中国慢性丙型肝炎基因型1b感染患者的直接抗病毒药物-真实世界的经验

中华传染病杂志 Pub Date : 2018-10-15 DOI:10.3760/CMA.J.ISSN.1000-6680.2018.10.006

D. Ji, Yandong Yang, Q. Shao, Zhongbin Li, Jiajie Liao

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引用次数: 0

摘要

目的评价直接作用抗病毒药物(DAA)治疗中国慢性丙型肝炎(CHC)基因型(GT) 1b HCV感染患者的有效性和安全性。方法选取2014年7月至2016年12月在中国302部队医院连续接受索非布韦(SOF) + daclatasvir (DCV)治疗的GT1b型CHC中国患者(n=62)或SOF + ledipasvir (LDV)治疗的患者(n=171)。所有患者治疗时间均为12周。在治疗结束(EOT)后4周至12周测量所有临床参数。比较两组患者的基线临床特征、治疗疗效、安全性和耐受性。采用COBAS TaqMan法检测血清HCV RNA浓度，最低检出限为15 IU/mL，采用FibroScan®检测肝脏硬度。持续病毒学应答(SVR)定义为EOT后12周低于定量下限的HCV RNA (SVR12)。组间比较酌情采用学生t检验、pearson χ2检验、Spearman秩相关分析和Fisher精确检验。结果233例患者中，173例HCV RNA基线水平≥6.0 lg IU/mL, 97例肝硬度测量值(LSM)≥17.5 kPa。两组患者的基线肝炎症、肝纤维化、HCV RNA载量无显著差异(均P < 0.05)。在12周治疗结束时，所有233例患者的HCV RNA均未检测到，而2例患者在EOT 12周后复发，总SVR12为99.1%。低LSM患者的HCV RNA下降明显快于高LSM患者(ρ=0.233, P=0.001)，低LSM患者的SVR12较高。SOF+ DCV组和SOF+ LVD组其他临床特征方面，丙氨酸转氨酶分别从(68.0±60.1)和(70.1±56.1)U/L降至(21.1±10.9)U/L和(15.3±9.5)U/L，总胆红素分别从(21.3±17.3)和(18.2±14.0)μmol/L降至(13.2±6.7)和(10.2±4.6)μmol/L，甲胎蛋白分别从19.6(10.6、62.3)和15.0(12.0、25.0)μmol/L降至6.5(4.5、18.7)和7.8(5.3、15.4)μmol/L, LSM分别从17.6(8.9、25.4)和15.7 (7.8)μmol/L, LSM分别从17.6(8.9、25.4)和15.7 (15.8)μmol/L，分别从23.9 kPa升高到13.9(6.5,21.4)和9.1(5.6,19.9)kPa，血清album分别从(37.5±5.8)和(38.7±5.5)g/L升高到(41.3±4.7)和(42.8±5.1)g/L，血小板分别从(120.9±78.2)×109/L和(136.6±65.8)×109/L升高到(139.5±71.8)×109/L和(149.7±71.4)×109/L。两组的不良事件报告均较低。结论对于中国CHC GT1b患者，sofv + DCV和sofv /LDV治疗均可达到高达98%的SVR12，显著降低LSM值，且安全性好。关键词:丙型肝炎;慢性;治疗;直接作用抗病毒药物

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Direct acting antiviral agent for Chinese patients with chronic hepatitis C genotype 1b infection——a real world experience

Objective To evaluate the effectiveness and safety of direct-acting antiviral agents (DAA) treatment in Chinese chronic hepatitis C (CHC) patients with genotype (GT) 1b HCV infection in a real world setting. Methods The consecutive GT1b CHC Chinese patients treated with sofosbuvir (SOF) plus daclatasvir (DCV) (n=62) or SOF plus ledipasvir (LDV) (n=171) were enrolled from July 2014 to December 2016 at 302 Military Hospital of China. The treatment duration for all the patients was 12 weeks. All the clinical parameters were measured at baseline and then 4-weekly till 12 weeks after the end-of-treatment (EOT). Baseline clinical characteristics, treatment efficacy, safety and tolerance were compared. Serum HCV RNA concentration was detected by means of COBAS TaqMan assay with a lower detection limit of 15 IU/mL, and liver stiffness was measured using FibroScan®. Sustained virologic response (SVR) was defined as HCV RNA under the lower limit of quantification 12 weeks after EOT (SVR12). Students′ t-test, pearson χ2 test, Spearman rank correlation analysis and Fisher exact test were used for comparison between groups when appropriate. Results Among 233 patients, 173 cases had baseline HCV RNA level ≥6.0 lg IU/mL and 97 cases hade liver stiffness measurement (LSM)≥17.5 kPa. The baseline liver inflamation, liver fibrosis, and HCV RNA load of patients in the two groups were not significantly different (all P>0.05). The HCV RNA of all the 233 patients was undetectable at the end of 12-week treatment, while 2 patients relapsed after 12 weeks of EOT with the overall SVR12 of 99.1%. HCV RNA decline was significantly faster in patients with lower LSM than those with higher LSM (ρ=0.233, P=0.001), and SVR12 was higher in those with lower LSM. In terms of other clinical characteristics of SOF+ DCV and SOF+ LVD groups, alanine transaminase declined from (68.0±60.1) and (70.1±56.1) U/L to (21.1±10.9) U/L and (15.3±9.5) U/L, respectively, total bilirubin declined from (21.3±17.3) and (18.2±14.0) μmol/L to (13.2±6.7) and (10.2±4.6) μmol/L, respectively, AFP declined from 19.6 (10.6, 62.3) and 15.0 (12.0, 25.0) μg/L to 6.5(4.5, 18.7) and 7.8(5.3, 15.4) μg/L, respectively, LSM declined from 17.6 (8.9, 25.4) and 15.7 (7.8, 23.9) kPa to 13.9(6.5, 21.4) and 9.1(5.6, 19.9) kPa, respectively, serum album elevated form (37.5±5.8) and (38.7±5.5) g/L to (41.3±4.7) and (42.8±5.1) g/L, respectively, platelet elevated from (120.9±78.2) ×109/L and (136.6±65.8)×109/L to (139.5±71.8)×109/L and (149.7±71.4)×109/L, respectively. Reports of adverse events were low in both groups. Conclusions Both SOF+ DCV and SOF/LDV therapy are highly effective with >98% of SVR12 and reduce LSM value significantly with good safety for CHC GT1b Chinese patients. Key words: Hepatitis C, chronic; Treatment; Direct-acting antiviral agents

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中华传染病杂志

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期刊介绍： The Chinese Journal of Infectious Diseases was founded in February 1983. It is an academic journal on infectious diseases supervised by the China Association for Science and Technology, sponsored by the Chinese Medical Association, and hosted by the Shanghai Medical Association. The journal targets infectious disease physicians as its main readers, taking into account physicians of other interdisciplinary disciplines, and timely reports on leading scientific research results and clinical diagnosis and treatment experience in the field of infectious diseases, as well as basic theoretical research that has a guiding role in the clinical practice of infectious diseases and is closely integrated with the actual clinical practice of infectious diseases. Columns include reviews (including editor-in-chief reviews), expert lectures, consensus and guidelines (including interpretations), monographs, short monographs, academic debates, epidemic news, international dynamics, case reports, reviews, lectures, meeting minutes, etc.