Heathcote E J, Keeffe E B, Lee S S, Feinman S V, Tong M J, Reddy K R, Albert D G, Witt K, Blatt L M
University of Toronto, Ontario, Canada.
Hepatology. 1998 Apr;27(4):1136-43. doi: 10.1002/hep.510270431.
A multicenter, open-label, phase 3 study was conducted in 337 patients with chronic hepatitis C virus (HCV) infection who had either not responded to previous interferon therapy or had relapsed after discontinuation of therapy with either consensus interferon (9 microg) or interferon alpha-2b (3 million U) three times a week for 24 weeks. Patients were randomized to receive a higher dose of consensus interferon (15 microg) administered subcutaneously three times a week for 24 or 48 weeks and then were observed for an additional 24 weeks. Patients who had relapsed after prior interferon therapy were more likely to have a sustained alanine aminotransferase response and HCV RNA response (as measured by reverse transcription-polymerase chain reaction with a sensitivity of < 100 copies/mL) than were patients who had not responded to prior interferon therapy. For relapsers, the sustained HCV RNA response rate was 58% (48 weeks) and 28% (24 weeks). The sustained alanine aminotransferase response for relapsers was 52% (48 weeks) and 39% (24 weeks). The sustained HCV RNA response rate among prior nonresponders was 13% (48 weeks) and 5% (24 weeks), and the sustained alanine aminotransferase response rate for nonresponders was 17% (48 weeks) and 12% (24 weeks). The administration of 15 microg of consensus interferon was well tolerated and was not associated with an increase in the incidence of side effects. These data demonstrate that re-treatment with 15 microg of consensus interferon is safe and effective therapy for patients with chronic hepatitis C who have either not responded to previous interferon therapy or relapsed after discontinuation of interferon therapy.
一项多中心、开放标签的3期研究纳入了337例慢性丙型肝炎病毒（HCV）感染患者，这些患者既往对干扰素治疗无反应，或在用9微克的共识干扰素或300万单位的α-2b干扰素每周3次、共治疗24周后停药复发。患者被随机分配接受皮下注射更高剂量（15微克）的共识干扰素，每周3次，共24或48周，随后再观察24周。既往干扰素治疗后复发的患者比既往对干扰素治疗无反应的患者更有可能获得持续的丙氨酸氨基转移酶反应和HCV RNA反应（通过逆转录-聚合酶链反应测定，灵敏度<100拷贝/毫升）。对于复发患者，持续HCV RNA反应率在48周时为58%，24周时为28%。复发患者的持续丙氨酸氨基转移酶反应率在48周时为52%，24周时为39%。既往无反应者的持续HCV RNA反应率在48周时为13%，24周时为5%，无反应者的持续丙氨酸氨基转移酶反应率在48周时为17%，24周时为12%。15微克共识干扰素的给药耐受性良好，且与副作用发生率增加无关。这些数据表明，对于既往对干扰素治疗无反应或停药后复发的慢性丙型肝炎患者，再次使用15微克共识干扰素治疗是安全有效的。
