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RISS 인기검색어
- 검색키워드
- 저자 : ( Stephanie Moody ) (검색결과 2 건)
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( W. Ray Kim ),( Eric J. Lawitz ),( Peter Ruane ),( Catherine Stedman ),( Graham Foster ),( Robert H. Hyland ),( Sarah Coogan ),( Stephanie Moody ),( Hadas Dvory-sobo ),( Steven J. Knox ),( Diana M. B 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Significant advances in the treatment of chronic hepatitis C have been made with direct acting antiviral (DAA) regimens. While SVR rates may now be achieved in the majority of patients, data describing long-term virologic and clinical outcomes with these regimens are needed. Methods: We report interim data from two 3-year registry studies capturing long-term outcomes in patients with chronic hepatitis C treated with DAAs. Subjects are enrolled into two registries according to SVR status; SVR (SVR registry) versus non-SVR (Sequence registry). We determined the durability of SVR, relapse and reinfection rates. The persistence of resistance associated variants (RAVs) in treatment failures is followed. Liver disease progression is assessed by periodic clinical & labroratory evaluations. Results: 5433 patients enrolled in the SVR registry with a median (range) follow-up of 71 (0-156) weeks. 536 patients enrolled in the Sequence registry with a median (range) of follow-up of 44 (0-159) weeks. Demographic and disease characteristics are described below. In the SVR registry, at the time of data analysis, 99.7% (5414/5433) of patients have maintained SVR with 0.3% (19/5433) having emergent virus (6 relapses, 8 new infections, 5 to be confirmed). Viral emergence occurred by Week 96 in all patients. In the Sequence registry of 89 patients who received an NS5A inhibitor and had baseline sequencing data, 91.0% (81/89) had NS5A RAVs at Week 96. HCC was reported in 0.3% (16/5433) and 0.9% (5/536) of patients in the SVR and Sequence registries through Week 96 respectively. There were no significant changes in laboratory evaluations or liver disease assessments. Conclusions: SVR achieved following treatment with DAA regimens is durable. In patients failing NS5A-containing regimens, treatment- emergent NS5A RAVs persist. Rates of clinical disease progression and HCC are low. Ongoing reporting from these registry studies will be required to confirm these findings.
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( K Rajender Reddy ),( Marc Bourliere ),( Kosh Agarwal ),( Eric Lawitz ),( Leia Kim ),( Anu Osinusi ),( Kathryn Kersey ),( Gerald Crans ),( Stephanie Moody ),( Liyun Ni ),( Diana M. Brainard ),( John 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Sustained virologic response (SVR) after interferon (IFN)-based treatment for HCV infection is associated with reduced risk of hepatocellular cancer (HCC), although the risk is not eliminated. Less is known regarding the risk of de novo HCC following SVR with IFN-free direct acting antiviral (DAA) therapy. In this analysis, a review of incident HCC in patients treated with SOF-containing regimens was performed. Methods: Data from Gilead HCV clinical trials (from treatment start to 24 weeks post-treatment) and registry studies (3 to 5 year follow-up observation) were analyzed to evaluate the incidence of de novo HCC. The clinical database was searched to identify adverse events of liver tumors; the occurrence of HCC is recorded at each visit in the registry studies. Incidence rates and exposure-adjusted incidence rates, time to development, and risk factors for development of HCC were assessed in patients with and without cirrhosis (compensated and decompensated) who received IFN- containing (Peg- IFN+RBV±SOF) vs IFN-free treatment (SOF, ledipasvir/SOF, SOF/velpatasvir ± RBV), and SVR vs no SVR. Results: In the clinical trial database, 0.3% (36 of 13,525) patients had AEs of HCC or suspected HCC while in the registry study database, 0.5% (33 of 6675) were reported to have HCC. The rate was similar in non-cirrhotic patients who achieved SVR with an IFN-containing vs IFN-free regimen (0.09 vs 0.03 per 100 patient years of follow-up, respectively); few patients with compensated cirrhosis and none with decompensated cirrhosis received IFN-containing regimens. Among subjects treated with IFN-free regimens, higher rates were observed with advanced liver disease and non SVR (see table). Conclusions: Data from the Gilead clinical trial and registry study databases show incidence of HCC in subjects treated with IFN-free regimens is similar to that reported in the IFN-era in similar populations. While SVR significantly reduces the risk of HCC, the risk is not completely eliminated, particularly among patients with decompensated cirrhosis.
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