新型复方制剂Mavyret(glecaprevir/pibrentasvir)获批-有望8周治愈丙肝
近日，美国FDA批准艾伯维（AbbVie）旗下泛基因丙肝复方药物Mavyret(glecaprevir/pibrentasvir)复方片剂，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。
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。
Mavyret(glecaprevir/pibrentasvir)复方片推剂量：为每日一次，每次一片（100mg/40mg）。
批准日期: 2017年8月3日 公司: AbbVie Inc
Mavyret(glecaprevir and pibrentasvir Tablets)
MAVYRET Rx
Generic Name and Formulations:
Glecaprevir, pibrentasvir 100mg/40mg; tabs.
Company:
AbbVie
Indications for MAVYRET:
Chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. HCV genotype 1 infection in adults previously treated with an HCV NS5A inhibitor- or NS3/4A protease inhibitor-containing regimen, but not both.
Adult:
Test for HBV infection prior to initiation. Take with food. ≥18yrs: 3 tabs once daily. Treatment-naive: treat for 8 weeks (no cirrhosis) or 12 weeks (compensated cirrhosis). Treatment-experienced (genotype 1): treat for 16 weeks if previously treated with an NS5A inhibitor (without prior NS3/4A protease inhibitor) or for 12 weeks if previously treated with an NS3/4A protease inhibitor (without prior NS5A inhibitor); (genotypes 1, 2, 4, 5, 6): treat for 8 weeks (no cirrhosis) or 12 weeks (compensated cirrhosis) if previously treated with regimens containing IFN, PEG-IFN, ribavirin, and/or sofosbuvir, but no prior treatment with an HCV NS3/4A protease inhibitor or NS5A inhibitor; (genotype 3): treat for 16 weeks (with or without compensated cirrhosis) if previously treated with regimens containing IFN, PEG-IFN, ribavirin, and/or sofosbuvir, but no prior treatment with an HCV NS3/4A protease inhibitor or NS5A inhibitor. HCV/HIV-1 co-infected with or without compensated liver disease or renal impairment including on hemodialysis: follow same dosage regimen. See full labeling.
Children:
<18yrs: not established.
Contraindications:
Severe hepatic impairment (Child-Pugh C). Concomitant atazanavir or rifampin.
Warnings/Precautions:
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Moderate hepatic impairment (Child-Pugh B): not recommended. Pregnancy. Nursing mothers.
Interactions:
See Contraindications. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May be antagonized by P-gp/CYP3A inducers (eg, carbamazepine, efavirenz, St. John's wort); concomitant use not recommended. May increase risk of ALT elevations with concomitant ethinyl estradiol-containing drugs (eg, combined oral contraceptives): not recommended. Concomitant darunavir, lopinavir, ritonavir: not recommended. Concomitant dabigatran etexilate; refer to its prescribing information for dose modification. Potentiates digoxin (reduce dose by ½); monitor. Concomitant use may potentiate atorvastatin, lovastatin, simvastatin: not recommended. May potentiate pravastatin (reduce dose by ½), rosuvastatin (limit max dose at 10mg), fluvastatin, or pitavastatin (use lowest effective dose of both these drugs). Patients requiring cyclosporine doses >100mg/day: not recommended.
Pharmacological Class:
HCV NS3/4A protease inhibitor + HCV NS5A inhibitor.
Adverse Reactions:
Headache, fatigue, serum bilirubin elevations; HBV reactivation.
Generic Availability:
NO
How Supplied:
Carton—4-Week, 8-Week
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf