替諾福韋阿拉法酰胺富馬酸酯治療可預防高病毒血症慢性乙

StephenW

Tenofovir alafenamide fumarate therapy for the prevention of hepatitis B vertical transmission in highly viremic mothers with chronic hepatitis B



TAF in Pregnancy Helps Prevent Maternal Transmission of HBV to Infants

AASLD The Liver Meeting Digital Experience, November 13-16, 2020

Mark Mascolini

Tenofovir alafenamide (TAF) taken during the second and third trimester helped prevent mother-to-child transmission of HBV in a 71-woman, 73-infant nationwide observational analysis in China [1]. A similar 116-woman/117-infant study in China will be presented later at AASLD The Liver Meeting [2]. Both studies involved women with chronic HBV infection and an HBV load above 200,000 IU/mL.

Researchers who conducted the 71-woman study [1] noted that randomized controlled trials found lower perinatal transmission of HBV in women with high HBV loads taking the anti-HBV agents lamivudine, telbivudine, and tenofovir disoproxil fumarate (TDF). To assess the impact of TAF in preventing HBV transmission, a China/US team planned this multicenter, single-arm national cohort study [1], which was published online a few months before AASLD The Liver Meeting [3].

The investigators retrospectively enrolled women positive for HBeAg (indicating active HBV infection) with HBV DNA above 200,000 IU/mL. All women took TAF to prevent perinatal HBV transmission between December 4, 2018 and May 18, 2020. At birth infants received hepatitis B immunoglobulin, and they got the HBV vaccination at birth, 1 month, and 6 months.

The 71 women enrolled averaged 30.3 years in age when they started TAF in the second or third trimester. They took this anti-HBV nucleotide for an average 12.8 weeks until delivery. Neither women nor infants had severe adverse effects, and infants had no congenital defects or malformations. Growth measures in infants did not vary much from national standards for physical development. Eleven of 71 women (15.5%) had postpartum alanine aminotransferase (ALT) flares, with an average ALT peak of 140.2 U/mL.

Adherence to daily TAF before delivery stood at 77.5%. Sixty-one of 71 women (86%) reached an HBV DNA load below 200,000 IU/mL by delivery. HBV DNA dwindled by an average 3.69 log10 IU/mL from starting TAF to delivery, when HBV load averaged 4.09 log10 IU/mL (about 12,000 IU/mL).

After completing the immunoprophylaxis described above by age 24 to 28 weeks, all infants tested negative for HBsAg (indicating current HBV infection) and had undetectable HBV DNA (below 100 IU/mL). Two thirds of infants breastfed, and this did not affect chances of HBV acquisition.

The researchers concluded that TAF prophylaxis during pregnancy raises no safety concerns for mothers or infants and contributes to prevention of mother-to-child HBV transmission. They called for prospective studies with longer follow-up to confirm their results. Meanwhile, the investigators believe their study “suggests that TAF should be considered as one of the first-line treatments for preventing mother to child transmission [of HBV] in this special population” [3].

References
1. Ding Y, Cao L, Zhu L, et al. Tenofovir alafenamide fumarate therapy for the prevention of hepatitis B vertical transmission in highly viremic mothers with chronic hepatitis B. AASLD The Liver Meeting Digital Experience, November 13-16, 2020. Abstract 20.
2. Zeng QL, Yu Z, Wang FS. Tenofovir alafenamide to prevent perinatal hepatitis B transmission in mothers with high viral load: a multicenter, prospective, observational study. AASLD The Liver Meeting Digital Experience, November 13-16, 2020. Abstract 160.
3. Ding Y, Cao L, Zhu L, et al. Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. Aliment Pharmacol Ther. 2020;52:1377-1386. doi: 10.1111/apt.16043. https://onlinelibrary.wiley.com/doi/abs/10.1111/apt.16043

StephenW

替諾福韋阿拉法酰胺富馬酸酯治療可預防高病毒血症慢性乙型肝炎母親的乙型肝炎垂直傳播



孕婦中的TAF有助於防止母嬰傳播HBV。

AASLD肝臟會議數字體驗，2020年11月13日至16日

馬克·馬斯科利尼

在中國，由71名婦女和73名嬰兒組成的全國性觀察分析顯示，在妊娠中期和中期服用替諾福韋alafenamide（TAF）有助於預防母嬰傳播HBV [1]。稍後將在AASLD肝臟會議上發表類似的在中國由116名婦女/ 117名嬰兒組成的研究[2]。兩項研究均涉及患有慢性HBV感染且HBV負荷超過200,000 IU / mL的女性。

進行71位婦女研究的研究人員[1]指出，隨機對照試驗發現，服用抗HBV藥物拉米夫定，替比夫定和替諾福韋二富馬酸富馬酸（TDF）的高HBV感染婦女的圍產期HBV傳播率較低。為了評估TAF對預防HBV傳播的影響，一個中美團隊計劃了這項多中心，單組國家隊列研究[1]，該研究在AASLD肝臟會議[3]之前的幾個月內在線發表。

研究者回顧性收集了HBeAg陽性（表明活動性HBV感染）且HBV DNA高於200,000 IU / mL的女性。所有婦女均於2018年12月4日至2020年5月18日之間接受TAF預防圍產期HBV傳播。分娩時，嬰兒接受了乙型肝炎免疫球蛋白，並在出生後1個月和6個月接種了HBV疫苗。

在中期或中期開始進行TAF的71名女性平均年齡為30.3歲。他們平均服用該抗HBV核苷酸12.8週，直到分娩為止。婦女和嬰兒均無嚴重不良反應，嬰兒無先天性缺陷或畸形。嬰兒的生長指標與國家身體發育標準差異不大。 71名女性中有11名（15.5％）患有產後丙氨酸氨基轉移酶（ALT）耀斑，平均ALT峰值為140.2 U / mL。

分娩前每天TAF的堅持率為77.5％。 71名婦女中有61名（86％）通過分娩達到了低於200,000 IU / mL的HBV DNA負荷。從開始TAF到分娩，當HBV負荷平均為4.09 log10 IU / mL（約12,000 IU / mL）時，HBV DNA平均減少3.69 log10 IU / mL。

在24至28週齡之前完成上述免疫預防後，所有嬰兒的HBsAg均呈陰性（表明當前為HBV感染），並且檢測不到HBV DNA（低於100 IU / mL）。三分之二的嬰兒進行母乳喂養，這並不影響獲得HBV的機會。

研究人員得出結論，懷孕期間預防TAF不會對母親或嬰兒造成安全隱患，並有助於預防母嬰HBV傳播。他們呼籲進行長期隨訪的前瞻性研究，以證實其結果。同時，研究人員認為，他們的研究“建議應將TAF視為預防這一特殊人群[HBV]母嬰傳播的一線治療方法” [3]。

參考文獻
1.丁Y，曹L，朱L等。替諾福韋阿拉芬酰胺富馬酸酯療法可預防慢性乙型肝炎高病毒血症母親的乙型肝炎垂直傳播。AASLD肝臟會議數字體驗，2020年11月13日至16日。摘要20。
2.曾慶良，於忠，王FS。替諾福韋阿拉芬酰胺預防高病毒載量母親的圍產期乙型肝炎傳播：一項多中心，前瞻性和觀察性研究。 AASLD肝臟會議數字體驗，2020年11月13日至16日。摘要160。
3.丁Y，曹L，朱L等。替諾福韋阿拉芬酰胺富馬酸酯預防乙型肝炎病毒母嬰傳播的功效和安全性：一項國家隊列研究。食品藥理學。 2020; 52：1377-1386。 doi：10.1111 / apt.16043。 https://onlinelibrary.wiley.com/doi/abs/10.1111/apt.16043