Lai Wei1, Mingxiang Zhang2, Min Xu3, Wan-Long Chuang4, Wei Lu5, Wen Xie6, Zhansheng Jia7, Guozhong Gong8, Yueqi Li9, Si Hyun Bae10, Yong-Feng Yang11, Qing Xie12, Shumei Lin13, Xinyue Chen14, Junqi Niu15, Jidong Jia16, Tushar Garimella17, Anne Torbeyns18, Fiona McPhee19, Michelle Treitel17, Philip D Yin19, Ling Mo20. 1. Peking University People's Hospital and Peking University Hepatology Institute, Beijing. 2. The Sixth People's Hospital of Shenyang, Shenyang. 3. Guangzhou No.8 People's Hospital, Guangzhou. 4. Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung. 5. Tianjin Second People's Hospital, Tianjin. 6. Beijing Ditan Hospital, Capital Medical University, Beijing. 7. Tangdu Hospital, Xi'an. 8. The Second Xiangya Hospital of Central South University, Changsha. 9. 302 Military Hospital of China, Beijing. 10. Seoul St. Mary Hospital, The Catholic University of Korea, Seoul. 11. The 2nd Hospital of Nanjing, Affiliated to Medical School of South East University, Nanjing. 12. Shanghai Ruijin Hospital, Jiaotong University School of Medicine, Guangzhou. 13. The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an. 14. Beijing Youan Hospital, Capital Medical University, Beijing. 15. First Hospital of Jilin University, Changchun. 16. Beijing Friendship Hospital, Capital Medical University, Beijing. 17. Bristol-Myers Squibb, Princeton, NJ. 18. Bristol-Myers Squibb, Braine-l'Alleud. 19. Bristol-Myers Squibb, Wallingford, CT. 20. Bristol-Myers Squibb, Shanghai.
Abstract
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.
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.