妊娠中のテノフォビルとB型肝炎ウイルスの感染: ランダム化臨床試験
Calvin Q Pan1,2, Erhei Dai3, Zhongfu Mo4
1Guangzhou Medical Research Institute of Infectious Diseases, Center for Liver Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.
JAMA
|November 14, 2024
まとめ
B型肝炎ウイルス (HBV) 濃度が高い母親の妊娠16週にテノフォビルディゾプロキシルフマリート (TDF) の投与を開始することは,28週に標準治療より劣らない. この戦略は,特にHBIGが利用できない場合に,HBVの母子感染 (MTCT) を効果的に防止します.
科学分野:
- ヘパトロジー
- ウイルス学
- 産婦人科
背景:
- B型肝炎ウイルス (HBV) の母から子への感染 (MTCT) の標準的な予防には,妊娠28週から始まる母親の抗ウイルス予防と乳児のワクチン接種とHBIGが含まれます.
- B型肝炎の免疫グロブリン (HBIG) は,資源が限られている多くの環境では利用できませんので,代替戦略が必要になります.
研究 の 目的:
- 妊娠16週にテノフォビルディゾプロキシルフーマレート (TDF) を開始することは,高度にウイルス性である母親のHBV MTCTを予防するための標準の28週間のレジメンスに劣らないかどうかを評価する.
- 標準治療 (TDF 28週,乳児ワクチン,HBIG) と比較して,妊娠16週でのTDFと乳児HBVワクチン併用の有効性を評価する.
主な方法:
- HBV DNA > 200,000 IU/ mL の 280 人の妊婦を含む無盲,ランダム化,非劣等性試験.
- 参加者は,妊娠16週または妊娠28週からTDFを受けるようにランダムに割り当てられました.
- 乳児における検出可能なHBVDNAまたはHBsAg陽性によって定義されたMTCT率でした.
主要な成果:
- MTCT率は16週間のTDF群で0. 76%であり,28週間のTDF群では0%であった (プロトコル別分析: 0% 対 0%).
- 差異は劣等感がない基準を満たした (90%CI < 3%の上限).
- 16週間のTDFグループは28週間のグループ (6. 3%) に比べて先天性欠陥の割合が低い.
結論:
- 妊娠16週からTDFを開始することは,高度にウイルス性妊娠患者におけるHBV MTCTを予防するための標準の28週間のレジメンに劣らない.
- このTDFの初期化戦略は,HBIGが不足している地域では実行可能な代替案です.
- この発見は,母親と乳児のアウトカムを改善するために,HBV予防プロトコルを最適化することを支持しています.
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