Jayakumar Rajeswari, Joshi Yogendra Kumar, Singh Sarman
Division of Clinical Microbiology, Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi - 110 029, India.
J Lab Physicians. 2012 Jan;4(1):10-6. doi: 10.4103/0974-2727.98664.
Chronic hepatitis B is a disease of concern due to its life-threatening complications like cirrhosis, and hepatocellular carcinoma (HCC) in 20-40% of patients. There are about 400 million people affected worldwide with HBV, and over 300,000 die every year from HBV-related diseases. Oral antivirals like lamivudine, adefovir, entecavir, and tenofovir are commonly used to treat chronic hepatitis B. In this study, we tried to evaluate the comparative efficacy of these drugs alone and in combination.
Chronic hepatitis B patients with HBV-DNA more than 10⁴Copies/mL irrespective of their HBeAg status (n=60) were enrolled in a prospective study. 21, 20, and 19 patients were treated with lamivudine (100 mg/day) plus adefovir (10 mg/day) combination entecavir monotherapy (0.5 mg/day) and tenofovir monotherapy (300 mg/day), respectively and were followed up for 24 weeks with their virological, serological, and biochemical markers measured at 12 and 24 weeks.
After 24 weeks of treatment, there was no significant difference between the 3 groups in suppressing HBV-DNA to undetectable levels. The median decrease in HBV-DNA levels from baseline was better with tenofovir and entecavir monotherapies than lamivudine and adefovir combination, which was statistically significant. There was no significant difference between the 3 groups in HBsAg and HBeAg seroconversion and normalization of biochemical parameters.
Entecavir and tenofovir monotherapy were found to be more effective than lamivudine plus adefovir combination in reducing the HBV-DNA levels. However, lamivudine plus adefovir combination was not too inferior, especially when cost of treatment was taken into consideration.
慢性乙型肝炎是一种令人关注的疾病，因为它会引发诸如肝硬化和肝细胞癌（HCC）等危及生命的并发症，20%至40%的患者会出现此类情况。全球约有4亿人感染乙肝病毒，每年有超过30万人死于与乙肝相关的疾病。拉米夫定、阿德福韦、恩替卡韦和替诺福韦等口服抗病毒药物常用于治疗慢性乙型肝炎。在本研究中，我们试图评估这些药物单独使用及联合使用时的相对疗效。
将60例乙肝病毒脱氧核糖核酸（HBV-DNA）超过10⁴拷贝/毫升且不考虑其乙肝e抗原（HBeAg）状态的慢性乙型肝炎患者纳入一项前瞻性研究。分别有21例、20例和19例患者接受拉米夫定（100毫克/天）加阿德福韦（10毫克/天）联合治疗、恩替卡韦单药治疗（0.5毫克/天）和替诺福韦单药治疗（300毫克/天），并随访24周，在第12周和第24周测量其病毒学、血清学和生化指标。
治疗24周后，三组在将HBV-DNA抑制到无法检测水平方面无显著差异。替诺福韦和恩替卡韦单药治疗使HBV-DNA水平较基线的中位数下降幅度优于拉米夫定和阿德福韦联合治疗，差异具有统计学意义。三组在乙肝表面抗原（HBsAg）和HBeAg血清学转换以及生化参数正常化方面无显著差异。
在降低HBV-DNA水平方面，恩替卡韦和替诺福韦单药治疗比拉米夫定加阿德福韦联合治疗更有效。然而，拉米夫定加阿德福韦联合治疗也不算太差，尤其是考虑到治疗成本时。
