TDF减少母婴传播的病毒血症高母亲

StephenW

Da Hee Han, PharmD
November 17, 2015
TDF Reduces Perinatal HBV Transmission in Highly Viremic Mothers


SAN FRANCISCO, CA—Treatment with tenofovir disoproxil fumarate (TDF) in late pregnancy in highly viremic mothers with hepatitis B virus (HBV) infection effectively reduced mother-to-child transmission, a study reported at The Liver Meeting® 2015.

“The treatment was well tolerated, and no safety concerns were identified,” Calvin Pan, MD, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, NYU School of Medicine, New York, NY, and colleagues have found.

They recommended that TDF “be strongly considered for mothers whose HBV DNA levels exceed 200,000 IU/mL,” with treatment be initiated at gestation Week 30–32.

Dr. Pan noted that data on using such agents to prevent mother-to-child transmission of HBV “are scarce. The investigators conducted a multi-center, prospective, randomized controlled study in 5 US regions in which hepatitis B e antigen (HBeAg)-positive mothers with HBV DNA levels >200,000 IU/mL were randomly assigned 1:1 to receive TDF from gestation Week 30–32 to postpartum Week 4 (n=97) or no treatment (n=100).

The mothers were followed until postpartum Week 28, and all infants received immunoprophylaxis.

The primary outcome was mother-to-child transmission rate; endpoints included safety with TDF, maternal HBV DNA reduction at delivery, and HBeAg or hepatitis B s antigen loss/seroconversion at postpartum Week 28. A total of 180 mothers completed the study.

“At postpartum Week 28, the mother-to-child transmission rate was significantly lower in infants from TDF-treated mothers when compared to those from non-treated mothers,” they reported. This was observed in both the per-protocol analysis set (0% vs. 6.82%, P=0.013) and the intention-to-treat analysis set (5.16% vs. 18.0%, P=0.007).

The safety profile was similar between the two groups, with no difference in birth defect rates: 2.11% with TDF exposure vs. 1.14% without exposure (P=1.00).

In the TDF-treated mothers, HBV DNA levels decreased to <200,000 IU/mL in 68% prior to delivery, compared with 2.0% (2/100) in non-treated mothers (P<0.001). “The HBV serologic outcome did not differ between groups,” they concluded.

StephenW

大韩熙，药学博士
二○一五年十一月十七日
TDF减少母婴传播的病毒血症高母亲


新浪科技讯北京时间CA-治疗富马酸替诺福韦酯（TDF）的妊娠合并乙型肝炎病毒高病毒血症母亲晚（HBV）感染有效降低母亲传染给孩子，报道肝脏Meeting®2015年的研究。

“治疗的耐受性良好，没有安全问题进行了鉴定，”卡尔文潘医师，胃肠病学和肝病，纽约大学朗格尼医学中心，纽约，纽约州的纽约大学，和同事处找到。

他们建议，TDF“强烈考虑母亲的HBV DNA水平超过20万IU / mL时，”治疗可以在妊娠30-32周启动。

潘医生指出，使用这种药物，以防止母亲传染给孩子乙肝病毒“的数据很少。研究人员在5个美国地区中，乙肝e抗原（HBeAg）阳性的母亲与HBV DNA水平> 20万IU / mL的进行了多中心，前瞻性，随机对照研究，随机分配的1：1，从妊娠周获得TDF 30-32产后第4周（N = 97）或不治疗（N = 100）。

在母亲被随访至产后28周，和所有婴儿接受免疫预防。

主要成果是母亲对孩子的传输速率;终点包括安全与TDF，产妇HBV DNA减少分娩时，和HBeAg或乙型肝炎S抗原损失/血清转换在产后28周共180母亲完成了研究。

“在产后28周，相对于那些来自非治疗母亲的母亲传染给孩子率为来自TDF治疗母亲的婴儿显著降低，”他们的报告。这个发现，无论按方案分析集（0％和6.82％，P = 0.013）和意向性治疗分析集（5.16％比18.0％，P = 0.007）。

在安全性是两组相似，在出生缺陷率没有差异：无暴露2.11％，与TDF曝光与1.14％（P = 1.00）。

在TDF处理的母亲，HBV DNA水平交付之前降低至<200000国际单位/毫升的68％，其中2.0％（2/100）在未处理的母亲（P <0.001）。 “乙肝血清学结果并没有不同群体之间，”他们的结论。