Hepatitis C Medicines [Mavyret (glecaprevir and pibrentasvir), Zepatier (elbasvir and grazoprevir), and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)]: Drug Safety Communication - Rare Occurrence of Serious Liver Injury in Some Patients with Advanced Liver Disease
AUDIENCE: Gastroenterology, Infectious Disease, Health Professional, Patient, Pharmacy
ISSUE: FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat
chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
FDA identified 63 cases of worsening liver function called liver decompensation with regimens Mavyret, Zepatier, and Vosevi to treat Hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.
RECOMMENDATION: Health professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A).
Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation. Vosevi is indicated for patients who have previously failed certain other Hepatitis C Virus treatments and is not recommended in patients with any history of hepatic decompensation unless the benefits outweigh the risk of liver injury, liver failure or death.
Patients should be aware that the risk of serious liver injury is rare. However, patients should contact a health professional right away if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and?utm_campaign=FDA%20MedWatch%20-%20Hepatitis%20C%20Medicines%20%28Mavyret%2C%20Zepatier%2C%20and%20Vosevi%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
美國FDA已收到有關使用Mavyret、Zepatier或Vosevi治療中度至重度肝功能不全病人之慢性C型肝炎導致罕見的肝功能惡化或肝功能衰竭的報告。美國FDA發現在使用Mavyret、Zepatier和Vosevi治療C型肝炎的療程中，有63例肝功能惡化(又稱肝功能失償)。其中一些案例導致肝功能衰竭和死亡。這些案例病人大多數患有中度至重度肝功能不全，不應該使用這些藥物。
建議醫療專業人員應繼續依照仿單所示開立Mavyret、Zepatier或Vosevi之處方予無肝功能不全或輕度肝功能不全患者(Child-Pugh A)。Mavyret和Zepatier不應該開立於任何有肝功能失償病史的患者。Vosevi適用於先前對於其他C型肝炎治療失敗之病人，不建議用於有任何肝功能失償病史的患者，除非其益處大於肝損傷、肝衰竭或死亡的風險。
病人應了解嚴重肝損傷之風險很罕見。然而若出現疲勞、虛弱、食慾不振、噁心和嘔吐、眼睛或皮膚發黃或淺色糞便等肝損傷的徵兆，應立即聯繫醫療專業人員。
更多相關訊息與連結請參考FDA網址：
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and?utm_campaign=FDA%20MedWatch%20-%20Hepatitis%20C%20Medicines%20%28Mavyret%2C%20Zepatier%2C%20and%20Vosevi%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
[Posted 08/28/2019]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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