Volume 61, Issue 3, September 2014, Pages 502–507
Cover image
Research Article
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus
Astrid-Jane Greenup1,
Pok Kern Tan1,
Vi Nguyen1,
Anne Glass1,
Scott Davison1,
Ushmi Chatterjee2,
Susan Holdaway3,
Dev Samarasinghe3,
Kathy Jackson4,
Stephen A. Locarnini4,
Miriam T. Levy1, 2, ,
DOI: 10.1016/j.jhep.2014.04.038
Background & Aims
Perinatal transmission of hepatitis B virus still occurs despite immunoprophylaxis in approximately 9% of children from highly viraemic mothers. Antiviral therapy in this setting has been suggested, however with limited evidence to direct agent choice.
Methods
We conducted a multi-centre, prospective, opt-in observational study of antiviral safety and efficacy in pregnant women with high viral load (>7 log IU/ml); lamivudine was used from 2007 to 2010 and tenofovir disoproxil fumarate (TDF) from late 2010. Outcomes of treated and untreated cohorts were compared.
Results
120 women with 130 pregnancies used TDF (58), lamivudine (52 including four who switched due to TDF intolerance) and no therapy (20). 96% were HBeAg positive, with baseline viral load mean 7.8 log IU/ml (±0.72) and ALT median 25 U/L (18.75–33). Duration of antiviral theraphy before birth was mean 58 days (±19) TDF and 53 (±14) lamivudine. Viral load declined by 3.64 log IU/ml (±0.9) TDF and 2.81 log IU/ml (±1.33) lamivudine. Virologic failure (birth viral load >7 IU/ml) occurred in 3% and 18% respectively. Congenital abnormality rate and neonatal growth centiles were similar across cohorts. Perinatal transmission reduced significantly to 2% and 0% in TDF and lamivudine cohorts, compared with 20% in untreated.
Conclusions
TDF in this setting is safe, effective and more potent than lamivudine. Antiviral therapy did not adversely impact obstetric or infant parameters. More TDF intolerance occurred than expected. Perinatal transmission was significantly reduced in antiviral therapy cohorts.
Corresponding author. Address: Department of Gastroenterology and Hepatology (Locked Mail Bag 7103), Liverpool Hospital, Elizabeth St, Liverpool, New South Wales 2170, Australia. Tel.: +61 287384085; fax: +61 287383094.
120妇女怀孕130使用TDF（58），拉米夫定（52，包括4谁交换由于TDF不耐受），不治疗（20）。 96％的HBeAg阳性，与基线病毒载量平均7.8登录国际单位/毫升（±0.72）和ALT值25 U / L（18.75-33）。出生前的抗病毒联合治疗的时间为平均58天数（±19）TDF和53（±14）拉米夫定。病毒载量由3.64下降登录国际单位/毫升（±0.9），TDF和2.81日志IU/毫升（±1.33），拉米夫定。病毒学失败（出生病毒载量>7 IU /毫升）分别发生在3％和18％。先天性畸形率和新生儿的生长百分位数分别为跨世代相似。母婴传播显著至2％，在TDF和拉米夫定队列0％减少，与在未经处理的20％进行比较。
结论