Mangia Alessandra, Minerva Nicola, Bacca Donato, Cozzolongo Raffaele, Agostinacchio Ernesto, Sogari Fernando, Scotto Gaetano, Vinelli Francesco, Ricci Giovanni Luciano, Romano Mario, Carretta Vito, Petruzzellis Daniela, Andriulli Angelo
Liver Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni, Rotondo, Italy.
Hepatology. 2009 Feb;49(2):358-63. doi: 10.1002/hep.22679.
In hepatitis C virus (HCV) genotypes 2 and 3 patients, the high rate of relapse after 12 to 16 weeks of antiviral therapy is the main concern for shortening treatment duration. This study was undertaken to delineate predictors of relapse after short treatment in patients with undetectable HCV RNA at treatment week 4 (RVR), and to report in RVR patients with relapse the sustained virological response (SVR) after a second 24-week course of therapy. RVR patients received pegylated interferon (Peg-IFN) alfa-2b (1.5 microg/kg) and ribavirin (1000-1200 mg/day) for 12 weeks; those who relapsed were re-treated with the same drug doses but for the extended standard duration of 24 weeks. Logistic regression analysis was applied to delineate predictors of relapse by using age, sex, route of transmission, body mass index (BMI), serum alanine aminotransferase (ALT), HCV genotypes, serum HCV RNA levels, and platelet counts as covariates. Of 718 patients with genotypes 2 and 3 who were started on therapy, 496 (69.1%) had undetectable HCV RNA at week 4. Of them, 409 patients (82.5%, CI 79.1-85.8) attained SVR, and 67 (14.1%, CI 10.4-16.5) relapsed. At regression analysis, only platelet count less than 140,000 mm(3) [odds ratio, 2.51; confidence interval (CI), 1.49-4.20] and BMI 30 or higher (odds ratio, 1.7; CI, 1.03-2.70) were independently associated with relapse. Forty-three of 67 patients with relapse agreed to be re-treated, and an SVR was achieved in 30 (70.0%) of them.
We recommend 12 weeks course of therapy for patients with undetectable HCV RNA at treatment week 4, providing they present with no advanced fibrosis and low BMI.
在丙型肝炎病毒(HCV)2型和3型患者中,抗病毒治疗12至16周后复发率较高是缩短治疗疗程的主要关注点。本研究旨在明确治疗第4周时HCV RNA检测不到(快速病毒学应答,RVR)的患者短疗程治疗后复发的预测因素,并报告复发的RVR患者接受第二个24周疗程治疗后的持续病毒学应答(SVR)情况。RVR患者接受聚乙二醇化干扰素(Peg-IFN)α-2b(1.5μg/kg)和利巴韦林(1000 - 1200mg/天)治疗12周;复发患者采用相同药物剂量再次治疗,但疗程延长至标准的24周。采用逻辑回归分析,将年龄、性别、传播途径、体重指数(BMI)、血清丙氨酸氨基转移酶(ALT)、HCV基因型、血清HCV RNA水平和血小板计数作为协变量来明确复发的预测因素。在718例开始接受治疗的2型和3型患者中,496例(69.1%)在第4周时HCV RNA检测不到。其中,409例患者(82.5%,可信区间[CI] 79.1 - 85.8)获得SVR,67例(14.1%,CI 10.4 - 16.5)复发。回归分析显示,仅血小板计数低于140,000/mm³[比值比,2.51;可信区间(CI),1.49 - 4.20]和BMI为30或更高(比值比,1.7;CI,1.03 - 2.70)与复发独立相关。67例复发患者中有43例同意再次治疗,其中30例(70.0%)获得SVR。
对于治疗第4周时HCV RNA检测不到且无晚期肝纤维化和低BMI的患者,我们推荐1个疗程为12周的治疗方案。