Monash Medical Centre and Monash University, Melbourne, Vic., Australia.
J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.
Albinterferon alfa-2b (albIFN) is a fusion protein of recombinant human albumin/recombinant interferon (IFN)-α-2b, with ∼200-h half-life. Safety/efficacy of albIFN q4wk was evaluated in 391 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 2/3. Patients were randomized 3:4:4:4 to one of four open-label treatment groups: pegylated IFN (Peg-IFN)-α-2a 180 μg qwk or albIFN 900, 1200 or 1500 μg q4wk, plus oral ribavirin 800 mg/day, for 24 weeks. Primary efficacy endpoint was sustained virologic response (SVR; HCV RNA <20 IU/mL 24 weeks post-treatment). SVR rates were as follows: 85%, 76%, 76% and 78% with Peg-IFNα-2a and albIFN 900, 1200 and 1500 μg, respectively (P = NS); corresponding rapid virologic response rates (HCV RNA <43 IU/mL at week 4) were as follows: 78%, 49% (P < 0.001), 60% (P = 0.01) and 71%. SVR rates were not influenced by interleukin 28B genotype, although rapid virologic response rates were greater with interleukin 28B CC (P = NS). Serious adverse event rates were as follows: 4%, 11%, 3% and 3% with Peg-IFNα-2a and albIFN 900, 1200 and 1500 μg, respectively. No increase in serious/severe respiratory events was noted with albIFN. Fewer absolute neutrophil count reductions <750/mm(3) occurred with albIFN (P = 0.03), leading to fewer IFN dose reductions. Haemoglobin reductions <10 g/dL were less frequent with albIFN 900 and 1200 μg vs 1500 μg and Peg-IFNα-2a (P = 0.02), leading to fewer ribavirin dose reductions. albIFN administered q4wk produced fewer haematologic reductions than Peg-IFNα-2a, but had numerically lower SVR rates (P = NS) in patients with chronic HCV genotype 2/3.
阿巴西普干扰素 alfa-2b（albIFN）是一种重组人白蛋白/重组干扰素（IFN）-α-2b 的融合蛋白，半衰期约为 200 小时。在 391 名未经治疗的慢性丙型肝炎病毒（HCV）基因型 2/3 患者中，评估了 albIFN 每 4 周一次的安全性/疗效。患者随机分为 3:4:4:4 组，分别接受以下四种开放标签治疗组之一：聚乙二醇干扰素（Peg-IFN）-α-2a 180 μg 每周一次或 albIFN 900、1200 或 1500 μg 每 4 周一次，加用口服利巴韦林 800 mg/天，治疗 24 周。主要疗效终点为持续病毒学应答（SVR；治疗后 24 周时 HCV RNA <20 IU/mL）。SVR 率如下：Peg-IFNα-2a 组和 albIFN 900、1200 和 1500 μg 组分别为 85%、76%、76%和 78%（P = NS）；相应的快速病毒学应答率（第 4 周时 HCV RNA <43 IU/mL）分别为 78%、49%（P < 0.001）、60%（P = 0.01）和 71%。白细胞介素 28B 基因型对 SVR 率没有影响，但白细胞介素 28B CC 患者的快速病毒学应答率更高（P = NS）。严重不良事件率如下：Peg-IFNα-2a 组和 albIFN 900、1200 和 1500 μg 组分别为 4%、11%、3%和 3%。与 Peg-IFNα-2a 相比，albIFN 并未导致严重/严重呼吸系统事件发生率增加。使用 albIFN 时，中性粒细胞绝对计数降低 <750/mm(3)的情况较少（P = 0.03），因此需要减少 IFN 的剂量。血红蛋白降低 <10 g/dL 的情况在 albIFN 900 和 1200 μg 组比 1500 μg 组和 Peg-IFNα-2a 组较少（P = 0.02），因此需要减少利巴韦林的剂量。与 Peg-IFNα-2a 相比，albIFN 每 4 周一次给药可减少血液学减少，但在慢性 HCV 基因型 2/3 患者中，SVR 率较低（P = NS）。
