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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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