August-Jörg Barbara S E, Borovicka Jan, Dufour Jean-François, Gonvers Jean-Jacques, Henz Samuel, Hermann Rudolf, Meyenberger Christa, Weitz Manfred, Renner Eberhard L
Division of Gastroenterology, Cantonal Hospital, St. Gallen, Switzerland.
Swiss Med Wkly. 2003 Aug 23;133(33-34):455-60. doi: 10.4414/smw.2003.10300.
BACKGROUND/AIM: Roughly 50% of patients with chronic hepatitis C, who relapsed after a previous monotherapy with interferon alpha, will respond in a sustained fashion to 24 weeks of re-therapy with the combination of interferon alpha plus ribavirin. Whether prolonging treatment duration to 48 weeks will further increase sustained response rates remains ill defined. In this randomised controlled pilot trial we compared the efficacy and tolerability of a 24 week with that of a 48 week course of combination therapy with interferon alpha and ribavirin in interferon monotherapy relapsers with chronic hepatitis C.
Interferon alpha monotherapy relapsers with chronic hepatitis C were randomised to receive interferon alpha 2b (3 x 3 MIU sc weekly) and oral ribavirin (1000/1200 mg po daily) for either 24 weeks or 48 weeks. Virological response was evaluated by HCV RNA PCR at week 10 (initial response), at the end of treatment (end of- treatment response) and at the end of 24 weeks follow-up (sustained response). Only patients with negative HCV RNA at week 10 continued treatment. Adverse events were recorded at regular intervals.
Thirty-seven patients were enrolled, 19 (6 females, median age 43) in the 24 week and 18 (5 females, median age 40) in the 48 week treatment arm. Baseline characteristics were similar in both groups. At treatment week 10, 12/19 (63%) in the 24 week group and 14/18 (78%) patients in the 48 week group had lost HCV RNA in serum (p = 0.33). All initial responders remained HCV RNA negative throughout the treatment period. Sustained response rates were 10/19 (53%) in the 24 week group and 13/18 (72%) in the 48 week group (p = 0.31). Three patients discontinued treatment early (two due to moderate adverse events, one due to non-compliance). Dose modifications were necessary in 9 patients, 4 in the 24 week and 5 in the 48 week group for anaemia, neutropenia, nausea and depression, respectively.
Prolonging interferon / ribavirin combination therapy in interferon alpha monotherapy relapsers with chronic hepatitis C from 24 to 48 weeks may increase sustained response rates. Larger controlled trials using pegylated interferon alpha and ribavirin in relapsers with chronic hepatitis C seem warranted.
背景/目的：既往使用α干扰素单药治疗后复发的慢性丙型肝炎患者中，约50%对α干扰素联合利巴韦林再治疗24周有持续应答。将治疗疗程延长至48周是否会进一步提高持续应答率仍不明确。在这项随机对照试验中，我们比较了α干扰素联合利巴韦林24周和48周疗程的联合治疗，对既往使用α干扰素单药治疗后复发的慢性丙型肝炎患者的疗效和耐受性。
将既往使用α干扰素单药治疗后复发的慢性丙型肝炎患者随机分为两组，分别接受α干扰素2b（3×3 MIU皮下注射，每周1次）和口服利巴韦林（1000/1200 mg口服，每日1次）治疗24周或48周。在第10周（初始应答）、治疗结束时（治疗结束时应答）和随访24周结束时（持续应答），通过HCV RNA PCR评估病毒学应答。仅第10周HCV RNA阴性的患者继续治疗。定期记录不良事件。
共纳入37例患者，24周治疗组19例（6例女性，中位年龄43岁），48周治疗组18例（5例女性，中位年龄40岁）。两组基线特征相似。在治疗第10周时，24周治疗组12/19例（63%）和48周治疗组14/18例（78%）患者血清中HCV RNA转阴（p = 0.33）。所有初始应答者在整个治疗期间HCV RNA均保持阴性。24周治疗组持续应答率为10/19例（53%），48周治疗组为13/18例（72%）（p = 0.31）。3例患者提前停药（2例因中度不良事件，1例因依从性差）。9例患者需要调整剂量，24周治疗组4例，48周治疗组5例，分别因贫血、中性粒细胞减少、恶心和抑郁。
将既往使用α干扰素单药治疗后复发的慢性丙型肝炎患者的α干扰素/利巴韦林联合治疗疗程从24周延长至48周可能会提高持续应答率。似乎有必要开展更大规模的对照试验，使用聚乙二醇化α干扰素和利巴韦林治疗慢性丙型肝炎复发患者。
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