TDF治疗妊娠降低HBV DNA，垂直传播的危险

StephenW

TDF therapy in pregnancy reduces HBV DNA, risk of vertical transmission

Chen H-L. Hepatology. 2015;doi:10.1002/hep.27837.
August 3, 2015

   
Viremic mothers treated with tenofovir disoproxil fumarate during pregnancy had decreased hepatitis B virus infection DNA levels in their blood, which reduced the infection’s DNA serum levels in infants at birth and reduced overall mother-to-child transmission, according to study data.


“We conducted this clinical trial with the aims of evaluating the efficacy of [tenofovir disoproxil fumarate] administration initiated at 30 [to] 32 weeks of gestation in highly viremic pregnant mothers, assessing the efficacy in reducing mother-to-infant HBV transmission, and monitoring safety for the mothers and infants during pregnancy and the postpartum period,” the researchers wrote.

In a prospective trial, researchers enrolled 118 pregnant women between 20 and 40 years of age who were positive for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) with HBV DNA levels at or greater than 7.5 log10 IU/mL. Each patient was randomly assigned to either no medication (n = 56) or 300 mg of tenofovir disoproxil fumarate (TDF) per day between 30 and 32 weeks of gestation until 1 month after birth (n = 62).

The primary outcome was to determine the infant’s rate of HBsAg at 6 months old, according to the research.

The women in the TDF group had lower maternal HBV DNA levels at infant delivery compared with the control group (4.29 ± 0.93 vs. 8.1 ± 0.56 log10 IU/mL; P < .0001). The duration of treatment positively correlated with the reduced viral loads.

“At the time of delivery, [1.79%] of mothers in the control group and [98.39%] of mothers in the TDF group had HBV DNA levels below 6 log10 IU/mL, a level considered to indicate minimal risk for maternal HBV transmission,” the researchers wrote.

Of 121 newborns, the babies in the TDF group had lower rates of HBV DNA positivity at birth compared with the control group (6.15% vs. 31.48%; P = .0003), as well as lower HBsAg positivity at 6 months old compared with the control group (1.54% vs. 10.71%; P = .0481).

Multivariate analysis showed that infants in the TDF group had lower risk of HBV DNA positivity (P = .0434). In addition, it showed amniocentesis to be associated with an increased risk of infant HBsAg positivity (P = .022).

Women in the TDF group had less incidence of alanine aminotransferase levels above two times the upper limit of normal for 3 or more months compared with the control group (3.23% vs. 14.29%; P = .0455); a lower rate of ALT over five times the upper limit of normal at 2 months postpartum compared with the controls (1.64% vs. 14.29%; P = .0135); and decreased postpartum elevations of ALT (P = .007).

Creatinine and creatinine kinase levels of the mother, rates of congenital anomaly, premature birth and growth parameters in infants were comparable in both the treated and control groups. Treatment was well tolerated. One month post-treatment, HBV viral loads increased among mothers in the treated group. The HBV DNA serum levels were comparable to the control group patients at 4 and 6 months postpartum.

At 12 months, one child whose mother was treated with TDF developed HBsAg positivity due to postnatal infection and inefficient humoral responses to vaccines, according to the research.

“Our study demonstrates that short-term TDF treatment leads to fast and effective reduction in HBV DNA in highly viremic HBsAg/HBeAg double-positive mothers,” the researchers concluded. “Such treatment resulted in decreased rates of serum HBV DNA positivity in the newborns’ peripheral blood and HBsAg positivity in the infants at 6 months of age.” – by Melinda Stevens

Disclosures: Chen reports no relevant financial disclosures. Please see the study for a full list of all other authors’ relevant financial disclosures.

StephenW

TDF治疗妊娠降低HBV DNA，垂直传播的危险

陈H-L。肝病。 2015年，DOI：10.1002 / hep.27837。
2015年8月3日

   
怀孕期间与富马酸替诺福韦酯治疗的病毒血症的母亲在他们的血液中，从而减少婴儿感染的DNA血清水平在出生时并降低总体母亲传染给孩子减少乙肝病毒感染DNA水平，根据研究数据。


“我们与评估[富马酸替诺福韦酯]政府在30发起的功效的宗旨进行这项临床试验[转]在高度毒血症孕妇妊娠32周，评估在减少母亲向婴儿传播乙肝病毒的疗效，并安全监测怀孕和产后期间的母亲和婴儿，“研究人员写道。

在未来的试验中，研究人员招收20至40岁的人谁是阳性的乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg），乙肝病毒DNA水平或大于7.5日志10 IU / mL的118孕妇。每个患者在出生后被随机分配到没有30和32周妊娠之间的药物（56）或300毫克富马酸替诺福韦酯（TDF）每天1个月为止（62例）。

主要成果是确定HBsAg的婴儿率6个月大，根据研究。

该妇女的TDF组中有较低的母体HBV DNA水平在婴儿分娩与对照组相比（4.29±0.93对8.1±0.56日志10 IU /毫升; P <0.0001）。治疗的持续时间正相关的降低病毒载量相关。

“在交货TDF组在对照组母亲的母亲和[98.39％]的时间，[1.79％]有HBV DNA低于6日志10 IU / mL时，认为表明风险最小产妇乙肝病毒传播的水平水平，“研究人员写道。

121新生儿中，TDF集团在婴儿的HBV DNA阳性率较低，出生时与对照组（6.15％和31.48％，P = 0.0003）相比，在6个月大，以及较低的HBsAg阳性与比较对照组（1.54％和10.71％，P = 0.0481）。

多因素分析表明，TDF组婴儿的HBV DNA阳性（P = 0.0434）的风险较低。此外，它表明能与婴幼儿的HBsAg阳性（P = 0.022）的风险增加相关的羊膜穿刺术。

妇女的TDF组有谷丙转氨酶水平的较少发生上述的正常为3个或更多个月，与对照组（3.23％对14.29％，P = 0.0455）相比，两倍的上限; ALT的较低速率超过正常五倍上限在产后2个月与对照（1.64％对14.29％，P = 0.0135）相比;和ALT下降产后升高（P = 0.007）。

母亲的肌酸酐和肌酐激酶水平，先天性异常，早产和婴儿生长参数的率可比在两个治疗组和对照组。治疗的耐受性良好。一个月的治疗后，乙肝病毒载量增加，治疗组的母亲中。乙型肝炎病毒DNA血清水平相媲美的对照组患者在4和6个月产后。

在12个月，一个孩子的母亲用TDF治疗乙肝表面抗原开发的积极性，由于产后感染和低效体液应答疫苗，根据研究。

“我们的研究表明，短期治疗TDF导致快速和有效的降低HBV DNA高度毒血症的HBsAg / e抗原双阳性的母亲，”研究人员得出结论。 “这样的处理导致在6个月的年龄降低了新生儿外周血乙肝表面抗原阳性的新生儿血清HBV DNA阳性率。” - 由梅琳达·史蒂文斯

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