索非布韋/維帕他韋

索非布韋/維帕他韋(Sofosbuvir/velpatasvir)用於治療丙型肝炎的口服複方藥[2] [8] [7]。內含索非布韋維帕他韋英語Velpatasvir[2] [8]。它對基因型一至六的丙型肝炎病毒的療效超過 90%[2]。對同時合併肝硬化愛滋病的丙型肝炎患者也有效[2]

索非布韋/維帕他韋
組成
索非布韋NS5B英語NS5B聚合酶抑制劑
維帕他韋NS5A英語NS5A抑制劑
臨床資料
商品名英語Drug nomenclatureEpclusa, Sofosvel, Velpanat, others
AHFS/Drugs.comMonograph
MedlinePlusa616034
核准狀況
懷孕分級
給藥途徑口服給藥[2]
ATC碼
法律規範狀態
法律規範
識別資訊
CAS號1190307-88-0  checkY
1377049-84-7  checkY
PubChem CID
UNII
KEGG

此組合通常耐受性良好[2]。常見副作用包括頭痛、疲倦、睡眠困難和噁心[9] [10]。目前尚無孕期和母乳哺育的相關研究[9]。對同時感染乙型肝炎的患者,需要格外小心[9]。索非布韋會阻斷非結構蛋白5B英語Hepatitis C virus nonstructural protein 5B蛋白,而維帕他韋則是阻斷非結構蛋白5A英語Hepatitis C virus nonstructural protein 5A蛋白[9]

索非布韋/維帕他韋於 2016 年在美國和歐洲取得醫療使用許可[9] [8] [7]。名列世界衛生組織基本藥物標準清單[11]

參考文獻

  1. ^ Sofosbuvir / velpatasvir (Epclusa) Use During Pregnancy. Drugs.com. [13 December 2017]. (原始內容存檔於14 December 2017). 
  2. ^ 2.0 2.1 2.2 2.3 2.4 2.5 Sofosbuvir/Velpatasvir for the treatment of Hepatitis C (PDF). WHO. [29 June 2017]. (原始內容存檔 (PDF)於29 August 2021). 
  3. ^ Prescription medicines: registration of new chemical entities in Australia, 2016. Therapeutic Goods Administration (TGA). 21 June 2022 [10 April 2023]. 
  4. ^ Health Canada New Drug Authorizations: 2016 Highlights. Health Canada. 14 March 2017 [7 April 2024]. 
  5. ^ Epclusa 400 mg/100 mg film coated tablets. - Summary of Product Characteristics (SmPC). (emc). 4 November 2019 [1 March 2020]. (原始內容存檔於2 March 2020). 
  6. ^ Epclusa- velpatasvir and sofosbuvir tablet, film coated. DailyMed. 21 November 2019 [1 March 2020]. (原始內容存檔於16 March 2020). 
  7. ^ 7.0 7.1 7.2 Epclusa EPAR. European Medicines Agency (EMA). 27 February 2020 [1 March 2020]. (原始內容存檔於2 March 2020). 
  8. ^ 8.0 8.1 8.2 Epclusa- velpatasvir and sofosbuvir tablet, film coated. DailyMed. 21 November 2019 [1 March 2020]. (原始內容存檔於16 March 2020). 
  9. ^ 9.0 9.1 9.2 9.3 9.4 Sofosbuvir and Velpatasvir. The American Society of Health-System Pharmacists. [8 December 2017]. (原始內容存檔於14 December 2017). 
  10. ^ FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C. U.S. Food and Drug Administration (FDA) (新聞稿). 19 March 2020 [19 March 2020]. (原始內容存檔於19 March 2020). 
  11. ^ World Health Organization. World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. 2019. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.