Unit of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy.
Minerva Med. 2010 Dec;101(6):373-83.
The use of hepatitis B immunoglobulin (HBIg) combined with nucleos(t)ide analogues (NUCs) has improved outcomes in post-hepatitis B (PHB) liver transplant (LT), reducing the 1-year recurrence rate below 10%. The aim of this study was to evaluate efficacy and pharmacokinetics of prophylaxis with NUC(s) and intravenous (iv-) or intramuscular (im-) HBIg in 33 PHBLTs, transplanted for more than 1 year.
During the first six months of the study, 18 subjects received 5000 IU of iv-HBIg every four weeks and 15 patients 2160 IU/12 mL of im-HBIg every two weeks. In the following six months, 31 subjects were switched to two different concentrations of im-HBIg, 2160/12 mL (16 patients) or 2000 IU/6 mL every two weeks (15 patients).
All patients remained HBsAg-negative and 30/31 maintained anti-HBs >100 IU/L. Overall mean anti-HBs titer during treatment was 363 IU/mL. Mean HBIg half-life was 21.4, 27.3 and 26 days with intravenous, diluted or concentrated im-preparations, respectively.
These results confirm an analogue efficacy and tolerance of iv- and im-HBIg combined with antivirals in prophylaxis of hepatitis B after LT. Anti-HBs titers three times higher than aimed and four weeks mean half-life could suggest the reduction of doses and the elongation of the interval of administration of im-HBIg.
乙型肝炎免疫球蛋白（HBIg）联合核苷（酸）类似物（NUCs）在乙型肝炎后（PHB）肝移植（LT）中的应用改善了预后，将 1 年复发率降低至 10%以下。本研究旨在评估在 33 例 LT 后超过 1 年的患者中，NUC 和静脉（iv）或肌肉内（im）HBIg 预防的疗效和药代动力学。
在研究的前 6 个月，18 例患者每 4 周接受 5000IU 的 iv-HBIg，15 例患者每 2 周接受 2160IU/12mL 的 im-HBIg。在接下来的 6 个月中，31 例患者转换为两种不同浓度的 im-HBIg，2160/12mL（16 例）或 2000IU/6mL 每 2 周（15 例）。
所有患者均保持 HBsAg 阴性，30/31 例保持抗-HBs >100IU/L。治疗期间总体平均抗-HBs 滴度为 363IU/mL。静脉、稀释或浓缩 im 制剂的 HBIg 平均半衰期分别为 21.4、27.3 和 26 天。
这些结果证实了 iv 和 im-HBIg 联合抗病毒药物在 LT 后乙型肝炎预防中的类似物疗效和耐受性。抗-HBs 滴度比目标值高 3 倍，半衰期为 4 周，这可能提示可以减少 im-HBIg 的剂量并延长给药间隔。
