Di Marco Vito, Almasio Piero Luigi, Ferraro Donatella, Calvaruso Vincenza, Alaimo Giuseppe, Peralta Sergio, Di Stefano Rosa, Craxì Antonio
Cattedra di Gastroenterologia and Unità Operativa Complessa di Gastroenterologia ed Epatologia, Di.Bi.M.I.S, Piazza delle Cliniche 2, 90127 Palermo, Italy.
J Hepatol. 2007 Oct;47(4):484-91. doi: 10.1016/j.jhep.2007.04.020. Epub 2007 Jun 27.
BACKGROUND/AIMS: Risks and benefits of antiviral therapy in HCV cirrhosis with portal hypertension are poorly known.
We performed a randomized controlled trial in 102 HCV patients with compensated cirrhosis and portal hypertension: 51 received 1 microg/kg/week of Pegylated-interferon alpha-2b and 51 Pegylated-interferon plus 800 mg/day of ribavirin up to 52 weeks.
By intention-to-treat analysis, five patients on monotherapy and eleven on combination therapy achieved a sustained virological response (9.8% vs. 21.6%, p=0.06). The response was more frequent for genotypes 2 or 3 than genotype 1 (66.6% vs. 11.3%, p=0.001). Genotype 1, who had low viral load at start of therapy, were HCV-RNA negative at 4 weeks, and were adherent to the scheduled therapy had a higher probability of sustained virological response. Patients with sustained virological response had less disease events compared to nonresponders (6.2% vs. 38.3%, p=0.03 by log rank test) during follow-up.
In HCV cirrhosis with portal hypertension Peg-interferon plus ribavirin is a feasible treatment. Although the rate of viral eradication is modest, tailoring by genotype and early viral response allows to keep patients on treatment who are more likely to have viral eradication. Patients with viral eradication have fewer disease complications during follow-up.
背景/目的：抗病毒治疗在伴有门静脉高压的丙型肝炎肝硬化患者中的风险和益处鲜为人知。
我们对102例代偿期肝硬化且伴有门静脉高压的丙型肝炎患者进行了一项随机对照试验：51例患者接受每周1微克/千克的聚乙二醇化干扰素α-2b治疗，51例患者接受聚乙二醇化干扰素加每日800毫克利巴韦林治疗，疗程长达52周。
根据意向性分析，单药治疗组有5例患者、联合治疗组有11例患者获得了持续病毒学应答（9.8%对21.6%，p = 0.06）。2型或3型基因型患者的应答率高于1型基因型患者（66.6%对11.3%，p = 0.001）。治疗开始时病毒载量低、治疗4周时HCV-RNA呈阴性且坚持按计划治疗的1型基因型患者获得持续病毒学应答的可能性更高。在随访期间，获得持续病毒学应答的患者与无应答者相比疾病事件更少（6.2%对38.3%，对数秩检验p = 0.03）。
在伴有门静脉高压的丙型肝炎肝硬化患者中，聚乙二醇化干扰素加利巴韦林是一种可行的治疗方法。虽然病毒根除率不高，但根据基因型和早期病毒应答进行个体化治疗可使更有可能实现病毒根除的患者继续接受治疗。病毒根除的患者在随访期间疾病并发症更少。
