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）
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.
Brand Name
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Active Ingredient(s)
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Drug Manufacturer
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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
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AbbVie
|
Viekira Pak
|
Dasabuvir and ombitasvir and paritaprevir and ritonavir
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AbbVie
|
Viekira Pak XR
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Dasabuvir and ombitasvir and paritaprevir and ritonavir
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AbbVie
|
Zepatier
|
eEbasvir and grazoprevir
|
Merck Sharp Dohme
|
Source: FDA
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