A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin
单位：[1]Peking University People’s Hospital and Peking University Hepatology Institute[2]Beijing Ditan Hospital[3]Beijing Youan Hospital[4]Beijing Friendship Hospital, Capital Medical University首都医科大学附属北京友谊医院[5]302 Military Hospital of China, Beijing[6]The Sixth People’s Hospital of Shenyang, Shenyang,[7]Shanghai Ruijin Hospital, Jiaotong University School of Medicine[8]Bristol-Myers Squibb, Shanghai[9]Guangzhou No.8 People’s Hospital, Guangzhou[10]Tianjin Second People’s Hospital, Tianjin,[11]Tangdu Hospital,[12]The First Affiliated Hospital of Xi’an Jiaotong University, Xi'an[13]The Second Xiangya Hospital of Central South University, Changsha[14]he 2nd Hospital of Nanjing, Affiliated to Medical School of South East University, Nanjing[15]First Hospital of Jilin University, Changchun[16]Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung[17]Seoul St. Mary Hospital, The Catholic University of Korea, Seoul[18]Bristol-Myers Squibb, Princeton, NJ,[19]Bristol-Myers Squibb, Wallingford, CT[20]Bristol-Myers Squibb, Braine-l’Alleud
Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (+/- ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Methods: Interferon (+/- ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). Results: Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients, and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9%), particularly in mainland China (10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on treatment; none were considered related to study drugs. Two patients (1.3%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (+/- ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.
第一作者单位：[1]Peking University People’s Hospital and Peking University Hepatology Institute
通讯作者：
通讯机构：[8]Bristol-Myers Squibb, Shanghai[*1]Clinical Research Virology, China R&D, Bristol-Myers Squibb (China), 1717 Nanjing Road West, Floor 15, 16 and 17 Wheelock Square, Shanghai, 200040.
推荐引用方式(GB/T 7714)：
Wei Lai,Zhang Mingxiang,Xu Min,et al.A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin[J].JOURNAL of GASTROENTEROLOGY and HEPATOLOGY.2016,31(11):1860-1867.doi:10.1111/jgh.13379.
APA：
Wei, Lai,Zhang, Mingxiang,Xu, Min,Chuang, WanLong,Lu, Wei...&Mo, Ling.(2016).A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin.JOURNAL of GASTROENTEROLOGY and HEPATOLOGY,31,(11)
MLA：
Wei, Lai,et al."A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin".JOURNAL of GASTROENTEROLOGY and HEPATOLOGY 31..11(2016):1860-1867
