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- 저자 : ( Shelby Corman ) (검색결과 2 건)
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( Chizoba Nwankwo ),( Shelby Corman ),( Elamin H. Elbasha ),( Sunju Kim ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Daclatasvir (DCV) plus Asunaprevir (ASV) is one of the current direct-acting antiviral (DAA) therapy treatment options for patients with chronic hepatitis C (CHC) genotype (GT) 1b patients in Korea. Elbasvir/grazoprevir (EBR/GZR) is an emerging DAA therapy for patients with CHC GT1b. The objective of this analysis was to estimate and compare the impact of EBR/GZR on long-term incidence of liver- related complications compared with DCV+ASV G1b CHC treated patients in South Korea. Methods: A computer-based Markov model of the natural history of chronic HCV (CHC) genotype 1 infection was developed to estimate the cumulative incidence of cirrhosis, decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), liver-related deaths over a 30-year time horizon, and disease costs. The target population was G1b CHC treatment-naive and treatment-experienced infected patients. The model consisted of 16 health states encompassing METAVIR fibrosis score (F0-F4), treatment success or failure, DC, HCC, and liver-related death. Patients were assumed to be treated with 12 weeks of EBR/GZR (regardless of the presence of cirrhosis) or 24 weeks of DCV+ASV (based on Korean treatment guidelines). The proportions of patients achieving SVR for each treatment and subpopulation were obtained from clinical trials. The cost of disease management in Koreas was collected from published literature. Results: EBR/GZR was projected to reduce the cumulative incidence of cirrhosis to 1.6% compared with 8.3% for DCV+ASV. The cumulative incidence of DC and HCC were projected to be 8.2% and 6.4% respectively in patients treated with EBR/GZR compared with 10.1% and 7.5% respectively for DAC+ASV. This corresponded to a cumulative incidence of liver related death of 10.9% for EBR/GZR compared with 15.2% for DCV+ASV. The use of DCV+ASV also resulted in higher cumulative disease costs (4,267,442 KRW) compared with EBR/GZR (3,123,729 KRW). Conclusions: In Korea, the use of EBR/GZR for the treatment of CHC GT1b infected patients was projected to reduce the incidence of liver-related complications and mortality over a 30 year time horizon, compared with DCV+ASV. This was also estimated to lead to an increase in the cumulative disease costs that can be avoided when EBR/GZR is used to treat these patients compared with DCV+ASV in Korea.
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( Sam Keeping ),( Keith Chan ),( Eric Druyts ),( Shelby Corman ),( Chizoba Nwankwo ),( Park Hye-min ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Genotype 1b accounts for the majority of chronic hepatitis c virus (HCV) infections in high income countries in Asia. The combination of daclastasvir plus asunaprevir for 24 weeks (DCV24 + ASV24) is currently licensed for the treatment of genotype 1b patients in Japan, Korea and Taiwan, and can be considered one of the current standard of care in this population. The fixed-dose combination of elbasvir/grazoprevir taken for 12 weeks (EBR/GZR12) has also demonstrated high rates of sustained viral response (SVR) in genotype 1b patients. We performed a systematic review and indirect treatment comparison of EBR/GZR12 and DCV24 + ASV24 in HCV patients with genotype 1b. Methods: Randomized or single-arm clinical trials of at least one of the treatments of interest were identified by searching Medline (including Medline in Process), Embase, and Cochrane Central Register of Controlled Trials. For each intervention, an overall SVR across all trials was calculated using a fixed-effects model with inverse- variance weighting and no transformation of the underlying data. A naive comparison was then made using standard statistical methods (2x2 contingency tables, Normal test for difference), without accounting for differences across trial populations. Analyses were conducted for the overall population as well as subgroups stratified by prior-treatment experienced and cirrhosis status. Results: A total of 27 relevant citations were identified with information from 15 clinical trials (9 for EBR/GZR, 6 for DCV + ASV). The pooled SVRs in all patients were 98.28% (95% CI 97.07%, 99.48%) for EBR/GZR12, and 86.68% (95% CI 84.73%, 88.62%) for DCV24 + ASV24. In the naive comparison, a statistically significant difference was observed between the two treatments with a relative risk (RR) of 1.12 (95% CI 1.09, 1.16). The subgroup analysis showed that EBR/GZR12 had higher SVRs than DCV24 + ASV24 in all subgroups that were assessed. These differences in SVRs were also statistically significant in all patient groups except in treatment-naive patients with compensated cirrhosis (RR 1.10 [95% CI 0.99, 1.23]), where the lower bound of the confidence interval approached 1 (see Table 1). Due to a lack of head-to-head trials within the evidence base or trials with a common control group, it was not possible to carry out a network meta-analysis. Conclusions: These results suggest that EBR/GZR12 is likely to offer clinical benefits over DCV24 + ASV24 in terms of higher SVRs in patients with genotype 1b chronic hepatitis C infection.
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