CHAPAS-4試験におけるHIV感染児のセカンドライン治療におけるロピナビル/ リトナビルの薬理動態
Anne E M Kamphuis1, Timo Kiezebrink2, Hylke Waalewijn1,3
1Department of Pharmacy, Pharmacology & Toxicology, Radboud Research Institute for Medical Innovation (RIMI), Radboudumc, The Netherlands.
AIDS (London, England)
|August 29, 2025
まとめ
3歳から15歳の小児におけるロピナビル/ リトナビル (LPV/ r) の投与量は,適切な被曝度を達成し,HIVのセカンドライン治療におけるその使用を裏付けている. 大人のLPV/ rは,体重25~34. 9kgの子供に安全です.
科学分野:
- 小児感染症
- 薬剤代謝および薬剤代謝
- HIV/エイズの治療
背景:
- ロピナビル/ リトナビル (LPV/ r) は,小児のHIVに対する主要な抗レトロウイルス療法です.
- 特定の小児の体重帯と併用薬の薬理学的なデータは限られている.
研究 の 目的:
- 大人の製剤を使用した3~15歳の子供におけるLPV/ rの薬動性を評価する.
- テノフォビルアラフェナミド/エムトリチタビン (TAF/FTC) または標準の背骨と組み合わせたときのLPV/r被曝を評価する.
主な方法:
- CHAPAS-4試験の集中的な薬動学サブ研究
- LPV/ rの投与量は体重 (14-34. 9kgおよび≥35kg) に基づいていた.
- 世界保健機関 (WHO) が推奨する用量と比較した.
主要な成果:
- ウガンダ,ザンビア,ジンバブエ の 40 人 の 子ども が 登録 さ れ まし た.
- 濃度- 時間曲線の下のロピナビル (LPV) の面積 (AUC 0~12h) は基準値と同等であった.
- 特に体重25~34. 9kgの小児では,LPVの幾何学平均濃度が基準値より57%高かった.
結論:
- 3歳から15歳の子どもは,セカンドラインLPV/ rで十分な安全なLPV被曝を達成しました.
- 体重25~34. 9kgの子供にLPV/ rの投与と成人用LPV/ rの投与を推奨する.
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