慢性HCV感染の小児におけるダクラタスビル+ソフォスブービルの薬動学,安全性,有効性および受容性
Ahmed N Farrag1, Maggie M Abbassi1, Nirmeen A Sabry1
1Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
まとめ
慢性C型肝炎ウイルス (HCV) の子供に対して,成人用量の半分のソフォスブービル (SOF) とダクラタスビル (DCV) を検証した研究があります. この療法の安全性,有効性,受容性は成人の治療に匹敵することが示されました.
科学分野:
- ヘパトロジー
- 薬理学
- 子供 の 感染症
背景:
- Sofosbuvir (SOF) と daclatasvir (DCV) は慢性C型肝炎ウイルス (HCV) の主要な治療法です.
- WHOのガイドラインは,薬動学モデルに基づいて小児用量を減らすことを提案しており,臨床検証が必要である.
- この研究は,小児 HCV 集団における証拠に基づいた投与の必要性に対処しています.
研究 の 目的:
- SOFとDCVの小児用量の薬動学,安全性,有効性,受容性を評価する.
- 特定の体重の子供に対して推奨される成人用量の半分を臨床的に検証する.
- 3歳から13歳の慢性的なHCV患者の治療結果を評価する.
主な方法:
- 慢性的なHCVを患っている子供 (3~13歳; 14~35kg) を対象とした臨床試験.
- DCV (30 mg) とSOF (200 mg) の小児用製剤を12週間毎日投与する.
- 薬動学的サンプル採取,有効性評価 (SVR12) と安全性モニタリング.
主要な成果:
- 2つの体重グループ (14- < 17kgと17- 35kg) で23人の子どもが登録されました.
- SOF,DCV,GS- 331007の薬理学パラメータ (AUC24,Cmaxss) は両群で分析された.
- すべての患者は12週で持続的なウイルス反応 (SVR12) を達成し,良好な耐受性と重篤な有害事象はなかった.
結論:
- SOF (200 mg) とDCV (30 mg) の半成人用量は,体重14~35kgの小児に安全かつ有効である.
- この小児療法では,成人の治療に匹敵する薬物曝露,安全性,および有効性があります.
- 臨床的検証は,小児のHCV治療にこれらの用量を使用することを支持しています.
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