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在NS5A抑制剂供应有限地区,索磷布韦-利巴韦林与索磷布韦-达卡他韦治疗慢性丙型肝炎的疗效比较

Comparative efficacy of sofosbuvir-ribavirin versus sofosbuvir-daclatasvir for treatment of chronic hepatitis C in an area with limited NS5A inhibitor availability.

作者信息

Kurniawan Juferdy, Gani Rino Alvani, Hasan Irsan, Sulaiman Andri Sanityoso, Lesmana Cosmas Rinaldi A, Jasirwan Chynthia Olivia Maurine, Kalista Kemal Fariz, Nababan Saut Horas Hatoguan, Zulkifly Steven

机构信息

Hepatobiliary Division, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo National General Hospital, Jalan Diponegoro Number 71, Central Jakarta, Jakarta, 10430, Indonesia.

出版信息

Indian J Gastroenterol. 2018 Nov;37(6):520-525. doi: 10.1007/s12664-018-0921-2. Epub 2019 Jan 12.

Abstract

INTRODUCTION

Sofosbuvir (SOF) and daclatasvir (DCV) regimens are recommended for all genotypes of hepatitis C virus (HCV) infection. However, DCV accessibility is still low in several low- and middle-income countries. Ribavirin (RBV) is more affordable and has been known for chronic HCV treatment along with SOF or interferon. The aim of this study was to assess the efficacy of SOF + RBV and SOF + DCV regimens for treatment of chronic HCV in Indonesia.

METHODS

We conducted a retrospective study among patients with chronic HCV who were treated with SOF. Data on SOV + RBV were collected from 2015 to 2016, while those on SOF + DCV were collected from 2016 to 2017. The baseline characteristics were recorded from the medical record unit in Cipto Mangunkusumo General Hospital, Jakarta, Indonesia. The primary outcome was the achievement of sustained virological response at 12 weeks (SVR12).

RESULTS

Of 309 patients, 64.4% (199/309) had genotype 1 infections, 29.8% (92/309) had cirrhosis, and 4.9% (15/309) had co-infection with human immunodeficiency virus (HIV). At the end of treatment (EOT), 99.3% (136/137) patients in the SOF + RBV group and 99.4% (164/165) in SOF + DCV group had no detectable viral load. The criterion for SVR12 was met in 90.8% (109/120) patients in SOF + RBV regimen and 98.2% (108/110) in SOF + DCV regimen. Among patients with cirrhosis, 84.4% (38/45) patients and 100% (27/27) achieved SVR12 in the SOF + RBV and SOF + DCV groups, respectively.

CONCLUSION

SOF + DCV regimen had higher SVR rates compared to SOF + RBV regimen (p = 0.034). However, both the regimens showed an impressive outcome, with overall SVR12 rates above 90%, irrespective of presence of cirrhosis and HCV genotype. In non-structural protein 5A inhibitor limited setting, SOF + RBV regimen still can be used as treatment for HCV infection, particularly in non-cirrhotic patients.

摘要

引言

索磷布韦(SOF)和达卡他韦(DCV)联合治疗方案被推荐用于所有基因型丙型肝炎病毒(HCV)感染。然而,在一些低收入和中等收入国家,达卡他韦的可及性仍然较低。利巴韦林(RBV)价格更为亲民,并且与索磷布韦或干扰素联合用于慢性HCV治疗已为人所知。本研究的目的是评估索磷布韦+利巴韦林和索磷布韦+达卡他韦联合治疗方案在印度尼西亚治疗慢性HCV的疗效。

方法

我们对接受索磷布韦治疗的慢性HCV患者进行了一项回顾性研究。索磷布韦+利巴韦林的数据收集于2015年至2016年,而索磷布韦+达卡他韦的数据收集于2016年至2017年。基线特征从印度尼西亚雅加达西托·曼古库苏莫综合医院的病历科室记录。主要结局是12周时达到持续病毒学应答(SVR12)。

结果

在309例患者中,64.4%(199/309)为1型感染,29.8%(92/309)有肝硬化,4.9%(15/309)合并人类免疫缺陷病毒(HIV)感染。在治疗结束时(EOT),索磷布韦+利巴韦林组99.3%(136/137)的患者和索磷布韦+达卡他韦组99.4%(164/165)的患者病毒载量不可检测。索磷布韦+利巴韦林治疗方案90.8%(109/120)的患者和索磷布韦+达卡他韦治疗方案98.2%(108/110)的患者达到SVR12标准。在肝硬化患者中,索磷布韦+利巴韦林组和索磷布韦+达卡他韦组分别有84.4%(38/45)和100%(27/27)的患者实现SVR12。

结论

与索磷布韦+利巴韦林治疗方案相比,索磷布韦+达卡他韦治疗方案的SVR率更高(p = 0.034)。然而,两种治疗方案均显示出令人印象深刻的结果,总体SVR12率均高于90%,无论是否存在肝硬化和HCV基因型。在非结构蛋白5A抑制剂受限的情况下,索磷布韦+利巴韦林治疗方案仍可用于HCV感染的治疗,特别是在非肝硬化患者中。

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