2017年8月8日，由美国生物技术巨头艾伯维（AbbVie）开发的泛基因丙肝复方药物Mavyret (glecaprevir/pibrentasvir)获FDA批准，用于治疗全部6种基因型（GT1-6）慢性丙型肝炎病毒（HCV）成人患者，该药主要面向尚未出现肝硬化的HCV患者，以及HCV初治患者。此外，对于患有代偿性肝硬化或者治疗选择受限（如慢性肾病）的HCV患者，该复方药物同样适用。
Maviret由固定剂量的2种特定抗病毒药物组成，其中glecaprevir（G，100mg）是一种NS3/4A蛋白酶抑制剂，pibrentasvir（P，40mg）则是一种NS5A抑制剂。该药治疗疗程为8周。临床试验显示，HCV患者按疗程服用Maviret后，病毒学治愈率达到98%，该疗效优势成为FDA批准其上市的主要理由。
早几日，欧盟委员会（EC）已批准Maviret用于全部6种基因型（GT1-6）慢性丙型肝炎病毒（HCV）成人感染者的治疗。
Mavyret将以4周（每月）或8周纸箱的100mg/40mg固定剂量片剂提供。每个纸箱包含七个日剂量包装。
推剂量为每日一次，每日一次，服用三个口服片剂，餐饮。
AbbVie Receives U.S. FDA Approval of MAVYRET? (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks
The Food and Drug Administration (FDA) recently approved AbbVie’s Mavyret, the newest treatment for chronic hepatitis C virus infection for people without cirrhosis or with compensated cirrhosis. Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken once daily (three tablets for a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg) to treat genotypes 1 through 6.
What You Need to Know about Mavyret
AbbVie’s Mavyret is one pill containing two drugs. Both are direct-acting antivirals (DAAs) which means they directly interfere with hepatitis C virus replication. One drug, glecaprevir is an HCV NS3/4A protease inhibitor. The second drug is pibrentasvir, an NS5A inhibitor.
Here is a brief summary of Mavyret:
?Mavyret is limited to patients without cirrhosis or with compensated cirrhosis defined as Child-Pugh A.
?The recommended dose of Mavyret for people without cirrhosis who have never been treated for hepatitis C is three pills taken daily with food for 8 weeks.
?People without cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 8 weeks.
?People with compensated cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 12 weeks.
?People with or without cirrhosis who have genotype 3 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 16 weeks.
?People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin are treated for 16 weeks.
?People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin are treated for 12 weeks.
Warning: The FDA gave Mavyret a boxed warning in its product label concerning the risk of hepatitis B virus reactivation among those coinfected with HBV and HCV. This warning applies to all direct-acting antiviral treatments for hepatitis C.
Drug Interactions
Mavyret should not be taken with atazanavir or rifampin. Mavyret interferes with some other drugs, most notably carbamazepine, efavirenz and St. John’s wort. Let your doctor and pharmacist know all the drugs (prescription and nonprescription) and supplements that you are taking. Other drugs may interact with Mavyret, but may still be taken as long as they are taken under medical supervision. Some examples are acid-reducing drugs, statins, certain anti-seizure medications, and some HIV and TB drugs.
Although some herbs and drugs have the potential to interact with Mavyret, this doesn’t mean you can’t take drugs that may potentially interact. It usually means that your doctor or pharmacist will advise you on how to space out the timing of your medications. To see if a medication you are taking has the potential to interact with Mavyret, see the prescribing information.
Adverse Events (Side Effects)
The majority of reported side effects were mild; headache, fatigue and nausea were the most common.
Pregnancy/breastfeeding Mavyret should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Similarly, the effects of Mavyret on infants whose mothers are breastfeeding are unknown.
How effective is Mavyret?
Data from nine clinical trials reported cure rates ranging between 92 and 100 percent. |
