Calleja José Luis, Peñas Beatriz
Hospital Universitario Puerta de Hierro, Madrid, España.
Enferm Infecc Microbiol Clin. 2008 May;26 Suppl 7:39-48. doi: 10.1016/s0213-005x(08)76518-2.
Chronic hepatitis B continues to be a serious problem worldwide. Because a high viral load is associated with greater progression to cirrhosis and hepatocarcinoma in these patients, new drugs that achieve rapid, potent and lasting suppression of viral replication must be sought. Entecavir is a new, highly potent antiviral agent; phase II and III studies have demonstrated this drug to be superior to placebo and lamivudine in patients with chronic hepatitis B virus in terms of histological improvement, efficacy in achieving suppression of viral replication and normalizing transaminase counts. The drug is well tolerated, since its adverse effects are usually mild or moderate and their incidence is similar to that found with placebo or lamivudine. Moreover, in treatment-naïve patients, no resistance has been observed after 3 years of therapy. However, in patients with prior resistance to lamivudine, the incidence of resistance is approximately 15% at 3 years. Further studies are required that compare this drug with other currently available therapeutic options, as well as longer term trials to evaluate its safety. It seems that entecavir will occupy a major place in the treatment of patients with chronic hepatitis B virus infection.
慢性乙型肝炎在全球范围内仍然是一个严重问题。由于这些患者中高病毒载量与进展为肝硬化和肝癌的可能性更大相关,因此必须寻找能够快速、强效且持久抑制病毒复制的新药。恩替卡韦是一种新型高效抗病毒药物;II期和III期研究表明,在慢性乙型肝炎病毒患者中,就组织学改善、抑制病毒复制的疗效以及使转氨酶计数恢复正常而言,该药物优于安慰剂和拉米夫定。该药物耐受性良好,因为其不良反应通常为轻度或中度,且发生率与安慰剂或拉米夫定相似。此外,在初治患者中,治疗3年后未观察到耐药性。然而,在先前对拉米夫定耐药的患者中,3年时耐药发生率约为15%。需要进一步开展研究,将该药物与其他现有治疗方案进行比较,以及进行长期试验以评估其安全性。恩替卡韦似乎将在慢性乙型肝炎病毒感染患者的治疗中占据重要地位。