新型直接作用抗病毒药物（DAA）治疗慢性 HCV 感染：巴西南部真实世界经验的首次报告。

Treatment of Chronic HCV Infection with the New Direct Acting Antivirals (DAA): First Report of a Real World Experience in Southern Brazil.

机构信息

Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil Hospital de Clínicas de Porto Alegre e Programa de Pós-Graduação em Gastroenterologia e Hepatologia.

Pró-Fígado, São Paulo, São Paulo, Brazil.

出版信息

Ann Hepatol. 2017 Sep-Oct;16(5):727-733. doi: 10.5604/01.3001.0010.2717.

DOI:10.5604/01.3001.0010.2717

PMID:28809742

Abstract

INTRODUCTION AND AIM

There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil.

MATERIALS AND METHODS

Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis.

RESULTS

219 patients were analyzed. Mean age was 57.4 ± 10.9 years and 142/219 (64.8%) were male. Genotype 1 was present in 166 patients (75.8%; 1a 29.2%, 1b 46.6%); Genotypes 2, 3 and 4 in 8 (3.7%), 43 (19.6%) and 2 (0.9%), respectively. 96 (43.8%) were cirrhotic. 134 (59.5%) were treatment experienced. DAA therapies were: sofosbuvir (SOF) + ribavirin (RBV) in 10 patients; SOF + simeprevir (SMV) ± RBV in 73; SOF + pegylated interferon (PEG-IFN) + RBV in 6; SOF + daclatasvir (DCV) ± RBV in 51, SOF + ledipasvir (LDV) ± RBV in 61, and paritaprevir/ ritonavir + ombitasvir + dasabuvir (PTVr/OBV/DSV) ± RBV in 18 patients. SVR-12 was achieved in 208/219 (95%). Ten patients had virologic failure: 6 cirrhotic, 7 treatment experienced, and 6 either genotype 3 or 1a. No adverse event was attributed to the DAA therapy.

CONCLUSIONS

Real world experience with DAA therapy in Southern Brazil showed a high rate of SVR and excellent tolerability. Failure to achieve SVR was mainly observed among patients with at least one negative predictor of response: cirrhosis and/or genotypes 1a or 3.

摘要

简介和目的

关于直接作用抗病毒药物（DAAs）治疗在巴西的疗效，几乎没有数据。本历史队列研究的目的是描述南里奥格兰德州三个肝病中心的代偿性慢性丙型肝炎患者的持续病毒学应答（SVR）率。

材料和方法

如果患者在治疗结束后至少有 12 周的随访，则将其纳入研究。在本意向治疗分析中，失访或因任何原因提前中断治疗的患者被视为治疗失败。

结果

共分析了 219 例患者。平均年龄为 57.4±10.9 岁，142/219（64.8%）为男性。166 例患者存在基因型 1（75.8%；1a 29.2%，1b 46.6%）；8 例（3.7%）、43 例（19.6%）和 2 例（0.9%）分别存在基因型 2、3 和 4。96 例（43.8%）为肝硬化。134 例（59.5%）为治疗经验丰富的患者。DAA 治疗方案包括：10 例患者接受索非布韦（SOF）+利巴韦林（RBV）治疗；73 例患者接受 SOF+西美瑞韦（SMV）±RBV 治疗；6 例患者接受 SOF+聚乙二醇干扰素（PEG-IFN）+RBV 治疗；51 例患者接受 SOF+达卡他韦（DCV）±RBV 治疗，61 例患者接受 SOF+雷迪帕韦（LDV）±RBV 治疗，18 例患者接受帕立瑞韦/利托那韦+奥比他韦+达沙布韦（PTVr/OBV/DSV）±RBV 治疗。219 例患者中 208 例（95%）获得 SVR-12。10 例患者发生病毒学失败：6 例为肝硬化，7 例为治疗经验丰富，6 例为基因型 3 或 1a。没有不良事件归因于 DAA 治疗。