Tong M J, Blatt L M, McHutchison J G, Co R L, Conrad A
Liver Center, Huntington Memorial Hospital, Pasadena, CA 91105, USA.
Hepatology. 1997 Dec;26(6):1640-5. doi: 10.1002/hep.510260637.
Patients with chronic hepatitis C (n = 103) were treated for 24 weeks with interferon alfa 2b and followed up for 24 weeks after cessation of therapy (week 48). When hepatitis C virus (HCV) RNA at week 48 was used to assess interferon response, 15 (14.6%) were virological complete responders, and all have remained HCV RNA negative for a mean of 3 years. At week 48, 3 of 15 virological complete responders had elevated alanine transaminase (ALT) values. When serum ALT level was used at week 48 to determine response to interferon, 20 (19.4%) were biochemical complete responders. However, 8 of the 20 patients with normal ALT levels were HCV RNA positive at week 48, and 7 of these individuals have had a recurrence of elevated ALT levels within 3 years after cessation of treatment. These findings indicate that measurement of HCV RNA was more accurate than ALT in determining true responses to interferon therapy. Identification of nonresponders early during the course of interferon treatment showed that an elevated ALT level at week 12 was 92% predictive (odds ratio 3.7) but misidentified 33% (5 of 15) of the patients who were virological complete responders at week 48. In contrast, a positive HCV RNA at week 12 of treatment was 98% predictive (odds ratio 35.5) and misidentified only 6.7% (1 of 15) of the virological complete responders. Thus, positive HCV RNA at week 12 of therapy was more accurate in identifying eventual virological nonresponders than measurement of ALT at this time. Termination of interferon therapy in patients who were HCV RNA positive at week 12 would result in a 27% reduction in the direct medical costs and keep patients from undergoing unnecessary treatment. Therefore, testing for HCV RNA at week 12 to identify nonresponders and then discontinuing their treatment is practical, cost-efficient and beneficial both to patients and to third-party payers.
103例慢性丙型肝炎患者接受了24周的干扰素α-2b治疗，并在治疗停止后（第48周）进行了24周的随访。当用第48周的丙型肝炎病毒（HCV）RNA评估干扰素反应时，15例（14.6%）为病毒学完全应答者，所有这些患者的HCV RNA平均3年保持阴性。在第48周时，15例病毒学完全应答者中有3例丙氨酸转氨酶（ALT）值升高。当用第48周的血清ALT水平来确定对干扰素的反应时，20例（19.4%）为生化完全应答者。然而，20例ALT水平正常的患者中有8例在第48周时HCV RNA呈阳性，其中7例在治疗停止后的3年内ALT水平再次升高。这些发现表明，在确定对干扰素治疗的真正反应方面，检测HCV RNA比检测ALT更准确。在干扰素治疗过程早期识别无应答者表明，第12周时ALT水平升高的预测准确率为92%（优势比3.7），但错误地将第48周时病毒学完全应答的患者中的33%（15例中的5例）识别为无应答者。相比之下，治疗第12周时HCV RNA呈阳性的预测准确率为98%（优势比35.5），且仅将病毒学完全应答者中的6.7%（15例中的1例）错误识别。因此，治疗第12周时HCV RNA呈阳性在识别最终病毒学无应答者方面比此时检测ALT更准确。对于第12周时HCV RNA呈阳性的患者终止干扰素治疗，将使直接医疗费用降低27%，并避免患者接受不必要的治疗。因此，在第12周检测HCV RNA以识别无应答者，然后停止他们的治疗，这既切实可行、具有成本效益，又对患者和第三方支付者都有益。
