Behera Manas K, Pati Girish K, Narayan Jimmy, Mishra Debakanta, Meher Lalit K, Singh Ayaskant, Uthansingh Kanishka, Sahu Manoj K
Department of Gastroenterology, IMS and SUM Hospital, Siksha "O" Anusandhan (Deemed to Be University), K8, Kalinga Nagar, Bhubaneswar, 751003, Odisha, India.
Bolangir Government Medical College, Odisha, India.
J Clin Exp Hepatol. 2021 Jan-Feb;11(1):37-44. doi: 10.1016/j.jceh.2020.05.003. Epub 2020 May 19.
Chronic Hepatitis B (CHB) is a global health problem affecting around 400 million of people worldwide. Two available first-line antiviral drugs are tenofovir disoproxil fumarate (TDF) and Entecavir (ETV). Till date,there are few published reports from India comparing efficacy of TDF and ETV in CHB cases. Therefore, this present study was carried out with an aim to compare the efficacy of ETV and TDF in patients with nucleos(t)ide naïve CHB.
This retrospective cohort study was carried out in 192 treatment naïve CHB cases, who completed 24 months of treatment with either TDF or ETV between March 2015 and August 2017. The primary end point of the study was undetectable hepatitis B virus DNA after 24 months of therapy.
Of total 192 patients with CHB, 38 hepatitis B e-antigen (HBeAg)-positive and 53 HBeAg-negative patients were treated with tenofovir, whereas 40 HBeAg-positive and 61 HBeAg-negative patients were treated with ETV. Pretreatment characteristics at baseline were not statistically different between the TDF and ETV groups. Patients treated with TDF achieved significantly higher complete viral suppression as compared with ETV-treated patients (Log rank: 7.04, = 0.008) in HBeAg-positive CHB during the 24 months follow-up time; whereas no significant difference in viral suppression rate could be noticed in HBeAg-negative patients (Log rank: 0.98, = 0.38). Both univariate and multivariate analysis by cox proportional hazard model confirmed that tenofovir had significant rate of complete viral suppression in comparison with ETV in HBeAg-positive patients ( < 0.05); whereas complete viral suppression rates were similar in HBeAg-negative patients.
In our study, tenofovir had more effective antiviral suppressive effect compared with ETV in HBeAg-positive, nucleos(t)ide-naïve CHB cases.
慢性乙型肝炎(CHB)是一个全球性的健康问题,全球约有4亿人受其影响。两种可用的一线抗病毒药物是替诺福韦酯(TDF)和恩替卡韦(ETV)。迄今为止,印度很少有已发表的报告比较TDF和ETV在CHB病例中的疗效。因此,本研究旨在比较ETV和TDF在初治核苷(酸)类CHB患者中的疗效。
本回顾性队列研究纳入了192例初治CHB患者,他们在2015年3月至2017年8月期间接受了TDF或ETV治疗,疗程为24个月。该研究的主要终点是治疗24个月后乙肝病毒DNA检测不到。
在192例CHB患者中,38例乙肝e抗原(HBeAg)阳性和53例HBeAg阴性患者接受了替诺福韦治疗,而40例HBeAg阳性和61例HBeAg阴性患者接受了ETV治疗。TDF组和ETV组在基线时的治疗前特征无统计学差异。在24个月的随访期内,与接受ETV治疗的患者相比,接受TDF治疗的患者在HBeAg阳性CHB中实现了显著更高的完全病毒抑制(对数秩检验:7.04,P = 0.008);而在HBeAg阴性患者中未观察到病毒抑制率的显著差异(对数秩检验:0.98,P = 0.38)。通过cox比例风险模型进行的单因素和多因素分析均证实,与ETV相比,替诺福韦在HBeAg阳性患者中具有显著更高的完全病毒抑制率(P < 0.05);而在HBeAg阴性患者中,完全病毒抑制率相似。
在我们的研究中,在HBeAg阳性、初治核苷(酸)类CHB病例中,替诺福韦与ETV相比具有更有效的抗病毒抑制作用。