Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892-1800, USA.
Aliment Pharmacol Ther. 2010 May;31(9):1018-27. doi: 10.1111/j.1365-2036.2010.04263.x. Epub 2010 Jan 16.
Chronic infection with hepatitis C, genotype 2/3, responds better than other genotypes to peginterferon and ribavirin treatment. We hypothesized that a lower dose of peginterferon would be as effective, but less toxic than standard doses.
To test the hypothesis that a lower dose of peginterferon would be as effective as, but less toxic than, standard doses.
A total of 30 patients were treated with low-dose peginterferon alfa-2a (90 microg/week) and 27 patients with standard doses (180 microg/week) for 24 weeks in combination with 800 mg/day of ribavirin. Patients who failed treatment were offered 48 weeks of standard-dose treatment. Viral and serum inducible protein 10 (IP-10) levels were measured and early viral kinetic parameters were calculated.
Sustained virological response was achieved in 68% of the low-dose and 87% of the standard-dose patients (per protocol, P = 0.79 for non-inferiority). Re-treatment was successful in all patients who tolerated full dose and duration. The standard-dose group had greater first-phase declines of viral levels and faster time to negativity. The second-phase slope was not dose-dependent. IP-10 induction was significantly greater with the standard dose. Although fatigue and general feeling during treatment were worse for standard dose, haematological toxicity and depression did not differ between groups.
A lower dose of peginterferon is associated with some symptomatic benefit, but the response is not equivalent to standard dosing.
慢性丙型肝炎感染,基因型 2/3,对聚乙二醇干扰素和利巴韦林治疗的反应优于其他基因型。我们假设低剂量聚乙二醇干扰素的效果与标准剂量相当,但毒性更小。
检验低剂量聚乙二醇干扰素与标准剂量相当但毒性更小的假设。
共有 30 例患者接受低剂量聚乙二醇干扰素 alfa-2a(90μg/周)和 27 例患者接受标准剂量(180μg/周)治疗,联合利巴韦林 800mg/天,疗程 24 周。治疗失败的患者接受标准剂量治疗 48 周。检测病毒和血清诱导蛋白 10(IP-10)水平,并计算早期病毒动力学参数。
低剂量组和标准剂量组的持续病毒学应答率分别为 68%和 87%(按方案,非劣效性 P=0.79)。所有能耐受全剂量和全疗程的患者均成功进行了再治疗。标准剂量组病毒水平的第一相下降更大,达到阴性的时间更快。第二相斜率与剂量无关。标准剂量诱导的 IP-10 明显更高。虽然标准剂量组治疗期间的疲劳和全身不适更严重,但两组的血液学毒性和抑郁无差异。
低剂量聚乙二醇干扰素与一些症状改善相关,但反应与标准剂量不相当。