Department of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Infectious Diseases, Ezhou Central Hospital, Ezhou, China.
J Viral Hepat. 2023 May;30(5):427-436. doi: 10.1111/jvh.13792. Epub 2023 Jan 6.
Although there are therapeutic advantages for hepatitis B virus (HBV) withpegylated interferon alpha (peg-IFNα) treatment compared with nucleos(t)ide analog (NAs) therapy, the effect difference in infected population at different phases has not been well established. We studied the clinical efficacy of peg-IFNα in two populations with HBV infection, including inactive HBsAg carrier (IHC) and chronic hepatitis B (CHB). A total of 328 HBV-infected patients were included in this real-world analysis. Patients were divided into two groups according to the infected stages. Peg-IFNα monotherapy or combination therapy with NAs were used in IHCs, and peg-IFNα added-on NAs therapy was applied to patients with CHB. The primary efficacy endpoint was HBsAg loss at Week 24. Results: The Kaplan-Meier cumulative rates of HBsAg loss were 39.50% (n = 47/119) in IHC group and 28.71% (n = 60/209) in CHB group at Week 24 (p < .05). After Propensity Score Matching (PSM), the HBsAg loss rates were 36.84% (n = 35/95) and 32.63% (n = 31/95), respectively (p > .05). Patients with baseline HBsAg level < 100 IU/ml achieved higher rates of HBsAg clearance in IHC and CHB group (before PSM: 47.44% vs. 42.86%, after PSM: 49.12% vs. 45.83%, all p values > .05). Baseline HBsAg level and its level decline from baseline to Week 12 can be as the predictors for HBsAg loss at Week 24 in both groups. Hence, the efficacy of HBsAg clearance was broadly similar between IHCs and NA-treated CHB patients during the early peg-IFNα therapy. A significant downward trend of HBsAg level was observed in both groups during peg-IFNα therapy.
虽然聚乙二醇干扰素 alpha(peg-IFNα)治疗乙型肝炎病毒(HBV)与核苷(酸)类似物(NAs)治疗相比具有治疗优势,但在不同阶段感染人群中的效果差异尚未得到很好的证实。我们研究了 peg-IFNα 在两种乙型肝炎病毒感染人群中的临床疗效,包括乙型肝炎表面抗原(HBsAg)携带者(IHC)和慢性乙型肝炎(CHB)。这项真实世界分析共纳入 328 名 HBV 感染患者。根据感染阶段,患者分为两组。IHC 患者采用 peg-IFNα 单药或与 NAs 的联合治疗,CHB 患者采用 peg-IFNα 加用 NAs 治疗。主要疗效终点是第 24 周时 HBsAg 丢失。结果:在第 24 周时,IHC 组的 HBsAg 丢失累积率为 39.50%(n=47/119),CHB 组为 28.71%(n=60/209)(p<.05)。经过倾向评分匹配(PSM)后,HBsAg 丢失率分别为 36.84%(n=35/95)和 32.63%(n=31/95)(p>.05)。基线 HBsAg 水平<100 IU/ml 的患者在 IHC 和 CHB 组中获得更高的 HBsAg 清除率(PSM 前:47.44%比 42.86%,PSM 后:49.12%比 45.83%,所有 p 值均>.05)。基线 HBsAg 水平及其从基线到第 12 周的下降水平可作为两组患者第 24 周时 HBsAg 丢失的预测因素。因此,在 peg-IFNα 治疗早期,IHC 和 NA 治疗的 CHB 患者之间 HBsAg 清除的疗效大致相似。在 peg-IFNα 治疗期间,两组患者的 HBsAg 水平均呈显著下降趋势。