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C型肝炎ウイルスゲノタイプ1bに対する全口投与ダクラタスヴィル+アスナプレヴィル:多国間,第3相,マルチコホート研究
Michael Manns1, Stanislas Pol2, Ira M Jacobson3
1Hannover Medical School, Hannover, Germany; German Center for Infection Research (DZIF), Hannover-Braunschweig, Germany.
Lancet (London, England)
|August 1, 2014
まとめ
この研究では,ダクラタスヴィルとアスナプレヴィルが併用され,慢性C型肝炎ウイルス (HCV) ゲノタイプ1b感染に対する効果的な全口投与,インターフェロンなし,リバビリンなしの治療法であることを示しています. 肝硬変を患っている患者を含む,治療未経験および治療経験のある患者で,高い持続性ウイルス学的応答率が観察されました.
科学分野:
- 肝臓病理学 肝臓病理学
- ウイルス学 ウイルス学 ウイルス学
- 薬理学 薬理学とは
背景:
- 慢性C型肝炎ウイルス (HCV) 感染症は,新しい治療戦略を必要とします.
- 既存の治療法は,しばしば制限があるインターフェロンとリバビリンを含む.
- インターフェロンフリーおよびリバビリンフリー療法の需要は満たされていない.
研究 の 目的:
- ダクラタスヴィルとアスナプレヴィルによる全口投与療法の有効性と安全性を評価する.
- 慢性HCV遺伝子型1b感染症の患者でこの治療法を評価する.
- 肝硬変の患者など,満たされていないニーズが大きい患者集団を対象にすること.
主な方法:
- 3期,マルチコホート,ランダム化,ダブルブラインド,プラセボ対照試験 (HALLMARK-DUAL).
- これまでに治療を受けていない患者,反応しない患者,および以前の治療に不適格/不耐性のある患者を含む.
- プライマリエンドポイント:治療後の第12週に持続したウイルス学的反応.
主要な成果:
- 高い持続性ウイルス学応答 (SVR) 率:未治療群では90%,未対応群では82%,不適格/不耐性群では82%.
- ダクラタスヴィルとアスナプレヴィルの併用はよく耐えました.
- 重篤な有害事象や治療中止はまれでした.
結論:
- ダクラタスヴィルとアスナプレヴィルは,HCV遺伝子型1b感染の患者で高い有効性を示しています.
- この完全口服,インターフェロンなし,リバビリンなしのレジメンは,多様な患者集団にとって有効な選択肢です.
- 治療はよく耐受され,臨床実務での使用を支えています.
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