[Clinical efficacy analysis of TMF for the treatment of hyperviremia HBeAg-positive chronic hepatitis B patients with incomplete response to first-line oral antiviral nucleos(t)ide analogues].

Objective: To prospectively explore the treatment strategies for clinical difficulties in patients with hyperviremia HBeAg-positive chronic hepatitis B with incomplete response to first-line nucleos(t)ide analogues (NAs). Methods: Patients with hyperviremia HBeAg-positive chronic hepatitis B were treated with first-line NAs, including entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) for 48 weeks or more. Tenofovir amibufenamide (TMF) or TAF therapy was changed when HBV DNA remained positive and then divided into a TMF group and a TAF group. Clinical efficacy of treatment was evaluated at 24 and 48 weeks, including HBV DNA undetectable rates and virological and serological responses in both patient groups. Results: In the TMF group and the TAF groups, 30 and 26 cases completed 24-week follow-up, while 18 and 12 cases completed 48-week follow-up. There were no statistically significant differences in baseline HBV DNA, HBsAg, and HBeAg levels between the two groups before switching to TMF/TAF therapy (P > 0.05). At 24 weeks of treatment, 19 (19/30, 63.33%) cases in the TMF group had HBV DNA negative conversion, while 14 (14/26, 53.85%) cases in the TAF group had HBV DNA negative conversion (P > 0.05). Among the patients who completed 48 weeks of follow-up, 15 (15/18, 83.33%) cases in the TMF group and 7 (7/12, 58.33%) cases in the TAF group had negative HBV DNA tests (P > 0.05). The changes in HBsAg and HBeAg levels between the two groups of patients at 24 and 48 weeks of treatment were not statistically significant compared to baseline (P > 0.05). Conclusion: TMF is effective in treating patients with hyperviremia HBeAg-positive CHB with an incomplete response to first-line NAs treatment, but there is no significant difference compared to TAF.目的： 对乙型肝炎e抗原（HBeAg）阳性高病毒血症慢性乙型肝炎（CHB）患者应用一线核苷（酸）类似物（NAs）治疗不完全应答的临床难点问题，前瞻性探索NAs经治不完全应答患者的治疗策略。 方法： HBeAg阳性高病毒血症CHB患者应用一线NAs治疗，包括恩替卡韦、富马酸替诺福韦二吡呋酯（TDF）、富马酸丙酚替诺福韦（TAF）治疗48周及以上，若HBV DNA仍阳性，更换为艾米替诺福韦（TMF）或TAF治疗，分别为TMF组及TAF组。评价2组患者治疗24周及48周的HBV DNA阴转率、病毒学及血清学应答情况。计量资料组间比较采用t检验，计数资料组间比较采用χ(2)检验或Fisher确切概率法。 结果： TMF组、TAF组分别有30例、26例患者完成24周随访，18例、12例患者完成48周随访。2组患者在更换为TMF/TAF治疗前的基线HBV DNA（t = 0.390，P = 0.698）、HBsAg（t = 1.492，P = 0.142）和HBeAg（t = 0.555，P = 0.581）水平差异均无统计学意义。治疗24周，TMF组有19例（19/30，63.33%）HBV DNA阴转，TAF组14例（14/26，53.85%）HBV DNA阴转（χ(2) = 0.518，P = 0.472）。在完成48周随访的患者中，TMF组、TAF组分别有15例（15/18，83.33%）、7例（7/12，58.33%）患者HBV DNA检测为阴性（χ(2) = 2.301，P = 0.210）。2组患者治疗24周、48周的HBsAg和HBeAg水平与基线相比，差异无统计学意义（P>0.05）。 结论： TMF治疗HBeAg阳性高病毒血症CHB口服一线NAs经治不完全应答的患者有效，但与TAF相比，无明显差异。.