Samuel Didier, Bizollon Thierry, Feray Cyrille, Roche Bruno, Ahmed Si Nafa Si, Lemonnier Catherine, Cohard Marielle, Reynes Michel, Chevallier Michelle, Ducerf Christian, Baulieux Jacques, Geffner Michael, Albrecht Janice K, Bismuth Henri, Trepo Christian
Centre HépatoBiliaire, Hôpital Paul Brousse Assistance Publique-Hôpitaux de Paris, Faculté de Médecine Paris Sud, EA 3541, EPI 99-41 et Association Claude Bernard, Villejuif, France.
Gastroenterology. 2003 Mar;124(3):642-50. doi: 10.1053/gast.2003.50095.
Hepatitis C virus (HCV) reinfection after liver transplantation is frequent and leads to chronic hepatitis and cirrhosis. The use of antiviral therapy in this situation remains controversial. This study aimed to assess the safety and efficacy of interferon alfa-2b plus ribavirin for recurrent hepatitis C following liver transplantation.
Transplant recipients with recurrent chronic hepatitis C were randomized to receive either no treatment or therapy with interferon alfa-2b (3 MU 3 times a week) plus 1000-1200 mg/day ribavirin for 1 year. Patients were followed up for 6 months after the end of treatment. The primary end point was loss of HCV RNA 6 months after the end of treatment.
Fifty-two patients were randomized (treatment, 28; placebo, 24). Sixteen patients were withdrawn from the study; 12 (43%) were from the treated group (mainly for anemia [7 patients]) and 4 (17%) from the control group. In the treated group, serum HCV RNA was undetectable in 9 patients (32%) at the end of treatment and 6 (21.4%) at the end of the follow-up period, whereas no patient in the control group lost HCV RNA at any point (P = 0.036 at the end of follow-up). However, there was no significant histologic improvement.
The combination of interferon alfa-2b plus ribavirin induced a sustained virologic response in 21% of transplant recipients with recurrent hepatitis C. However, 43% discontinued therapy due to adverse events (primarily severe anemia). Strategies to enable treatment with lower doses of ribavirin need to be explored.
肝移植后丙型肝炎病毒（HCV）再感染很常见，并会导致慢性肝炎和肝硬化。在这种情况下使用抗病毒治疗仍存在争议。本研究旨在评估干扰素α-2b联合利巴韦林治疗肝移植后复发性丙型肝炎的安全性和疗效。
将复发性慢性丙型肝炎的移植受者随机分为不治疗组或接受干扰素α-2b（3MU，每周3次）联合1000 - 1200mg/天利巴韦林治疗1年的治疗组。治疗结束后对患者进行6个月的随访。主要终点是治疗结束后6个月HCV RNA转阴。
52例患者被随机分组（治疗组28例；安慰剂组24例）。16例患者退出研究；12例（43%）来自治疗组（主要因贫血[7例]），4例（17%）来自对照组。治疗组中，治疗结束时9例（32%）患者血清HCV RNA检测不到，随访期末6例（21.4%）检测不到，而对照组在任何时间点均无患者HCV RNA转阴（随访期末P = 0.036）。然而，组织学上无显著改善。
干扰素α-2b联合利巴韦林可使21%的肝移植后复发性丙型肝炎受者获得持续病毒学应答。然而，43%的患者因不良事件（主要是严重贫血）中断治疗。需要探索使用更低剂量利巴韦林进行治疗的策略。
