格卡瑞韦/哌仑他韦治疗基因1b型慢性丙型肝炎患者疗效及安全性分析*

doi:10.3969/j.issn.1672-5069.2022.03.014

摘要/Abstract

摘要： 目的探讨应用格卡瑞韦/哌仑他韦治疗基因1b型慢性丙型肝炎(CHC)患者疗效及安全性。方法 2019年7月～2020年8月周口市中心医院收治的基因1b型CHC患者138例,采用随机数字表法将患者分为DAA组69例,给予格卡瑞韦/哌仑他韦治疗,和PR组69例,给予聚乙二醇干扰素-α2b注射剂联合利巴韦林治疗,两组均治疗12 w,随访12 w。常规检测血清天冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、HCV RNA及白细胞(WBC)和血小板(PLT)计数。结果在治疗结束时,DAA治疗组血清AST和ALT水平分别为(35.2±6.2)U/L和(30.7±5.4)U/L,均显著低于PR治疗组【分别为(48.4±6.9)U/L和(45.4±6.1)U/L,均P＜0.05】;DAA治疗组快速病毒学应答率、治疗结束病毒学应答率和持续病毒学应答率分别为78.3%、95.7%和95.7%,均显著高于PR治疗组的65.2%、76.8%和76.8%(均P＜0.05);在治疗过程中,PR治疗组外周血白细胞计数和血小板计数分别为(3.4±1.4)×10⁹/L和(110.7±30.8)×10⁹/L,均显著低于DAA治疗组【分别为(6.3±1.3)×10⁹/L和(208.3±30.2)×10⁹/L,P<0.05】;在治疗期间,DAA组不良反应发生率为5.8%,显著低于PR组的84.1%(P<0.001)。结论应用格卡瑞韦/哌仑他韦治疗基因1b型CHC患者病毒学应答率高,疗效好,而不良反应小,值得进一步临床观察。

关键词: 慢性丙型肝炎, 基因1b型, 直接抗病毒药物, 格卡瑞韦/哌仑他韦, 治疗

Abstract: Objective The aim of this study was to investigate the efficacy and safety of glecaprevir/pibrentasvir therapy in the treatment of patients with chronic hepatitis C (CHC) and genotype 1b infection. Methods A total of 138 patients with CHC and genotype 1b infection were admitted to the our hospital between July 2019 and August 2020, and were randomly divided into DAA-treated group, receiving glecaprevir/pibrentasvir treatment in 69 cases, and PR-treated group, receiving pegylated interferon alpha-2b and ribavirin combination treatment in another 69 cases. The regimen lasted for 12 weeks in both groups. The biochemical, hematology and virologic parameters were routinely detected. Results At the end of the treatment, serum aspartate aminotransferase and alanine aminotransferase levels in DAA-treated patients were (35.2±6.2)U/L and (30.7±5.4)U/L, both significantly lower than [(48.4±6.9)U/L and (45.4±6.1)U/L, respectively, P＜0.05] in PR-treated patients; the rapid virologic response, virologic response at end of treatment and sustained virologic response in DAA-treated patients were 78.3%, 95.7% and 95.7%, all significantly higher than 65.2%, 76.8% and 76.8%(P＜0.05) in PR-treated patients; during the treatment, the white blood cell counts and platelet counts in PR-treated patients were (3.4±1.4)×10⁹/L and (110.7±30.8)×10⁹/L, both significantly lower than [(6.3±1.3)×10⁹/L and (208.3±30.2)×10⁹/L, P<0.05] in DAA-treated patients; the incidence of untoward effects in patients receiving DAA treatment was 5.8%, very significantly lower than 84.1%(P<0.001) in patients receiving PR treatment. Conclusion The administration of glecaprevir/pibrentasvir in treating patients with genotype 1b-infected CHC is efficacious and safe with promising virologic response and low side effects, which warrants further clinical investigation.

Key words: Hepatitis C, Genotype 1b, Direct antiviral agents, Glecaprevir/pibrentasvir, Therapy

胡春霞, 杨娇楠, 张丰晓, 胡敬华. 格卡瑞韦/哌仑他韦治疗基因1b型慢性丙型肝炎患者疗效及安全性分析^*[J]. 实用肝脏病杂志, 2022, 25(3): 359-362.

Hu Chunxia, Yang Jiaonan, Zhang Fengxiao et al. Efficacy and safety of glecaprevir/pibrentasvir therapy in the treatment of patients with chronic hepatitis C and genotype 1b infection[J]. Journal of Practical Hepatology, 2022, 25(3): 359-362.

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格卡瑞韦/哌仑他韦治疗基因1b型慢性丙型肝炎患者疗效及安全性分析^*

Efficacy and safety of glecaprevir/pibrentasvir therapy in the treatment of patients with chronic hepatitis C and genotype 1b infection

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