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      저자 : ( Joe Llewellyn ) (검색결과 1 건)
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      • Twelve Weeks of Ledipasvir/Sofosbuvir for Patients with Chronic Hepatitis C Genotype 2 Infection: Integrated Analysis of Three Clinical Studies

        ( Chung-feng Huang ),( Yasuhiro Asahina ),( Chun-jen Liu ),( Edward Gane ),( Yoshito Itoh ),( Norifumi Kawada ),( Yoshiyuki Ueno ),( Jin Youn ),( Chen-yu Wang ),( Joe Llewellyn ),( Anu Osinusi ),( Jen 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

        Aims: HCV genotype (GT) 2 is the second most common genotype in several Asian countries including Taiwan and Korea. Treatment options for GT2 remain limited in these countries. The once-daily fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) was evaluated for the treatment of GT 2, in patients with or without compensated cirrhosis, in three phase 2 and 3 studies. Methods: This was a retrospective analysis of subjects treated with LDV/SOF for 12 weeks in the GS-US-337-1655 (Taiwan), GS-US-337-1903 (Japan) and GS-US-1468 (New Zealand) studies. Subjects analyzed in this integrated analysis were either mono-infected with HCV GT2, or co-infected with HCV GT2 and HBV. The data was pooled and safety and efficacy were analyzed. Results: Overall 200 subjects were treated and analyzed; 88% of subjects were Asian, 46% male, 31% had prior treatment failure, 15% were cirrhotic, 25% were IL28B non-CC, 34% were 65 years or older and 22% (n=43) were co-infected with HBV. The overall SVR rate was 97% (194/200), and was 93% (27/29) among patients with cirrhosis and 97% (59/61) in patients who had failed previous therapy. Of the 197 patients with available testing; NS5A resistance-associated substitutions (RASs) were present in 86% (169/197) at baseline. SVR12 rate was 98% (165/169) in patients with baseline NS5A RASs compared with 100% (28/28) in patients without NS5A RASs. No new RASs emerged in patients with virologic failure. Treatment with LDV/SOF for 12 weeks was well tolerated. Overall the most common adverse events AEs were headache and nasopharyngitis. Few subjects experienced serious AEs, none of which were assessed as treatment related. One patient discontinued treatment due to AE. Conclusions: Treatment with LDV/SOF for 12 weeks is highly effective and well tolerated in patients with GT2 HCV infection, including patients who are treatment experienced and/or have compensated cirrhosis, baseline NS5A RASs and with HBV/HCV coinfection.

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