Department of Infectious Diseases Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.
Community Health Service Center of Lin He Street, Guangzhou, China.
Antivir Ther. 2020;25(1):33-41. doi: 10.3851/IMP3345.
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.
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.
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).
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.
替比夫定（LdT）和替诺福韦（TDF）广泛用于孕妇以预防垂直传播；然而，关于这两种药物的临床疗效和安全性差异的数据有限。
共纳入 307 例 HBeAg 阳性的孕妇，这些患者具有完整的随访数据，且基线时丙氨酸氨基转移酶（ALT）水平<1×正常值上限（ULN）的患者被纳入队列 1，从 28±4 孕周开始治疗至分娩，而基线时 ALT 水平>1×ULN 的患者被纳入队列 2，从 28±4 孕周开始治疗并持续至分娩后。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 例患者进行了核苷类似物（NA）相关耐药突变的基线和分娩后的分析。
结果显示，与基线相比，分娩时 HBV DNA 水平显著降低（P<0.001），但在两个队列中，LdT 和 TDF 治疗患者在不同时间点的 HBV DNA、ALT、总胆红素和总胆汁酸水平的降低没有差异（P>0.05）。然而，TDF 治疗患者的胃肠道不良反应（呕吐）发生率高于 LdT 治疗患者（6.6%对 0.0%；P=0.001）。队列 1 中 NA 相关耐药突变分析结果显示，LdT 或 TDF 的短期治疗并未显著改变 NA 相关耐药突变（P>0.05）。
本研究表明，LdT 或 TDF 治疗 HBeAg 阳性中国孕妇的临床疗效相似，TDF 治疗患者更常发生胃肠道不良反应。
