Haohui Deng, Shuzhen Liang, Min Xu, Li Zhuo, Hongbo Gao, Keng Chen, Yuming Shi, Huihui Li, Qian Jiao, Liansheng Lin, Yan Lei, Huiyuan Liu
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引用次数: 0
摘要
背景:替比夫定(LdT)和替诺福韦(TDF)被广泛用于孕妇预防垂直传播;然而，关于两种药物的临床疗效和安全性差异的数据有限。方法:选取随访资料完整的乙型肝炎e抗原(HBeAg)阳性孕妇307例，将基线丙氨酸转氨酶(ALT)水平1×ULN的患者纳入队列2，从妊娠28±4周开始治疗，分娩后继续治疗。比较LdT和tdf治疗患者的临床疗效和安全性。此外，对队列1中的32例患者在基线和分娩后进行核苷类似物(NA)相关耐药突变分析。结果:两组患者分娩时HBV DNA水平均显著低于基线水平(P0.05)。然而，tdf治疗的胃肠道不良反应(呕吐)发生率高于ldt治疗的患者(6.6% vs 0.0%;P = 0.001)。队列1的na相关耐药突变分析结果显示，短期LdT或TDF治疗没有显著改变na相关耐药突变(P>0.05)。结论:本研究揭示了LdT或tdf治疗hbeag阳性中国孕妇的临床疗效相似，且tdf治疗的患者胃肠道不良反应发生率更高。
Clinical efficacy and safety in telbivudine- or tenofovir-treated hepatitis B e antigen-positive pregnant women.
Background: Telbivudine (LdT) and tenofovir (TDF) are widely used in pregnant women to prevent vertical transmission; however, limited data are available on the differences in clinical efficacy and safety between the two drugs.
Methods: A total of 307 hepatitis B e antigen (HBeAg)-positive pregnant women with complete follow-up data were enrolled, the patients with alanine aminotransferase (ALT) levels <1×ULN at baseline were enrolled to cohort 1 for treatment from 28 ±4 weeks gestation to delivery, while ALT levels >1×ULN at baseline were enrolled to cohort 2 for treatment from 28 ±4 weeks gestation and continued after delivery. The clinical efficacy and safety was compared in LdT- and TDF-treated patients. In addition, 32 patients in cohort 1 were analysed for nucleoside analogue (NA)-related resistance mutations at baseline and after delivery.
Results: The results showed that HBV DNA levels were significantly lower at delivery than at baseline (P<0.001), but the decreases in HBV DNA, ALT, total bilirubin and total bile acid levels did not differ between the LdT- and TDF-treated patients at different time points (P>0.05) in the two cohorts. However, gastrointestinal adverse effects (vomiting) occurred more frequently in TDF-treated than LdT-treated patients (6.6% versus 0.0%; P=0.001). The results of NA-related resistance mutations analysis in cohort 1 revealed that short-term LdT or TDF treatment did not significantly change the NA-related resistance mutations (P>0.05).
Conclusions: This study revealed that the clinical efficacy in LdT- or TDF-treated HBeAg-positive Chinese pregnant women is similar, and gastrointestinal adverse effects occurred more frequently in TDF-treated patients.
期刊介绍：
Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases.
The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.
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