Vemlidy防止乙型肝炎從母親傳播到嬰兒

StephenW

Vemlidy Prevents Transmission of Hepatitis B From Mother to Infant

Two different studies found that Vemlidy was safe and effective for pregnant women and their infants.

November 30, 2020 • By Sukanya Charuchandra

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Vemlidy (tenofovir alafenamide, or TAF) was found to prevent transmission of hepatitis B virus (HBV) from mother to infant, based on two studies presented at the AASLD Liver Meeting Digital Experience.

HBV is commonly transmitted from mother to child. Transmission can be prevented by vaccinating the infant at birth, and further bolstered by the administration of hep B immunoglobulin, or injected antibodies. But when pregnant women have a high viral load, these precautions can be insufficient.

According to the World Health Organization, pregnant women having a high viral load should be given tenofovir from week 28 of pregnancy until delivery. This was based on research that found Viread (tenofovir disoproxil fumarate, or TDF) is safe and effective at preventing HBV transmission from mother to child.

Vemlidy is a newer formulation of tenofovir that is less toxic to the kidneys and bones compared to Viread. On the other hand, Vemlidy is also linked with higher blood lipid levels and a higher risk of weight gain. But little information in available on the safety and efficacy of Vemlidy administration during pregnancy as a means of preventing vertical transmission of hep B.

Calvin Q. Pan, MD, of NYU Langone Health in New York City, and colleagues ran a multicenter study that enrolled 71 mothers who were positive for hepatitis B ’e’ antigen between December 2018 and May 2020. These women received Vemlidy during their second or third trimester to prevent vertical transmission. Their children were given hepatitis B immunoglobulin and multiple doses of the HBV vaccine at birth and at one and six months after birth.

Around 78% of the study population adhered to their daily antiviral regimen. The researchers found that 86% of mothers experienced a reduction in HBV viral load below 200,000 IU/mL at the time of delivery, with an average drop of 3.69 log IU/mL over the course of treatment, resulting in an average value of 4.09 log IU/mL at delivery.

All of the delivered infants tested negative for hepatitis B surface antigen (HBsAg), which is a sign of current infection. Despite two thirds of these babies being breastfed, none became infected.

The researchers found that the mothers and infants did not experience any severe adverse events, and no congenital defects were observed in the babies. These infants also met national standard measures for weight, height and head circumference. About 16% of the mothers had abnormal levels of the liver enzyme alanine transaminase (ALT).

“TAF therapy for highly viremic mothers was well tolerated and effectively prevented mother-to-child transmission of HBV,” the researchers said.

In another study, Qing-Lei Zeng, MD, of the The First Affiliated Hospital of Zhengzhou University, in China, and colleagues conducted a multicenter study including pregnant women with high levels of HBV DNA. These 232 women received Vemlidy or Viread from weeks 24 to 35 of pregnancy. Their babies were given hepatitis B immunoglobin at birth and doses of the HBV vaccine at birth and at months one and six.

Women in this study all completed their course of treatment. All the women had a drop in HBV DNA levels at the time of delivery, by about 3,000 IU/mL for those on Vemlidy and 2,500 UI/mL for those on Viread.

None of the infants born to these women, including those who were breastfed, tested positive for HBsAg at seven months. Further, they had no congenital defects and their physical and neurological measures were comparable to the World Health Organization’s standard and the national average in China.

Vemlidy was well tolerated, with no discontinuations because of adverse effects. Themost common adverse event was (19%). A few women had abnormal levels of ALT.

The researchers concluded that “TAF was safe for highly viremic pregnant women and their infants until 7 months, and reduced the mother-to-child rate of HBV to 0%.”

Click here to read the first study abstract from The Liver Meeting Digital Experience.

Click here to read the second study abstract from The Liver Meeting Digital Experience.

StephenW

Vemlidy防止乙型肝炎從母親傳播到嬰兒

兩項不同的研究發現，Vemlidy對孕婦及其嬰兒是安全有效的。

2020年11月30日•Sukanya Charuchandra發表

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根據AASLD肝臟會議數字體驗會議上發表的兩項研究，發現Vemlidy（替諾福韋alafenamide或TAF）可防止乙型肝炎病毒（HBV）從母親傳播給嬰兒。

乙肝病毒通常從母親傳播給孩子。可以通過在出生時給嬰兒接種疫苗來預防傳播，並通過給予Hep B免疫球蛋白或註射的抗體進一步加強傳播。但是，當孕婦的病毒載量很高時，這些預防措施可能是不夠的。

根據世界衛生組織的報告，從懷孕第二十八周到分娩前，應向病毒載量高的孕婦服用替諾福韋。這是基於一項研究發現的，Viread（替諾福韋富馬酸替諾福韋酯或TDF）在預防HBV從母嬰傳播方面是安全有效的。

Vemlidy是替諾福韋的較新配方，與Viread相比，對腎臟和骨骼的毒性較小。另一方面，Vemlidy也與較高的血脂水平和較高的體重增加風險相關。但是，關於懷孕期間使用Vemlidy作為預防乙肝垂直傳播的安全性和有效性的信息很少。

紐約市紐約大學朗格健康中心的醫學博士Calvin Q. Pan和同事進行了一項多中心研究，納入了71位在2018年12月至2020年5月之間檢測出乙型肝炎e抗原陽性的母親。這些婦女在第二次接受Vemlidy治療或中期，以防止垂直傳播。他們的孩子在出生時以及出生後一個月和六個月時均接種了乙肝免疫球蛋白和多劑HBV疫苗。

大約78％的研究人群堅持每日抗病毒治療方案。研究人員發現，有86％的母親在分娩時將HBV病毒載量降低到200,000 IU / mL以下，在治療過程中平均下降了3.69 logIU / mL，平均平均值為4.09 log分娩時IU / mL。

所有分娩的嬰兒的乙型肝炎表面抗原（HBsAg）均呈陰性，這表明當前已感染。儘管這些嬰兒中有三分之二是母乳喂養的，但沒有一個被感染。

研究人員發現，母嬰沒有發生任何嚴重的不良事件，嬰兒中也沒有觀察到先天性缺陷。這些嬰兒還符合體重，身高和頭圍的國家標準。大約16％的母親的肝酶丙氨酸轉氨酶（ALT）水平異常。

研究人員說：“針對高病毒血症母親的TAF療法具有良好的耐受性，可以有效防止母嬰傳播HBV。”

在另一項研究中，中國鄭州大學第一附屬醫院的曾慶磊醫學博士及其同事進行了一項多中心研究，其中包括高水平HBV DNA孕婦。這232名婦女在懷孕的第24至35週內接受了Vemlidy或Viread。他們的嬰兒在出生時和接種後的第一個月和第六個月接受了乙型肝炎免疫球蛋白治療，並接種了乙肝疫苗。

本研究中的女性均已完成治療過程。所有婦女在分娩時的HBV DNA水平都下降了，Vemlidy組的女性下降了約3,000 IU / mL，Viread組的女性下降了2,500 UI / mL。

這些婦女（包括母乳喂養的婦女）出生的嬰兒在七個月內均未檢測出HBsAg陽性。此外，它們沒有先天性缺陷，其物理和神經學措施可與世界衛生組織的標準和中國的全國平均水平相提並論。

Vemlidy具有良好的耐受性，不會因不良反應而停藥。最常見的不良事件是（19％）。少數婦女的ALT水平異常。

研究人員得出結論：“ TAF對高病毒血症孕婦及其嬰兒至7個月都是安全的，並將HBV的母嬰率降至0％。”

單擊此處以閱讀《肝臟會議數字體驗》中的第一篇研究摘要。

單擊此處以閱讀《肝臟會議數字體驗》中的第二篇研究摘要。

StephenW

https://www.hepmag.com/article/v ... tis-b-mother-infant