Hossain Sharker M S, Mahtab Mamun A, Das Dulal C, Noor-E-Alam Sheikh M, Mamun Ayub A, Khan Md Sakirul I, Akbar Sheikh M F, Rahman Md Zakiur, Rahman Salimur
Department of Medicine, Kurmitola General Hospital, Dhaka, Bangladesh.
Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
J Family Med Prim Care. 2021 Jul;10(7):2642-2645. doi: 10.4103/jfmpc.jfmpc_2299_20. Epub 2021 Jul 30.
The aim of the study was to compare the safety and efficacy of tenofovir versus entecavir for treatment of naive acute on chronic liver failure (ACLF) due to hepatitis B virus (HBV) (ACLF-B).
Thirty-two patients aged 14-65 years were enrolled in the study. Diagnosis of ACLF was confirmed by clinical condition, biochemical analysis, and virological data. The causes of both chronic liver damages and acute insult in all patients were HBV. They were expressing HBV DNA in the sera, positive for IgM anti-HBc, had increased levels of serum bilirubin, compromised prothrombin time; and more than 50% patients had encephalopathy. The standard dose of tenofovir and entecavir was given.
The antiviral effects of tenofovir and entecavir were evident as most patients became negative for HBV DNA in the sera after 90 days of therapy. Also, the levels of serum bilirubin, CTP (Child-Turcotte-Pugh) and MELD (model for end-stage liver disease) score exhibited significant improvement due to antiviral therapy. Although the improvement of liver functions, and liver damages were detected in patients receiving both tenofovir and entecavir, the survival of the patients was significantly higher in those receiving tenofovir compared to entecavir-treated patients.
This prospective study with limited number patients provides a challenge to assess the real potential of tenofovir over entecavir as therapeutic option for ACLF-B by conducting a multicenter clinical trial enrolling patient of different races and background.
本研究的目的是比较替诺福韦与恩替卡韦治疗初治的乙型肝炎病毒(HBV)所致慢性加急性肝衰竭(ACLF)(ACLF-B)的安全性和疗效。
32例年龄在14至65岁之间的患者纳入本研究。通过临床状况、生化分析和病毒学数据确诊ACLF。所有患者慢性肝损伤和急性损伤的病因均为HBV。他们血清中HBV DNA呈阳性,IgM抗-HBc阳性,血清胆红素水平升高,凝血酶原时间受损;超过50%的患者有肝性脑病。给予替诺福韦和恩替卡韦标准剂量。
替诺福韦和恩替卡韦的抗病毒作用明显,因为大多数患者在治疗90天后血清中HBV DNA转阴。此外,抗病毒治疗使血清胆红素水平、CTP(Child-Turcotte-Pugh)和MELD(终末期肝病模型)评分显著改善。虽然接受替诺福韦和恩替卡韦治疗的患者均检测到肝功能改善和肝损伤减轻,但与恩替卡韦治疗的患者相比,接受替诺福韦治疗的患者生存率显著更高。
这项患者数量有限的前瞻性研究提出了一项挑战,即通过开展一项纳入不同种族和背景患者的多中心临床试验,来评估替诺福韦相对于恩替卡韦作为ACLF-B治疗选择的真正潜力。