Ferenci Peter, Laferl Hermann, Scherzer Thomas-Matthias, Gschwantler Michael, Maieron Andreas, Brunner Harald, Stauber Rudolf, Bischof Martin, Bauer Bernhard, Datz Christian, Löschenberger Karin, Formann Elisabeth, Staufer Katharina, Steindl-Munda Petra
Department of Internal Medicine III, Medical University, Vienna, Austria.
Gastroenterology. 2008 Aug;135(2):451-8. doi: 10.1053/j.gastro.2008.04.015. Epub 2008 May 27.
BACKGROUND & AIMS: This analysis reports the rate of sustained virological response (SVR) in patients infected with hepatitis C virus (HCV) genotype 1 or 4 who were assigned to 24 weeks of treatment with pegylated interferon (peginterferon) alfa-2a 180 mug/wk plus ribavirin 1000/1200 mg/day after achieving a rapid virological response (RVR; HCV RNA level <50 IU/mL) at week 4 in a prospective trial investigating response-guided therapy.
Non-RVR patients with an early virological response were randomized to 48 or 72 weeks of therapy (this is a still-ongoing trial).
A total of 150 of 516 patients (29%) had an RVR, 143 of whom completed 24 weeks of treatment. Younger patients, leaner patients, and those with an HCV RNA level </=400,000 IU/mL and HCV genotype 4 infection were more likely to achieve an RVR; however, among patients with an RVR, no baseline factor predicted SVR. The SVR rate was 80.4% (115/143; 95% confidence interval [CI], 72.9-86.6) in patients who completed 24 weeks of treatment. The SVR rate was 86.7% (26/30; 95% CI, 69.3%-96.2%) in patients infected with genotype 4 and 78.8% in those infected with genotype 1 (89/113; 95% CI, 70.1%-85.9%; intent to treat: 89/120; 74.2%; 65.4-81.7%). Treatment was well tolerated.
This prospective study confirms that a 24-week regimen of peginterferon alfa-2a plus ribavirin 1000/1200 mg/day is appropriate in genotype 1 and 4 patients with a low baseline HCV RNA level who achieve an RVR by week 4 of therapy.
本分析报告了在一项研究应答指导治疗的前瞻性试验中，丙型肝炎病毒（HCV）1型或4型感染患者在第4周达到快速病毒学应答（RVR；HCV RNA水平<50 IU/mL）后，接受聚乙二醇化干扰素（peginterferon）α-2a 180 μg/周加利巴韦林1000/1200 mg/天治疗24周的持续病毒学应答（SVR）率。
非RVR但有早期病毒学应答的患者被随机分配接受48周或72周治疗（此试验仍在进行中）。
516例患者中有150例（29%）达到RVR，其中143例完成了24周治疗。年龄较小、体型较瘦、HCV RNA水平≤400,000 IU/mL以及感染HCV基因型4的患者更有可能达到RVR；然而，在达到RVR的患者中，没有基线因素可预测SVR。完成24周治疗的患者SVR率为80.4%（115/143；95%置信区间[CI]，72.9 - 86.6）。基因型4感染患者的SVR率为86.7%（26/30；95% CI，69.3% - 96.2%），基因型1感染患者为78.8%（89/113；95% CI，70.1% - 85.9%；意向性治疗：89/120；74.2%；65.4 - 81.7%）。治疗耐受性良好。
这项前瞻性研究证实，对于治疗第4周达到RVR且基线HCV RNA水平较低的基因型1和4型患者，聚乙二醇化干扰素α-2a加利巴韦林1000/1200 mg/天的24周治疗方案是合适的。
