Infectious Diseases, University of Foggia, Foggia, Italy.
Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.
Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated.
Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.
急性丙型肝炎（AHC）的治疗尚未标准化，仍有几个问题尚未解决。这项开放、随机、多中心试验旨在评估聚乙二醇干扰素（Peg-IFN）α-2b 24 周疗程与 Peg-IFNα-2b 单独或与利巴韦林（RBV）联合治疗 12 周在 AHC 患者中的疗效和安全性。连续纳入 130 例丙型肝炎病毒急性感染患者，这些患者在发病后 12 周内未自发缓解，随后被随机分为三组：接受 Peg-IFNα-2b 单药治疗（1.5μg/kg/周）24 周或 12 周（第 1 组，n=44；第 2 组，n=43）或联合 RBV（10.6mg/kg/天）治疗 12 周（第 3 组，n=43）。主要终点是治疗后 6 个月随访时 HCV RNA 不可检测（持续病毒学应答；SVR）。所有患者在停药后 48 周内均接受随访。基线、第 4 周、治疗结束时以及治疗后 6 和 12 个月时，在中央实验室采用实时聚合酶链反应（检测限：15IU/ml）检测 HCV RNA 水平。采用意向治疗分析，总体 SVR 率为 71.5%。具体而言，第 1、2 和 3 组分别有 31/44（70.5%）、31/43（72.1%）和 31/43（72.1%）的患者达到 SVR（P=0.898）。16 例（12.3%）患者提前停药或失访；因此，第 1、2 和 3 组患者的持续应答率分别为 81.6%、81.6%和 81.6%。多变量分析显示，治疗第 4 周的病毒学应答是 SVR 的独立预测因素。Peg-IFNα-2b 耐受性良好。
聚乙二醇干扰素（Peg-IFN）α-2b 可诱导慢性进展性 AHC 患者获得高 SVR。应答率不受联合治疗或治疗持续时间的影响。
