产地国家：美国 处 方 药：是 所属类别：100毫克/片 30片/瓶 包装规格：100毫克/片 30片/瓶 计价单位：瓶 生产厂家中文参考译名：默克公司 生产厂家英文名：Merck 原产地英文商品名：PIFELTRO 100mg/tablets 30tablets 原产地英文药品名：doravirine 中文参考商品译名：PIFELTRO片 100毫克/片 30片/瓶 中文参考药品译名：多拉韦林

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：默克公司 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。 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]。

英文版说明书

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 eva luated 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.