近日，美国食品和药物管理局（FDA）已批准Pifeltro（联合其他抗逆转录病毒）和Delstrigo（作为一种完整治疗方案）的补充新药申请（sNDA），扩大其适应症，纳入接受一种稳定的抗逆转录病毒治疗方案实现病毒学抑制（HIV RNA＜50拷贝/毫升）、没有治疗失败历史、也没有与Pifeltro或Delstrigo的单个组分耐药相关突变的HIV-1成人感染者。
Pifeltro（doravirine，100mg）是一种新型、每日一次的非核苷类逆转录酶抑制剂（NNRTI），用于与其他ARV药物联合用药，用于治疗HIV-1成人感染者，具体为：（1）用于无既往ARV治疗史的患者；（2）用于接受稳定ARV方案实现病毒学抑制（HIV-1 RNA＜50拷贝/毫升）、没有治疗失败史、没有已知的与doravirine耐药相关替代突变的患者，取代其当前ARV方案。
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。
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 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.