Hepatology Section, Hospital General de Valencia, Valencia, Spain.
Hepatology. 2010 Jun;51(6):1897-903. doi: 10.1002/hep.23531.
The objective of this analysis was to compare sustained virological response (SVR) and relapse rates in patients with a rapid virological response (RVR, HCV RNA <50 IU/mL at week 4) randomized to 24 or 16 weeks of treatment with peginterferon alfa-2a (40KD) 180 microg/week plus ribavirin 800 mg/day in the multinational ACCELERATE study. The analysis was restricted to patients who received treatment for 80% or more of the planned duration. Of 1309 eligible patients, 863 individuals (65.9%) achieved an RVR and were included in this analysis (458 assigned to 16 weeks and 405 assigned to 24 weeks). The overall SVR rate was significantly higher in patients randomized to 24 weeks of treatment (91% versus 82%; P = 0.0006) and among patients infected with genotype 2 (92% versus 81%; P = 0.0010) but not genotype 3 (90% versus 84%; P = 0.1308). Relapse rates were significantly lower among all patients randomized to 24 weeks of treatment: overall (6% versus 15%, P < 0.0001); in those infected with genotype 2 (5% versus 17%, P = 0.0001), and genotype 3 (7% versus 14%, P = 0.0489). SVR rates in patients with a viral load of 400,000 IU/mL or less randomized to 24 and 16 weeks of treatment were similar, 95% and 91% (P = 0.2012). Significant pretreatment predictors of SVR included assignment to 24 weeks of treatment (P = 0.0006), absence of advanced fibrosis on liver biopsy (P = 0.0032), lower HCV RNA level (P = 0.0017), and lower body weight (P < 0.0001).
The standard 24-week regimen of peginterferon alfa-2a (40KD) plus ribavirin is significantly more effective than an abbreviated 16-week regimen in genotype 2/3 patients who achieve an RVR. Abbreviated regimens may be considered in patients with a low baseline viral load who achieve an RVR.
本分析旨在比较在多国 ACCELERATE 研究中接受聚乙二醇干扰素 alfa-2a（40KD）180μg/周加利巴韦林 800mg/天治疗 24 或 16 周的快速病毒学应答（RVR，第 4 周 HCV RNA<50IU/mL）患者的持续病毒学应答（SVR）和复发率。该分析仅限于接受 80%或更多计划治疗时间的患者。在 1309 名合格患者中，863 名患者（65.9%）达到 RVR 并纳入本分析（458 名患者分配至 16 周，405 名患者分配至 24 周）。接受 24 周治疗的患者 SVR 率显著高于接受 16 周治疗的患者（91%比 82%；P=0.0006），且在感染基因型 2 的患者中（92%比 81%；P=0.0010），但在感染基因型 3 的患者中（90%比 84%；P=0.1308）差异无统计学意义。所有接受 24 周治疗的患者的复发率均显著降低：总体（6%比 15%，P<0.0001）；在感染基因型 2 的患者中（5%比 17%，P=0.0001），感染基因型 3 的患者中（7%比 14%，P=0.0489）。接受 24 周和 16 周治疗的病毒载量为 400000IU/mL 或更低的患者的 SVR 率相似，分别为 95%和 91%（P=0.2012）。SVR 的显著预测因素包括治疗方案为 24 周（P=0.0006）、肝活检无晚期纤维化（P=0.0032）、HCV RNA 水平较低（P=0.0017）和体重较低（P<0.0001）。
在获得 RVR 的基因型 2/3 患者中，聚乙二醇干扰素 alfa-2a（40KD）加利巴韦林标准 24 周方案明显优于缩短的 16 周方案。对于获得 RVR 的低基线病毒载量患者，可以考虑缩短治疗方案。
