单位：[1]Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China[2]People’s Hospital of Henan Province, Henan, China[3]West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[4]Peking University People’s Hospital, Beijing, China[5]Xiangya Hospital of Central South University, Changsha, Hunan, China[6]Guangzhou Eighth People’s Hospital, Guangzhou, Guangdong, China[7]Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University, Beijing, China[8]Huashan Hospital, Fudan University, Shanghai, China[9]The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China中山大学附属第三医院[10]The Sixth People’s Hospital of Shenyang, Shenyang, Liaoning, China[11]People’s Hospital of Jiangsu Province, Nanjing, Jiangsu, China[12]Beijing Friendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[13]Nanjing Medical University Affiliated Second Hospital, Nanjing, Jiangsu, China[14]Liuzhou People’s Hospital, Liuzhou, China[15]Liver Disease Center of PLA, The 81st Hospital of PLA, Nanjing, Jiangsu, China[16]Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China[17]Baoji Central Hospital, Baoji, Shaanxi, China[18]The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China[19]The First Hospital Affiliated to Jilin University, Changchun, Jilin, China[20]The First Hospital of Changsha, Changsha, Hunan, China[21]The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China[22]The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China[23]Beijing Ditan Hospital, Capital Medical University, Beijing, China[24]Ascletis BioScience Co., Ltd., Hangzhou, Zhejiang, China
Background and Aims: Genotype (GT) 1 remains the predominant hepatitis c virus (HCV) GT in Chinese patients. Over 80% of those Chinese patients harbor the interferon-sensitive CC allele of IFNL4rs12979860, which is favorable for interferon-based treatment regimens. This phase III clinical trial aimed to evaluate the efficacy and safety of the ritonavir-boosted danoprevir plus pegylated-interferon alpha-2a and ribavirin regimen for 12 weeks in treatment-naive mainland Chinese patients infected with HCV GT1 without cirrhosis. Methods: One hundred and forty-one treatment-naive, non-cirrhotic HCV GT1 Chinese patients (age >= 18 years) were enrolled for this single-arm, multicenter, phase III MAN-ASA study (NCT03020082). Patients received a combination of ritonavir-boosted danoprevir (100 mg/100 mg) twice a day plus subcutaneous injection of weekly pegylated-interferon alpha-2a (180 mu g) and oral ribavirin (1000/1200 mg/day body weight <75/>= 75 kg) for 12 weeks. The primary end-point was sustained virologic response rate at 12 weeks after the end of treatment. The secondary end-points were safety outcomes, tolerability, virologic response over time and relapse rate. Results: All enrolled patients were HCV GT1-infected, and most among them (97.9%, 123/141) had the HCV GT1b subtype. Single-nucleotide polymorphism test showed that the majority of patients were of the IFNL4 rs12979860 CC genotype (87.2%, 123/141). Overall, 140 patients completed the 12-week treatment, and 97.1% (136/140) patients achieved sustained virologic response at 12 weeks (per protocol population group, 95% confidence interval: 92.9-99.2%). Only drug-related serious adverse event occurred. Most of the adverse events were grade 1 and grade 2 alanine aminotransferase elevation or liver dysfunction. One patient discontinued treatment because of severe head injury in a car accident. Conclusions: The triple regimen of ritonavir-boosted danoprevir plus pegylated-interferon a-2a and ribavirin produced a sustained virologic response rate of 97.1% after 12 weeks treatment in noncirrhotic HCV GT1-infected Chinese patients, and was safe and well tolerated.
第一作者单位：[1]Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China[*1]Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing 100191, China
通讯作者：
通讯机构：[1]Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China[*1]Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing 100191, China
推荐引用方式(GB/T 7714)：
Lai Wei,Jia Shang,Yuanji Ma,et al.Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C[J].JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY.2019,7(3):221-225.doi:10.14218/JCTH.2019.00018.
APA：
Lai Wei,Jia Shang,Yuanji Ma,Xiaoyuan Xu,Yan Huang...&Jinzi J. Wu.(2019).Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C.JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY,7,(3)
MLA：
Lai Wei,et al."Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C".JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY 7..3(2019):221-225
