Xiao Zhiqi, Zhou Fuyuan, Zhou Bin, Yang Jie
State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
Nan Fang Yi Ke Da Xue Xue Bao. 2019 Feb 28;39(2):150-155. doi: 10.12122/j.issn.1673-4254.2019.09.04.
To evaluate the therapeutic effects of entecavir (ETV) and interferon- (IFN-) treatments for 48 weeks for chronic hepatitis B (CHB) in patients with different baseline alanine aminotransferase (ALT) levels.
We retrospectively analyzed the data of 369 CHB patients receiving ETV and IFN- treatments for 48 weeks. We compared the virological response rates, HBsAg clearance, and HBsAg reduction between the patients receiving ETV and IFN- treatments with different baseline ALT levels[≤ 5×upper limits of normal (ULN) level (subgroup 1), 5-10×ULN (subgroup 2), and > 10× ULN (subgroup 3)].
In patients receiving ETV treatment, the virological response rate was 83.3% in subgroup 1, 91.4% in subgroup 2, and 95.5% in subgroup 3, as compared with 19.7%, 40%, and 42.9% in the 3 subgroups with IFN- treatment, respectively, showing significantly differences both among different subgroups with the same treatment and between the same subgroup with different treatments ( < 0.05). HBeAg clearance rates in the 3 subgroups were 8.3%, 16.7% and 35.5% in patients with ETV treatment and were 1.8%, 41.9%, and 38.1% in patients with IFN- treatment, respectively, showing significant differences among the 3 subgroups with the same treatment ( < 0.05); in the same subgroups with different treatments, the rates differed significantly only between subgroups 2 ( < 0.05). In ETV group, the rate of HBsAg reduction to below 200 IU/ml was 2.5% in subgroup 1 and 13.8% in subgroup 2, showing no significant difference between the two subgroups; in IFN- group, the rates were also similar between subgroups 1 and 2 (30.6% 33.3%, > 0.05); but the rates differed significantly between the same subgroups with different treatments ( < 0.05).
In all the subgroups with different baseline ALT levels, ETV treatment for 48 weeks results in significantly higher virological response rates than IFN- treatment in patients with CHB. In patients with a baseline ALT of 5-10 ×ULN, IFN- can result in a higher HBeAg clearance rate than ETV. In patients with comparable baseline ALT level, IFN- more effectively reduces HBsAg level than ETV. The patients with a relatively high baseline ALT level (> 5 × ULN) show better responses to both ETV and IFN- treatment than those with ALT level below 5×ULN. We thus recommend IFN- for patients with a baseline ALT of 5-10×ULN and ETV for patients with a baseline ALT either below 5 × ULN or beyond 10×ULN.
评估恩替卡韦(ETV)和干扰素-α(IFN-α)治疗48周对不同基线丙氨酸氨基转移酶(ALT)水平的慢性乙型肝炎(CHB)患者的疗效。
我们回顾性分析了369例接受ETV和IFN-α治疗48周的CHB患者的数据。我们比较了不同基线ALT水平[≤5×正常上限(ULN)水平(亚组1)、5 - 10×ULN(亚组2)和>10×ULN(亚组3)]的接受ETV和IFN-α治疗患者之间的病毒学应答率、HBsAg清除率及HBsAg下降情况。
接受ETV治疗的患者中,亚组1的病毒学应答率为83.3%,亚组2为91.4%,亚组3为95.5%;而接受IFN-α治疗的3个亚组的病毒学应答率分别为19.7%、40%和42.9%,同一治疗方法的不同亚组间以及同一亚组的不同治疗方法间均存在显著差异(P<0.05)。接受ETV治疗的3个亚组的HBeAg清除率分别为8.3%、16.7%和35.5%,接受IFN-α治疗的分别为1.8%、41.9%和38.1%,同一治疗方法的3个亚组间存在显著差异(P<0.05);同一亚组的不同治疗方法间,仅亚组2存在显著差异(P<0.05)。在ETV组,亚组1中HBsAg降至200 IU/ml以下的比例为2.5%,亚组2为13.8%,两组间无显著差异;在IFN-α组,亚组1和亚组2的比例也相似(30.6%对33.3%,P>0.05);但同一亚组的不同治疗方法间差异显著(P<0.05)。
在所有不同基线ALT水平的亚组中,CHB患者接受ETV治疗48周的病毒学应答率显著高于IFN-α治疗。基线ALT为5 - 10×ULN的患者,IFN-α治疗的HBeAg清除率高于ETV。在基线ALT水平相当的患者中,IFN-α降低HBsAg水平比ETV更有效。基线ALT水平相对较高(>5×ULN)的患者对ETV和IFN-α治疗的反应均优于ALT水平低于5×ULN的患者。因此,我们推荐基线ALT为5 - 10×ULN的患者使用IFN-α,基线ALT低于5×ULN或高于10×ULN的患者使用ETV。