更新于：2024-12-09

Emtricitabine

恩曲他滨

更新于：2024-12-09

概要

概要

基本信息

药物类型

小分子化药

别名

(2R-cis)-4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone、(−)-(2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine、(−)-2'-deoxy-5-fluoro-3'-thiacytidine

+ [18]

靶点

作用机制

RT抑制剂(逆转录酶抑制剂)

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症

HIV感染

非在研适应症

合并感染乙型肝炎慢性乙型肝炎+ [1]

原研机构

Gilead Sciences, Inc.

在研机构

Gilead Sciences Ireland UC

Gilead Sciences, Inc.

乐声药业石家庄有限公司

非在研机构

Triangle Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2003-07-02),

HIV感染

最高研发阶段(中国)批准上市

特殊审评孤儿药 (日本)

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结构

分子式C8H10FN3O3S

InChIKeyXQSPYNMVSIKCOC-NTSWFWBYSA-N

CAS号143491-57-0

关联

121

项与恩曲他滨相关的临床试验

IRCT20240803062623N5 / SuspendedIIT

Intervention group: single dose, one oral tablets Descovy Emtricitabine 200 mg with Tenofovir Alfenamide Fumarate 25 mg as a reference product. after washout period, the volunteers received Emtricitabine 200 mgwith Tenofovir Alfenamide Fumarate 25 mg Tadbir Kalaye jam pharmaceutical Co. Iran

开始日期2024-11-21

申办/合作机构-

NCT06338826 / Not yet recruiting临床2期IIT

Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses

The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy

开始日期2024-10-01

申办/合作机构

ANRS, Emerging Infectious Diseases

NCT06250504 / Recruiting临床3期IIT

Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.
Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.

开始日期2024-02-27

申办/合作机构-

100 项与恩曲他滨相关的临床结果

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100 项与恩曲他滨相关的转化医学

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100 项与恩曲他滨相关的专利（医药）

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4,281

项与恩曲他滨相关的文献（医药）

2025-01-01·Medicina de Familia-SEMERGEN

Optimization of adherence to fixed-dose combination therapy in the treatment of cardiovascular risk factors in primary care

Article

作者: Montero Peña, C ; Espinosa García, J ; Escobar Cervantes, C ; Ricote Belinchón, M ; López Simarro, F ; Panero Hidalgo, P ; Manzano Vilches, A ; Alonso Moreno, F J ; Aliaga Gutiérrez, L

OBJECTIVE:

Provide consensus recommendations for the optimal management of fixed-dose combination therapies (FCT) in patients with cardiovascular risk factors (CVRF) in primary care (PC).

MATERIAL AND METHODS:

A modified Delphi technique was used. A scientific committee wrote 80 statements addressing controversial issues regarding adherence and the use of FCT in patients with CVRF. A panel of 52 PC specialists, experts in CVRF management and adherence evaluated the questionnaire in two rounds. The work was promoted by the Network of Experts in Adherence in Primary Care (REAAP).

RESULTS:

Agreement was reached on 66 of the 80 issues (82.5%). The panellists considered that the adherence of patients with CVRF treated in PC was inadequate, which could have clinical implications. The use of FCT might increase adherence compared to separate treatments. FCT usage promotion in PC was considered necessary, especially in polymedicated patients. Measures such as establishing specific protocols or improving the training of professionals in the FTC use are necessary. The FTC use was recommended as a reduction in long-term cardiovascular events in hypertension was observed, together with changes of the concept of high-intensity statins to high-intensity lipid-lowering therapy in dyslipidemia, or considering the use of FCT if the option was available in type 2 diabetes mellitus.

CONCLUSIONS:

The expert consensus recommendations from this work may facilitate the use of FCT in patients with CVRF in PC.

2024-12-31·HIV Research & Clinical Practice

A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT

Article

作者: Kang, Sujin ; Henderson, Merle ; Soler-Carracedo, Alfredo ; Clarke, Amanda ; Xhikola, Arnold ; Whitlock, Gary ; Fidler, Sarah ; Boffito, Marta ; Khawaja, Akif ; Adams, Tanya ; Jahan, Ishrat ; Milinkovic, Ana ; Taylor, Graham

BACKGROUND:

Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. This study, BIC-T&T, evaluates the efficacy and tolerability of B vs D in a UK test-and-treat setting.

SETTING:

BIC-T&T was a randomised, open-label, multi-centre, study in which participants initiated ART within 14 days after confirmed HIV-1 diagnosis before baseline laboratory.

METHODS:

The primary endpoint is the virological response (HIV RNA < 50copies/mL) at week 12 by time-weighted average change in log₁₀ HIV RNA recorded in viral load assays from treatment initiation to week 12, using two-sample Wilcoxon rank-sum test.

RESULTS:

36 participants were randomised: 94% were male, 53% white; mean (SD) age was 35 years (11.8). Baseline mean (±SD) log₁₀ HIV-RNA was 4.79 (± 0.87) log₁₀ copies/mL and CD4 505 (±253) cells/mm³. The mean (±SD) time from confirmed HIV diagnosis to ART initiation was 7.9 (± 3.7) days. The time-weighted mean decrease in log₁₀ HIV RNA from treatment initiation to week 12 was significantly greater in B in comparison to D (3.1 vs. 2.6 log₁₀ copies/mL, p < 0.001). Both regimens demonstrated good tolerability with infrequent laboratory abnormalities and no grade 3 or 4 adverse events.

CONCLUSION:

In this first head-to-head study in the context of ART initiation, HIV RNA decline from baseline to week 12 was significantly more rapid for BIC/F/TAF compared with DRV/c/F/TAF.

2024-12-01·HIV Research & Clinical Practice

Impact of switching to injectables cabotegravir and rilpivirine on sleep disturbances in a cohort of people living with HIV.

Article

作者: Sasset, Lolita ; Agostini, Elena ; Presa, Nicolò ; Gardin, Samuele ; Mazzitelli, Maria ; Leoni, Davide ; Scaglione, Vincenzo ; Vania, Eleonora ; Cattelan, Annamaria

BACKGROUND:

Recently, injectable cabotegravir/rilpivirine (ICAB/RPV) became available for HIV treatment. However, there are no real-life data on the impact of switching to ICAB/RPV on sleep disturbances (SD). Therefore, we aimed at assessing and investigating this aspect in our cohort.

METHODS:

A SD multidimensional assessment (Epworth Sleepiness scale, Insomnia severity Index, Berlin Questionnaire, and Pittsburg Sleep Quality Index, PSQI) was performed to all people who consented before starting ICAB/RPV and 12 wk after the switch. Demographics, life-style habits, laboratory, and clinical data were collected from medical health records.

RESULTS:

To June 2023, 46 people were included, 76.1% males, with a median age of 48.5 (IQR: 41-57), 50% had multimorbidity, 13% was on polypharmacy. Median age with HIV and CD4 + T cell count nadir were 10 (5-19.5) years and 360 (205-500) cell/mm³, respectively. The reason to start a long-acting strategy was person's choice in all cases. Baseline antiretroviral regimens were mostly: tenofovir alafenamide/emtricitabine/rilpivirine (39.1%) and dolutegravir/lamivudine (32.6%). No significant changes were observed in any of the scores for each questionnaire, but for a worsening PSQI. 37% people reported a subjectively improved sleep quality, even if statistically significant changes were not observed in almost all the sleep parameters.

CONCLUSIONS:

To the best of our knowledge, this is the first study exploring impact of switching to ICAB/RPV on SD. Despite integrase inhibitor have been associated with SD, we did not observed a negative impact on sleep quality after the switch to ICAB/RPV. More studies and with larger number of people are necessary to confirm our results.

231

项与恩曲他滨相关的新闻（医药）

2024-12-05

·医学新视点

如何诊治艾滋病？一文了解2024年中国新指南更新要点

艾滋病，即获得性免疫缺陷综合征（AIDS），其病原体为人类免疫缺陷病毒（HIV），亦称艾滋病病毒。AIDS是影响公众健康的重要公共卫生问题之一。《中国艾滋病诊疗指南（2024版）》重点对抗病毒治疗、全程管理、机会性感染、人类免疫缺陷病毒（HIV）感染合并肿瘤、HIV感染的预防与干预等内容进行了更新，并新增“艾滋病免疫重建不全（INR）”内容，首次提出了“艾滋病脆弱人群”的概念，增加了诊治推荐意见及其推荐证据和推荐强度。新版指南包括流行病学、实验室检测、常见机会性感染、抗病毒治疗、免疫重建炎性综合征、INR、HIV母婴垂直传播阻断及单阳家庭生育等内容。流行病学推荐意见1 对HIV/AIDS患者的配偶和性伴、与HIV/AIDS患者共用注射器的静脉药物依赖者、HIV/AIDS患者所生子女，以及具有疑似HIV感染高危行为和/或临床症状的临床就诊者，医务人员应主动提供HIV相关检测及相应的咨询服务（C1）。实验室检测推荐意见2 HIV筛查试验阳性者需进一步通过补充试验包括抗体补充试验（HIV-1/2抗体确证试验）和核酸补充试验（HIV-1核酸定性和定量检测）来确认HIV感染（A1）。推荐意见3 初治HIV感染者在启动抗反转录病毒治疗（ART）之前应进行基因型耐药检测。新确诊HIV感染者或使用长效卡替拉韦（CAB-LA）进行PrEP后仍感染HIV的患者，如考虑存在HIV对INSTI耐药，则应进行整合酶基因突变检测（C1）。诊断标准推荐意见4 HIV感染的全过程可分3个期，即急性期、无症状期和AIDS期；HIV/AIDS的诊断需结合流行病学史、临床表现和实验室检查结果进行综合分析，慎重做出诊断，并进行临床分期（A1）。常见机会性感染肺孢子菌肺炎（PCP）推荐意见5 PCP的病原治疗首选复方磺胺甲噁唑（SMZ-TMP），甲氧苄啶（TMP）15～20 mg/（kg·d），磺胺甲噁唑（SMZ）75～100 mg/（kg·d），分3～4次用，疗程为21 d；重症患者（PaO2＜70 mm Hg或肺泡-动脉血氧分压差＞35 mm Hg）早期（72 h内）可应用糖皮质激素（泼尼松或静脉用甲泼尼龙）治疗，激素总疗程为21 d（A1）。推荐意见6 CD4+T淋巴细胞计数＜200个/μL的HIV/AIDS患者应使用SMZ-TMP预防PCP，一级预防为1片/天，二级预防2片/天；ART后CD4+T淋巴细胞计数增加到＞200个/μL并持续≥3～6个月可停止预防用药（A1）。结核病推荐意见7 HIV/AIDS患者在每次就诊时均应系统接受结核病筛查，临床上应注意结合病史、结核病典型症状和体征，以及影像学和实验室检查，系统筛查结核病的可能（B1）。推荐意见8 HIV/AIDS患者结核病的治疗原则与普通结核病患者相同，但抗结核药物使用时应注意与抗病毒药物之间的相互作用及配伍禁忌（A1）。推荐意见9 所有合并结核病的HIV/AIDS患者无论CD4+T淋巴细胞计数水平的高低均应尽早接受ART，推荐在抗结核治疗后2周内尽早启动ART。合并耐药结核病，在使用二线抗结核药物后8周内开始ART；对于中枢神经系统结核病患者，通常建议在抗结核后的4～8周启动ART（C1），使用糖皮质激素治疗的AIDS合并结核性脑膜炎的患者，建议在启动抗结核后2周内启动ART（C1）。活动性结核病或非结核分枝杆菌（NTM）感染推荐意见10 HIV/AIDS合并NTM感染主要为鸟分枝杆菌（MAC）感染，确诊MAC病有赖于从患者血液、淋巴结、骨髓及其他无菌组织或体液中培养出MAC（A1）。推荐意见11 MAC病首选病原治疗方案为：克拉霉素500 mg/次，2次/天（或阿奇毒素500 mg/d）+乙胺丁醇15 mg/（kg·d），同时联合应用利福布汀（300～600 mg/d）。严重感染及严重免疫抑制（CD4+T淋巴细胞计数＜50个/μL）患者可加用阿米卡星［10 mg/（kg·d），肌内注射，1次/天］或喹诺酮类抗菌药物如左氧氟沙星或莫西沙星（B1）。疗程通常至少为12个月。抗MAC治疗开始2周后尽快启动ART（B1）。巨细胞病毒（CMV）感染推荐意见12 CMV视网膜炎的确诊有赖于检眼镜检查，治疗可选择更昔洛韦、缬更昔洛韦、膦甲酸钠，疗程为2～3周；局部治疗：玻璃体内注射更昔洛韦或膦甲酸，每周重复1次，疗程到视网膜病变被控制、病变不活动为止（A1）。推荐意见13 不推荐HIV/AIDS患者对CMV感染进行一级预防。二级预防方案推荐首选更昔洛韦（1.0 g，3次/天，口服），在CD4+T淋巴细胞计数＞100个/μL且持续3～6个月以上时可考虑停止二级预防（B1）。弓形虫脑病推荐意见14 弓形虫脑病病原治疗首选乙胺嘧啶（负荷剂量为100 mg，口服，2次/天，此后50～75 mg/d维持）+磺胺嘧啶（1～1.5 g，口服，4次/天），替代治疗：SMZ-TMP（3片，每日3次，口服）联合克林霉素（600 mg/次，静脉给药，每6小时1次）或阿奇霉素（0.5 g/d）。疗程至少为6周（A1）。推荐意见15 对无弓形虫脑病病史但CD4+T淋巴细胞计数＜200个/μL且弓形虫IgG抗体阳性的HIV/AIDS患者应使用SMZ-TMP（2片/次，1次/天）来预防弓形虫脑病（B1）。接受ART后，CD4+T淋巴细胞计数增加到＞200个/μL并持续＞3个月，可停止预防用药（A1）；或ART后CD4+T淋巴细胞计数在100～200个/μL，病毒载量持续低于检测下限3～6个月，也可考虑停止预防用药（B1）。推荐意见16 对既往患过弓形虫脑病者要长期使用乙胺嘧啶（25～50 mg/d）联合磺胺嘧啶（2～4 g/d）预防，直至CD4+T淋巴细胞计数增加到＞200个/μL并持续≥6个月（A1）。一旦CD4+T淋巴细胞计数下降到＜200个/μL，需重启预防用药（C1）。真菌感染推荐意见17 HIV/AIDS合并隐球菌性脑膜炎的病原体治疗分为诱导期、巩固期、维持期3个阶段，诱导期首选两性霉素B［0.5~0.7 mg/(kg·d)］或两性霉素 B 脂质体（L-AMB）［3~4 mg/(kg·d)］+氟胞嘧啶［100 mg/(kg·d)］，诱导期至少4周，巩固期首选氟康唑（600～800 mg/d）治疗至少6周，维持期选择氟康唑（200 mg/d），维持期至少1年，持续至患者通过ART后CD4+T淋巴细胞计数＞100个/μL并持续至少6个月时可停药（A1）。推荐意见18 HIV/AIDS合并隐球菌性脑膜炎诱导期可首选单次L-AMB 10 mg/kg联合使用2周的氟胞嘧啶［100 mg/(kg·d) ］和氟康唑（600~800 mg/d）进行治疗（A1）。推荐意见19 HIV/AIDS合并隐球菌性脑膜炎患者正规抗隐球菌治疗4～6周后启动ART (A1)。推荐意见20 合并隐球菌性抗原血症的HIV/AIDS患者建议给予氟康唑400～800 mg/d口服10周，而后改为200 mg/d口服预防性治疗，总疗程为6～12个月（C1）。推荐意见21 HIV/AIDS合并马尔尼菲篮状菌病诱导期抗真菌治疗方案首选两性霉素B［0.5～0.7 mg/(kg·d) ］或L-AMB［3～5 mg/(kg·d) ］或两性霉素B胆固醇硫酸酯复合物［3~4 mg/(kg·d) ］，静脉滴注2周（A1）；巩固期为口服伊曲康唑或伏立康唑200 mg，每12小时1次，共10周；随后进行二级预防，口服伊曲康唑200 mg，1次/d（B1），至患者通过ART后CD4+T淋巴细胞计数＞100个/μL，并持续至少6个月可停药（B）。一旦CD4+T淋巴细胞计数＜100个/μL，需要重启预防治疗（C1）。抗病毒治疗成人及青少年抗病毒治疗时机与方案 ①成人及青少年启动ART的时机：推荐意见22 所有HIV感染无论CD4+T淋巴细胞水平高低均建议尽早开始ART，以降低发病率和病死率，并预防HIV传播（B1）；有条件患者建议快速启动ART（确诊后7 d内）或确诊当天启动ART（A1）。 ②成人及青少年初始ART方案：推荐意见23 成人初治患者推荐ART方案通常由2种核苷类反转录酶抑制剂（NRTI）类骨干药物联合第三类药物组成，第三类药物可以为整合酶链转移抑制剂（INSTI）或非核苷类反转录酶抑制剂（NNRTI）或者增强型蛋白酶抑制剂（PI，含利托那韦或考比司他）；也可以选用复方单片制剂（STR）（A1）；对于HBV表面抗原（HBsAg）阴性、病毒载量＜5×105拷贝/mL的初治患者可首选多替拉韦/拉米夫定的ART方案（A1）。特殊人群抗病毒治疗儿童：推荐意见24 儿童一旦确诊HIV感染，无论CD4+T淋巴细胞水平高低，均建议立即开始ART（B1）。推荐意见25 儿童初治患者ART方案推荐为2种NRTI类骨干药物联合第三类药物治疗，第三类药物可以为INSTI或NNRTI或者增强型PI（含利托那韦或考比司他）（B1）。合并结核分枝杆菌感染者：推荐意见26 HIV/AIDS合并结核病患者推荐首选ART方案为替诺福韦（齐多夫定）+拉米夫定（恩曲他滨）+依非韦伦或多替拉韦（A1），与利福平合用时，多替拉韦的剂量建议加倍（50 mg，2次/天）（A1）。合并HBV感染者：推荐意见27 HIV/HBV合并感染者不论CD4+T淋巴细胞计数水平如何，均建议尽早启动ART，ART方案中应包含2种具有抗HBV活性的抗病毒药物，ART骨干药物中的核苷类药物推荐选择替诺福韦（或丙酚替诺福韦[TAF]）+拉米夫定（或恩曲他滨）（B1）。合并HCV感染者：推荐意见28 HIV合并HCV感染者应尽早启动ART和积极抗HCV治疗，抗HCV治疗的方案和疗程与单纯HCV感染者相同，应注意与ART药物间的相互作用（A1）。抗病毒治疗监测推荐意见29 启动ART后建议每3～6个月进行病毒学、免疫学和临床情况随访以评价ART的疗效，及时发现抗病毒药物的不良反应及是否出现病毒耐药等，以便及时更换药物而保证ART成功（C1）。药物相互作用推荐意见30 推荐病毒载量检测作为发现和确认抗病毒治疗失败的首选方法（C1）；一旦确认抗病毒治疗失败，则应尽快进行HIV耐药检测（C1）。推荐意见31 病毒出现病毒学失败时应首先评估患者的治疗依从性、药物-药物或药物-食物相互作用，尤其服药依从性是治疗成败的决定因素。ART失败的患者应根据HIV耐药检测结果来进行ART方案调整，方案选择的原则是更换至少2种ART药物，最好选择3种具有抗病毒活性的药物；新的ART方案通常应包括1种具有完全抗病毒活性的增强PI或INSTI或未曾使用过的新的作用机制药物如衣壳抑制剂和FI，或上述药物联合应用（A1）。推荐意见32 低病毒血症（LLV）需评估患者的依从性、耐受性和药物不良反应、药物相互作用（A1）。LLV通常不需要改变治疗方案（B1），但需每3个月监测1次HIV RNA，以评估是否需要调整ART方案（C1）。 IRIS 推荐意见33 HIV感染者接受ART后出现如发热、潜伏感染变成活动性感染、原有感染的加重或恶化等炎症相关表现时，应考虑存在IRIS的可能，但应注意排除由HIV疾病进展、新发感染、HIV相关肿瘤、药物不良反应、治疗失败等情况带来的干扰。临床上应根据IRIS的严重程度，开始或继续治疗相关机会性感染，严重者可短期应用糖皮质激素或非甾体抗炎药（C1）。免疫功能重建不全推荐意见34 接受ART 4年以上，外周血病毒载量低于检测下限（＜50拷贝/mL）超过3年，CD4+T淋巴细胞计数仍持续低于350个/μL，同时排除其他可能导致CD4+T淋巴细胞计数长期低下的原因，需考虑为免疫功能重建不全（B1）。推荐意见35 免疫功能重建不全缺乏明确有效的治疗方法，临床应定期监测，并需根据CD4+T淋巴细胞水平进行机会性感染的预防和NADE的筛查。对于已实现病毒学抑制的患者，不建议为改善免疫重建而随意进行ART调整（B1）。 AIDS相关肿瘤推荐意见36 HIV感染者在随访过程中应注意筛查AIDS定义性肿瘤和非AIDS定义性肿瘤。年龄在25岁以上的女性HIV感染者，建议定期进行宫颈癌的筛查（C1）。所有AIDS合并肿瘤的患者均建议尽早启动ART，需注意抗病毒药物和抗肿瘤药物之间的相互作用，应选用骨髓抑制作用和药物相互作用小的ART方案。提倡MDT模式来为HIV合并肿瘤患者提供标准化诊疗（C1）。 HIV母婴传播阻断及单阳家庭生育抗反转录病毒药物干预推荐意见37 所有感染HIV的孕妇不论其CD4+T淋巴细胞计数多少或疾病临床分期如何，均应尽早终身接受ART（B1）；孕妇ART首选包含多替拉韦或拉替拉韦的三联ART方案（A1）。推荐意见38 HIV感染母亲所生婴儿应在出生后尽早（6 h内）预防性服用抗病毒药物，并根据暴露风险来确定服药方案（B1）。产后喂养指导推荐意见39 HIV阳性孕产妇所生婴儿推荐科学喂养，避免母乳喂养，杜绝混合喂养（A1）；对因不具备人工喂养条件而选择母乳喂养的感染产妇及其家人，要做好充分的咨询和知情，指导其坚持正确的纯母乳喂养，且在整个哺乳期间必须坚持ART，喂养时间不超过6个月（A1）。 HIV暴露前后预防与阻断暴露后预防（PEP）推荐意见40 HIV预防阻断前检测建议进行HIV RNA检测，尤其对既往有阻断用药史的求询者（A1）；在发生HIV暴露后尽可能在最短的时间内（尽可能在2 h内）进行预防性用药，最好在24 h内，但不超过72 h，连续服用28 d（C1）；暴露后阻断方案首选恩曲他滨/替诺福韦（FTC/TDF）或恩曲他滨/丙酚替诺福韦（FTC/TAF）联合INSTI（比克替拉韦[BIC]或多替拉韦或拉替拉韦）的方案（C1）。暴露前预防（PrEP）推荐意见41 实施PrEP前应做好HIV暴露风险评估和医学及适应性评估（C1），PrEP的口服方案有两种，分别为每日服药方案和事件驱动服药方案，药物可选择FTC/TDF（或FTC/TAF）（A1）；不能选择口服药物的可选择长效卡替拉韦（CAB-LA）肌内注射的方案（A1）。 HIV感染的全程管理推荐意见42 所有HIV感染者均推荐按照全程管理的模式来进行管理（C1）。推荐意见43 对于晚发现的HIV感染者尤其是处于HIV感染疾病晚期的患者要进行各种机会性感染的筛查，应将结核病和隐球菌病的筛查作为临床诊疗常规（A1）。推荐意见44 推荐对CD4+T淋巴细胞计数＜200个/μL的HIV感染者开展血清CrAg筛查，阳性者应进行脑脊液检查以排除隐球菌性脑膜炎的可能（B1）。推荐意见45 启动ART之前，建议进行相应的基线检测和评估，这些检测包括：HIV RNA、CD4+T淋巴细胞计数、HIV耐药检测、血常规、尿常规、肝肾功能、血糖、血脂、是否存在合并感染（如病毒性肝炎、隐球菌病、结核病、STI等）的相关检测等（C1）。推荐意见46 需特别关注脆弱人群抗病毒治疗和随访的相关问题，脆弱人群主要包括：年龄超过50岁的老年患者；儿童患者；孕妇；具有多种基础疾病的患者；免疫高度抑制的患者如CD4+T淋巴细胞计数＜50个/μL；ART后免疫功能重建不全的患者。这类患者要更为积极地进行ART，积极治疗基础疾病，注意多学科协作诊治（C1）。推荐意见47 对于ART后病毒得到有效抑制的患者，不建议随意进行治疗方案的调整。优化治疗应当以维持病毒抑制为基础，并且不对未来的药物选择构成威胁。在进行ART方案优化时，应特别注意患者之前是否存在HIV耐药及有无合并HBV或HCV感染的情况（A1）；病毒学抑制且无传播性或获得性HIV耐药史的HIV感染者，通常可以转换为任何首选推荐的初始ART方案并维持病毒学抑制（A1）。推荐意见48 所有HIV感染者均应定期接受CVD风险评估、筛查和预防干预，对于CVD风险高的患者，应相应调整ART方案，同时积极控制相关CVD风险因素如戒烟、血糖、血脂、肥胖和血压等（C1）。推荐意见49 应创造各种条件促进HIV/AIDS患者便利接受各种诊疗服务，确保医疗服务的可持续性（B1）；应对HIV/AIDS患者进行疫苗接种指导（C1）。通信作者北京协和医院李太生感染内科主任，教授，主任医师，博士生导师。中国国家卫生健康委艾滋病专家咨询委员会临床组组长，中华医学会感染性疾病分会副主任委员兼艾滋病学组组长，曾任中华医学会热带病和寄生虫分会主任委员。共发表学术论文200余篇，其中在SCI收录的杂志上发表论文50余篇，被他人引用超过2500次。推荐阅读每月一次，效果可维持11个月！《自然-医学》：三联抗体组合长效抑制HIV 80%的中风可预防！权威指南：降压、降糖、地中海饮食……关注10大要点更新全球约30%的人有脂肪肝！《柳叶刀》子刊：3大危险因素、4类治疗策略 JAMA子刊：结直肠癌肝转移一线治疗，“简化方案”有望成为首选欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料 [1] 中华医学会感染病学分会艾滋病学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南(2024版)[J]. 协和医学杂志, 2024, 15(6): 1261-1288. DOI: 10.12290/xhyxzz.2024-0766 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。《协和医学杂志》倡导尊重和保护知识产权，欢迎转载、引用，但需取得本平台授权。如您对文章内容及版权存疑，请发送邮件至medj@pumch.cn，我们会与您及时沟通处理。图文内容仅供交流、学习使用，不以盈利为目的；科普内容仅用于大众健康知识普及，读者切勿作为个体诊疗根据，自行处置，以免延误治疗。治病就医相关需求请于北京协和医院APP线上或线下就诊。分享，点赞，在看，传递医学新知

临床结果

2024-12-03

·drugs

Incidence of HIV Lower With Twice-Yearly Subcutaneous Lenacapavir

TUESDAY, Dec. 3, 2024 -- In a population of cisgender men, transgender women, transgender men, and gender-nonbinary persons, the incidence of HIV is lower with receipt of twice-yearly subcutaneous lenacapavir compared with daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), according to a study published online Nov. 27 in the New England Journal Medicine . Colleen F. Kelley, M.D., M.P.H., from the Hope Clinic of the Emory University School of Medicine in Decatur, Georgia, and colleagues randomly assigned cisgender men, transgender women, transgender men, and gender-nonbinary persons to receive subcutaneous lenacapavir every 26 weeks or daily oral F/TDF in a 2:1 ratio in a phase 3 trial. The modified intention-to-treat analysis included 3,265 participants: 2,183 were assigned to lenacapavir and 1,088 to F/TDF. The researchers found that HIV infections occurred in two and nine participants in the lenacapavir and F/TDF groups, respectively (0.10 and 0.93, respectively, per 100 person-years). In the screened population (4,634 participants), the background incidence was 2.37 per 100 person-years. In the lenacapavir group, the incidence of HIV infection was significantly lower than the background incidence and the incidence in the F/TDF group (incidence rate ratios, 0.04 and 0.11, respectively). There were no safety concerns reported. Overall, 1.2 and 0.3 percent of the lenacapavir and F/TDF groups, respectively, discontinued the trial regimen due to injection site reactions. "Twice-yearly lenacapavir offers an efficacious choice for prevention of HIV infection, which may increase preexposure prophylaxis uptake," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures lenacapavir and funded the study.

临床3期临床结果

2024-12-03

·Pharmaceutical Technology

Trump 2.0 could see a rise in biopharmaceutical M&A deals

The second Trump administration is expected to focus on domestic M&A. Credit Brandon Bell / Getty Images. Trump’s return to the White House will mean a shift in personnel at the US Federal Trade Commission (FTC), which could mean more biopharmaceutical M&A deal activity in the country, an analyst has said. Considering the likely changes under the incoming Trump administration, GlobalData business fundamentals analyst Alison Labya commented: “A change in FTC leadership may encourage more M&A deals by large biopharmaceutical companies , as well as create a more favourable environment for smaller biotech companies to exit via acquisitions.” GlobalData is the parent company of Pharmaceutical Technology . The FTC’s role is to protect competition across US markets through the enforcement of antitrust laws. Trump is likely to replace its current chair Lina Khan, under whom M&A activity (in biopharmaceuticals and beyond) has seen increased scrutiny. FTC under Khan One pharmaceutical merger stopped by the FTC was Sanofi’s $750m licensing agreement with US-based biotech Maze Therapeutics, which has shared positive Phase I results for its glycogen synthase 1 inhibitor MZE001, an orally administered Pompe disease drug to be taken at home. Sanofi’s own Pompe treatment requires intravenous administration by a healthcare provider and costs around $750,000 for a year of treatment. In a statement , issued by Khan and Federal Trade Commissioner Rebecca Kelly Slaughter, the FTC claimed that Sanofi was “seek[ing] to buy out those competing treatments directly, eliminating the competitive pressure to innovate and offer more affordable drugs”. Following the FTC’s lawsuit, Sanofi terminated the licensing agreement and the complaint was dropped. However, Khan’s three years as FTC chair have earned her the reputation of being too tough. A report by the Committee of Oversight and Accountability published in October found that “Chair Khan seems committed to using all the FTC’s powers to throw sand into all the possible gears over proposed mergers, thereby halting many mergers by abuse of process and chilling other potential mergers from even being suggested”. FTC with a Trump pick Likely new agency leadership under Trump could well choose to unpick the Democrat-commissioner-approved 2023 guidelines, which reduced the Herfindahl-Hirschman Index (HHI) thresholds required for transactions to trigger a presumption of competitive harm. The FTC may therefore swing to a period of less rigorous antitrust scrutiny, at least in horizontal M&A. Regardless, businesses are preparing for a period of increased focus on domestic priorities. In his first term, Trump enacted the Foreign Investment Risk Review Modernization Act, which granted US regulators greater authority to review and block foreign M&A activity, both in biopharmaceuticals and beyond. Labya explained: “It remains uncertain whether Trump’s ‘America First’ foreign policies will pose challenges for companies outside of the US, especially those headquartered in China, looking to acquire US-based biopharmaceutical companies.” Trump has also made clear that he plans to impose heavy tariffs – “the most beautiful word in the dictionary”, he said – on imports. He has proposed a 60% tariff on goods from China and 20% on other countries. As a result, biopharmaceutical companies outside of the US may look to acquire US facilities to manufacture drugs domestically. However, Labya also warned that while some Trumpian policies may increase M&A activity, others risk deterring investors, quashing crucial biopharmaceutical innovation: “Furthermore, Trump’s plans to appoint Robert F Kennedy Jr – a known anti-vaccine advocate and critic of the FDA – as the head of the US Department of Health and Human Services may create challenges for future US drug approvals, which could dampen investor confidence and slow innovation in the biopharmaceutical industry.”

临床1期引进/卖出疫苗

100 项与恩曲他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01199	恩曲他滨	J05AF09	DB00879

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	美国	Gilead Sciences, Inc.	2003-07-02

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性乙型肝炎	临床2期	美国	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	澳大利亚	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	加拿大	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	法国	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	德国	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	中国香港	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	新西兰	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	波兰	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	新加坡	Gilead Sciences, Inc.	2007-09-01
慢性乙型肝炎	临床2期	中国台湾	Gilead Sciences, Inc.	2007-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02150993 (FIT-2, Pubmed) 人工标引	临床2期	HIV感染一线	210	Tenofovir-boEmtricitabineirLamivudineZidovudine	鏇製淵糧醖顧齋遞積構(艱網糧膚齋製遞鑰齋範) = 夢鑰醖夢獵糧廠顧壓鬱夢簾觸鬱鏇醖繭鹽範製 (鹽蓋廠齋鹽製遞膚齋壓 ) 更多	积极	2024-06-01
NCT02150993 (FIT-2, Pubmed) 人工标引	临床2期	HIV感染一线	210	tenofovirirEmtricitabineLamivudine	糧衊選製積顧構壓壓餘(顧蓋夢鹹鏇衊糧簾觸淵) = 襯淵餘鑰顧構鬱淵選餘糧壓鹹窪襯製齋艱夢衊 (網蓋鹽齋積艱糧夢齋醖, 47 ~ 66) 更多	积极	2024-06-01
Rainbow study (Pubmed \| Int J Antimicrob Agents)	临床4期	HIV感染 HIV-RNA	30	BIC/FTC/TAF	憲艱膚齋繭選鹽積繭窪(壓遞廠憲醖淵蓋築廠鬱) = Two participants developed IRIS 夢醖衊遞繭選淵顧餘糧 (壓淵製構廠淵獵襯壓壓 ) 更多	积极	2024-01-01
NCT03917420 (CTgov)	临床1期	获得性免疫缺陷综合征	10	Tenofovir 300Mg Oral Tablet+Emtricitabine 200 MG	蓋蓋糧衊廠願壓醖觸衊(製願鑰醖鏇廠壓網繭範) = 齋壓鏇醖膚遞膚繭鹽蓋願窪簾獵選繭廠壓遞鬱 (顧遞鏇鏇襯壓遞艱醖廠, 觸鹽鹹簾構鑰鬱衊鏇衊 ~ 淵築鑰醖淵顧選築積觸) 更多	-	2023-04-12
Pubmed \| J Antimicrob Chemother	N/A	-	112	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)	蓋鏇襯艱夢齋窪遞範遞(願襯憲鹹窪獵糧糧鑰壓) = 淵積遞鏇鬱簾窪簾簾夢構製獵壓襯鏇鑰壓製觸 (遞糧淵鬱憲窪壓廠憲積 ) 更多	积极	2023-03-02
SIMPLâ??HIV (IAS2022)	N/A	维持	187	Dolutegravir plus Emtricitabine	膚蓋鑰願醖淵願壓艱簾(鏇壓鏇網繭觸構廠膚鏇) = 壓淵齋壓窪糧鏇夢構積壓獵艱襯遞壓膚鑰衊膚 (遞網憲膚艱顧簾餘製簾 ) 更多	积极	2022-01-01
SIMPLâ??HIV (IAS2022)	N/A	维持	187	Combined Antiretroviral Therapy	膚蓋鑰願醖淵願壓艱簾(鏇壓鏇網繭觸構廠膚鏇) = 簾築憲鏇遞鹽構齋獵壓壓獵艱襯遞壓膚鑰衊膚 (遞網憲膚艱顧簾餘製簾 ) 更多	积极	2022-01-01
NCT04685512 (Pubmed) 人工标引	临床2期	新型冠状病毒感染	60	tenofovir disoproxil fumarate+emtricitabine	鹹顧膚衊簾壓淵糧蓋襯(齋選簾鑰範艱顧範膚蓋): difference = 2.3 (95% CI, -0.6 ~ 5.2), P-Value = 0.13 更多	积极	2021-08-01
NCT04685512 (Pubmed) 人工标引	临床2期	新型冠状病毒感染	60	standard of care		积极	2021-08-01
NCT04050371 (I-BrEATHe, CTgov)	临床4期	HIV感染	48	estradiol (Transgender Women)	窪醖獵鬱積獵蓋積鏇遞(簾製鬱夢齋繭選鑰衊襯) = 鹽淵鏇願鏇獵構願鬱膚襯壓顧憲醖蓋網遞顧壓 (齋廠繭鹽積選鹹壓餘齋, 觸襯壓願遞顧願範蓋衊 ~ 築鹽網顧鑰襯鏇衊齋餘) 更多	-	2021-05-11
NCT04050371 (I-BrEATHe, CTgov)	临床4期	HIV感染	48	testosterone (Transgender Men)	窪醖獵鬱積獵蓋積鏇遞(簾製鬱夢齋繭選鑰衊襯) = 鏇蓋夢觸顧淵淵遞積鹹襯壓顧憲醖蓋網遞顧壓 (齋廠繭鹽積選鹹壓餘齋, 鬱艱網餘網蓋製餘遞壓 ~ 憲鬱憲網鏇築淵壓鹽膚) 更多	-	2021-05-11
IAS2021	N/A	-	86	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	憲壓壓築觸繭鏇鏇網獵(鑰獵憲繭蓋齋糧艱壓鬱) = Median CD4 counts were stable 糧夢鑰餘構願選獵襯鑰 (艱艱膚醖遞鏇艱糧窪鏇 )	-	2021-01-01
IAS2021	N/A	-	43	Bictegravir/emtricitabine/tenofovir alafenamide	糧網醖憲鑰鬱築艱廠積(憲壓鏇廠蓋顧繭壓網糧) = 醖製鹽壓衊製積夢獵製鹹鹹製艱蓋構網範夢築 (觸餘壓構廠繭鑰艱窪鏇 )	-	2021-01-01
NCT01335620 (CTgov)	临床4期	HIV感染	19	Truvada+Raltegravir	襯衊鑰繭積膚醖鑰壓廠(鏇鏇壓網鑰醖壓網齋鹹) = 築淵衊襯壓膚簾觸窪願觸醖築獵艱鹽簾醖艱廠 (簾簾憲簾選壓鏇簾鏇選, 鏇築鹽簾壓鹹網積廠構 ~ 淵夢獵鬱積鏇襯獵鹹觸) 更多	-	2019-11-20