*Hôpital Beaujon, Boulevard du Général Leclerc, Clichy, France †Instituto Di Clinica Medica Policlinico, Palermo ∥Department of Clinical Medicine, University of Bologna, Bologna, BO, Italy ‡Internal Medicine Department, Hepatology Division, Gaffrèe e Güinle University Hospital, College of Medicine & Surgery, University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil §Department of Internal Medicine, Saint Louis University School of Medicine, St Louis ¶Kansas City Gastroenterology and Hepatology, LLC, Kansas City, MO #Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA **Hospital La Paz de Madrid, Madrid, Spain ††Interdisziplinäres Facharztzentrum Sachsenhausen, MVZ-Sachsenhausen, Frankfurt ‡‡IST GmbH, Mannheim, Germany §§Roche Products Ltd, Welwyn, UK ∥∥F. Hoffmann-La Roche Ltd, Basel, Switzerland ¶¶Center for Liver Diseases, University of Chicago Hospitals, Chicago, IL.
J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.
To evaluate the predictive value of complete early virological response (cEVR) on sustained virological response (SVR) following retreatment with peginterferon alpha-2a (40 kDa) plus ribavirin in previous nonresponders to peginterferon alpha-2b (12 kDa).
In the randomized multinational retreatment with Pegasys in patients not responding to PegIntron therapy study, a 72-week regimen of peginterferon alpha-2a (40 kDa) plus ribavirin improved SVR rates over a standard 48-week regimen in previous nonresponders to peginterferon alpha-2b (12 kDa). cEVR, defined as hepatitis C virus RNA <50 IU/mL at treatment week 12, was an important predictor of SVR.
We conducted an exploratory analysis of the retreatment with Pegasys in patients not responding to PegIntron therapy study data to better define the predictive value of cEVR for SVR in this patient population.
In total, 157 of the 942 patients achieved a cEVR (16.7%). SVR rates were higher with 72 versus 48 weeks of retreatment in patients with a cEVR (57% vs. 35%), whereas SVR rates were <5% in patients without cEVR in both groups. The relative adverse event (AE) burden was lower with 72 weeks of treatment (8.1 vs. 10.1 AEs/y of treatment) as was the estimated number of AEs per SVR achieved (55 vs. 100). Cumulative treatment duration required to achieve 1 SVR was lower with 72 weeks of treatment (6.7 vs. 10.0 y/SVR) and lower still assuming that treatment was stopped at week 12 for non-cEVR patients (3.6 vs. 7.1 y/SVR).
cEVR is a reliable predictor of SVR in patients retreated with peginterferon alpha-2a (40 kDa) plus ribavirin. Seventy-two-week retreatment has a more favorable benefit-risk ratio than 48 weeks, especially when cEVR is used to identify patients most likely to be cured.
评估完全早期病毒学应答（cEVR）对既往对聚乙二醇干扰素α-2b（12 kDa）无应答的患者再次使用聚乙二醇干扰素α-2a（40 kDa）加利巴韦林治疗后的持续病毒学应答（SVR）的预测价值。
在 Pegasys 治疗复发患者的随机多中心研究中，与标准的 48 周治疗方案相比，聚乙二醇干扰素α-2a（40 kDa）加利巴韦林的 72 周治疗方案提高了既往对聚乙二醇干扰素α-2b（12 kDa）无应答患者的 SVR 率。cEVR 定义为治疗第 12 周时丙型肝炎病毒 RNA <50 IU/ml，是 SVR 的重要预测指标。
我们对 Pegasys 治疗复发患者的 PegIntron 治疗研究数据进行了探索性分析，以更好地确定 cEVR 在该患者人群中对 SVR 的预测价值。
在 942 例患者中，共有 157 例达到 cEVR（16.7%）。在有 cEVR 的患者中，72 周与 48 周的再治疗相比，SVR 率更高（57%比 35%），而在两组均无 cEVR 的患者中，SVR 率<5%。72 周治疗的相对不良事件（AE）负担较低（8.1 比 10.1 AE/y 的治疗），每获得 1 例 SVR 的估计 AE 数也较低（55 比 100）。72 周治疗获得 1 例 SVR 所需的累积治疗时间较低（6.7 比 10.0 y/SVR），并且假设对于无 cEVR 的患者在第 12 周停止治疗，则所需的时间更低（3.6 比 7.1 y/SVR）。
cEVR 是使用聚乙二醇干扰素α-2a（40 kDa）加利巴韦林再次治疗的患者 SVR 的可靠预测指标。72 周的再治疗比 48 周具有更有利的利弊比，特别是当使用 cEVR 来识别最有可能治愈的患者时。
