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- 저자 : ( Tami Pilot-matias ) (검색결과 1 건)
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( Lai Wei ),( Jinlin Hou ),( Yan Luo ),( Jeong Heo ),( Chi-jen Chu ),( Zhongping Duan ),( Mong Cho ),( Jun Cheng ),( Jun Li ),( Jidong Jia ),( Wenjing Lu ),( Linda M Fredrick ),( Tami Pilot-matias ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: HCV genotype 1b is the most common genotype in Asian patients. ONYX-I is a phase 3, randomised, double-blind, placebo-controlled study of the 3-DAA regimen of OBV/PTV/r and DSV in treatment- naive and treatment-experienced non-cirrhotic patients with HCV GT1b infection in China, South Korea and Taiwan. Methods: In this study, the safety/efficacy of OBV/PTV/r + DSV administered for 12 weeks were evaluated in non-cirrhotic Asian patients. Patients in Arm A received active study drug during a 12-week double-blind (DB) period, while patients in Arm B received placebo during the same period followed by an open-label (OL) period in which they received 12 weeks of active study drug. Efficacy was assessed by SVR12 and SVR24. Efficacy and safety were assessed in all patients who received at least one dose of active study drugs. Results: 650 HCV GT1b patients (54% female, 100% Asian, 44% treatment-experienced) were enrolled from China (n=410) South Korea (n=120) and Taiwan (n=120), and randomised 1:1 to Arms A and B. In Arm A, SVR12 and SVR24 rates were 99.5% (183/184) in treatment-naive patients and 100% (141/141) in treatment- experienced patients. Most treatment-emergent adverse events (TEAEs) in patients receiving the active drug were mild in severity. The most common (≥5%) TEAEs in Arm A were upper respiratory tract infection (10.5%), headache (6.2%) and dizziness (5.2%). Seven patients had serious AEs during active treatment (Arm A) and one patient in Arm A discontinued treatment. Conclusions: In non-cirrhotic Asian adults with HCV GT1b-infection, treated with OBV/PTV/r + DSV for 12 weeks, SVR24 rates equalled previously reported SVR12 rates from this study (99.5% of treatment- naive and 100% of treatment-experienced patients), and are consistent with other clinical trials with this drug combination. The treatment was generally well tolerated with mostly mild TEAEs reported.
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