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頁籤選單縮合
題名 | 治療慢性C型肝炎新藥Sofosbuvir=Sofosbuvir for the Treatment of Chronic Hepatitis C Infection |
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作者 | 沈威廷; 吳俊男; 林俊哲; | 書刊名 | 藥學雜誌 |
卷期 | 31:1=122 2015.03[民104.03] |
頁次 | 頁32-38 |
分類號 | 418.285 |
關鍵詞 | 慢性C型肝炎; Sofosbuvir; Direct acting antiviral; |
語文 | 中文(Chinese) |
中文摘要 | 目前臨床上慢性C型肝炎的治療有著顯著長足的進步,傳統以干擾素為基礎的治 療由於其療效低、耐受性差及有些患者對干擾素是禁忌而受到限制。但是,近年來許 多直接抗病毒藥品 (direct-acting antiviral, DAA) 如雨後春筍般出現,增加治療功效及 改善耐受性和安全性。其中 sofosbuvir (GS-7977, SOF) 於2013年12月被 FDA 核准上市 用於慢性C型肝炎的治療,是屬於聚合酶 (NS5B polymerase inhibitors) 的特定核苷酸 抑制物,針對目前所有基因型皆有不錯的療效。在臨床試驗上,針對基因型第一型未 治療過的患者,SOF/Peg-IFN/RBV 三合一療法治療12週,其療效高達90%。全口服用 藥 (SOF/RBV) 不含干擾素的治療,針對基因型第二、三型一樣非常有效。在藥物不 良反應方面,常見的是疲勞、頭痛、噁心、失眠等,與傳統治療相比較具有較少的藥 物不良反應。本文將提供 SOF 的特性及幾個臨床試驗概況,提供大家參考。 |
英文摘要 | Treatment of chronic hepatitis C (CHC) is currently undergoing a significant change. Traditional interferon-based therapy has been limited by both efficacy and tolerability, and many direct acting antiviral (DAA) drugs are emerging. Sofosbuvir was approved for use by the Food and Drug Administration in December 2013 for the treatment of chronic hepatitis C. It belongs to nucleotide inhibitors of viral polymerase NS5B and acts as a chain terminator during the HCV replication process, exhibiting pan-genotypic antiviral activity with a high barrier to resistance. In clinical trials, 12 weeks of SOF with concomitant Peg-IFN and RBV therapy in treatment-naive HCV genotype 1 patients resulted in SVR rates of > 90%. An alloral regimen of SOF/RBV is highly effective for genotype 2 and 3 patients. SOF was found to be tolerable with minimal adverse effects (AEs). This article provides an overview of SOF features and the main clinical trials, discussing key results and potential future developments. |
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