New Treatments for Hepatitis C （C型肝炎新治療薬認可）
千葉県木更津市 はやさかクリニック 院長 肝臓専門医 早坂章です。米国肝臓学会では、FDAがC型肝炎治療薬、2剤を認可したと発表しました。
使用適応に関する注意がきちんと書かれています。 日本語訳はのちほどで申し訳ありません。
The FDA has just approved two direct-acting antivirals for the treatment of hepatitis C (HCV): boceprevir and telaprevir.
Each of them improves cure rates in selected patients infected with HCV genotype 1 — when used in combination with pegylated interferon and ribavirin. Approved treatment schedules will be complex and different for each of them. AASLD will soon release updated treatment guidelines for hepatitis C that will include specifics of therapy with each of these drugs.
In the meantime, the following are important issues regarding these drugs:
- Neither drug can be used alone. Each of them can only be used in combination with pegylated interferon and ribavirin. When used alone, the drug will not be effective and will cause emergence of antiviral-resistant mutants that could be difficult to treat subsequently.
- They are only approved for use in patients with HCV genotype 1.
- They are not approved for use in post-transplant recurrent HCV.
- They are not approved for use in HIV/HCV coinfected patients.
- They are not approved for use in children.
- The newly approved treatment schedules have more side effects than pegylated interferon and ribavirin, and should be managed carefully.
An announcement will be made as soon as the updated AASLD guidelines are available.