The efficacy of addition of Tenofovir Disoproxil Fumarate to Peg-IFNα-2b is superior to the addition of Entecavir in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone
The efficacy of addition of Tenofovir Disoproxil Fumarate to Peg-IFNα-2b is superior to the addition of Entecavir in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone
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对于单独使用 Peg-IFN α-2b 治疗 12 周后反应不佳的 HBeAg 阳性 CHB 患者，在 Peg-IFN α-2b 中添加富马酸替诺福韦二吡呋酯的疗效优于添加恩替卡韦
DOI：
10.7150/ijms.45658
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发表时间：
2020-01-01
影响因子：
3.6
通讯作者：
Huang, Huanhuan
中科院分区：
文献类型：
--
作者：
Lin, Sheng;Fu, Ya;Huang, Huanhuan
富马酸二异山梨酯（TDF）对PEG-IFN α-2 B治疗HBeAg阳性慢性B（CH B）患者的疗效观察，对PEG-IFN α-2 B无早期应答。在这项研究中，我们的目的是评估ETV和TDF在HBeAg阳性CHB患者的疗效，这些患者在12周的单药治疗结束时对Peg-INF α-2b反应较差。患者接受皮下注射聚乙二醇干扰素α-2b（180 μ g），每周一次，持续12周。然而，在12周单药治疗结束时，患者对Peg-INF α-2b的反应较差。然后将患者分为两个治疗方案组：（1）A组：患者每周皮下注射Peg-IFN α-2 B（180 μ g），每天口服一次ETV（0.5 mg），持续48周;（2）B组：患者每周皮下注射Peg-IFN α-2 B（180 μ g），每天口服一次TDF（300 mg），持续48周。评价疗效。在基线和每12周采集一次血液样本。采用自动生化技术检测ALT、AST等常规生化指标。使用TaqMan PCR测定法定量HBV DNA。结果：治疗前12周，两组HBsAg水平均迅速下降，36周后逐渐下降;第48周时，Peg-IFN α-2b +TDF组的平均Delta HBsAg水平显著高于Peg-IFN α-2b +ETV组（-1.799 +/- 0.3063 vs. -1.078 +/- 0.2028，P=0.0491）。治疗48周时，TDF添加组HBeAg转阴率为40%，ETV添加组为10%，差异有统计学意义（P=0.028）。在第48周，检测不到HBV DNA的患者比例（
disoproxil fumarate (TDF) to Peg-IFN alpha-2b in HBeAg positive chronic hepatitis B (CHB) patients without early response to Peg-IFN alpha-2b. In this study, we aimed to evaluate the efficacy of ETV and TDF in HBeAg positive CHB patients who had a poor response to Peg-INF alpha-2b at the end of 12 weeks of monotherapy.Methods: A total of 40 HBeAg-positive CHB patients who were naive to antiviral therapy were recruited. The patients received a subcutaneous injection of Peg-IFN alpha-2b (180 mu g) once a week for 12 weeks. However, the patients had a poor response to Peg-INF alpha-2b at the end of the 12-week-period monotherapy. The patients were then divided into two therapeutic protocol groups: (1) Group A: Patients received Peg-IFN alpha-2b (180 mu g) subcutaneously weekly and ETV (0.5 mg) orally once daily for 48 weeks; (2) Group B: Patients received Peg-IFNa-2b (180 mu g) subcutaneously weekly and TDF (300 mg) orally once daily for 48 weeks. The therapeutic efficacy was evaluated. Blood samples were collected at baseline and every 12 weeks. Routine biochemical tests including ALT, AST, etc. were measured by automated biochemical technique. HBV DNA was quantified using the TaqMan PCR assay. The levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were measured using a commercial chemiluminescent microparticle immunoassay.Results: The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks. At week 48, the mean Delta HBsAg level in Peg-IFN alpha-2b+TDF group was significantly higher than that in Peg-IFN alpha-2b +ETV group (-1.799 +/- 0.3063 vs. -1.078 +/- 0.2028, P=0.0491). The HBeAg loss rate was significantly higher in TDF add-on group than that in ETV add-on group at week 48 (40% vs. 10%, P=0.028). At week 48, the proportions of patients with undetectable HBV DNA (