预约演示
更新于：2026-02-27
Cabotegravir/Rilpivirine
卡博特韦/利匹韦林
更新于：2026-02-27
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2020-03-18), |
最高研发阶段(中国)- |
特殊审评快速通道 (美国) |
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结构/序列
分子式C22H19ClN6 |
InChIKeyKZVVGZKAVZUACK-BJILWQEISA-N |
CAS号700361-47-3 |
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关联
15
项与 卡博特韦/利匹韦林 相关的临床试验NCT07370649
Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study
This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype.
Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.
The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.
The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.
Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.
The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.
The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.
开始日期2026-02-01 |
申办/合作机构 |
NCT06694805
A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
开始日期2024-12-02 |
申办/合作机构 |
NCT06468995
Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
开始日期2024-12-02 |
申办/合作机构 |
100 项与 卡博特韦/利匹韦林 相关的临床结果
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100 项与 卡博特韦/利匹韦林 相关的转化医学
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100 项与 卡博特韦/利匹韦林 相关的专利（医药）
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8
项与 卡博特韦/利匹韦林 相关的文献（医药）2026-03-01·Contemporary Clinical Trials
Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa
Article
作者: Nazzinda, Rashidah ; Mugerwa, Henry ; Walker, Simon ; Apoto, Naomi ; Kiilu, Cecilia ; Akabwai, George ; Namukwaya, Stella ; South, Annabelle ; Seeley, Janet ; Green, Alexandra ; Kityo Mutuluuza, Cissy ; Spittle, Ben ; Thomason, Margaret J ; Arumugam, Tiyara ; Burger, David ; Bevers, Lisanne ; Ford, Deborah ; Anena, Diana ; Archary, Moherndran ; Jafta, Lungile ; Pett, Sarah L ; Bamford, Alasdair ; Chappell, Elizabeth ; Bwakura-Dangarembizi, Mutsa ; Kekitiinwa, Adeodata R ; Bush, Molly ; Siika, Abraham ; Chitsamatanga, Moses
BACKGROUND:
Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.
METHODS:
LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.
CONCLUSION:
LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.
TRIAL REGISTRATION:
This trial has been registered with ClinicalTrials.gov (NCT05154747).
2022-08-03·Expert review of anti-infective therapy
Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV
Review
作者: Namvar, Ali ; Heidary, Mohsen ; Ghahramanpour, Hossein ; Soleimani, Faezeh ; Taki, Elahe ; Asadi, Arezoo
INTRODUCTION:
The development of long-acting (LA) drugs has changed the management of common medical conditions for human replication immunodeficiency virus (HIV). Cabenuva (cabotegravir/Rilpivirine) is the first LA antiretroviral injectable drug composed of nano-formulation of cabotegravir (CAB) and rilpivirine (RPV).
AREAS COVERED:
In this review article, we aim to have a brief overview of results of major clinical trials that administrated Cabotegravir/Rilpivirine for patients considering the efficacy and safety profiles. Moreover, we discuss about CAB and RPV chemical structure, mechanism of action, activity against drug-sensitive and -resistant HIV, and pharmacodynamics/pharmacokinetics properties.
EXPERT OPINION:
Based on the results of the ATLAS and FLAIR trials, Cabotegravir/Rilpivirine regimen once-monthly has shown equal effectivity to oral combination antiretroviral therapy (cART) in maintaining HIV-1 suppression in patients. Furthermore, ATLAS-2 M study revealed the non-inferiority of Cabotegravir/Rilpivirine regimen every 8 weeks compared to every 4 weeks. The injectable LA ART reduces the number of treatment intake as well as increases adherence, especially in patients with HIV-related stigma. Administration of extended-release agents probably minimize the risk of treatment-related toxicity and resistance related to sub-optimal adherence to oral ART, so Cabotegravir/Rilpivirine can be suggested as a suitable alternative for HIV infection control in current era.
2022-08-01·AIDS (London, England)
Cabotegravir–rilpivirine treatment initiation in a nonvirologically suppressed patient
Article
作者: Armas-Kolostroubis, Laura ; Barnett, Steven K. ; Riedel, David J. ; Sension, Michael
Currently, there is a single option for a complete parenteral HIV antiretroviral therapy (ART) regimen.Cabotegravir rilpivirine is a complete HIV ART regimen combining an extended-release injectable integrase strand inhibitor (INSTI) solution (cabotegravir) with an extended-release injectable nonnucleoside reverse transcriptase inhibitor (NNRTI) solution (rilpivirine), which allows for once-amonth dosing.We describe a patient who had failed four different traditional oral HIV ART regimens and had no ART resistance who was initiated on a once-monthly injection of cabotegravir-rilpivirine to circumvent poor pill adherence and gastrointestinal concerns.
173
项与 卡博特韦/利匹韦林 相关的新闻（医药）2026-02-26
Clinical Infectious Diseases Volume 82 Issue 1
临床传染病学 82卷1期
https://academic.oup.com/cid/issue/
ID Art Through the Ages（穿越时代的传染病学技艺）
1
Peasants' Revolt, 1381
1381年农民起义
Mary Grizzard and Michael Grizzard
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page i, https://doi.org/10.1093/cid/ciaf692
In the Literature（文献概览）
2
In the Literature
文献概览
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages ii–iii, https://doi.org/10.1093/cid/ciaf631
State-of-the-Art Review（最新技术综述）
3
State-of-the-Art Review: Diagnosis and Management of Acute and Chronic Bacterial Prostatitis
最新技术综述：急性和慢性细菌性前列腺炎的诊断与治疗
Prathit A Kulkarni and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 1–13, https://doi.org/10.1093/cid/ciaf483
Clinical Dilemmas in Infectious Diseases（传染病临床难题）
4
“Insisting on Treatment”
“坚持治疗”
Kevin Andrew Smith and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 14–18, https://doi.org/10.1093/cid/ciaf282
Voices of ID（传染病之声）
5
Martin Arrowsmith and Me
马丁·阿罗史密斯与我
Janet R Gilsdorf
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 19–20, https://doi.org/10.1093/cid/ciaf277
Invited Commentary（特邀述评）
6
The 2025 Centers for Disease Control and Prevention Nonoccupational HIV Postexposure Prophylaxis Guidelines: Updated Regimens and Remaining Questions
2025年美国疾病控制与预防中心非职业性艾滋病毒暴露后预防指南：更新方案及遗留问题
Lao-Tzu Allan-Blitz and Kenneth H Mayer
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 21–24, https://doi.org/10.1093/cid/ciaf567
Antimicrobial Resistance and Stewardship（抗菌药物耐药性与管控）
7
Modeling the Impact and Cost of a Culture-Dependent Molecular Test for Antimicrobial Resistance in Resource-Limited Settings
资源有限环境下，基于培养的分子检测法对抗菌药物耐药性的影响和成本建模
Joshua M Chevalier and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 25–32, https://doi.org/10.1093/cid/ciaf236
8
The Xpert MTB/RIF Cycle Threshold Value Predicts Mycobacterium tuberculosis Transmission to Close Contacts in a Brazilian Prospective Multicenter Cohort
巴西一项前瞻性多中心队列研究中Xpert MTB/RIF循环阈值可预测结核分枝杆菌在密切接触者中的传播
Leandro S Garcia and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 33–41, https://doi.org/10.1093/cid/ciad794
9
Beyond Diagnosis: Xpert Cycle Threshold Values as Predictors of Tuberculosis Transmission
超越诊断：Xpert循环阈值作为结核病传播的预测指标
Lauren Linde and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 42–43, https://doi.org/10.1093/cid/ciad791
10
First Report of Treatment-Emergent Resistance to Cefepime-Zidebactam in Pseudomonas aeruginosa
铜绿假单胞菌在头孢吡肟-齐德巴坦治疗中出现耐药性的首例报告
Ava J Dorazio and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 44–48, https://doi.org/10.1093/cid/ciaf638
Clinical Practice and Policy（临床实践与政策）
11
Sputum and Tongue Swab Molecular Testing for the In-Home Diagnosis of Tuberculosis in Unselected Household Contacts: A Cost and Cost-Effectiveness Analysis
痰液和舌拭子分子检测用于未筛选家庭接触者结核病居家诊断的成本及成本效益分析
Charl Bezuidenhout and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 49–57, https://doi.org/10.1093/cid/ciaf389
12
You’ve Got a Friend in Me: Curbside Questions Infectious Diseases Clinicians Ask Infectious Diseases Pharmacists
我是你的朋友：传染病临床医生向传染病药剂师咨询的即兴问题
Matthew R Davis and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 58–61, https://doi.org/10.1093/cid/ciaf250
13
Home Testing for Contagious Illness: Historical Context and Modern Caveats
传染性疾病居家检测：历史背景与现代注意事项
Abigail Zuger
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 62–66, https://doi.org/10.1093/cid/ciaf623
Fungal Infections（真菌感染）
14
Evaluating the Use of Lower Dose Flucytosine for the Treatment of Cryptococcal Meningitis: A Clinical Trial
评估低剂量氟胞嘧啶治疗隐球菌性脑膜炎的临床试验
Morris K Rutakingirwa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 67–74, https://doi.org/10.1093/cid/ciaf432
15
Association Between Duration of Candidemia and Clinical and Healthcare Resource Utilization Outcomes Among Hospitalized Adult Patients With Candidemia Who Received Empiric Treatment With an Echinocandin Across United States Hospitals
美国各医院中接受棘白菌素经验性治疗的念珠菌血症成年住院患者中，念珠菌血症持续时间与临床和医疗资源利用结局之间的关联
Thomas P Lodise and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 75–85, https://doi.org/10.1093/cid/ciaf472
16
Aspergillosis-Attributable Mortality in the United States: Analysis of Death Certificate Data
美国隐球菌病导致的死亡率分析：基于死亡证明数据
Thomas J Walsh and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 86–92, https://doi.org/10.1093/cid/ciaf653
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
17
Outcomes of Critical Illness in People With Advanced HIV Disease: 30 Years of Binational Data
晚期艾滋病患者危重症结局：30年的双国数据
Bryan Tan and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 93–99, https://doi.org/10.1093/cid/ciaf362
18
Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357
长效卡博特韦和VRC07-523LS用于HIV-1感染成人病毒抑制的2期试验：ACTG A5357
Babafemi O Taiwo and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 100–108, https://doi.org/10.1093/cid/ciaf375
19
Therapeutic Drug Monitoring of Long-Acting Cabotegravir and Rilpivirine in a National Cohort of People With HIV-1: First Results From the ANRS-MIE CARLAPOP Study
全国HIV-1感染者队列中长效卡博特韦和利匹韦林的治疗药物监测：ANRS-MIE CARLAPOP研究的首批结果
Nadège Néant and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 109–118, https://doi.org/10.1093/cid/ciaf385
20
Is Therapeutic Drug Monitoring of Long-Acting Cabotegravir and Rilpivirine of Clinical Utility?
长效卡博特韦和利匹韦林的治疗药物监测是否具有临床实用性？
Catia Marzolini
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 119–121, https://doi.org/10.1093/cid/ciaf386
21
Efficacy and Safety of Dual Therapy With Dolutegravir/Lamivudine in Treatment-naive Persons With CD4 Counts <200/mm3: 48-Week Results of the DOLCE Study
多替拉韦/拉米夫定双药治疗在CD4计数<200/mm³的初治患者中的疗效和安全性：DOLCE研究48周结果
Maria Ines Figueroa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 122–131, https://doi.org/10.1093/cid/ciaf415
22
DOLCE: Sweet Success for Dolutegravir/Lamivudine?
DOLCE研究：多替拉韦/拉米夫定双药治疗是否取得完美成功？
Laura J Waters
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 132–133, https://doi.org/10.1093/cid/ciaf416
Infection Control and Hospital Epidemiology（感染控制与医院流行病学）
23
Real-Time Genomic Surveillance for Enhanced Healthcare Outbreak Detection and Control: Clinical and Economic Impact
实时基因组监测用于加强医疗保健机构疫情检测与控制：临床与经济影响
Alexander J Sundermann and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 134–141, https://doi.org/10.1093/cid/ciaf216
24
Patient Perspectives Regarding Different Contact Precaution Policies for Methicillin-resistant Staphylococcus aureus Across Two Hospitals: Patients Are in Favor of Contact Precautions
两家医院患者对耐甲氧西林金黄色葡萄球菌不同接触预防政策的态度：患者支持接触预防措施
Nicholas F Angelino and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 142–144, https://doi.org/10.1093/cid/ciaf330
Photo Quiz（影像问答）
25
The Clue That Wriggled into View
蜿蜒入目的线索
Nitin Gupta and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 145–147, https://doi.org/10.1093/cid/ciaf427
Infection Control and Hospital Epidemiology（感染控制与医院流行病学）
26
Comparing Generative Artificial Intelligence vs Experts for Detection of Catheter-Associated Urinary Tract Infection
比较生成式人工智能与专家在导管相关尿路感染检测中的应用
Shatha Alshanqeeti and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 148–150, https://doi.org/10.1093/cid/ciaf486
Sexually Transmitted Infections（性传播感染）
27
Viability of Chlamydia trachomatis in Different Anatomical Sites—a Systematic Review and Meta-analysis
不同解剖部位沙眼衣原体的存活能力——系统综述和荟萃分析
Arthur Wong and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 151–158, https://doi.org/10.1093/cid/ciae401
Photo Quiz（影像问答）
28
A 46-Year-Old With Persistent Altered Mental Status and Respiratory Failure
一例46岁患者持续出现意识状态改变伴呼吸衰竭
Ann F Yang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 159–161, https://doi.org/10.1093/cid/ciaf439
Sexually Transmitted Infections（性传播感染）
29
Mpox in People With HIV: Predictors of Diagnosis, Outcomes, and Vaccine Effectiveness in a Multisite Cohort
HIV感染者中的猴痘：多站点队列中诊断、预后和疫苗有效性的预测因素
Michalina Montaño and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 162–172, https://doi.org/10.1093/cid/ciae464
30
Development and Evaluation of a Novel Algorithm to Identify Doxycycline Postexposure Prophylaxis Users at a Large Healthcare System in the Bronx, New York
开发和评估一种新型算法，用于识别纽约布朗克斯区一家大型医疗系统中多西环素暴露后预防用药者
Caroline E Mullis and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 173–176, https://doi.org/10.1093/cid/ciaf109
31
Evidence-Informed Provision of Doxycycline Postexposure Prophylaxis for Prevention of Bacterial Sexually Transmitted Infections
为预防细菌性性传播感染提供基于证据的多西环素暴露后预防用药
Julia C Dombrowski and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 177–184, https://doi.org/10.1093/cid/ciae527
Bacterial Infections（细菌性感染）
32
Long-term Mortality Trends Among Individuals With Tuberculosis: A Retrospective Cohort Study of Individuals Diagnosed With Tuberculosis in Brazil
巴西结核病患者的长期死亡率趋势：一项针对巴西结核病诊断患者的回顾性队列研究
Sun Kim and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e1–e8, https://doi.org/10.1093/cid/ciaf206
33
Clinical and Microbiological Characteristics of Meningococcal Eye Infections: Retrospective National Surveillance in England, 2010–2022
脑膜炎球菌眼部感染的临床和微生物学特征：2010 - 2022年英格兰全国回顾性监测
Stephen A Clark and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e9–e16, https://doi.org/10.1093/cid/ciaf274
34
Does Piperacillin-Tazobactam Increase Mortality Risk Compared With Cefepime? Collider Bias and the Importance of Assumptions in Instrumental Variable Analyses
与头孢吡肟相比，哌拉西林-他唑巴坦是否会增加死亡率风险？工具变量分析中的混杂偏倚和假设的重要性
Fergus Hamilton and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e17–e23, https://doi.org/10.1093/cid/ciaf317
COVID-19 / SARS COV-2（新冠肺炎/严重急性呼吸综合征冠状病毒2型）
35
Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With COVID-19 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
奥贝德西韦在高危非住院COVID-19患者（BIRCH研究）中的疗效和安全性：一项3期、随机、双盲、安慰剂对照研究
Anca Streinu-Cercel and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e24–e32, https://doi.org/10.1093/cid/ciaf406
36
Retreatment With Nirmatrelvir/Ritonavir Following Return of COVID-19 Symptoms and SARS-CoV-2 Positivity
COVID-19症状复发且SARS-CoV-2检测呈阳性后使用奈玛特韦/利托那韦重新治疗
Wuyan Zhang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e33–e40, https://doi.org/10.1093/cid/ciaf548
Emerging Infections(新兴感染)
37
“I Didn’t Know Him Before the Pandemic… Now He's on My Speed Dial”: Strengthening Collaboration Between Infectious Diseases Physicians and State and Local Public Health for Future Public Health Emergencies
“疫情前我并不认识他……现在他已是我的快速拨号对象”：加强传染病医生与州和地方公共卫生部门在未来突发公共卫生事件中的合作
Diana Valencia and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e41–e46, https://doi.org/10.1093/cid/ciaf179
38
Identification of and Response to Influenza A(H5) in Off-the-Shelf Raw Milk—Santa Clara County, California, November–December 2024
2024年11 - 12月加利福尼亚州圣克拉拉县在现成生牛奶中检出甲型流感（H5）病毒及应对措施
Alessandra Løchen and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e47–e48, https://doi.org/10.1093/cid/ciaf420
39
The Indispensable Value of Small-Molecule Antivirals in Epidemic and Pandemic Preparedness
小分子抗病毒药物在流行病和大流行病防范中的不可或缺价值
Ruxandra Draghia-Akli and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e49–e55, https://doi.org/10.1093/cid/ciaf476
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
40
Increasing HIV Testing During Gonorrhea and Chlamydia Evaluations in Urgent Care and Emergency Departments: A Large Health System Initiative
在紧急护理和急诊科进行淋病和衣原体检测时增加HIV检测：一项大型医疗系统倡议
Allan M Seibert and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e56–e67, https://doi.org/10.1093/cid/ciaf434
41
Clinical Predictors and Incidence of Kaposi Sarcoma Among Males With HIV in the Treat-All Era in the United States and Canada
美国和加拿大“全员治疗”时代男性HIV感染者卡波西肉瘤的临床预测因素和发病率
Sally B Coburn and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e68–e77, https://doi.org/10.1093/cid/ciaf446
42
Integrase Strand Transfer Inhibitors for Treatment-experienced Young Adults With Perinatal HIV in the US: Immunologic, Virologic, and Anthropometric Outcomes
美国接受过治疗的围产期感染HIV的年轻成人使用整合酶链转移抑制剂的免疫学、病毒学和人体测量学结果
Kunjal Patel and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e78–e88, https://doi.org/10.1093/cid/ciaf538
43
Win Ratio Aligns With and Enhances Interpretation of REPRIEVE's Primary Findings
Win比值与REPRIEVE研究的主要发现一致并增强了其解释性
Emma Davies Smith and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e89–e92, https://doi.org/10.1093/cid/ciaf477
44
The Critical Importance of Clinical Use Case to Inform Point-of-Care Technology Development: A Case Study of HIV Nucleic Acid Assays in the United States
临床应用案例对于指导即时检测技术开发的重要性：以美国HIV核酸检测为例
Yukari C Manabe and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e93–e99, https://doi.org/10.1093/cid/ciaf510
Mycobacterial Infections（分枝杆菌感染）
45
Body Mass Index and Incident Tuberculosis in Close Tuberculosis Contacts
结核密切接触者中体重指数与新发结核病的关系
María B Arriaga and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e100–e109, https://doi.org/10.1093/cid/ciaf475
46
The Role of Youths in Within-Household Tuberculosis Transmission: A Household Contact Cohort Study
青年在家庭内结核病传播中的作用：一项家庭接触队列研究
Meredith B Brooks and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e110–e118, https://doi.org/10.1093/cid/ciaf490
47
Cost-effectiveness of Targeted Next-Generation Sequencing for Tuberculosis Drug-resistance Testing as an Alternative to the Standard of Care in South Africa
南非以靶向下一代测序作为结核病耐药检测标准护理方案的替代方案的成本效益分析
Alexandra de Nooy and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e119–e125, https://doi.org/10.1093/cid/ciaf495
48
Xpert MTB/RIF Cycle Threshold as a Marker of Tuberculosis (TB) Disease Severity: Implications for TB Treatment Stratification
Xpert MTB/RIF循环阈值作为结核病（TB）疾病严重程度的标志物：对结核病治疗分层的启示
Daniel J Grint and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e126–e134, https://doi.org/10.1093/cid/ciaf527
49
The Role of β-Lactam Antibiotics in Treating Mycobacterium abscessus: From Laboratory Insights to Clinical Applications and the Case for Clinical Trials
β-内酰胺类抗生素在治疗脓肿分枝杆菌中的作用：从实验室见解到临床应用及开展临床试验的必要性
Khalid M Dousa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e135–e145, https://doi.org/10.1093/cid/ciaf547
Pediatric and Maternal Infectious Diseases（儿科与孕产妇传染病）
50
Efficacy, Immunogenicity, and Safety of an Investigational Maternal Respiratory Syncytial Virus Prefusion F Protein–Based Vaccine
一种研究性孕产妇呼吸道合胞病毒融合前F蛋白疫苗的疗效、免疫原性和安全性
Peyman Banooni and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e146–e155, https://doi.org/10.1093/cid/ciaf033
51
Hepatotoxicity Among People With HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and Pharmacogenetics
HIV感染者在孕期和产后接受异烟肼预防性治疗时的肝毒性：抗逆转录病毒治疗方案和药物基因组学的作用
Grace Montepiedra and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e156–e164, https://doi.org/10.1093/cid/ciaf198
52
Transplacental Transfer of Lumefantrine, Mefloquine, and Piperaquine: A Comparison of Concentrations in Mothers, Neonates, and Cord Blood
青蒿素、甲氟喹和哌喹的胎盘转运：母亲、新生儿和脐带血中浓度的比较
Makoto Saito and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e165–e173, https://doi.org/10.1093/cid/ciaf552
53
Why Did the Antimalarial Drug Cross the Placenta?
抗疟药为何要穿过胎盘？
Stephen J Rogerson and Holger W Unger
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e174–e175, https://doi.org/10.1093/cid/ciaf553
Viral Infections（病毒性传染病）
54
Kinetics and Predictors of Hepatitis B Surface Antigen Loss After Commencing Hepatitis B Virus (HBV)–Active Antiretroviral Therapy in the Setting of HIV and Chronic HBV Coinfection
HIV和慢性乙型肝炎病毒（HBV）共感染患者开始使用HBV活性抗逆转录病毒治疗后乙型肝炎表面抗原消失的动力学和预测因素
Jennifer Audsley and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e176–e184, https://doi.org/10.1093/cid/ciaf281
55
Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections
患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病
Lauren A Powers and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e185–e190, https://doi.org/10.1093/cid/ciaf285
Correspondence（读者来信）
56
Unveiling Latent Risk Patterns in Antimicrobial-Resistant Bacteremia: A Deeper Look at Pathogen-Specific Mortality
揭示抗菌药物耐药性菌血症中的潜在风险模式：深入探究病原体特异性死亡率
Yuan-Ti Lee and Shiuan-Chih Chen
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e191, https://doi.org/10.1093/cid/ciaf493
57
Resistance to Antibiotics With High Empiric Treatment Relevance Explains Attributable Mortality Across 110 Pathogen-antibiotic Combinations
对经验性治疗具有高度相关性的抗生素耐药性可解释110种病原体 - 抗生素组合的归因死亡率
Kevin A Brown and Nick Daneman
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e191–e192, https://doi.org/10.1093/cid/ciaf494
58
Culture Clash: Dual-Pathogen Endocarditis and the Metagenomic Next-Generation Sequencing Studies We Need
文化冲突：双病原体心内膜炎以及我们所需的宏基因组下一代测序研究
Carl Boodman and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e193–e195, https://doi.org/10.1093/cid/ciaf518
59
Metagenomic Next-Generation Sequencing and Cardiovascular Infections: Promise and Pitfalls of Polymicrobial Detection
宏基因组下一代测序与心血管感染：多微生物检测的前景与陷阱
Sarwat Khalil and M Rizwan Sohail
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e196, https://doi.org/10.1093/cid/ciaf519
60
It Is Time to Go Beyond the Association Between Colistin and Meropenem for Invasive Carbapenem-Resistant Acinetobacter baumannii Infections
是时候超越多粘菌素和美罗培南联合治疗侵袭性碳青霉烯耐药鲍曼不动杆菌感染了
Alberto Enrico Maraolo and Giancarlo Ceccarelli
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e197–e198, https://doi.org/10.1093/cid/ciaf533
61
Actually, It May be Time to Return to Colistin and Meropenem in Some Patients Infected With Carbapenem-resistant Acinetobacter baumannii (CRAB)
实际上，对于某些感染碳青霉烯耐药鲍曼不动杆菌（CRAB）的患者，或许是时候重新使用多粘菌素和美罗培南了
Jason M Pogue and Keith S Kaye
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e198–e199, https://doi.org/10.1093/cid/ciaf534
62
COVID-19 and Bacterial Pneumonia: Protective Effect or Diagnostic Bias?
COVID-19和细菌性肺炎：保护作用还是诊断偏差？
Duygu Aydın and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e200, https://doi.org/10.1093/cid/ciaf539
63
Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections: A Follow Up
患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病：后续研究
John C Hu and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e200–e201, https://doi.org/10.1093/cid/ciaf540
64
Long-Acting Cabotegravir/Rilpivirine in Viremic People With HIV: Bumpy Road to Perfection
长效卡博特韦/利匹韦林用于病毒载量阳性的HIV感染者：通往完美的坎坷之路
Beatrice Barda and Marco Bongiovanni
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e201–e202, https://doi.org/10.1093/cid/ciaf482
65
Beyond the Sequence: Operationalizing Whole-Genome Sequencing for Real-time Infection Control in Low- and Middle-Income-Country Healthcare Settings Healthcare Settings
超越序列：在中低收入国家医疗环境中实际应用全基因组测序进行实时感染控制
Schawanya Kaewpitoon Rattanapitoon and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e202–e203, https://doi.org/10.1093/cid/ciaf535
66
Reassessing Adherence Trajectories in Multidrug-Resistant Tuberculosis: Recovery Advantage and Hidden Biases
重新评估耐多药结核病的依从性轨迹：康复优势和隐藏偏差
Shiuan-Chih Chen and Chun-Chieh Chen
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e203–e204, https://doi.org/10.1093/cid/ciaf536
67
Metagenomic Sequencing of Blood Culture Broth for Diagnosing Fastidious Endocarditis
血培养肉汤宏基因组测序用于诊断苛养性心内膜炎
Po-Hsiu Huang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e204–e205, https://doi.org/10.1093/cid/ciaf554
Corrections（更正）
68
Correction to: Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections
《患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病》更正
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e206, https://doi.org/10.1093/cid/ciaf572
69
Correction to: Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa
《南非高HIV流行率、项目化环境中口服短程利福平耐药结核病治疗方案的治疗结果》更正
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e207, https://doi.org/10.1093/cid/ciaf711
Clinical Infectious Diseases Volume 82 Issue Supplement_1
临床传染病学 82卷 增刊1期
https://academic.oup.com/cid/issue/82/Supplement_1
SUPPLEMENT（增刊）
Laboratory and Point-of-care Testing to Detect Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Available Evidence
实验室及即时检测技术用于检测沙眼衣原体和淋病奈瑟菌：现有证据综述
SUPPLEMENT ARTICLES（增刊论著）
1
Evidence Review for Centers for Disease Control and Prevention Guidance Development on the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
美国疾病控制与预防中心沙眼衣原体和淋病奈瑟菌检测指南制定证据综述
Amanda C Smith and Ellen N Kersh
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S1–S5, https://doi.org/10.1093/cid/ciaf665
2
Narrative Review of Chlamydia trachomatis Culture, Viability Testing, and Sequencing Methods
沙眼衣原体培养、活性检测及测序方法的叙述性综述
Alana K Sterkel and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S6–S12, https://doi.org/10.1093/cid/ciaf697
3
Culture and Identification of Neisseria gonorrhoeae: A Narrative Review of Current Laboratory Methods
淋病奈瑟菌培养与鉴定：当前实验室方法叙述性综述
Olusegun O Soge and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S13–S18, https://doi.org/10.1093/cid/ciaf698
4
Review of the Performance of Laboratory-Based Molecular Diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae
实验室分子诊断技术检测沙眼衣原体和淋病奈瑟菌的性能综述
Megan Crumpler and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S19–S35, https://doi.org/10.1093/cid/ciaf696
5
Review of Methods for Detecting Antimicrobial Resistance of Neisseria gonorrhoeae
淋病奈瑟菌抗菌药物耐药性检测方法综述
Kara K Mitchell and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S36–S42, https://doi.org/10.1093/cid/ciaf706
6
Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature
沙眼衣原体和淋病奈瑟菌即时检测技术文献综述
Yukari C Manabe and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S43–S51, https://doi.org/10.1093/cid/ciaf699
Clinical Infectious Diseases Volume 82 Issue 2
临床传染病学 82卷 2期
https://academic.oup.com/cid/issue/
ID Art Through the Ages（穿越时代的传染病技艺）
1
Interior of the Old Jersey Prison Ship in the Revolutionary War
美国革命战争中老泽西监狱船的内部景象
Mary Grizzard and Michael Grizzard
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Page i, https://doi.org/10.1093/cid/ciaf693
In the Literature（本期精选）
2
In the Literature
本期精选
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages ii–v, https://doi.org/10.1093/cid/ciag011
IDSA 2025 Collections Editorial（美国传染病学会2025年专题合集社论）
3
2025 Content Collections from the IDSA Journals
IDSA期刊2025年内容合集
Roger Bedimo and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 185–186, https://doi.org/10.1093/cid/ciag041
State-of-the-Art Review（前沿综述）
4
State-of-the-Art Review: Chagas Disease—an Enduring Challenge
前沿综述：恰加斯病——一个持续存在的挑战
Nelson Iván Agudelo Higuita and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 187–205, https://doi.org/10.1093/cid/ciaf654
IDSA Features（美国传染病学会特色内容）
5
Policy Recommendations to Support Equitable Access to Long-Acting Injectables for HIV Prevention and Treatment: A Policy Paper of the Infectious Diseases Society of America and the HIV Medicine Association
支持公平获取用于艾滋病毒预防和治疗的长效注射剂的政策建议：美国传染病学会与艾滋病毒医学协会的政策文件
Julia L Marcus and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 206–211, https://doi.org/10.1093/cid/ciae648
Voices of ID（传染病之声）
6
A “Terminal Infection”
“绝症感染”
Jennifer Furin
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 212–214, https://doi.org/10.1093/cid/ciaf332
Invited Commentary（特邀评论）
7
A Rapid Test to Differentiate Viral From Bacterial Infections: Searching for the Holy Grail
区分病毒与细菌感染的快速检测：寻找“圣杯”
Lao-Tzu Allan-Blitz and Jeffrey D Klausner
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 215–218, https://doi.org/10.1093/cid/ciaf585
Bacterial Infections（细菌感染）
8
Nonoperative Versus Neurosurgical Treatment of Brain Abscess: An Emulated Trial Nested Within a Nationwide, Population-Based Cohort
脑脓肿的非手术治疗与神经外科治疗：一项基于全国人群队列的模拟试验
Emilie Marie Eriksen and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 219–227, https://doi.org/10.1093/cid/ciaf304
9
What Is the Impact of Anti-Enterococcal Empirical Therapy on Survival of Patients With Enterococcal Bloodstream Infections?
抗肠球菌经验性治疗对肠球菌血流感染患者生存率的影响是什么？
Linda Bussini and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 228–237, https://doi.org/10.1093/cid/ciaf323
10
Adjunctive Fosfomycin for the Treatment of Staphylococcus aureus Bacteremia: A Pooled Post Hoc Analysis of Individual Participant Data From 2 Randomized Trials
辅助使用磷霉素治疗金黄色葡萄球菌菌血症：两项随机试验个体参与者数据的汇总事后分析
Francesc Escrihuela-Vidal and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 238–245, https://doi.org/10.1093/cid/ciaf387
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
11
Kinetics of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations in HIV-1 Proviral Cellular Reservoirs in Non-nucleoside Reverse Transcriptase Inhibitor-experienced Persons
在接受过非核苷类逆转录酶抑制剂治疗的HIV-1感染者中，非核苷类逆转录酶抑制剂耐药相关突变在HIV-1前病毒细胞储存库中的动力学
Thomas Drumel and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 246–251, https://doi.org/10.1093/cid/ciaf430
12
Impact of Different Integrase Strand Transfer Inhibitors on Body Mass Index Among People With HIV Who Newly Started Antiretroviral Therapy in Shenzhen, China: A Real-World Data Analysis
中国深圳新开始抗逆转录病毒治疗的HIV感染者使用不同整合酶链转移抑制剂对体重指数的影响：一项现实数据分析
Lukun Zhang and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 252–261, https://doi.org/10.1093/cid/ciaf466
13
Consequences of Stopping Antiretroviral Treatment in a Persistently Seronegative Individual with HIV-1
HIV-1持续血清阴性个体停止抗逆转录病毒治疗的后果
Marc Wirden and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 262–264, https://doi.org/10.1093/cid/ciaf422
14
Approaches to the Management of Virologic Failure on Dolutegravir-Based Antiretroviral Therapy in the 50 Countries With the Highest Adult HIV Prevalence
在成人HIV患病率最高的50个国家中，多替拉韦为基础的抗逆转录病毒治疗出现病毒学失败的治疗方法
Cameron T Nutt and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 265–273, https://doi.org/10.1093/cid/ciaf444
Mycobacterial Infections（结核分枝杆菌感染）
15
Retrospective Cohort Analysis for Identification of Discordant Rifampicin-resistant Xpert MTB/RIF Assay Results in South Kivu, Eastern Democratic Republic of the Congo, a High Burden Tuberculosis Setting
刚果民主共和国东部南基伍这一结核病高负荷地区，识别利福平耐药不一致的Xpert MTB/RIF检测结果的回顾性队列分析
Bertin C Bisimwa and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 274–281, https://doi.org/10.1093/cid/ciaf451
16
Prevention of Tuberculosis in Patients Treated With Biological Therapies: 20 Years' Experience in a Specialized Tuberculosis Clinic in a Low-prevalence Country
生物疗法治疗患者中结核病的预防：某低流行国家一个专科结核病诊所20年的经验
Sandra Pérez-Recio and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 282–290, https://doi.org/10.1093/cid/ciaf491
17
Reducing Household Tuberculosis Transmission: A Pilot Cluster-Randomized Controlled Trial
减少家庭内结核病传播：一项试点整群随机对照试验
Cinthya Ruiz-Tagle and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 291–298, https://doi.org/10.1093/cid/ciaf526
18
(Un)masking Tuberculosis
（揭开）结核病的“面具”
Joseph N Burzynski and Neil W Schluger
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 299–300, https://doi.org/10.1093/cid/ciaf528
19
Estimating the Accuracy and Additionality of TB-LAM to Diagnose TB in Children Without HIV (AccuLAM)
评估TB-LAM在无HIV儿童中诊断结核病的准确性和额外价值（AccuLAM）
Lucía CarratalàCastro and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 301–303, https://doi.org/10.1093/cid/ciaf525
Sexually Transmitted Infections（性传播感染）
20
Potential Impact of Doxycycline Post-exposure Prophylaxis Prescribing Strategies on Incidence of Bacterial Sexually Transmitted Infections
多西环素暴露后预防用药策略对细菌性性传播感染发病率的影响
Michael W Traeger and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 304–311, https://doi.org/10.1093/cid/ciad488
21
Filling in the Gaps: Updates on Doxycycline Prophylaxis for Bacterial Sexually Transmitted Infections
填补空白：多西环素预防细菌性性传播感染的最新进展
Aniruddha Hazra and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 312–320, https://doi.org/10.1093/cid/ciae062
22
Reported Neurologic Manifestations Among Persons With Syphilis by Stage of Infection—12 States, 2019–2022
2019-2022年12个州按感染阶段划分的梅毒患者报告的神经系统表现
Sarah B Wondmeneh and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 321–325, https://doi.org/10.1093/cid/ciaf015
Viral Infections（病毒性感染）
23
Investigating the Role of Cytomegalovirus as a Cause of Stillbirths and Child Deaths in Low- and Middle-Income Countries Through Postmortem Minimally Invasive Tissue Sampling
通过死后微创组织采样，调查巨细胞病毒在低收入和中等收入国家死胎和儿童死亡原因中的作用
Sithembiso Velaphi and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 326–336, https://doi.org/10.1093/cid/ciaf098
Photo Quiz（影像问答）
24
Bursting at the Seams
“撑破”
Maxwell Olenski and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 337–340, https://doi.org/10.1093/cid/ciaf488
Viral Infections（病毒性感染）
25
Clinical and Epidemiological Investigation of Vaccine-Derived Poliovirus Type 2 Outbreak in Pakistan During 2019–2021
2019-2021年巴基斯坦2型疫苗衍生脊髓灰质炎病毒疫情的临床和流行病学调查
Nayab Mehmood and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 341–351, https://doi.org/10.1093/cid/ciaf151
26
Inactivated Polio Vaccine Must Be an Essential Part of Polio Eradication
灭活脊髓灰质炎疫苗必须是根除脊髓灰质炎的重要组成部分
Konstantin Chumakov and Stanley A Plotkin
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 352–353, https://doi.org/10.1093/cid/ciaf215
Photo Quiz（影像问答）
27
Intracranial Lesion in a Patient With Chronic Myeloid Leukemia
慢性髓性白血病患者颅内病变
Mohammed Shakeel Sillat and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 354–357, https://doi.org/10.1093/cid/ciaf441
Viral Infections（病毒性感染）
28
Respiratory Syncytial Virus Co-Detection With Other Respiratory Viruses Is Not Significantly Associated With Worse Clinical Outcomes Among Children Aged <2 Years: New Vaccine Surveillance Network, 2016–2020
在<2岁的婴幼儿中，呼吸道合胞病毒与其他呼吸道病毒共同检测与临床预后恶化无显著关联：2016-2020年新疫苗监测网络数据
Justin Z Amarin and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 358–365, https://doi.org/10.1093/cid/ciaf194
29
Transfer of Herpes Simplex Virus Type 1 (HSV-1) Specific T Cells in a Pediatric Patient Post-HSCT With Severe, Acyclovir-resistant HSV-1 Infection
一例异基因造血干细胞移植后严重、阿昔洛韦耐药的单纯疱疹病毒1型（HSV-1）感染患儿的HSV-1特异性T细胞的输注
Astrid Wintering and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 366–369, https://doi.org/10.1093/cid/ciaf125
Clinical Trials（临床实验）
30
Interferon-α Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial
干扰素-α鼻喷雾剂预防可降低癌症患者新冠病毒感染率：一项随机、双盲、安慰剂对照试验
Michelle K Yong and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e208–e216, https://doi.org/10.1093/cid/ciaf409
31
A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18–64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8
一项3期随机试验，调查V116（一种成人特异性肺炎球菌结合疫苗）在未接种过肺炎球菌疫苗且患肺炎球菌疾病风险增加的18-64岁年龄段成人中的安全性、耐受性和免疫原性，STRIDE-8试验
Paul T Scott and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e217–e226, https://doi.org/10.1093/cid/ciaf604
32
Effect of Direct-from-blood Bacterial Testing on Antibiotics Administration in Adults Presenting With Acute Infection: A Randomized Trial
直接从血液进行细菌检测对急性感染成年患者抗生素给药的影响：一项随机试验
David C Gaston and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e227–e235, https://doi.org/10.1093/cid/ciaf677
33
The Tantalizing Pursuit for a Perfect Diagnostic Test: Balancing Innovation With Stewardship
对完美诊断检测的诱人追求：平衡创新与管理
K C Coffey and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e236–e238, https://doi.org/10.1093/cid/ciaf674
Global Health and Neglected Tropical Diseases（全球健康与被忽视的热带病）
34
Diagnostic Accuracy of Tuberculosis Screening Tests in a Prospective Multinational Cohort: Chest Radiography With Computer-Aided Detection, Xpert Tuberculosis Host Response, and C-Reactive Protein
在一项前瞻性多国队列研究中，结核病筛查试验的诊断准确性：计算机辅助检测的胸部X光片、Xpert结核宿主反应检测和C反应蛋白
Rebecca Crowder and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e239–e247, https://doi.org/10.1093/cid/ciae549
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
35
Risk Assessment in a Global CVD Prevention Cohort of People With HIV by PCE, PREVENT, and SCORE2
通过PCE、PREVENT和SCORE2对全球心血管疾病预防队列中艾滋病毒感染者进行风险评估
Steven K Grinspoon and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e248–e257, https://doi.org/10.1093/cid/ciaf542
36
REPRIEVE Analysis of New Cardiovascular Risk Calculators in HIV: Underpredicting Risk Means Preventing Fewer Heart Attacks
HIV新心血管风险计算器的REPRIEVE分析：低估风险意味着预防的心脏病发作更少
Matthew S Durstenfeld
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e258–e261, https://doi.org/10.1093/cid/ciaf543
37
Comparable Inflammatory and Metabolic Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Continuing Dolutegravir/Lamivudine in Virologically Suppressed Adults With HIV (INSTINCT/GESIDA10918 Study)
在病毒学抑制的HIV感染成人中，转换为比克替拉韦/恩曲他滨/丙酚替诺福韦与继续使用多替拉韦/拉米夫定后的炎症和代谢结局相当（INSTINCT/GESIDA10918研究）
Sergio Serrano-Villar and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e262–e274, https://doi.org/10.1093/cid/ciaf565
38
Tenofovir Alafenamide and Body Weight: Have We Finally Tipped the Scale?
丙酚替诺福韦与体重：我们最终是否打破了平衡？
John R Koethe
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e275–e277, https://doi.org/10.1093/cid/ciaf566
39
Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study
在Tatelo研究中，接受VRC01LS和10-1074单克隆抗体治疗的儿童的长期临床、免疫学和病毒储存库结局
Gbolahan Ajibola and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e278–e285, https://doi.org/10.1093/cid/ciaf568
40
Trends in Persons Prescribed HIV Postexposure Prophylaxis in the United States, 2015–2023
2015-2023年美国开具HIV暴露后预防处方的患者趋势
John N Le and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e286–e295, https://doi.org/10.1093/cid/ciaf581
Immunocompromised Hosts（免疫功能低下宿主）
41
Epidemiology, Risk Factors, and Outcomes of Neutropenic Enterocolitis in Onco-Hematological Patients According to Chemotherapy Regimen
根据化疗方案分析肿瘤血液学患者中性粒细胞减少性肠结肠炎的流行病学、危险因素和预后
Anne-Sophie Brunel and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e296–e307, https://doi.org/10.1093/cid/ciaf134
42
An Analysis of Cytomegalovirus-Specific Cell-Mediated Immunity in a Phase 3, Randomized, Placebo-Controlled Trial of Letermovir Prophylaxis in Cytomegalovirus-Seropositive Recipients of an Allogeneic Hematopoietic Cell Transplant
在一项3期随机、安慰剂对照试验中，分析来特莫韦预防对巨细胞病毒血清阳性异基因造血细胞移植受者巨细胞病毒特异性细胞介导免疫的影响
Genovefa A Papanicolaou and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e308–e315, https://doi.org/10.1093/cid/ciaf646
43
Cytomegalovirus (CMV)-Specific Cell-Mediated Immunity for Prediction of Postprophylaxis CMV Disease in a Phase 3 Trial of Letermovir Versus Valganciclovir Prophylaxis in Donor CMV-Seropositive/Recipient CMV-Seronegative Kidney Transplant Recipients
在供体巨细胞病毒血清阳性/受体巨细胞病毒血清阴性的肾移植受者中，来特莫韦与缬更昔洛韦预防的3期试验中，巨细胞病毒（CMV）特异性细胞介导免疫对预防后CMV疾病的预测作用
Ajit P Limaye and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e316–e324, https://doi.org/10.1093/cid/ciaf632
44
The Role of Cytomegalovirus-Specific Cellular Immunity in Transplant Recipients with Letermovir Prophylaxis: To be Determined
来特莫韦预防移植受者中巨细胞病毒特异性细胞免疫的作用：有待确定
Yoichiro Natori and Martina Sester
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e325–e327, https://doi.org/10.1093/cid/ciaf633
45
IL12RB1 Deficiency Appearing in North America: Expanding the Clinical Phenotypes
北美出现的IL12RB1缺陷：拓展临床表型
Chen Wang and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e328–e331, https://doi.org/10.1093/cid/ciaf637
Vaccines（疫苗）
46
A Phase IV, Open-label, Single-Arm, Multicentric Clinical Trial for Evaluation of Human Papillomavirus 9vHPV Vaccine Immunogenicity in Men Who Have Sex With Men With HIV: GeSIDA Study 10 017
一项评估人乳头瘤病毒9vHPV疫苗在感染HIV的男男性行为者中免疫原性的IV期、开放标签、单臂、多中心临床试验：GeSIDA 10 017研究
Raquel Ron and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e332–e342, https://doi.org/10.1093/cid/ciaf435
47
Immunogenicity and Safety of the COVID-19 Messenger RNA Vaccine Coadministered With Influenza and 23-valent Pneumococcal Polysaccharide Vaccines
与流感疫苗和23价肺炎球菌多糖疫苗同时接种的COVID-19信使核糖核酸疫苗的免疫原性和安全性
Omid Rezahosseini and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e343–e351, https://doi.org/10.1093/cid/ciaf455
48
Intestinal Mucosal Immune Responses to Novel Oral Poliovirus Vaccine Type 2 in Healthy Newborns
健康新生儿对新型2型口服脊髓灰质炎疫苗的肠道黏膜免疫反应
Audrey Godin and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e352–e360, https://doi.org/10.1093/cid/ciaf484
49
Estimated Vaccine Effectiveness for Respiratory Syncytial Virus–Related Acute Respiratory Illness in Older Adults: Findings From the First Postlicensure Season
老年人呼吸道合胞病毒相关急性呼吸道疾病的估计疫苗有效性：首个上市后季节的研究结果
Sara Y Tartof and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e361–e370, https://doi.org/10.1093/cid/ciaf496
Sexually Transmitted Infections（性传播感染）
50
Systematic Review and Meta-analysis of the Association Between Mycoplasma genitalium and Pelvic Inflammatory Disease (PID)
生殖支原体与盆腔炎性疾病（PID）关联的系统综述和荟萃分析
Kay Htaik and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e371–e379, https://doi.org/10.1093/cid/ciae295
51
Sexually Transmitted Infection (STI)/HIV Testing, STIs, and HIV Pre-exposure Prophylaxis Use Among Men Who Have Sex With Men and Men Who Have Sex With Men and Women in the United States, 2019–2022
2019-2022年美国男男性行为者以及男男性行为者和女性性行为者中性传播感染（STI）/HIV检测、性传播感染和HIV暴露前预防用药情况
Guoyu Tao and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e380–e386, https://doi.org/10.1093/cid/ciae314
52
Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083
卡博特韦在细菌性性传播感染情况下维持保护效力：HPTN 083的二次分析
Meredith E Clement and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e387–e395, https://doi.org/10.1093/cid/ciae572
Viral Infections（病毒性感染）
53
Comprehensive Analysis of Cardiovascular Events and Risk Factors in Patients Hospitalized With Respiratory Syncytial Virus
对因呼吸道合胞病毒感染住院患者的心血管事件和危险因素的综合分析
Paulina Sudnik and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e396–e403, https://doi.org/10.1093/cid/ciaf310
54
In Critical Condition: The Urgent Need to Support Mpox Therapeutic and Diagnostic Pipelines
处于危急状况：迫切需要支持猴痘治疗和诊断管线
Carmen Perez Casas and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e404–e408, https://doi.org/10.1093/cid/ciaf529
Correspondence（读者来信）
55
Caution in Interpreting INSTIs and Weight in Observational Studies
在观察性研究中解读整合酶抑制剂与体重关系时需谨慎
Esteban Martínez
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Page e409, https://doi.org/10.1093/cid/ciaf569
56
Weight Trajectories With Integrase Inhibitors: Unaddressed Insights and Limitations in a Chinese Cohort
整合酶抑制剂与体重变化轨迹：中国队列中未解决的见解和局限性
Yuan-Ti Lee and Shiuan-Chih Chen
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e409–e410, https://doi.org/10.1093/cid/ciaf570
57
Real-World Evidence as a Complement to Randomized Trials in Interpreting Weight Gain on Modern INSTI Regimens
现实证据作为随机试验的补充，用于解读现代整合酶抑制剂方案导致的体重增加
Xinsheng Wu and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e410–e411, https://doi.org/10.1093/cid/ciaf571
58
C-reactive Protein in TB Meningitis: Signal, Surrogate, or Saboteur?
结核性脑膜炎中的C反应蛋白：信号、替代指标还是破坏因素？
Patrick K Moonan and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e411–e412, https://doi.org/10.1093/cid/ciaf575
59
C-Reactive Protein in Tuberculous Meningitis: A Viable Biomarker for Individualized Care
结核性脑膜炎中的C反应蛋白：个体化护理的可行生物标志物
Lillian Tugume and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e412–e413, https://doi.org/10.1093/cid/ciaf576
60
The Win Ratio Should Be Complemented by Other Win Statistics to Provide a Comprehensive Picture of Relative and Absolute Treatment Effects: The Case Study of the REPRIEVE Trial
胜利比率应与其他胜利统计数据相结合，以全面呈现相对和绝对治疗效果：REPRIEVE试验案例研究
Melissa J Hardy and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e413–e414, https://doi.org/10.1093/cid/ciaf587
61
Small Effects, Big Impact: Multiple Win Measures Aid Interpretation, But Do Not Forget the Bigger Picture
效应虽小，影响重大：多种胜利衡量指标有助于解读，但不要忘记整体情况
Emma Davies Smith and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e414–e416, https://doi.org/10.1093/cid/ciaf588
62
Does Oral Antibiotic Switching Therapy Show Similar Efficacy to Intravenous Administration for Treating Infective Endocarditis?
口服抗生素转换疗法治疗感染性心内膜炎的疗效是否与静脉给药相似？
Jun Suzuki and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e416–e417, https://doi.org/10.1093/cid/ciaf598
63
Toward a Wider Use of Oral Antibiotic Switch in Infective Endocarditis
朝着更广泛地使用感染性心内膜炎口服抗生素转换疗法迈进
Romane Pouy and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e417–e418, https://doi.org/10.1093/cid/ciaf599
64
Operationalizing Sepsis Definitions With Artificial Intelligence: Toward Smarter Antibiotic Use
利用人工智能实现败血症定义的落地应用：迈向更明智的抗生素使用
James S Ford and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e418–e419, https://doi.org/10.1093/cid/ciaf601
65
Balancing Innovation in Artificial Intelligence With Practical Sepsis Definitions
平衡人工智能创新与实用的败血症定义
Chanu Rhee and Michael Klompas
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e419–e420, https://doi.org/10.1093/cid/ciaf602
66
Precision Prevention of Tuberculosis in Biologic Therapy: Lessons Beyond Screening Strategies
生物疗法中结核病的精准预防：筛查策略之外的启示
Shiuan-Chih Chen and Yuan-Ti Lee
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e420–e421, https://doi.org/10.1093/cid/ciaf559
67
Recalibrating COVID-19 Booster Policy: Lessons From Hybrid Immunity and Global Equity Gaps
重新调整COVID-19加强针政策：从混合免疫和全球公平差距中吸取教训
Nathkapach K Rattanapitoon and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e421–e422, https://doi.org/10.1093/cid/ciaf605
2026-02-22
下面是2026年2月16日至2026年2月22日这一周国际头部药企（top30）的国际审批、合作授权、收并购、临床进展及财务业绩情况国际审批方面： 强生：2月17日，强生宣布，美国FDA已批准RYBREVANT FASPRO (amivantamab和透明质酸酶，埃万妥单抗)的新的简化月度给药方案。与口服LAZCLUZE (lazertinib，拉泽替尼)联合用于一线治疗表皮生长因子受体突变的晚期非小细胞肺癌。将给药时间从数小时缩短至几分钟，并且与静脉注射给药方式相比，可使与给药相关的不良反应减少五倍。根据新获批的每月给药方案，患者最早在第5周就可以转为每月给药。在2025年世界肺癌大会（WCLC）上公布的PALOMA-2研究数据表明，每月使用RYBREVANT FASPRO联合LAZCLUZE进行治疗，在未接受过治疗且具有EGFR突变的晚期非小细胞肺癌患者中，实现了较高的客观缓解率。与传统的静脉注射给药相比，口服给药显著降低了不良反应发生率，并且与每两周的皮下注射给药具有相似的缓解率。皮下注射方案采用Halozyme的EHANCE药物递送技术以及重组人透明质酸酶PH20（rHuPH20）。埃万妥单抗为EGFR/MET双特异性抗体，通过胞外结合抑制EGFR与配体EGF、MET与配体HGF的结合，直接阻断下游促增殖信号传导；其诱导受体-抗体复合物内吞并加速降解，显著降低肿瘤细胞表面EGFR/MET表达量；埃万妥单抗的Fc段通过抗体依赖性细胞毒性作用招募自然杀伤细胞等免疫效应细胞，直接杀伤肿瘤细胞。拉泽替尼是口服的第三代、能穿透大脑的EGFR酪氨酸激酶抑制剂，既能针对T790M突变和激活的EGFR突变，又能避开野生型EGFR。2018年，杨森生物技术公司与柳韩洋行（Yuhan Corporation）签订了许可及合作协议，共同开发拉泽替尼。 罗氏：2月20日，罗氏宣布，美国FDA已受理其giredestrant与依维莫司（everolimus）联合用药的申请，用于治疗接受过内分泌治疗后复发或进展的雌激素受体阳性、人表皮生长因子受体2阴性、ESR1突变的局部晚期或转移性乳腺癌的成年患者。申请基于三期evERA乳腺癌研究的结果，显示在意向治疗人群及ESR1突变人群疾病进展或死亡风险分别降低44%和62%，与标准内分泌治疗加everolimus相比，效果更显著。在ESR1突变人群中，中位无进展生存期为9.99个月，对照组为5.45个月。在意向治疗人群中，中位无进展生存期为8.77个月，对照组为5.49个月。总生存期数据尚不成熟。Giredestrant是强效选择性雌激素受体降解剂及全阻断剂。能够阻止雌激素与雌激素受体结合，促使雌激素受体发生分解，并抑制或减缓癌细胞的生长。 艾伯维：2月20日，艾伯维宣布，美国FDA已批准补充新药申请，同意其VENCLEXTA（venetoclax）与阿斯利康的Calquence（acalabrutinib，阿可替尼）的联合疗法用于治疗先前未接受过治疗的成人慢性淋巴细胞白血病患者。批准基于三期临床试验AMPLIFY的数据。结果表明，联合疗法相较于化疗免疫疗法，降低了35%的疾病进展或死亡风险。联合疗法患者中有77%在三年后病情未出现进展，而67%接受标准治疗方案化疗的患者未出现进展（由研究者自行选择氟达拉滨-环磷酰胺-利妥昔单抗或苯达莫司汀-利妥昔单抗）。中位无进展生存期未达到，而化疗免疫疗法的中位无进展生存期为47.6个月。VENCLEXTA（venetoclax）能够与B细胞淋巴瘤-2蛋白（BCL-2）结合。BCL-2阻止癌细胞自然死亡。VENCLEXTA针对BCL-2 蛋白发挥作用，帮助恢复凋亡过程。VENCLEXTA由艾伯维和罗氏共同研发。在美国，由艾伯维和罗氏旗下的基因泰克联合进行商业化；在美国以外地区，则由艾伯维负责商业化。Calquence（acalabrutinib）是第二代、具有选择性的布鲁顿酪氨酸激酶（BTK）抑制剂。与BTK发生共价结合，抑制其活性。在B细胞中，BTK信号传导会导致B细胞增殖、转运、趋化和黏附等必要途径的激活。 葛兰素史克：2月17日，葛兰素史克宣布，欧盟委员会已批准Exdensur(depemokimab，德莫奇单抗)用于以下两种适应症：作为针对成人及青少年（12岁及以上）严重哮喘（其特征为血液嗜酸性粒细胞计数，且尽管使用高剂量吸入性糖皮质激素及其他哮喘控制药物但病情仍未能得到充分控制）的附加性维持治疗方案；以及作为鼻腔用糖皮质激素的附加疗法，用于治疗系统性糖皮质激素治疗及/或手术无法充分控制病情的严重慢性鼻窦炎伴鼻息肉成年患者。批准基于SWIFT和ANCHOR三期临床试验数据，表明使用德莫奇单抗的两年一次给药方案具有持续疗效。试验均达到了其主要或共同主要终点，且结果具有统计学和临床意义。SWIFT-1和SWIFT-2试验中，使用德莫奇单抗治疗后，患者每年哮喘发作的频率分别降低了58%和48%，与安慰剂相比：SWIFT-1每年哮喘发作次数为0.46次相比1.11次；SWIFT-2每年哮喘发作次数为0.56次相比1.08次。在SWIFT-1和SWIFT-2试验的次要指标中，患者出现需要住院或急诊就诊的病情加重事件的次数明显少于安慰剂组（分别为1%和4%，相8%和10%）。在52周内，治疗组与安慰剂组相比，临床显著加重事件（需要住院或急诊就诊）的年发生率降低了72%，治疗组年发生率0.02相比安慰剂组0.09。在ANCHOR三期试验中，在52周时鼻息肉评分较基线水平有所改善，ANCHOR-1降低0.7，ANCHOR-2降低0.6。在第49至52周的鼻塞口头反应评分方面也有改善，ANCHOR-1评分降低0.23；ANCHOR-2评分降低0.25。Exdensur是针对某些伴有2型炎症基础的呼吸系统疾病的超长效生物制剂。具有高亲和力的白细胞介素-5结合能力，有延长的半衰期，能够实现每年两次的给药。 阿斯利康：2月20日，阿斯利康宣布，其Calquence (acalabrutinib)联合艾伯维的venetoclax已获美国批准，用于治疗成人慢性淋巴细胞白血病和小淋巴细胞淋巴瘤。详见以上艾伯维的新闻。 百时美施贵宝：2月17日，百时美施贵宝宣布，美国FDA已受理iberdomide联合标准治疗（达雷妥尤单抗+地塞米松），用于复发或难治性多发性骨髓瘤患者的新型药物申请。iberdomide属于Cereblon E3连接酶调节剂。申请基于3期EXCALIBER-RRMM研究中微小残留病阴性率的预期分析结论。 诺和诺德：2月17日，诺和诺德宣布，欧盟委员会已批准7.2毫克、每周一次的Wegovy（司美格鲁肽注射液）用于患有肥胖症的成年人。适用于在使用2.4毫克剂量后仍需进一步减重的患者。在STEP UP和STEP UP T2D研究中，患有肥胖症的成年人（一部分没有2型糖尿病，另一部分患有2型糖尿病），每周使用7.2毫克的剂量，同时做出生活方式的改变，与服用安慰剂的人相比，体重减轻幅度要大得多。体重减轻了21%，而使用安慰剂的患者体重减轻幅度约为2%。约三分之一的患者减重达25%或更多。约84%的体重减轻来自脂肪量，测试显示肌肉功能得以保持。司美格鲁肽是长效胰高糖素样肽-1受体激动剂（GLP-1RA），结构与天然人胰高糖素样肽-1具有94%的氨基酸序列同源性。 梯瓦：2月20日，梯瓦以及Medincell宣布，美国FDA已受理其关于奥氮平缓释注射混悬液（TEV-'749）用于治疗成人精神分裂症的新药申请。TEV-'749旨在提高实际治疗的依从性，并帮助患者维持长期稳定状态。申请基于3期SOLARIS试验结果，表明其疗效和安全性与目前可用的奥氮平制剂一致。TEV-'749是新型第二代非典型抗精神病药物奥氮平的单次月度皮下注射剂。TEV-'749 采用了SteadyTeq技术，由Medincell专有的共聚物技术，实现奥氮平的可控、持续缓慢释放。 再生元：2月19日，再生元宣布，美国FDA已受理其garetosmab治疗进行性肌肉骨化症成人患者的生物制品许可申请。Garetosmab是单抗，能够阻断激活素A，对患者异位骨化病变至关重要的蛋白质。申请得到了3期OPTIMA试验的支持，两种剂量（3毫克/千克和10毫克/千克）在56周时均在减少新发生异位骨化病变的总数和总体积方面表现出极高的有效性，与安慰剂相比效果显著。接受3毫克/千克剂量的患者减少了94%，而接受10毫克/千克剂量的患者减少了90%。两种剂量均比安慰剂在新病变总体积（立方厘米）方面显示出超过99%的减少（3毫克/千克：0.01立方厘米相比安慰剂10.45立方厘米；10毫克/千克：0.02立方厘米相比安慰剂10.45立方厘米）。激活素A在疾病中起着关键作用，能驱动异味骨化。garetosmab能够与激活素A结合并使其失去活性。 第一三共：2月19日，欧洲药品管理局已受理了ENHERTU（德曲妥珠单抗，trastuzumab deruxtecan）的II类变更申请，将其作为HER2阳性（免疫组化[IHC]3+或原位杂交[ISH]+）乳腺癌成年患者的单一疗法，患者在新辅助HER2靶向治疗后患有残余侵袭性疾病。ENHERTU是靶向HER2的DXd抗体偶联药物，由第一三共和阿斯利康联合开发和商业化。DESTINY-Breast05 3期试验数据中，与trastuzumab emtansine (T-DM1)相比，ENHERTU在新辅助治疗后HER2阳性乳腺癌伴残余侵袭性疾病患者的侵袭性无病生存率方面有统计学和临床意义的改善。 中外制药：2月19日，Zenyaku Kogyo Co., Ltd.和中外制药宣布，Zenyaku已获得监管部门批准，其抗CD20单抗利妥昔单抗静脉注射剂100毫克和500毫克（Rituxan，）rituximab，用于治疗自身免疫性溶血性贫血。药品由两家公司共同销售。利妥昔单抗是针对CD20的单抗，能与CD20蛋白结合，利用人体自身的免疫系统攻击并损害靶B细胞。 中外制药：2月20日，中外制药宣布，其推出了ELEVIDYS静脉注射剂（delandistrogene moxeparvovec），于2025年5月13日在日本获得有条件限时的批准，用于治疗杜氏肌营养不良症。适用于治疗的患者为无杜氏肌营养不良症基因中任何部分或全部第8和/或第9外显子缺失、抗AAVrh74抗体呈阴性、年龄在3岁至8岁之间的可行走患者。批准基于临床研究结果，包括全球性的III期临床研究EMBARK，评估了ELEVIDYS对患有杜氏肌营养不良症且年龄在4至7岁的门诊患儿长达2年的疗效和安全性。主要指标North Star Ambulatory Assessment (NSAA)运动功能评估在52周时与安慰剂组相比，未显示出统计学意义，但在关键的次要指标（从地面起身的时间、10米步行时间、相邻步幅速度第95百分位数以及上4个台阶的时间）方面观察到了有意义的临床改善。此外，海外有两例使用ELEVIDYS治疗的非门诊患者出现急性肝功能衰竭的死亡病例。ELEVIDYS为患者体内输送一段正常的dystrophin基因，来修复肌肉中缺失的dystrophin蛋白。ELEVIDYS由Sarepta Therapeutics发现，由其和罗氏共同开发。中外制药从罗氏获得了ELEVIDYS的授权，作为日本的上市许可持有人，拥有 ELEVIDYS在日本的独家营销权。临床进展方面： 强生：2月19日，强生公布了临床1b/2期OrigAMI-4试验的阶段性结果。表明对于复发或转移性、PD-L1阳性且与人乳头瘤病毒无关的头颈部鳞状细胞癌患者，一线使用皮下注射透明质酸酶RYBREVANT FASPRO（埃万妥单抗，amivantamab）并联合PD-1抑制剂，能够实现具有临床意义且持久的抗肿瘤效果。在OrigAMI-4研究的第二组中，采用每三周一次的皮下注射方式使用埃万妥单抗联合帕博利珠单抗进行治疗，总体缓解率为56%，其中包括6例完全缓解（10%的完全缓解率）和18例部分缓解。在中位随访10.4个月，46%的患者仍在接受治疗。82%的患者观察到靶病灶的肿瘤缩小。临床获益率定义为确认的反应或持久的稳定疾病，为74%。首次反应的中位时间为9.7周，截至数据截止时，64%的确认反应患者仍在接受治疗。中位无进展生存期为7.7个月，总生存期未能估计。 强生：2月18日，强生宣布，美国FDA已授予透明质酸酶埃万妥单抗用于单药治疗成人头颈部鳞状细胞癌的突破性疗法认定，该癌在铂类化疗后出现复发或转移，并且与人乳头瘤病毒无关。突破性疗法认定基于1b/2期OrigAMI-4试验结果。 强生：2月21日，强生公布QUASAR长期扩展研究的新数据，显示TREMFYA (guselkumab，古塞奇尤单抗)在患有中度至重度活动性溃疡性结肠炎的成年患者中，其临床、内镜和组织学方面的效果在第140周仍持续良好。在第140周时，服用 TREMFYA的患者中有80.8%处于临床缓解状态。此外，78.6%的患者实现了组织内镜下黏膜改善，53.6%的患者达到了内镜缓解状态。大约89%的符合条件的参与者在第140周时完成了治疗。在第140周达到临床缓解的几乎所有患者至少在8周内未使用皮质类固醇药物。该研究还表明，在第44周达到临床缓解的患者中，有87.5%在第140周仍保持临床缓解状态。TREMFYA是首个唯一获批的双效单抗，既能阻断IL-23，又能与产生IL-23的细胞表面的CD64受体相结合。 罗氏：2月16日，罗氏宣布，针对成人原发性膜性肾病的III期MAJESTY研究达到了其主要终点，使用Gazyva/Gazyvaro(obinutuzumab，奥比妥珠单抗)取得了具有统计学和临床意义的结果。显示在两年（104周）后，达到完全缓解的人数显著多于使用他克莫司的患者。奥比妥珠单抗是经过设计的人源化单抗，其具有II型抗CD20区域，能够直接导致B细胞死亡；同时其Fc区域经过糖工程化改造，具有更高的结合亲和力和更强的抗体依赖性细胞毒性作用。CD20是存在于某些类型B细胞上的蛋白质。 辉瑞：2月17日，辉瑞宣布，在关键试验BREAKWATER的第三组（独立的随机分组部分）中取得了最长无进展生存期数据。评估BRAFTOVI(encorafenib)联合西妥昔单抗（ERBITUX，爱必妥）以及氟尿嘧啶、亚叶酸钙和伊立替康组成的方案，在先前未接受过治疗的转移性结直肠癌患者，的疗效，患者具有BRAF V600E突变。与使用氟尿嘧啶、亚叶酸钙和伊立替康的治疗方案（无论是否联合贝伐珠单抗）相比，在无进展生存期方面显示出具有统计学和临床意义的显著改善。总生存期也显示出显著延长的临床改善效果。BRAFTOVI是口服小分子激酶抑制剂。 葛兰素史克：2月17日，葛兰素史克公布了其佐剂重组呼吸道合胞病毒疫苗的新有效性数据。在美国回顾性队列研究，在预防60岁及以上成年人因病毒感染导致的住院方面，接种疫苗后的中位随访期（接种后5.6个月，最长可达9.7个月）内，与呼吸道合胞病毒相关住院治疗的保护效力为75.6%。探索性指标显示，因病毒感染导致住院期间，主要不良心血管事件（包括心脏病发作和中风）中，疫苗的有效性为63.1%。严重慢性阻塞性肺病和哮喘发作中，疫苗的有效性分别为74.4%和61.6%。在丹麦开展的针对年龄≥60岁慢性阻塞性肺疾病患者的全国性队列研究中，疫苗在预防与呼吸道合胞病毒相关的住院治疗方面具有100%的疫苗效力。呼吸道合胞病毒疫苗（重组佐剂型）包含重组的呼吸道合胞病毒糖蛋白F，其处于前融合构象状态（RSVPreF3）。该抗原在接种前与葛兰素史克的专有AS01E佐剂相结合。 葛兰素史克：2月18日，葛兰素史克宣布，由葛兰素史克控股、辉瑞和盐野义参股的ViiV Healthcare，公布了LATITUDE三期临床试验的最终数据，证实其长效注射型艾滋病治疗药物Cabenuva (cabotegravir + rilpivirine)（卡替拉韦+利匹韦林）在有抗逆转录病毒治疗依从性问题史的患者中，相比每日口服疗法，能更有效地维持病毒载量抑制。LATITUDE研究主要终点指标是对比两组的治疗方案失败率，定义为病毒学失败与因任何原因而停止治疗的总和。48周治疗期间的治疗方案失败累积风险降低了近一半，转换为长效注射治疗的患者为22.8%，而继续每日口服治疗的患者为41.2%。在长效治疗组中，有29人（19%）出现治疗方案失败的情况，其中5人（3%）出现了病毒学应答失败，另外24人（16%）以病毒学应答失败作为其首次出现的不良事件。在每日口服治疗组中，有55人（36%）出现治疗方案失败，其中32人（21%）以病毒学应答失败作为首次出现的不良事件，23人（15%）以永久性治疗中断作为首次出现的不良事件。卡替拉韦为整合酶链转移抑制剂，通过阻止病毒DNA融入人类免疫细胞（T细胞）的遗传物质中来抑制HIV的复制。利匹韦林由Janssen Sciences Ireland Unlimited Company研发，为非核苷类逆转录酶抑制剂，干扰逆转录酶，阻止病毒增殖。 诺华：2月18日，诺华宣布，其针对慢性诱导性荨麻疹的口服remibrutinib关键性III期RemIND试验取得了积极的初步结果。主要指标在三种最常见的疾病类型中均达成目标，包括有症状的皮肤划痕症、寒冷性荨麻疹和胆碱能性荨麻疹，与安慰剂相比，在第12周时完全缓解率显著提高。remibrutinib是高度选择性的口服BTK抑制剂，能够阻断与组胺释放相关的BTK通路，组胺是引发荨麻疹风团和肿胀的关键因素。 礼来：2月16日，礼来公布，其针对Retevmo (selpercatinib)作为辅助疗法安慰剂对比的III期LIBRETTO-432临床试验取得了积极的初步结果。达到了主要重点，证明在患有早期（II-IIIA期）转录重排（RET）融合阳性非小细胞肺癌的患者中，无事件生存期有统计学和临床意义的改善。总生存率结果显示具有优势，但尚不成熟。Retevmo（LOXO-292）是高度选择性RET酶抑制剂，具有中枢神经系统活性。 礼来：2月18日，礼来公布了TOGETHER-PsO开放标签3b期临床试验的初步积极结果。评估在患有中重度斑块型银屑病且伴有肥胖或超重状况的成人患者中，同时使用Taltz (ixekizumab)和Zepbound (tirzepatide，替尔泊肽)与仅使用Taltz相比的效果。在36周时，联合治疗达到了主要和所有关键次要终点，相比单独使用Taltz，实现了更出色的皮肤清除率和体重减轻效果。联合治疗的患者中有27.1%实现了皮肤完全清除，并且至少减轻了10%的体重，而仅接受Taltz治疗的患者中这一比例为5.8%，达到了主要终点。在关键的次要终点指标中，联合治疗在达到皮肤完全清除的患者比例方面比单独疗法有40%的相对提高（分别为40.6%和29.0%），表明使用能够减轻银屑病的负担。Taltz是单抗，能够特异性地与白细胞介素17A（IL-17A）细胞因子结合，并抑制其与IL-17受体的相互作用。Zepbound是GIP（葡萄糖依赖性促胰岛素多肽）和GLP-1（胰高血糖素样肽-1）受体激动剂肥胖管理药物。 礼来：2月19日，礼来宣布，来自3期VIVID-2开放标签扩展研究数据表明，Omvoh (mirikizumab，米吉珠单抗，安妥来)，在患有中度至重度活动性克罗恩病的成年人中，能持续发挥疗效长达三年。来自3期VIVID-1（克罗恩病）和LUCENT-3（溃疡性结肠炎）临床试验的其他数据表明，患者住院和手术的次数极少。3期VIVID-1，152周试验结果显示，92.4%患者实现临床缓解，91.2%患者实现脱离糖皮质激素的临床缓解，82.1%的患者实现肠道疾病严重程度（UNRS）评分大于等于3分的缓解，71.7%的患者实现严重程度评分小于2分。接受治疗且在一年内实现内镜缓解的患者，其炎症状况在三年内持续得到改善，通过持续降低炎症生物标志物（C 反应蛋白和粪便钙卫蛋白）来衡量。除了三年期克罗恩病研究的结果外，额外事后数据也表明，患者严重疾病相关并发症的发生率一直很低。在VIVID-1试验中，与安慰剂组相比，前12周内将克罗恩病相关住院和/或手术次数减少了近一半（发生率：16.9次相比30.9次/100人年），在第12周至第52周期间减少了近70%（4.5次相比对14.0次）。在 LUCENT-3试验中，在为期三年的长期扩展期中报告了1次溃疡性结肠炎相关住院和0次溃疡性结肠炎相关手术（分别对应的发生率：0.1次和0次/100 人年）。Omvoh是白细胞介素-23p19（IL-23p19）拮抗剂，用于治疗成人中度至重度活动性溃疡性结肠炎和克罗恩病。白细胞介素-23通路过度激活所引起的炎症在炎症性肠病的发病机制中起着关键作用。 赛诺菲：2月16日，赛诺菲宣布，其发表在《柳叶刀传染病》杂志上的新研究显示，采用Beyfortus (nirsevimab，尼塞韦单抗，乐唯初)的通用型呼吸道合胞病毒免疫计划，在第二轮呼吸道合胞病毒季中，对在第一轮免疫中接种过疫苗的婴儿而言，与相关的住院病例数量显著减少相关。NIRSE-GAL研究在西班牙加利西亚开展，对比接种疫苗的婴儿在第二个感染季节的住院人数与基于近期季节数据预期的住院病例数，疫苗作用得以呈现。研究显示，在第一个季节中，与呼吸道合胞病毒相关的下呼吸道感染住院病例减少了85.9%。在婴儿期接种了疫苗的婴儿中，第二个感染季的住院病例减少了55.3%。这些婴儿日后患呼吸道合胞病毒或其他感染导致的住院的可能性会降低。在第一个呼吸道合胞病毒流行季期间，就诊次数有所减少，具体包括：急性支气管炎或细支气管炎的首次就诊次数减少了30.8%；下呼吸道感染的就诊次数减少了33.4%；哮喘的就诊次数减少了27.7%。在因呼吸道合胞病毒而曾住院的婴儿中，第二个流行季度再住院率大幅下降，与呼吸道合胞病毒感染的再住院率降低了78.2%，下呼吸道感染的再住院率降低了62.4%。Nirsevimab是重组中和人源IgG1κ长效单抗，靶点为RSV F蛋白融合前构象，通过对其Fc区域的三重氨基酸置换进行修饰，以延长血清半衰期。Nirsevimab与融合前蛋白上高度保守的抗原位点Ø表位结合，抑制病毒进入细胞过程中必要的膜融合步骤，中和病毒并阻断细胞间融合。 赛诺菲：2月17日，赛诺菲宣布，duvakitug的RELIEVE UCCD长期扩展研究的阳性结果表明，最初对诱导阶段治疗有反应的溃疡性结肠炎和克罗恩病患者，在44周的治疗期内仍能保持显著的临床和内镜治疗效果。在第14周时，相比使用安慰剂的患者，实现了具有临床意义的治疗效果。患者分别接受每四周一次、每次450毫克或900毫克的皮下注射剂量的duvakitug，最长持续58周的用药。在维持治疗阶段的第44周：溃疡性结直肠炎方面，58%（900毫克）和47%（450毫克）达到了根据改良梅奥评分确定的临床缓解这一主要指标。克罗恩病方面：55%（900 毫克）和41%（450 毫克）达到了由克罗恩病简易内镜评分定义的内镜反应这一主要指标。两种疾病中，各项额外的疗效指标均观察到了一致的益处。duvakitug是针对TL1A的人源单抗，TL1A信号通路被认为会增强炎症反应，通过与受体DR3结合来驱动与炎症性肠病相关的纤维化。相比与DcR3结合，duvakitug优先抑制TL1A-DR3信号通路，这有可能减轻炎症和纤维化。梯瓦和赛诺菲共同开发并推广用于duvakitug。两家公司将按同等比例在全球范围内分担研发成本，并在主要市场分享净利润和亏损情况，在其他市场采用特许权使用费的方式。赛诺菲负责3期临床开发。梯瓦负责该产品的欧洲、以色列以及特定其他国家的商业化工作，赛诺菲负责在北美、日本、亚洲其他地区以及世界其他地区的商业化工作。 武田制药：2月19日，武田制药公布了3期临床试验KEPLER的积极数据。表明ENTYVIO (vedolizumab，维得利珠单抗)能够为2岁及以上患有中度至重度活动性溃疡性结肠炎的患者提供临床缓解的可能性。研究中患者对常规治疗（如类固醇和免疫调节剂）以及肿瘤坏死因子拮抗剂的治疗反应不佳。参与者在为期14周的开放标签诱导期期间接受开放标签静脉注射维得利珠单抗治疗。在第14周时达到临床缓解的患者随后被随机分配至低剂量或高剂量的维持治疗组，每8周一次。患者中：近一半（47.3%）的参与者在第54周时达到了临床缓解这一主要指标；超过三分之一（34.7%）的患者在14周时达到了临床缓解；超过四分之一（29%）的参与者在第14周和第54周均达到了持续临床缓解。维得利珠单抗能特异性地与α4β7整合素结合，并阻断其与主要在肠道内皮细胞上表达的MAdCAM-1的相互作用。财务业绩及股息发放方面： 艾伯维：2月19日，艾伯维宣布，季度股息为每股1.73美元，将于2026年5月15日支付给截至2026年4月15日的在册股东。 雅培：2月20日，雅培宣布，每股派发季度普通股股息63美分，将于2026年5月 15日支付给截至2026年4月15日营业结束时登记在册的股东。 博士康：2月18日，博士康宣布，其2025年第4季度实现营业收入27.96亿美元，相比2024年增长9%。2025年全年实现营业收入102.66亿美元，相比2024年增长7%。
并购临床3期加速审批申请上市
2026-02-20
·药明康德
长效HIV疗法3期结果登《新英格兰医学杂志》
ViiV Healthcare近日宣布，其3期LATITUDE临床试验的最终结果显示，长效注射型HIV治疗方案Cabenuva（cabotegravir + rilpivirine）在维持病毒载量抑制方面的表现优于每日口服抗逆转录病毒治疗（ART），尤其是在既往治疗依从性困难的人群中。该研究的48周数据已发表于《新英格兰医学杂志》。
LATITUDE是一项随机、开放标签的3期研究，共纳入453名难以坚持每日口服ART或曾中断HIV医疗管理的受试者，旨在评估长效治疗方案在真实世界场景中的治疗益处。研究的主要终点为两组治疗方案的治疗失败率比较，治疗失败定义为病毒学失败与因任何原因导致的方案中止的综合指标。结果显示，在48周治疗期间，接受长效注射Cabenuva方案的患者累计治疗失败风险为22.8%（29/152），而继续每日口服ART治疗人群为41.2%（55/154），风险降低近一半。该研究结果进一步支持长效注射治疗在改善依从性困难患者治疗结局方面的潜力，提示其有望成为特定HIV患者群体的治疗选择。
FDA批准全口服抗癌小分子联合疗法
阿斯利康（AstraZeneca）与罗氏（Roche）旗下基因泰克（Genentech）宣布，布鲁顿氏酪氨酸激酶（BTK）抑制剂Calquence（acalabrutinib）联合BCL-2抑制剂Venclexta（venetoclax，维奈克拉）的全口服治疗方案已获得美国FDA批准，用于治疗成人慢性淋巴细胞白血病（CLL）和小淋巴细胞淋巴瘤（SLL）患者。根据新闻稿，这是用于该患者群体的首个全口服、固定疗程的获批治疗方案。
此次批准基于AMPLIFY临床3期试验取得的积极结果。数据显示，在接受acalabrutinib联合venetoclax治疗的患者中，三年无进展生存率达到77%，而接受研究者选择的标准化疗免疫方案患者为67%。同时，联合治疗组的中位无进展生存期尚未达到，而对照组为47.6个月。与化疗免疫治疗相比，该联合方案将疾病进展或死亡风险降低35%（HR=0.65；95% CI：0.49–0.87；p=0.0038），进一步验证了该固定疗程全口服方案在提升疗效与疾病长期控制方面的潜在益处。
强生双抗联合疗法一线治疗癌症获积极结果！
强生（Johnson & Johnson）近日公布了1b/2期OrigAMI-4研究的最新结果。数据显示，皮下注射人源化EGFR/MET靶向双特异性抗体Rybrevant Faspro（amivantamab + hyaluronidase）皮下制剂联合PD-1抑制剂治疗，在复发或转移性、PD-L1阳性且与人乳头瘤病毒（HPV）无关的头颈部鳞状细胞癌（HNSCC）患者中，展现出具有临床意义且持久的抗肿瘤活性。
在OrigAMI-4研究的Cohort 2队列中，患者每三周接受一次Rybrevant Faspro联合pembrolizumab治疗，确认的总缓解率（ORR）达到56%（22/39；95% CI：40–72），其中包括4例确认完全缓解和18例确认部分缓解。中位随访10.4个月时，仍有46%的患者持续接受治疗，82%的患者靶病灶出现肿瘤缩小。临床获益率为74%，中位首次缓解时间为9.7周，且在数据截止时64%的已确认缓解患者仍在接受治疗。疗效指标方面，中位无进展生存期为7.7个月，而中位总生存期尚未达到，进一步显示出该联合方案在延长疾病控制方面的潜在益处。
参考资料：
[1] RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer. Retrieved February 20, 2026 from https://www.jnj.com/media-center/press-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-plus-immunotherapy-shows-strong-clinical-benefit-with-56-percent-overall-response-rate-in-first-line-recurrent-or-metastatic-head-and-neck-cancer
[2] ViiV Healthcare’s long-acting Cabenuva (cabotegravir + rilpivirine) for HIV demonstrates superior efficacy compared to daily oral therapy for people with adherence challenges; results published in NEJM. Retrieved February 20, 2026 from https://www.businesswire.com/news/home/20260218371644/en/ViiV-Healthcares-long-acting-Cabenuva-cabotegravir-rilpivirine-for-HIV-demonstrates-superior-efficacy-compared-to-daily-oral-therapy-for-people-with-adherence-challenges-results-published-in-NEJM
[3] CALQUENCE® plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukemia in the 1st-line setting. Retrieved February 20, 2026 from https://www.businesswire.com/news/home/20260220286386/en/CALQUENCE-plus-venetoclax-approved-in-the-US-as-first-all-oral-fixed-duration-combination-for-patients-with-chronic-lymphocytic-leukemia-in-the-1st-line-setting
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| HIV感染 | 加拿大 | 2020-03-18 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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| HIV血清阳性 | 临床3期 | 肯尼亚 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 肯尼亚 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 南非 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 南非 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 乌干达 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 乌干达 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 津巴布韦 | 2023-06-22 | |
| HIV血清阳性 | 临床3期 | 津巴布韦 | 2023-06-22 |
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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 |
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临床3期 | 476 | 構糧簾餘積窪艱獵蓋艱(鹽網襯糧衊襯蓋繭簾蓋) = 簾廠願齋艱製鹹簾鑰醖 衊鬱範鹹廠製壓獵製築 (憲淵餘廠製鹹蓋鹹衊繭 ) 更多 | 积极 | 2026-01-01 | |||
tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir | 構糧簾餘積窪艱獵蓋艱(夢餘艱膚積鏇壓艱獵願) = 遞鏇鹽鹽製鹹鏇選衊選 齋鬱鏇壓窪網襯築範顧 (繭網繭選鏇醖構繭夢築 ) 更多 | ||||||
临床2期 | 309 | (CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)) | 窪鑰網範繭構願獵網構 = 膚鏇窪窪遞蓋願築艱餘 襯餘構構鬱鹽餘鏇襯簾 (夢廠鹽鑰積簾醖範艱構, 鑰衊積顧齋淵襯衊選窪 ~ 齋積鹹齋糧簾齋衊鬱繭) 更多 | - | 2020-08-31 | ||
(CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)) | 窪鑰網範繭構願獵網構 = 範網顧網網蓋醖鹽襯繭 襯餘構構鬱鹽餘鏇襯簾 (夢廠鹽鑰積簾醖範艱構, 遞糧餘構夢網夢廠艱鑰 ~ 觸鏇鹹繭廠鏇衊願簾廠) 更多 | ||||||
临床2期 | 286 | (Q8W IM) | 鏇顧淵襯範襯繭顧製願(觸鹽積觸鬱壓遞鹽齋艱) = 願選積願憲鹽鬱餘襯鏇 襯顧鑰壓鑰觸艱齋蓋顧 (網淵蓋積襯網範築獵鏇 ) 更多 | 积极 | 2016-07-18 | ||
(Q4W IM) | 鏇顧淵襯範襯繭顧製願(觸鹽積觸鬱壓遞鹽齋艱) = 選遞鹹鏇繭憲選淵繭築 襯顧鑰壓鑰觸艱齋蓋顧 (網淵蓋積襯網範築獵鏇 ) 更多 | ||||||
临床2期 | 286 | (Q8W IM) | 醖膚蓋衊衊襯築顧積壓(範鑰淵憲夢壓築膚鹽築) = 獵夢鑰蓋簾製選艱積醖 衊簾鏇糧壓觸遞蓋積夢 (遞夢選蓋壓襯觸鏇遞願 ) 更多 | 积极 | 2016-02-22 | ||
(Q4W IM) | 醖膚蓋衊衊襯築顧積壓(範鑰淵憲夢壓築膚鹽築) = 餘選顧憲廠鹹顧選網淵 衊簾鏇糧壓觸遞蓋積夢 (遞夢選蓋壓襯觸鏇遞願 ) 更多 |
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