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RISS 인기검색어
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- 저자 : ( Roger Trinh ) (검색결과 2 건)
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( Lai Wei ),( Yan Luo ),( Wang-long Chuang ),( Seung Woon Paik ),( Ming-lung Yu ),( Linda M Fredrick ),( Andrew Campbell ),( Roger Trinh ),( Jeffrey Enejosa ),( Nancy S Shulman ),( Jeong Heo ),( Nilou 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: ONYX-I and ONYX-II are Phase 3 studies exploring the PK, safety, and efficacy of the 3-DAA ± ribavirin regimen in a HCV GT1b-infected Asian population. Comparable PK exposures of the 3-DAA regimen between the Asian and predominantly Caucasian (thereafter referred to as “Western”) HCV GT1-infected patients in other studies have been published. Methods: We compared the safety/efficacy profiles of the 3-DAA regimen (+ ribavirin for patients with compensated cirrhosis) in Asian patients in ONYX-I and -II Phase 3 studies conducted in China, Taiwan, and South Korea with Western patients enrolled in PEARL-II (treatment-experienced), PEARL-III (treatment-naive), and TURQUOISE-II (compensated cirrhosis) Phase 3 studies conducted exclusively in North America, Europe, and Australia. Results: Among treatment-naive non-cirrhotic patients, sustained virologic response at post treatment week 12 (SVR12) was achieved by 99.5% (183/184; 95% CI 97.0-99.9) of Asian patients compared with 99.0% (207/209; 95% CI 97.7-100) of Western patients (GT1b). In non-cirrhotic treatment-experienced patients, SVR12 was achieved by 100% (141/141; 95% CI 97.4-100) of Asian patients and 100% (91/91; 95% CI 95.9-100) of Western patients (GT1b). Among cirrhotic patients, SVR12 was achieved by 100% (104/104; 95% CI 96.4-100) of Asian patients compared with 98.5% (67/68; 95% CI 95.3-100) of Western patients (GT1a and -1b-infected patients). The majority of Asian and Western patients with or without cirrhosis had at least 1 treatment-emergent adverse event (TEAE). A low percentage of Asian and Western patients (<4%) experienced serious TEAEs. TEAEs leading to treatment discontinuation, in both Asian and Western patients, were rare. No patients without cirrhosis and 1 subject with cirrhosis discontinued treatment due to a TEAE. Only 1 death occurred across the studies, which was not due to a TEAE. Conclusions: The safety/efficacy profiles were consistent between the Asian and Western HCV GT1b-infected patients treated with OBV+PTV/r + DSV.
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( Christoph Sarrazin ),( Mark S. Sulkowski ),( Preethi Krishnan ),( Rakesh Tripathi ),( Gretja Schnell ),( Yan Xie ),( Daniel E. Cohen ),( Roger Trinh ),( Lino Rodrigues-jr. ),( Yan Luo3,Nancy S. Shul 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The 3 direct-acting antiviral (3-DAA) regimen of ombitasvir, ritonavir-boosted paritaprevir and dasabuvir ± RBV is approved in the US and EU for treatment of hepatitis C virus (HCV) genotype (GT) 1 infection. Baseline resistance associated variants (RAVs) in HCV NS3 or NS5A can impact response to other DAA regimens; we assessed the prevalence and impact of RAVs on response to the 3-DAA regimen. Methods: Next-generation sequencing (Illumina MiSeq) assessed baseline samples from treatment-naive (PEARL-IV), -experienced (SAPPHIRE- II), or cirrhotic (TURQUOISE-II) GT1a patients who received 3-DAA + RBV, and treatment-experienced (PEARL-II) or cirrhotic (TURQUOISE-III) GT1b patients who received 3-DAA alone. Thresholds of 1 and 15%, respectively, detected the prevalence and impact of baseline RAVs; impact of RAVs conferring ≥ 5-fold resistance to components of the 3-DAA regimen on response was determined by com- paring SVR rates in patients with or without RAVs. Results: SVR rates were 96% and 100% in patients with GT1a and GT1b, respectively. One or more NS5A RAVs were present in 11% of treatment-experienced or cirrhotic GT1a patients, whereas NS5A RAVs were found in 19% of GT1b patients (15% threshold). Similar SVR rates were seen in GT1a patients with or without NS5A RAVs. All GT1b patients with NS5A RAVs, including at position Y93, achieved SVR. NS3 RAVs were uncommon (≤2%). NS3 RAVs were not seen in any of the 14 virologic failures and an NS5B RAV was seen in 1 virologic failure. The presence of the GT1a NS3 Q80K polymorphism had no impact on SVR. Conclusions: Understanding impact of baseline NS5A RAVs on treatment outcomes is important for relevant HCV therapies. Patients with HCV GT1a-infection treated with the 3-DAA regimen + RBV achieved high SVR rates, regardless of the presence of baseline RAVs. All GT1b patients treated with the 3-DAA regimen alone achieved SVR.
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