Neff Guy W, Kemmer Nyingi, Kaiser Tiffany E, Zacharias Victoria C, Alonzo Michele, Thomas Mark, Buell Joseph
Department of Medicine, Division of Digestive Diseases, University of Cincinnati, Cincinnati, Ohio 45267, USA.
Dig Dis Sci. 2007 Oct;52(10):2497-500. doi: 10.1007/s10620-006-9658-3. Epub 2007 Apr 3.
Conventional therapy to prevent HBV recurrence in liver transplant (LTx) recipients consists of Hepatitis B Immune Globulin (HBIg). The aim of this review is to investigate the safety and efficacy of converting HBIg and LAM therapy to ADV and LAM therapy.
A retrospective review involving all liver transplant patients with HBV maintained on HBIg and LAM therapy. Results collected included: gender, age, HBV serological and DNA status (COBAS AmpliScreen PCR-based testing). Serologic testing was done every three months. Patients were followed for drug reactions, therapy compliance, and immune suppression compliance. A cost benefit analysis was done for drug comparisons using United States currency values.
Patient demographics included: Male (n=6), Female (n=4), mean age 44 years (range 33 to 65). The mean length of follow up since therapy conversion (from HBIg and LMV to ADV and LMV) was 21 months (range 16 to 25 months). Serological status at time of conversion revealed that DNA status remained negative in all patients, HBsAg negative in 10/10, HB eAg (+) (5/10) and HBeAb (+)(5/10). None of the patients experienced an increase in transaminases while on dual ADV and LAM therapy. All patients were maintained on immune suppression monotherapy (tacrolimus) at 7-9 ng/mL. All patients reported compliance with the dual therapy and that they experienced no drug related side effects. Mean yearly costs for ADV and LAM was 7,235.00 United States dollars (range 6,550.00 to 8,225.00); while mean monthly costs for HBIg and LAM; 9225.00 (range 7205.00 to 12005.00).
The above results demonstrate beneficial effects of ADV and LAM in place of the current standard of HBIg and LAM therapy. Safety and short term results show nucleoside therapy is adequate at preventing HBV viral recurrence. Lastly, the economic benefit for ADV and LAM vastly outweighed the HBIg and LAM group.
预防肝移植(LTx)受者乙肝病毒(HBV)复发的传统疗法包括使用乙肝免疫球蛋白(HBIg)。本综述的目的是研究将HBIg和拉米夫定(LAM)疗法转换为阿德福韦酯(ADV)和LAM疗法的安全性和有效性。
对所有接受HBIg和LAM治疗的乙肝病毒感染肝移植患者进行回顾性研究。收集的结果包括:性别、年龄、HBV血清学和DNA状态(基于COBAS AmpliScreen PCR的检测)。每三个月进行一次血清学检测。对患者进行药物反应、治疗依从性和免疫抑制依从性的随访。使用美元价值对药物比较进行成本效益分析。
患者人口统计学数据包括:男性(n = 6),女性(n = 4),平均年龄44岁(范围33至65岁)。自治疗转换(从HBIg和拉米夫定(LMV)转换为ADV和LMV)后的平均随访时间为21个月(范围16至25个月)。转换时的血清学状态显示,所有患者的DNA状态均保持阴性,10/10患者的乙肝表面抗原(HBsAg)呈阴性,乙肝e抗原(HBeAg)阳性(5/10),乙肝e抗体(HBeAb)阳性(5/10)。在接受ADV和LAM联合治疗期间,没有患者的转氨酶升高。所有患者均接受免疫抑制单一疗法(他克莫司),血药浓度维持在7 - 9 ng/mL。所有患者均报告遵守联合治疗,且未出现与药物相关的副作用。ADV和LAM的平均年费用为7235.00美元(范围6550.00至8225.00美元);而HBIg和LAM的平均月费用为9225.00美元(范围7205.00至12005.00美元)。
上述结果表明,ADV和LAM替代目前的HBIg和LAM标准疗法具有有益效果。安全性和短期结果表明,核苷类疗法足以预防HBV病毒复发。最后,ADV和LAM的经济效益大大超过了HBIg和LAM组。