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慢性丙型肝炎病毒基因型 3 患者伴有晚期肝纤维化的高持续病毒学应答:格鲁吉亚丙型肝炎消除计划的真实世界数据。

High sustained viral response among HCV genotype 3 patients with advanced liver fibrosis: real-world data of HCV elimination program in Georgia.

机构信息

Clinic NEOLAB, 47 Tashkenti Street, Tbilisi, 0160, Georgia.

CDC Foundation, 9 Asatiani Street, Tbilisi, 0177, Georgia.

出版信息

BMC Res Notes. 2020 Jul 11;13(1):332. doi: 10.1186/s13104-020-05173-4.

Abstract

OBJECTIVE

In 2015, Georgia launched HCV elimination program. Initially, patients with advanced liver disease were treated with sofosbuvir-based regimen-the only DAA available for all genotypes. Purpose of the study was assessing real-world data of treatment outcome among patients with HCV GEN3 and advanced liver fibrosis with sofosbuvir-based regimens.

RESULTS

Totally 1525 genotype 3 patients were eligible for analysis; most (72.6%) were aged > 45 years, majority were males (95.1%), and all (100%) had advanced liver disease (F3 or F4 by METAVIR score based on elastography). Of those who received sofosbuvir/ribavirin (SOF/RBV) for 24 weeks, 79.3% achieved SVR, while 96.5% who received sofosbuvir/pegylated interferon/ribavirin (SOF/PEG/RBV) for 12 weeks achieved SVR (p < 0.01). Among patients with liver cirrhosis (defined as F4) overall cure rate was 85.7% as opposed to 96.4% for those with F3. Females were more likely to be cured (98.7% vs 89.7%; OR = 8.54). Patients aged 31-45 years had higher likelihood of achieving SVR compared to patients aged 46-60 years (95.7% vs 87.4%; OR = 0.32,). Independent predictors of SVR were treatment with SOF/PEG/RBV (aOR = 6.72) and lower fibrosis stage (F3) (aOR = 4.18). Real-world experience among HCV GEN3 patients with advanced liver fibrosis and treated by sofosbuvir regimen w/o PEGIFN, demonstrated overall high SVR rate.

摘要

目的

2015 年,格鲁吉亚启动 HCV 消除计划。最初,所有基因型的患者均采用索非布韦为基础的方案治疗晚期肝病。本研究旨在评估 HCV GEN3 和晚期纤维化患者采用索非布韦为基础的方案治疗的真实世界数据。

结果

共 1525 例 3 型患者符合分析条件;大多数(72.6%)年龄>45 岁,大多数为男性(95.1%),所有患者(100%)均患有晚期肝病(基于弹性成像的 METAVIR 评分 F3 或 F4)。接受索非布韦/利巴韦林(SOF/RBV)24 周治疗的患者中,79.3%实现 SVR,而接受索非布韦/聚乙二醇干扰素/利巴韦林(SOF/PEG/RBV)12 周治疗的患者中,96.5%实现 SVR(p<0.01)。在肝硬化(定义为 F4)患者中,总体治愈率为 85.7%,而 F3 患者的治愈率为 96.4%。女性更有可能治愈(98.7%比 89.7%;OR=8.54)。与 46-60 岁患者相比,31-45 岁患者实现 SVR 的可能性更高(95.7%比 87.4%;OR=0.32)。SVR 的独立预测因素是采用 SOF/PEG/RBV 治疗(aOR=6.72)和较低的纤维化分期(F3)(aOR=4.18)。无 PEGIFN 的索非布韦方案治疗 HCV GEN3 患者的真实世界经验表明,总体 SVR 率较高。

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