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- 검색키워드
- 저자 : ( Liyun Ni ) (검색결과 3 건)
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High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir
( Kathleen Schwarz ),( Karen F. Murray ),( Philip Rosenthal ),( Sanjay Bansal ),( Chuan-hao Lin ),( Sooji Lee ),( Liyun Ni ),( Bittoo Kanwar ),( Jenna Fraser ),( Polina German ),( Diana M. Brainard ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Although direct acting antivirals have transformed HCV treatment of adults, the standard of care for adolescents and younger children with GT1 HCV is still limited to treatment with pegylated interferon+ribavirin for 48 weeks. The aim of this study was to evaluate the safety, efficacy and pharmacokinetics of the fixed dose single tablet regimen, ledipasvir/sofosbuvir (LDV/SOF), administered for 12weeks in GT1 HCV-infected adolescent patients. Methods: Treatment-naive and treatment-experienced adolescent patients aged 12 to less than 18 years old with chronic GT1 HCV were enrolled into this open-label ongoing study to receive 12 weeks of treatment with LDV/SOF 90mg/400 mg once daily. The primary efficacy endpoint is SVR12 (HCV RNA<lower limit of quantitation). Safety is assessed by clinical evaluation and laboratory monitoring. Intensive pharmacokinetic (PK) sampling was done on Day 10 in the first 10 patients (PK lead-in) to confirm the appropriateness of the adult dose in the adolescent population. Results: 100 GT1 patients have been enrolled and treated. The majority are GT1a (81%), female (63%), white (90%), treatment-naive (80%), and vertically infected (84%). The mean age is 15 (range 12-17) years. In the PK lead-in, administration of 1 tablet daily of LDV/SOF provided comparable plasma exposures of LDV, SOF, and GS-331007 (SOF primary metabolite) to those observed in adults. SVR12 rate was 97% (97/100). 3 patients were lost to follow-up. No serious adverse events (AEs) have been reported. AEs are generally mild in severity and grade 3/4 laboratory abnormalities have been infrequent and transient. Conclusions: The 12-week regimen of LDV/SOF 90mg/400 mg has resulted in high SVR rates and is well-tolerated. This regimen provides a safe and effective therapy for adolescents with GT1 HCV infection. Further evaluation is ongoing in children aged 3-11 years old.
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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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( Eric Lawitz ),( Michael Manns ),( Marc Bourliere ),( Sooji Lee ),( Nelson Cheinquer ),( Luisa Stamm ),( Robert H. Hyland ),( Liyun Ni ),( Hadas Dvory-sobol ),( Diana Brainard ),( Mani Subramanian ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: The pangenotypic fixed-dose combination (FDC) of sofosbuvir (SOF), a HCV NS5B inhibitor, velpatasvir (VEL), a HCV NS5A inhibitor, and voxilaprevir (VOX), a HCV NS3/4A protease inhibitor, is an salvage regimen for direct acting antiviral (DAA)-experienced patients based on the safety and efficacy demonstrated in Phase 2 and Phase 3 trials in this population. Methods: This was a retrospective analysis of data from 454 NS5A inhibitor-experienced patients treated with SOF/VEL FDC+VOX or SOF/VEL/VOX FDC in the Phase 2 and Phase 3 trials. Efficacy was assessed by SVR12 and relapse rates. Safety was assessed by treatment-emergent adverse events (AEs) and laboratory abnormalities. Results: Of 454 NS5A inhibitor-experienced patients treated, 77% were male, 41% had compensated cirrhosis, 86% had NS5A and NS3 baseline resistance-associated substitutions (RASs), 74% had genotype 1 HCV infection. Most patients (53%) had previously been exposed to NS5A inhibitor+NS5B inhibitor, with 39% exposed to NS5A inhibitor+NS3/4A protease inhibitor±NS5B inhibitor and 8% exposed to NS5A inhibitor±another DAA. Overall, the SVR12 rate was 97% with a relapse rate of 2%. The SVR12 rate in patients with compensated cirrhosis was 95% and in patients with baseline RASs was 97%. The SVR12 rates by prior regimen were: NS5A inhibitor+NS5B inhibitor 95%; NS5A inhibitor+NS3/4A protease inhibitor±NS5B inhibitor 99%; and NS5A inhibitor±another DAA 100%. Treatment-emergent RASs were uncommon, present in 3 of 10 patients who relapsed. Only 1 patient (0.2%) discontinued treatment due to an AE. No serious adverse events attributed to study medication were reported. Conclusions: Results in over 450 NS5A inhibitor-experienced patients enrolled in Phase 2 or Phase 3 trials demonstrate that the 3-DAA combination of SOF, VEL and VOX for 12 weeks is a safe, well tolerated and effective treatment for patients who previously failed an NS5A inhibitor-containing regimen, irrespective of the other drugs in the prior treatment.
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