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( F. Mcphee ),( L. Wei ),( Q. Xie ),( Y. Suzuki ),( J. Toyota ),( Y. Karino ),( K. Chayama ),( Y. Kawakami ),( M. L. Yu ),( S. H. Ahn ),( N. Zhou ),( H. Kumada ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Daclatasvir (DCV) plus asunaprevir (ASV) has demonstrated highsustained virologic response (SVR) in HCV genotype (GT-)1b infection.NS5A-Y93H and NS5A-L31 resistance-associated polymorphisms(RAPs) to DCV are known to impact DCV+ASV response in GT-1b-infectedJapanese. The effect of RAPs on SVR at posttreatment week12 (SVR12) to DCV+ASV was explored in mainland Chinese, Korean,and Taiwanese.Methods: Pooled data from 2 studies of DCV (60 mg daily) + ASV(100 mg capsule, twice-daily) for 24 weeks in GT-1b-infected interferon/ribavirin-naive and -experienced patients from mainland China,Korea, and Taiwan. Similar Japanese data (4 studies; n=445) werepooled for comparison. SVR12 with versus without baseline Y93Hand/or L31 RAPs was compared by age (<65 vs ≥65 years), cirrhosisstatus, and baseline HCV-RNA.Results: SVR12 and baseline NS5A sequences were available for 282patients (126 mainland Chinese [45%〕, 80 Koreans [28%〕, 76Taiwanese [27%〕). NS5A-Y93H and/or -L31 RAPs were observed pretreatmentin 8% mainland Chinese, 14% Korean, and 18%Taiwanese patients, compared with 19% in Japanese. SVR12 in allnon-Japanese patients is shown (Figure); rates were broadly similarbetween countries and with Japanese data (Japanese: 96% overallwithout RAPs, 41% with RAPs). Responses were lower among patientswith baseline RAPs. By contrast, SVR12 in patients without RAPs washigh (92-100%), irrespective of cirrhosis, age, or baseline HCV-RNA.Conclusions: At least 95% of HCV GT-1b-infected patients from mainlandChina, Korea or Taiwan without baseline NS5A-Y93H or -L31polymorphisms who had HCV-RNA ≤7 log10 IU/mL achieved SVR12on DCV+ASV, regardless of cirrhosis status and age.
( KR Reddy ),( S Pol ),( PJ Thuluvath ),( H Kumada ),( J Toyota ),( K Chayama ),( J Levin ),( E Lawitz ),( A Gadano ),( W Ghesquiere ),( G Gerken ),( M Brunetto ),( CY Peng ),( M Silva ),( S Strasser 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Background/aims: Daclatasvir plus other direct-acting antivirals (DAAs) and/or peg-interferon/ribavirin has achieved high rates of sustained virologic response (SVR) in multiple clinical studies of patients. This follow-up study evaluates the long-term efficacy and safety outcomes in these patients. Methods: : This 144-week observational study enrolled patients treated with ≥ 1 dose of daclatasvir within 6 months of either completing their parent studies or protocol availability at the study site. The study objectives were to evaluate SVR12 durability, persistence of emergent NS5A and NS3 substitutions in non-responders, and to characterize events of hepatic disease progression or hepatocellular carcinoma. Results: This study enrolled 1503 patients treated with DAA-only (n = 893) or interferon-containing (n = 610) regimens of daclatasvir, of whom 60% were male, 18% were aged ≥ 65 years, 87% had HCV genotype 1 infection, and 18% had cirrhosis. Overall, 1329/1489 evaluable patients archived SVR12 in parent studies; 1316 (99%) maintained SVR until their most recent follow-up visit. 12 responders relapsed after achieving SVR12 (9 on/before and 3 after post-treatment week 24); 1 was re-infected. Relapse occurred in 3/842 (0.4%) and 9/487 responders (2%) treated with DAA-only regimens and interferon-containing regimens, respectively. From parent study end of treatment, hepatic disease progression (n = 15) or new hepatocellular carcinoma (n = 23) were diagnosed in 36 patients (two had both); median time to diagnosis was 70 weeks (range, 0.4-206 weeks). These 36 patients were generally older (median, 61 years versus 56 years), more had cirrhosis at baseline (50% versus 18%), and most were infected with HCV genotype 1a (36%) or 1b (61%). Complete replacement of emergent NS5A, NS3 substitutions by wild-type sequences was observed in 27/157 (17%), 35/47 (74%) non-responders, respectively. Conclusions: The results suggest that SVR12 achieved with daclatasvir- based regimens is durable in the long term. Hepatic disease progression events and new hepatocellular carcinoma were infrequent.