 had eGFR >60 mL/min/1.73 m2 (Table). Demographics were similar in both groups except for a higher proportion of HIV-co-infected patients in the CKD 3 group (41% vs. 17%). Patients with CKD 3 and those with eGFR >60 mL/min/1.73 m2 at baseline did not show any decrease in eGFR during treatment or follow-up. Conclusions: EBR/GZR did not affect eGFR in patients with pre-existing eGFR >60 mL/min/1.73 m2 or those with CKD3. Treatment duration, RBV co-administration, cirrhosis, or HIV coinfection did not adversely affect renal outcome.
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