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全口服直接抗病毒药物治疗丙型肝炎病毒与人类免疫缺陷病毒合并感染患者的耐受性良好且治疗反应高效。

Well tolerability and highly effective treatment response for hepatitis C virus-human immunodeficiency virus-coinfected patients treated by all-oral direct-acting antivirals.

作者信息

Su Pin-Shuo, Su Chien-Wei, Wu Sih-Hsien, Wei Tien-Hsin, Chu Chi-Jen, Lin Chung-Chi, Lee Shou-Dong, Wang Yuan-Jen, Lee Fa-Yauh, Huang Yi-Hsiang, Hou Ming-Chih

机构信息

Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.

Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.

出版信息

J Chin Med Assoc. 2021 May 1;84(5):465-471. doi: 10.1097/JCMA.0000000000000528.

Abstract

BACKGROUND

Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection is common because the two pathogens share their transmission route. Studies have suggested that coinfection is associated with accelerated hepatic fibrosis, increased hepatic decompensation, and hepatocellular carcinoma development. Historically, the sustained virological response (SVR) rates for patients undergoing pegylated interferon (PEG-IFN)-based therapy are poor owing to advanced liver disease, immune dysfunction, and poor medical adherence. This study aimed to investigate the efficacy and safety of oral direct-acting antivirals (DAAs) in HCV-HIV-coinfected patients.

METHODS

Between January 2017 and February 2020, 52 consecutive HCV-HIV-coinfected patients treated with oral DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir: 7; daclatasvir and asunaprevir: 1; glecaprevir and pibrentasvir: 15; and sofosbuvir-based drugs: 29) were enrolled. The DAA regimen was selected based on the genotype/subtypes, patient characteristics, potential drug-drug interaction profiles, and health insurance reimbursement criteria. SVR12 was defined as undetectable HCV RNA (<15 IU/mL) at the end of therapy and 12 weeks after therapy completion.

RESULTS

The mean age of the enrolled patients was 42 ± 10.2 years; 92.3% of the patients were male and 32.7% had advanced fibrosis or cirrhosis. Nine (17.3%) patients had failed previous IFN therapy. The genotype distribution was as follows: 1a: 8; 1b: 23; 2: 14; 3: 1; and 6: 6. The baseline HCV RNA level before DAA administration was 6.56 ± 0.9 log10 IU/mL, and 67.3% of patients had baseline HCV RNA >2 000 000 IU/mL. After posttreatment follow-up, all 52 patients (100%) achieved SVR12. Subjective and laboratory adverse events during therapy were generally mild, and none of the patients terminated therapy early.

CONCLUSION

A highly effective treatment response and good tolerability were achieved using the oral DAAs for the HCV-HIV-coinfected patient population, which has been considered difficult to treat using IFN-based therapy in the past with urgent unmet medical needs.

摘要

背景

丙型肝炎病毒(HCV)与人类免疫缺陷病毒(HIV)合并感染很常见,因为这两种病原体有着共同的传播途径。研究表明,合并感染与肝纤维化加速、肝失代偿增加以及肝细胞癌的发生有关。从历史上看,由于肝病晚期、免疫功能障碍以及较差的药物依从性,接受聚乙二醇干扰素(PEG-IFN)治疗的患者的持续病毒学应答(SVR)率较低。本研究旨在调查口服直接抗病毒药物(DAA)对HCV-HIV合并感染患者的疗效和安全性。

方法

在2017年1月至2月期间,连续纳入了52例接受口服DAA治疗的HCV-HIV合并感染患者(帕利瑞韦/利托那韦、奥比他韦和达沙布韦:7例;达拉他韦和阿舒瑞韦:1例;格卡瑞韦和哌柏西利:15例;基于索磷布韦的药物:29例)。根据基因型/亚型、患者特征、潜在的药物相互作用情况以及医疗保险报销标准选择DAA治疗方案。SVR12定义为治疗结束时以及治疗完成后12周时检测不到HCV RNA(<15 IU/mL)。

结果

纳入患者的平均年龄为42±10.2岁;92.3%的患者为男性,32.7%的患者有晚期纤维化或肝硬化。9例(17.3%)患者既往干扰素治疗失败。基因型分布如下:1a型:8例;1b型:23例;2型:14例;3型:1例;6型:6例。给予DAA治疗前的基线HCV RNA水平为6.56±0.9 log10 IU/mL,67.3%的患者基线HCV RNA>2 000 000 IU/mL。治疗后随访发现,所有52例患者(100%)均实现了SVR12。治疗期间的主观和实验室不良事件一般较轻,没有患者提前终止治疗。

结论

对于HCV-HIV合并感染患者群体,口服DAA治疗取得了高效的治疗应答和良好的耐受性,而该群体在过去被认为使用基于干扰素的治疗难以治疗,存在迫切未满足的医疗需求。

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