Ferenci Peter, Aires Rodrigo, Ancuta Ioan, Arohnson Andrew, Cheinquer Hugo, Delic Dragan, Gschwantler Michael, Larrey Dominique, Tallarico Ludovico, Schmitz Manuela, Tatsch Fernando, Ouzan Denis
Medical University of Vienna, Vienna, Austria.
Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.
BACKGROUND & AIMS: Pretreatment identification of patients likely to achieve a sustained virological response (SVR) with peginterferon alfa-2a/ribavirin would be useful for individualizing treatment choices. The aim of this analysis was to devise a simple scoring system to identify patients with high probability of achieving an SVR with peginterferon alfa-2a/ribavirin.
Using data from 2109 Caucasian treatment-naive hepatitis C virus (HCV) genotype 1 mono-infected patients from the PROPHESYS cohorts, the relationship between favourable baseline characteristics and SVR was explored using generalized additive model analysis, and a scoring system was devised to predict SVR.
Points were assigned for: age (years) (≤35: 2; >35, ≤45: 1; >45: 0); body mass index (kg/m(2)) (≤20: 2; >20, ≤22: 1; >22: 0); HCV RNA (IU/ml) (≤100,000: 3; >100,000-400,000: 2; >400,000-800,000: 1; >800,000: 0); platelets (>150 ×10(9)/l: 1; ≤150 ×10(9)/l: 0); alanine aminotransferase [×upper limit of normal (ULN)] (>3: 1; ≤3: 0); serum aspartate aminotransferase (×ULN) (≤1: 1; >1: 0). 1029, 698 and 382 patients had scores of 0-2, 3-4 and ≥5, respectively, among whom SVR rates were 35.0, 54.9 and 76.7%. SVR in patients with scores ≥5 and undetectable HCV RNA by week 4 was 86.7%. The score was tested against two databases of patients who received peginterferon alfa-2a/ribavirin in other clinical trials; similar high SVR rates in patients with scores ≥5 were reported.
The scoring system can reliably identify treatment-naive HCV genotype 1 mono-infected Caucasian patients who have a high probability of achieving an SVR with peginterferon alfa-2a/ribavirin and will be particularly useful where protease inhibitors are not readily available.
治疗前识别出可能通过聚乙二醇化干扰素α-2a/利巴韦林实现持续病毒学应答（SVR）的患者，将有助于个体化治疗选择。本分析的目的是设计一种简单的评分系统，以识别使用聚乙二醇化干扰素α-2a/利巴韦林实现SVR可能性高的患者。
利用来自PROPHESYS队列中2109例初治的白种人丙型肝炎病毒（HCV）基因1型单感染患者的数据，采用广义相加模型分析探讨有利的基线特征与SVR之间的关系，并设计一种评分系统来预测SVR。
根据以下因素计分：年龄（岁）（≤35：2分；>35且≤45：1分；>45：0分）；体重指数（kg/m²）（≤20：2分；>20且≤22：1分；>22：0分）；HCV RNA（IU/ml）（≤100,000：3分；>100,000至400,000：2分；>400,000至800,000：1分；>800,000：0分）；血小板（>150×10⁹/l：1分；≤150×10⁹/l：0分）；丙氨酸氨基转移酶[×正常上限（ULN）]（>3：1分；≤3：0分）；血清天冬氨酸氨基转移酶（×ULN）（≤1：1分；>1：0分）。分别有1029、698和382例患者的得分是0 - 2分、3 - 4分和≥5分，其中SVR率分别为35.0%、54.9%和76.7%。得分≥5且在第4周时HCV RNA检测不到的患者中SVR率为86.7%。该评分系统在其他临床试验中接受聚乙二醇化干扰素α-2a/利巴韦林治疗的两个患者数据库中进行了验证；报告显示得分≥5的患者中SVR率同样很高。
该评分系统能够可靠地识别初治的HCV基因1型单感染白种人患者，这些患者使用聚乙二醇化干扰素α-2a/利巴韦林实现SVR的可能性很高，在蛋白酶抑制剂不易获得的情况下将特别有用。
