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High Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms

DC FieldValueLanguage
dc.description.abstractINTRODUCTION: Oral daclatasvir (DCV; pangenotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease inhibitor) is approved in Japan and Korea for treatment of chronic hepatitis C virus (HCV) genotype 1. Response to DCV + ASV is affected by DCV resistance-associated polymorphisms (RAPs) in HCV NS5A. The prevalence and influence of these RAPs on 12-week sustained virologic response (SVR12) to DCV + ASV was evaluated in Asian and non-Asian patients. METHODS: Data were pooled from 5 national and international studies of patients with HCV genotype 1b (GT-1b) receiving DCV + ASV at their recommended doses. Baseline NS5A RAPs and their effect on SVR12 were assessed overall, in older (≥65 years) patients, patients with cirrhosis, and in patients stratified by baseline HCV RNA or prior treatment experience with interferon-based therapy. RESULTS: Baseline NS5A sequences were available from 988 patients (374 Japanese; 125 Korean/Taiwanese; 489 from non-Asian countries), 979 of whom were assessed for SVR12. Pretreatment NS5A-L31F/I/M/V and/or NS5A-Y93H polymorphisms were present in 18% of Japanese and 12-13% of non-Japanese patients; these RAPs reduced SVR12 by 54.9% overall (93.9% [787/838] SVR12 when absent, 39.0% [55/141] SVR12 when present), with comparable reductions observed in Asians and non-Asians and across all categories of treatment experience, age, and cirrhosis. RAP-associated SVR12 rates declined with increasing baseline HCV RNA (SVR12 with RAPs: 64.7% [11/17] at 5-6 log10 IU/mL, 29.8% [14/47] at 7-8 log10). Without baseline RAPs, very high SVR12 rates (92-100%) were observed in older patients and patients with cirrhosis irrespective of national origin, with similarly high rates observed among treatment-naïve and interferon-experienced patients and those with high baseline HCV RNA. CONCLUSIONS: Following DCV + ASV treatment, the SVR12 rates in GT-1b patients without baseline NS5A-L31F/I/M/V and/or NS5A-Y93H polymorphisms were very high (approximately 90-100%), irrespective of age, cirrhosis, prior interferon treatment, or baseline HCV RNA. FUNDING: Bristol-Myers Squibb.-
dc.relation.isPartOfAdvances in Therapy-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleHigh Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학)-
dc.contributor.googleauthorFiona McPhee-
dc.contributor.googleauthorYoshiyuki Suzuki-
dc.contributor.googleauthorJoji Toyota-
dc.contributor.googleauthorYoshiyasu Karino-
dc.contributor.googleauthorKasuaki Chayama-
dc.contributor.googleauthorYoshiiku Kawakami-
dc.contributor.googleauthorMin Lung Yu-
dc.contributor.googleauthorSang Hoon Ahn-
dc.contributor.googleauthorHiroki Ishikawa-
dc.contributor.googleauthorRafia Bhore-
dc.contributor.googleauthorNannan Zhou-
dc.contributor.googleauthorDennis Hernandez-
dc.contributor.googleauthorPatricia Mendez-
dc.contributor.googleauthorHiromitsu Kumada-
dc.contributor.alternativeNameAhn, Sang Hoon-
dc.contributor.affiliatedAuthorAhn, Sang Hoon-
dc.identifier.bibliographicCitationAdvances in Therapy, Vol.32(7) : 637-649, 2015-
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)


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