Klinikum der J. W. Goethe Universität, Medizinische Klinik 1, Frankfurt am Main, Germany.
Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22.
BACKGROUND & AIMS: Guidelines recommend that patients with chronic hepatitis C virus (HCV) infection be treated with pegylated interferon and ribavirin for 24, 48, or 72 weeks, based on their virologic response to treatment. We investigated the effects of treating patients for individualized durations.
We treated 398 treatment-naïve patients who had HCV genotype 1 infections with pegylated interferon alfa-2b and ribavirin for 24, 30, 36, 42, 48, 60, or 72 weeks (mean of 39 weeks, termed individualized therapy); the duration of therapy was determined based on baseline viral load and the time point at which HCV RNA levels became undetectable (measured at weeks 4, 6, 8, 12, 24, and 30). Results were compared with those of 225 patients who received standard treatment for 48 weeks (mean of 38 weeks).
Rates of sustained virologic response (SVR) were 55% among patients who received individualized treatment and 48% among those who received standard treatment (P < .0001 for noninferiority). SVR rates, according to the time point at which HCV RNA levels became undetectable, did not differ significantly between groups. Patients with a rapid virologic response (undetectable levels of HCV RNA at week 4) who were treated for 24 to 30 weeks achieved high rates of SVR (86%-88%). Rates of SVR increased among slow responders who first tested negative for HCV RNA at week 24 and were treated for 60 to 72 weeks compared with those treated for 48 weeks (60%-68% vs 43%-44%). The CC polymorphism at IL28B rs129797860 was associated with an increased rate of SVR compared with the CT/TT polymorphism (P < .0001) at baseline but not among patients who had undetectable levels of HCV RNA following treatment.
Individualizing treatment of patients with chronic HCV genotype 1 infections for 24 to 72 weeks results in high rates of SVR among rapid responders and increases SVR among slow responders.
指南建议，慢性丙型肝炎病毒（HCV）感染者根据治疗中的病毒学应答，接受聚乙二醇干扰素和利巴韦林治疗 24、48 或 72 周。我们研究了根据患者的个体情况进行治疗的效果。
我们对 398 例初治的 HCV 基因型 1 感染者进行了治疗，他们接受了聚乙二醇干扰素 alfa-2b 和利巴韦林治疗，疗程为 24、30、36、42、48、60 或 72 周（平均 39 周，称为个体化治疗）；治疗时间根据基线病毒载量和 HCV RNA 水平变为不可检测的时间点确定（在第 4、6、8、12、24 和 30 周进行检测）。结果与 225 例接受标准 48 周治疗的患者（平均 38 周）进行了比较。
接受个体化治疗的患者持续病毒学应答（SVR）率为 55%，接受标准治疗的患者为 48%（非劣效性 P <.0001）。根据 HCV RNA 水平变为不可检测的时间点，两组间 SVR 率差异无统计学意义。在第 4 周 HCV RNA 水平不可检测的快速病毒学应答患者，治疗 24 至 30 周的 SVR 率很高（86%-88%）。在第 24 周首次检测到 HCV RNA 阴性的缓慢应答者中，治疗 60 至 72 周的 SVR 率高于治疗 48 周的患者（60%-68% vs 43%-44%）。IL28B rs129797860 的 CC 多态性与基线时 CT/TT 多态性（P <.0001）相比，与 SVR 率增加相关，但在治疗后 HCV RNA 水平不可检测的患者中则无相关性。
对慢性 HCV 基因型 1 感染者进行个体化治疗 24 至 72 周，可使快速应答者获得较高的 SVR 率，并提高缓慢应答者的 SVR 率。
