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Pifeltro Tablets(doravirine 多拉韦林片)

2018-09-10 03:05:35  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介: 近日,HIV药物被FDA批准用于没有抗逆转录病毒治疗经验的成年患者。Pifeltro也是一种新型的NNRTI,通过与HIV-1病毒的逆转录酶结合,抑制HIV-1病毒的RNA逆转录为DNA,从而阻断HIV-1病毒的复制,批准与其 ...

近日,HIV药物被FDA批准用于没有抗逆转录病毒治疗经验的成年患者。Pifeltro也是一种新型的NNRTI,通过与HIV-1病毒的逆转录酶结合,抑制HIV-1病毒的RNA逆转录为DNA,从而阻断HIV-1病毒的复制,批准与其他抗逆转录病毒药物联合使用。
批准日期:2018年8月31日 公司:默沙东
PIFELTRO(多拉韦林[doravirine])片剂,用于口服
美国最初批准:2018年
作用机制
多拉维林(PIFELTRO)是一种抗逆转录病毒药物[见微生物学]。
适应症和用法
PIFELTRO是一种非核苷类逆转录酶抑制剂(NNRTI),与其他抗逆转录病毒药物联合用于治疗成人患者的HIV-1感染,无先前的抗逆转录病毒治疗史。
剂量和给药
推荐剂量:每日一次口服一片,有或没有食物,成人患者。
用利福布丁调整剂量:每日服用一片(间隔约12小时)。
剂量形式和强度
片剂:100mg多拉韦林。
禁忌症
当与强细胞色素P450(CYP)3A酶诱导剂共同给药时,PIFELTRO是禁忌的,因为可能发生doravirine血浆浓度的显着降低,这可能降低PIFELTRO的有效性。
警告和注意事项
监测免疫重建综合症。
不良反应
最常见的不良反应(发病率大于或等于5%,所有等级)都是恶心,头晕,头痛,疲劳,腹泻,腹痛和异常梦。
要报告疑似不良反应,请联系Merck&Co.,Inc。的子公司Merck Sharp&Dohme Corp.,电话:1-877-888-4231,或致电1-800-FDA-1088或www.fda.gov/的MedWatch。
药物相互作用
在治疗前和治疗期间查阅完整的处方信息,以了解重要的潜在药物相互作用。
用于特定人群
哺乳期:由于HIV-1传播的可能性,不推荐母乳喂养。
包装提供/存储和处理
每片PIFELTRO片剂含有100毫克的多拉韦林,为白色,椭圆形和薄膜包衣,并在公司标志上印有凹凸,一面为700,另一面为平面。每瓶含有30片(NDC 0006-3069-01),含有硅胶干燥剂,并用防儿童封口封闭。
将PIFELTRO存放在原瓶中。保持瓶子紧闭,以防潮。不要去除干燥剂。
将PIFELTRO储存在20°C至25°C(68°F至77°F);允许偏移15°C至30°C(59°F至86°F)[见USP受控室温]。


完整资料附件:
https://aidsinfo.nih.gov/drugs/546/doravirine/213/professional
FDA Approves Two New Oral Treatments for HIV-1 Infection
Merck announced that the Food and Drug Administration (FDA) has approved Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate) fixed-dose tablets and Pifeltro (doravirine) tablets for the treatment of HIV-1 infection in appropriate patients.
Specifically, both Delstrigo and Pifeltro are indicated to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals. Both medications are given once daily with or without food.
Delstrigo combines doravirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), with lamivudine and tenofovir disoproxil fumarate, 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs). It carries a Boxed Warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection.
The FDA approval was supported by data from the Phase 3, randomized, multicenter, double-blind, active-controlled trials, DRIVE-AHEAD (N=728) and DRIVE-FORWARD (N=766), which evaluated the safety and efficacy of Delstrigo and Pifeltro, respectively.
In DRIVE-AHEAD, treatment with Delstrigo demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). Viral suppression (HIV-1 RNA <50 copies/mL) was achieved in 84% of patients in the Delstrigo group vs 81% in the EFV/FTC/TDF group (treatment difference 3.5%, 95% CI, -2.0%, 9.0%). At week 48, Delstrigo-treated patients had statistically significant superior lipid profiles (changes in LDL and non-HDL cholesterol) compared with EFV/FTC/TDF.
In DRIVE-FORWARD, treatment with Pifeltro demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy vs darunavir + ritaonvir (DRV+r), each in combination with FTC/TDF or abacavir (ABC)/3TC. Viral suppression was achieved in 84% of patients in the Pifeltro group vs 80% in the DRV+r group (treatment difference 3.9%, 95% CI, -1.6%, 9.4%). At week 48, Pifeltro-treated patients had statistically significant superior lipid profiles (changes in LDL and non-HDL cholesterol) compared with DRV+r.
Delstrigo will be available as 100mg/300mg/300mg strength tablets in 30-count bottles. Pifeltro will be available as 100mg strength tablets in 30-count bottles. The Company anticipates both products to be available within 1 month.

责任编辑:p53


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