TREATMENT OF CHRONIC HEPATITIS C WITH AMANTADINE HC1

丙型肝炎的治疗一直令人失望，不到三分之一 实现持续反应， 方面的影响. 虽然干扰素是FDA批准的唯一一种用于 治疗成人丙型肝炎，它不被批准用于儿童。 在宾夕法尼亚州立大学进行了一项试点试验， 在医学中，成年丙型肝炎患者未能 对干扰素有反应的患者用盐酸金刚烷胺治疗6个月。 64%的人血清丙氨酸氨基转移酶值降低， 接受金刚烷胺治疗的患者与未接受治疗的患者相比 或干扰素治疗。 27%的患者接受 金刚烷胺使ALT值正常化，丙型肝炎病毒消失 核糖核酸 试点研究的良好结果是进一步研究的理由。 调查 这项补助金假设， 盐酸金刚烷胺对慢性丙型肝炎患者的肝细胞有抑制作用， 通过抑制丙型肝炎病毒的复制来治疗炎症。 我们 我建议通过进行一项前瞻性的研究来调查这一假设。 在100名成人和50名 慢性丙型肝炎患儿。 以下具体 目的：1）评价金刚烷胺作为活性药物的疗效 成人丙型肝炎患者的抗病毒药物， 干扰素治疗失败，2）研究 金刚烷胺在丙型肝炎感染儿童中的应用，3）评价 金刚烷胺对肝脏炎症和血液中丙型肝炎病毒RNA的影响 在未接受干扰素治疗的患者中， 因医学原因不能服用干扰素的患者，4）研究应答率 接受6个月与12个月治疗的患者的反应和持久性 5）阐明金刚烷胺治疗对 病人的电梯质量。 这些研究是一个长期的 目标是了解感染的机制， 丙型肝炎病毒的治疗

Treatment of hepatitis C has been disappointing with less than one-third achieving a sustained response and most experiencing significant side effects. Although Interferon is the only FDA approved drug for the treatment of hepatitis C in adults, it is not approved for children. A pilot trial was conducted at Pennsylvania State University, College of Medicine in which adult patients with hepatitis C who had failed to respond to interferon were treated with amantadine-HC1 for six months. Serum alanine aminotransferase values decreased in 64 percent of the patients with amantadine therapy compared to intervals without therapy or to interferon therapy. Twenty-seven percent of patient treated with amantadine had normalization of ALT values and loss of hepatitis C virus RNA. Promising results of the pilot study are reason for further investigation. This grant hypothesizes that administration of amantadine-HC1 to patients with chronic hepatitis C will inhibit hepatic inflammation by repressing replication of the hepatitis C virus. We propose to investigate this hypothesis by conducting a prospective randomized double-blind placebo-controlled trial in 100 adult and 50 pediatric patients with chronic hepatitis C. The following specific aims are proposed: 1) Evaluate the efficacy of amantadine as an active antiviral agent for hepatitis C in adult patients who had previously failed therapy with interferon, 2) Study the safety and efficacy of amantadine in children with hepatitis C infection, 3) Evaluate the effects of amantadine on hepatic inflammation and hepatitis C RNA blood levels in naive patients who either decline from interferon therapy or who cannot take interferon for medical reasons, 4) Study response rate and durability of response in patients treated with six versus 12 months of amantadine, and 5) elucidate be effects of amantadine therapy on the patient's quality of lift. These studies are part of one long term goals towards understanding the mechanisms involved in infection and treatment of the hepatitis C virus.