Cammà C, Di Marco V, Lo Iacono O, Almasio P, Giunta M, Fuschi P, Vaccaro A, Fabiano C, Magrin S, Di Stefano R, Bonura C, Pagliaro L, Craxì A
Istituto Metodologie Diagnostiche Avanzate, Consiglio Nazionale delle Ricerche, Palermo, Italy.
J Hepatol. 1998 Apr;28(4):531-7. doi: 10.1016/s0168-8278(98)80274-2.
BACKGROUND/AIMS: To evaluate whether sustained response to a-interferon improves clinical outcome in patients with chronic hepatitis C.
A cohort of 410 consecutive patients (65% with chronic hepatitis, 35% with cirrhosis) were treated with a-interferon in two trials (mean follow-up 62.1 months, range 7-109 months). All were serum HCV RNA positive before therapy and received first 10 then 5 million units of a-2b or a-nl interferon three times weekly for 6 to 12 months. Sustained response was defined as normal aminotransferases 12 months after stopping interferon.
Sixty-two patients (15.1%: 54 with chronic hepatitis, eight with cirrhosis) were sustained responders. At the end of follow-up, 56 out of 62 sustained responders (90.3%) were serum HCV RNA negative. No biochemical relapse after 12 months was seen in sustained responders, regardless of initial histology, HCV genotype or persistence of HCV RNA. Although three died of non-hepatic causes, no liver-related events were observed among sustained responders. Complications of liver disease occurred in 34 relapsers/non-responders: nine hepatocellular carcinomas, 21 ascites and four portal hypertensive bleedings. Eleven relapsers/nonresponders died: eight of hepatic and three of non-hepatic causes. Event-free survival was significantly longer in sustained responders than in all the remaining patients. In a regression analysis, sustained response to interferon, low age and absence of cirrhosis were independent predictors of event-free survival.
Hepatitis C virus is probably eradicated and progression of liver disease is prevented in most patients who remain HCV RNA negative with normal transaminases for more than 1 year after stopping treatment.
背景/目的:评估α干扰素的持续应答是否能改善慢性丙型肝炎患者的临床结局。
在两项试验中,对410例连续患者(65%为慢性肝炎,35%为肝硬化)进行α干扰素治疗(平均随访62.1个月,范围7 - 109个月)。所有患者治疗前血清HCV RNA均为阳性,先接受10万单位,然后500万单位的α - 2b或α - n1干扰素,每周3次,共6至12个月。持续应答定义为停止干扰素治疗12个月后转氨酶正常。
62例患者(15.1%:54例慢性肝炎,8例肝硬化)为持续应答者。随访结束时,62例持续应答者中有56例(90.3%)血清HCV RNA阴性。无论初始组织学、HCV基因型或HCV RNA的持续存在情况如何,持续应答者在12个月后均未出现生化复发。尽管有3例死于非肝脏原因,但持续应答者中未观察到肝脏相关事件。34例复发者/无应答者出现肝脏疾病并发症:9例肝细胞癌,21例腹水和4例门静脉高压出血。11例复发者/无应答者死亡:8例死于肝脏相关原因,3例死于非肝脏相关原因。持续应答者的无事件生存期明显长于所有其余患者。在回归分析中,对干扰素的持续应答、低年龄和无肝硬化是无事件生存期的独立预测因素。
在停止治疗后转氨酶正常且HCV RNA阴性超过1年的大多数患者中,丙型肝炎病毒可能被根除,肝脏疾病进展得到预防。