9項C肝炎藥 FDA提出警告(增加B肝炎復發風險): Daklinza/ Epclusa/ Harvoni/ Olysio/ Sovaldi/ Technivie/ Viekira Pak/ Viekira Pak XR/ Zepatier

FDA引用港研究成果　警告抗病毒藥治丙肝或令乙肝復發 星島日報星島日報【星島日報報道】美國食品藥物管理局（FDA）於本月4日發布最新藥物安全警告，指若丙型肝炎病人同時感染乙型肝炎，他們在接受抗病毒藥品(Directly Acting Antivirals, DAAs )治療丙肝時，或會增加乙肝復發的風險。FDA建議醫生在使用DAAs為病人治療丙肝時，應先篩查病人是否同時感染乙肝，若同時感染兩種肝炎病毒 ，應在治療丙肝的同時以及完成治療後，定期監測乙肝復發的風險。FDA是次作出的藥物安全警告和建議，採納自肝臟權威、香港天下仁心醫療集團創辦人廖家傑醫生及其團隊發表在美國腸胃科學會期刊Clinical Gastroerology & Hepatology的最新研究。負責研究的肝臟專科醫生王程指，是次研究於內地兩間醫院進行，招募了327名丙肝病人，其中10人同時是乙肝感染顯性患者，另有124人是乙肝感染隱性患者，其餘並非乙肝帶菌者。124名隱性患者中，經DAAs治療後沒出現異常情況，但10名顯性患者中，則有3人有不同程度的乙肝復發，即乙肝病毒量上升100倍、乙肝炎指數增2倍，其中有人更嚴重至肝衰竭，需住院一個月。她解釋原理指，丙肝病毒可以通過患者的免疫系統，抑制乙肝病毒的複製，故當丙肝病毒被DAAs清除後，乙肝病毒會因免疫控制削弱而被激活。廖家傑表示，DAAs治癒丙肝的成功率高達90%，安全性相當高，過去沒曾發現副作用，而團隊是次研究則發現了其首個副作用。他料DAAs將於年底在中國註冊，隨著中國有3000萬名丙肝帶菌者，當中3%即90萬人同時患有乙肝，遂認為FDA的是次警告有助提升他們警覺。他透露，相關團隊將與亞太區其他地區包括台灣、中國、蒙古、巴基斯坦、印度和馬來西亞合作，進行一個超過300人的臨牀測試，料最快2018年展開。

HCV Drugs May Reactivate HBV, FDA Warns  Robert Lowes  Disclosures | October 04, 2016  Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV) infection, the US Food and Drug Administration (FDA) announced today. The agency will require a boxed warning for the drugs advising clinicians to screen patients for evidence of a past or current HBV infection before ordering antiviral treatment for HCV. The nine direct-acting antivirals prevent HCV from multiplying, and usually cure it. The FDA said in a news release that it had identified 24 cases of HBV reactivation in coinfected patients treated with these antivirals from November 22, 2013, to July 18, 2016, in reports to the agency and published literature. Two patients died, and one needed a liver transplant. "The mechanism through which HBV reactivation occurs with (direct-acting antivirals) is currently unknown," the FDA stated. It noted that clinical trials for the HCV drugs in question did not report HBV reactivation because they excluded patients infected with HBV. Flare-ups of inactive or once-resolved HBV with direct-acting antivirals have rung alarm bells before. In March, the European Medicines Agency announced that it had launched a review of six direct-acting antivirals for HCV on the basis of reports of HBV reactivation in individuals infected with both viruses. The study will evaluate how widespread HBV reactivation is in such patients and what can be done to optimize treatment.  And just last month, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of American issued updated guidelines that advise clinicians not to prescribe direct-acting antivirals to patients with HCV until the patients are screened for HBV, all because the societies were hearing about HBV reactivation in coinfected patients treated with the drugs. If patients who test positive for HBV warrant treatment, they should begin that treatment before or at the same time they start to receive direct-acting antivirals for HCV, according to the guidelines. Raymond Chung, MD, co-chair of the panel that produced the guidelines and director of hepatology at Massachusetts General Hospital in Boston, said HBV reactivation may result from HCV clearance rather than a drug-specific toxicity. More information about today's announcement is available on the FDA website. To report any problems with direct-acting antiviral drugs for HCV, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; byfax1-800-FDA-0178;online https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Brand Name	Active Ingredient(s)	Drug Manufacturer
Daklinza	Daclatasvir	Bristol-Myers Squibb
Epclusa	Sofosbuvir and velpatasvir	Gilead Sciences
Harvoni	Ledipasvir and sofosbuvir	Gilead Sciences
Olysio	Simeprevir	Janssen
Sovaldi	Sofosbuvir	Gilead Sciences
Technivie	Ombitasvir and paritaprevir and ritonavir	AbbVie
Viekira Pak	Dasabuvir and ombitasvir and paritaprevir and ritonavir	AbbVie
Viekira Pak XR	Dasabuvir and ombitasvir and paritaprevir and ritonavir	AbbVie
Zepatier	eEbasvir and grazoprevir	Merck Sharp Dohme
Source: FDA