Gramenzi Annagiulia, Andreone Pietro, Cursaro Carmela, Verucchi Gabriella, Boccia Sergio, Giacomoni Pier Luigi, Galli Silvia, Furlini Giuliano, Biselli Maurizio, Lorenzini Stefania, Attard Luciano, Bonvicini Fiorenza, Bernardi Mauro
Dipartimento di Medicina Interna, Cardioangiologia ed Epatologia, Policlinico S. Orsola, University of Bologna, Via Massarenti, 9-40138 Bologna, Italy.
J Gastroenterol. 2007 May;42(5):362-7. doi: 10.1007/s00535-007-2006-3. Epub 2007 May 25.
Efficacy and safety of interferon induction therapy alone or in combination with ribavirin or ribavirin plus amantadine were evaluated in chronic hepatitis C patients who were nonresponders to primary antiviral treatment.
The study was designed to have 225 HCV nonresponder patients, but at an interim analysis the response rate difference between groups was lower than expected and the enrollment was stopped when 75 patients had been randomized to receive interferon-alpha2a (group A, n = 26), interferon-alpha2a plus 15 mg/kg per day of ribavirin (group B, n = 24), or interferon-alpha2a plus ribavirin plus 200 mg/day of amantadine hydrochloride (group C, n = 25). Treatment duration was 48 weeks. The dose of interferon was 6 MU/day for 4 weeks followed by 3 MU/day for the remaining 44 weeks.
On intention-to-treat, the sustained virological response at 24 weeks of follow-up was 11.5% in group A, 12.5% in group B, and 12% in group C. Therapy was discontinued because of adverse effects in three patients in group A (11.5%), three in group B (12.5%), and two in group C (8%).
Nonresponders with chronic hepatitis C may achieve a sustained virological response rate of approximately 12% if retreated with interferon induction treatment followed by administration of a daily dose. The addition of ribavirin or amantadine did not seem to improve the response rates.
对初次抗病毒治疗无应答的慢性丙型肝炎患者，评估了单独使用干扰素诱导疗法或联合利巴韦林或利巴韦林加金刚烷胺的疗效和安全性。
该研究计划纳入225例丙型肝炎病毒无应答患者，但在中期分析时，各治疗组间的应答率差异低于预期，因此在75例患者随机分组接受α-干扰素2a（A组，n = 26）、α-干扰素2a加每日15mg/kg利巴韦林（B组，n = 24）或α-干扰素2a加利巴韦林加每日200mg盐酸金刚烷胺（C组，n = 25）治疗后，停止入组。治疗疗程为48周。干扰素剂量为第1至4周6MU/日，之后44周3MU/日。
在意向性分析中，随访24周时的持续病毒学应答率在A组为11.5%，B组为12.5%，C组为12%。A组有3例患者（11.5%）、B组有3例患者（12.5%）、C组有2例患者（8%）因不良反应而中断治疗。
慢性丙型肝炎无应答患者若接受干扰素诱导治疗，随后每日给药，可能获得约12%的持续病毒学应答率。添加利巴韦林或金刚烷胺似乎并未提高应答率。
