Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.

开始日期2026-05-15

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT05652478

/ Recruiting临床2期IIT

A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

开始日期2026-02-09

申办/合作机构

National Institute of Allergy & Infectious Diseases

CTR20254613

/ CompletedN/A

多替拉韦钠片在健康受试者中的生物等效性试验

本研究以成都倍特药业股份有限公司生产的多替拉韦钠片（50mg（以多替拉韦计））为受试制剂，以原研ViiV Healthcare B.V.持证，Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)生产的多替拉韦钠片（50mg（以多替拉韦计））（商品名：特威凯®）为参比制剂，评价受试制剂和参比制剂在空腹条件下给药时的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2025-12-26

申办/合作机构

成都倍特药业股份有限公司

100 项与多替拉韦钠相关的临床结果

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100 项与多替拉韦钠相关的转化医学

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100 项与多替拉韦钠相关的专利（医药）

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3,110

项与多替拉韦钠相关的文献（医药）

2026-03-01·ACTA PSYCHOLOGICA

Association between facial lipoatrophy and self-esteem in people living with HIV/AIDS on antiretroviral therapy in Brazil: A cross-sectional study

Article

作者: Mayitondelua, Nzuzi ; Buccio, Isabela Pietra ; Trevilatto, Paula Cristina ; de Oliveira, Jair Caetano ; Azevedo-Alanis, Luciana Reis ; Souza, Paulo Henrique Couto ; Macedo, Nayara Flores ; Kruppa, Mariele

BACKGROUND:

Facial lipoatrophy in people living with HIV/AIDS (PLWHA) may lead to body image dissatisfaction, social difficulties, and reduced self-esteem, potentially affecting adherence to antiretroviral therapy (ART). This study evaluated the influence of facial lipoatrophy on self-esteem in PLWHA.

METHODS:

Ninety-five adults with confirmed HIV diagnosis and on ART for at least six months completed the Sociodemographic and Clinical Health Characterization Form, Rosenberg Self-Esteem Scale, and Self-Perceived Body Changes Questionnaire. Facial Lipoatrophy Index (FLI) assessment was performed by physical examination. Statistical analyses included the Pearson chi-square, Kruskal-Wallis, and Student's t-test (p < 0.05).

RESULTS:

Participants were mostly men (77.9 %), homosexual (62.1 %), under 40 years (52.6 %), and caucasian (68.4 %). The most frequent ART regimen was an integrase inhibitor plus two nucleoside reverse transcriptase inhibitors (58.9 %). Severe facial lipoatrophy was significantly associated with zidovudine and efavirenz use, and mild cases with dolutegravir (p < 0.05). Most participants (76.8 %) reported body changes, mainly abdominal (71.2 %). The mean FLI was 2.15, and mean self-esteem score 31.98 ± 5.26; 67.4 % demonstrated high self-esteem. Caucasian participants had higher self-esteem (p < 0.05), but neither objective nor perceived facial fat loss significantly affected self-esteem (p > 0.05).

CONCLUSION:

Facial lipoatrophy did not significantly impact self-esteem among PLWHA. Overall, participants exhibited high self-esteem regardless of facial changes or ART regimen, suggesting resilience and effective psychological adaptation within this sample.

2026-03-01·MEDICAL IMAGE ANALYSIS

DTG: Dual transformers-based generative adversarial networks for retinal 2D/3D OCT image classification

Article

作者: Ait Hammou, Badr ; Boucher, Marie-Carole ; Duval, Renaud ; Cheriet, Farida

The automated identification of retinal disorders is one of the most popular real-world computer vision applications related to ophthalmology. It has several advantages and can help ophthalmologists identify diseases more accurately. Technically, it represents a retinal data classification problem. With the recent advances in Artificial Intelligence (AI) technologies, Transformer-based architectures have become powerful models commonly used for solving a wide range of tasks such as image classification. In general, even though Transformers have demonstrated excellent performance compared to existing cutting-edge models, they are data-hungry architectures and still need to perform better in automated medical diagnosis applications. In this paper, we propose a deep learning architecture named Dual Transformers-based Generative Adversarial Networks (DTG). It is designed for Optical Coherence Tomography (OCT) data classification. It adopts the Vision Transformer and Multiscale Vision Transformer to encode retinal 2D OCT images (i.e., B-scans) and 3D OCT images (i.e., OCT sequence of B-scans). Then, it employs a proposed Generative Adversarial Networks (GAN) architecture to infer high-quality semantic data representations. Next, it increases the training data by taking advantage of our proposed patient instance-based data augmentation technique. Finally, a weighted classifier analyzes the data and performs the retinal disease classification task. Extensive experiments are carried out on two real-world OCT datasets. The experimental results prove that our proposed approach DTG surpasses several competitors in terms of classification accuracy, precision, recall, f1-score, quadratic weighted kappa, AUC-PR, and AUC-ROC. In particular, it performs better than popular Convolutional Neural Networks and Transformers used for 2D image and 3D OCT image classification. Furthermore, it can improve the performance of several existing works for retinal data classification.

2026-03-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide fumarate: Real-world assessment of effectiveness and weight Gain in naïve people living with HIV of Asian OrigiN (DRAGON)

Article

作者: Hsih, Wen-Hsin ; Lai, Hsin-Hao ; Huang, Miao-Hui ; Zou, Meiyin ; Lee, Shu-Yuan ; Zhang, Xue ; Zhao, Qingxia ; Yang, Chia-Jui ; Cheng, Chien-Yu ; Chen, Tsung-Chia ; Hung, Tung-Che ; Lin, Yi-Chun ; Wu, Yi-Wen ; Li, Linghua ; Cheng, Shu-Hsing ; Chen, Cheng-Pin ; Ma, Ping ; Tsai, Mao-Song ; Ho, Mao-Wang

OBJECTIVES:

Among people living with HIV (PWH), the use of integrase strand transfer inhibitors (INSTIs) has been increasingly linked to notable weight gain, raising clinical concern. Much of the available evidence originates from trials in Western regions and Africa, while observational data from Asian settings remain scarce.

METHODS:

This retrospective, multicenter cohort study analyzed treatment-naïve PWH at eleven HIV care centers in Taiwan and mainland China between 2019 and 2025. Treatment-naïve patients initiating dolutegravir/lamivudine (DTG/3TC) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) were included. The primary endpoint was the proportion of patients with ≥10% weight gain. Secondary endpoints were virologic suppression (<200 copies/ml) between weeks 24-96 and changes in lipid profiles. Logistic regression with inverse probability weighting was used to identify the predictors of ≥10% weight gain.

RESULTS:

A total of 1087 patients were enrolled (DTG/3TC: 406; BIC/FTC/TAF: 681). Baseline CD4 counts were higher in the DTG/3TC group (315 vs 281 cells/µL, P = 0.01), while HIV RNA levels were lower (4.68 vs 4.96 log10 copies/ml, P < 0.01). Both regimens achieved comparable virologic suppression overall, including in participants presenting with advanced HIV disease. Weight gain was greater with BIC/FTC/TAF at week 48 (4.2 vs 2.2 kg; difference 2.0 kg; 95% CI: 1.1-2.9; P < 0.01) and week 96 (5.1 vs 2.8 kg; difference 2.3 kg; 95% CI: -1.1 to 3.5; P < 0.01). At week 48 and 96, 21.6% and 30.5% experienced ≥10% weight gain, respectively. After calculating IPTW, logistic regression analysis identified the following predictors included CD4 <200 cells/µL (aOR 2.54 and 2.89), BMI <24 kg/m² (aOR 2.59 and 2.35), and BIC/FTC/TAF (aOR 1.83 and 1.83) at week 48 and 96, respectively. At week 48 and 96, HDL cholesterol was significantly lower in the BIC/FTC/TAF group (mean differences = -2.4, and -2.4 mg/dl, respectively; P < 0.05).

CONCLUSION:

In this large real-world Asian cohort, BIC/FTC/TAF and DTG/3TC demonstrated comparable virological efficacy. However, TAF-containing regimen-particularly among individuals with lower CD4 counts and BMI-were associated with greater weight gain and attenuated increases in HDL cholesterol, highlighting the need for careful metabolic monitoring.

354

项与多替拉韦钠相关的新闻（医药）

2026-02-04

·抗体圈

GSK 2025：全年营收超 420 亿美元，肿瘤产品增长 43%

2 月 4 日，葛兰素史克（GSK）发布 2025 年财报，全年营收 326.67 亿英镑（427.94 亿美元），同比增长 7%（按固定汇率计算，下同）。研发投入 75.25 亿英镑（ 98.58 亿美元），同比增长 19%。来源：GSK 官网，下同 GSK 的业务主要分为特药（Specialty Medicines）、疫苗（Vaccines）以及普药（General Medicines）三个版块，2025 年分别贡献了 134.74 亿英镑（176.51 亿美元，+17%）、91.57 亿英镑（119.96 亿美元，2%）、100.36 亿英镑（131.47 亿美元，-1%）的业绩收入。肿瘤板块增长迅猛 HIV 产品持续增长具体来说，特药方面，GSK 在HIV、呼吸/免疫和肿瘤疾病领域分别斩获了 76.87 亿英镑（+11%）、38.10 亿英镑（+18%）、19.77 亿英镑（+43%），其中肿瘤板块增长迅猛，已经成为 GSK 业绩新的增长点。肿瘤领域，骨髓纤维化贫血患者药物 Ojjaara/Omjjara（莫洛昔尼）、PD-1 单抗 Jemperli（Dostarlimab）、PARP 抑制剂 Zejula（尼拉帕利）三款产品 2025 年销售额分别是 5.54 亿英镑（+60%）、8.61 亿英镑（+89%）、5.57 亿英镑（-4%）。呼吸/免疫领域，Nucala （美泊利珠单抗）和 Benlysta（贝利尤单抗）分别为 GSK 贡献了 20.08 亿英镑（+15%）和 17.73 亿英镑（+22%）的销售额。 HIV 领域，GSK 手握长效产品，销售额持续增长。Cabenuva（卡替拉韦+利匹韦林）在 2025 年销售额达到了 14.02 亿英镑，增长了 42%，主要得益于美国和欧洲地区患者需求的强劲增长；Apretude （卡替拉韦）与 2024 年相比增长了 62% 至 4.39 亿英镑；Dovato （多替拉韦+拉米夫定）是 HIV 产品线中规模最大的产品，在 2025 年斩获了 26.78 亿英镑，同比增长 22%。疫苗方面，重组带状疱疹疫苗 Shingrix 、RSV 疫苗 Arexvy、脑膜炎疫苗 Meningitis（包括 Bexsero 和 Menveo ）实现同比增长，销售额分别为 35.58 亿英镑（+8%）、5.93 亿英镑（+2%）、315.83 亿英镑（+12%）。 BD 交易加速预计 2031 年销售额超 400 亿英镑近两年，为弥补制药业务疲软的影响，GSK 在交易并购方面频频发力。Insight 数据库显示，自 2025 年起，GSK 共达成了 15 笔医药交易，包括 125 亿美元引进恒瑞一款核心药物和 11 个早期项目的全球权益、22 亿美元收购 RAPT 获得预防食物过敏的 Ozureprubart、收购一款 MASH 新药 Efimosfermin alfa 等。 2026 年，GSK 预计有 2 款新产品斩获监管机构批准，分别是有望成为治疗慢性乙型肝炎的首创药物的 Bepirovirsen，以及首个用于治疗复杂性尿路感染的口服药物 Tebipenem。展望未来，GSK 预计 2026 年营业额增长 3% 至 5%；核心营业利润增长 7% 至 9%；核心每股收益增长 7% 至 9%；预计到 2031 年销售额将超过 400 亿英镑。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗财报并购

2026-02-03

·北京医学感染与传染研究

抗菌化疗杂志81卷 1-2期（2026年2月3日更新）

Journal of Antimicrobial Chemotherapy Volume 81, Issue 1抗菌化疗杂志81卷 1期 https://academic.oup.com/jac/issue 50th Anniversary Collection 50周年纪念合集 Review（综述） 1 Artificial intelligence for improving decision-making in bacterial infection management: a narrative review 人工智能在改善细菌感染治疗决策中的应用：一项叙述性综述 Anisia Talianu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf470, https://doi.org/10.1093/jac/dkaf470 Reviews（综述） 2 Evolving landscape of methicillin-resistant Staphylococcus pseudintermedius: the emergence of new epidemic waves across Europe, Asia and North America 耐甲氧西林中间型葡萄球菌的演变格局：欧洲、亚洲和北美洲新流行浪潮的出现 Lillian Rose Giarratana and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf340, https://doi.org/10.1093/jac/dkaf340 3 Azithromycin resistance in non-typhoidal Salmonella: a review 非伤寒沙门氏菌对阿奇霉素的耐药性：综述 Zhe Zhu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf341, https://doi.org/10.1093/jac/dkaf341 4 Antibiotic pharmacodynamics: from MIC to advanced metrics and their applications 抗生素药效动力学：从最低抑菌浓度到高级指标及其应用 Malin Andersson and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf374, https://doi.org/10.1093/jac/dkaf374 5 Progress in the study of drug resistance mechanism of Bacillus cereus 蜡样芽孢杆菌耐药机制研究进展 Yuhang Zhang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf399, https://doi.org/10.1093/jac/dkaf399 6 The curious constraints on clofazimine 氯法齐明的奇特限制 Maple Goh and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf430, https://doi.org/10.1093/jac/dkaf430 7 Antiplasmid systems: a novel strategy to combat antibiotic resistance 抗质粒系统：对抗抗生素耐药性的新策略 Mohd Asim and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf472, https://doi.org/10.1093/jac/dkaf472 Systematic Review（系统综述） 8 Coccidioidomycosis in Europe: a systematic literature review of epidemiology, treatment and outcomes 欧洲球孢子菌病：流行病学、治疗和预后的系统文献综述 Priya Shastri and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf407, https://doi.org/10.1093/jac/dkaf407 9 Systematic review of antimicrobial pharmacokinetic/pharmacodynamic indices in murine thigh and hollow fibre dose fractionation studies analysed with a standard method 用标准方法分析小鼠大腿和空心纤维剂量分次研究中的抗菌药物药代动力学/药效动力学指数的系统综述 Najla Alabdulkarim and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf446, https://doi.org/10.1093/jac/dkaf446 Virtual Roundtable（虚拟圆桌会议） 10 Procalcitonin in the management of lower respiratory tract infection and sepsis 降钙素原在下呼吸道感染和败血症治疗中的应用 Ramy H Elshaboury and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf298, https://doi.org/10.1093/jac/dkaf298 Original Research（论著） 11 Model-based assessment of letermovir pharmacokinetics in allogeneic haematopoietic stem cell transplant recipients 来特莫韦在异基因造血干细胞移植受者中药代动力学的基于模型的评估 Chrisoula Tahtsidou and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf427, https://doi.org/10.1093/jac/dkaf427 12 In vitro exebacase (CF-301) activity against methicillin-susceptible or methicillin-resistant Staphylococcus aureus and coagulase-negative staphylococci strains isolated from patients with infective endocarditis 体外试验评估依拉环素（CF-301）对甲氧西林敏感或甲氧西林耐药金黄色葡萄球菌及凝固酶阴性葡萄球菌（从感染性心内膜炎患者中分离）的活性 María-Alexandra Cañas and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf435, https://doi.org/10.1093/jac/dkaf435 13 Evaluation of subcutaneous amoxicillin/clavulanic acid pharmacokinetics as an alternative to the intravenous route in older patients—the PhASAge Study 评估皮下注射阿莫西林/克拉维酸药代动力学作为老年患者静脉给药替代方案——PhASAge研究 Nicolas Grégoire and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf381, https://doi.org/10.1093/jac/dkaf381 14 Real-life use of isavuconazole in Spanish children and adolescents 西班牙儿童和青少年中艾沙康唑的实际使用情况 Natalia Mendoza-Palomar and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf394, https://doi.org/10.1093/jac/dkaf394 15 No pharmacovigilance signal of intracranial hypertension associated with glycylcyclines: a FAERS-based disproportionality analysis 基于FAERS数据库的不成比例性分析：未发现甘氨酰环素类与颅内高压相关的药物警戒信号 Slobodan M Jankovic and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf395, https://doi.org/10.1093/jac/dkaf395 16 Posaconazole enteral tube administration in adults: pharmacokinetic target attainment of oral suspension compared with crushed delayed-release tablet 成人经肠内营养管给予泊沙康唑：口服混悬液与碾碎的缓释片的药代动力学目标达成情况比较 Nirjan Bhattarai and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf396, https://doi.org/10.1093/jac/dkaf396 17 Characterizing CYP3A4-mediated drug interactions: a fixed-sequence pharmacokinetic Chinese study of posaconazole and ruxolitinib in haematological malignancies CYP3A4介导的药物相互作用特征：一项关于泊沙康唑和鲁索替尼在血液系统恶性肿瘤中的固定序列药代动力学中国研究 Beibei Liang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf398, https://doi.org/10.1093/jac/dkaf398 18 Differences in prescription for impetigo and cellulitis across years in three European countries 三个欧洲国家不同年份脓疱病和蜂窝织炎的处方差异 Thomas Bettuzzi and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf400, https://doi.org/10.1093/jac/dkaf400 19 β-Lactam concentrations monitored in the early phase of community-acquired sepsis in the intensive care unit 重症监护室社区获得性脓毒症早期阶段监测的β-内酰胺浓度 Karolina Liljedahl Prytz and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf401, https://doi.org/10.1093/jac/dkaf401 20 Enhanced antimycobacterial efficacy of simulated inhaled clofazimine versus oral clofazimine in combination with azithromycin and ethambutol in a hollow-fiber system 在空心纤维系统中，模拟吸入氯法齐明与口服氯法齐明联合阿奇霉素和乙胺丁醇的抗结核分枝杆菌疗效增强比较 Jelmer Raaijmakers and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf402, https://doi.org/10.1093/jac/dkaf402 21 Identification of antimicrobial resistance genes in Escherichia coli through network diffusion 通过网络扩散法鉴定大肠杆菌中的抗生素耐药基因 Anis Mansouri and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf404, https://doi.org/10.1093/jac/dkaf404 22 Preclinical evaluation of epetraborole in the hollow fibre system model of Mycobacterium abscessus lung disease 依培硼罗在脓肿分枝杆菌肺病空心纤维系统模型中的临床前评估 Sanjay Singh and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf405, https://doi.org/10.1093/jac/dkaf405 23 The β-lactamase inhibitor concentration-dependent minimum inhibitory concentration (MICcBLI) as methodology to assess the pharmacokinetic/pharmacodynamic relationship of piperacillin/tazobactam for dosing optimization β-内酰胺酶抑制剂浓度依赖性最低抑菌浓度（MICcBLI）作为评估哌拉西林/他唑巴坦药代动力学/药效动力学关系以优化给药的方法 Malin Andersson and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf406, https://doi.org/10.1093/jac/dkaf406 24 Unravelling the triad of penicillin-binding proteins, β-lactamase activity, and mRNA dynamics in Pseudomonas aeruginosa AmpC induction 解析铜绿假单胞菌AmpC诱导过程中青霉素结合蛋白、β-内酰胺酶活性和mRNA动态的三元关系 Maria Montaner and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf408, https://doi.org/10.1093/jac/dkaf408 25 Unnoticed spread of linear VanA-plasmids in vancomycin-variable Enterococcus faecium strains across different regions: a diagnostics challenge 不同地区万古霉素可变型粪肠球菌菌株中线性VanA质粒的未被察觉的传播：一项诊断挑战 Ana C Almeida-Santos and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf409, https://doi.org/10.1093/jac/dkaf409 26 Switching from etravirine to doravirine in virologically suppressed people with HIV: results from the French multicentre SWEED observational study 在病毒学抑制的HIV感染者中从依曲韦林切换至多拉韦林：法国多中心SWEED观察性研究的结果 Romain Palich and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf410, https://doi.org/10.1093/jac/dkaf410 27 HIV-1 drug resistance among pregnant and breastfeeding mothers and its association with paediatric HIV infections in the Dolutegravir era in Uganda 乌干达多替拉韦时代孕产妇及哺乳期母亲中HIV-1耐药情况及其与儿童HIV感染的关联 Anne Kapaata and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf411, https://doi.org/10.1093/jac/dkaf411 28 Outpatient antibiotic prescribing for medically attended respiratory syncytial virus, influenza, or human metapneumovirus illness among high-risk adults in rural Wisconsin, United States 美国威斯康星州农村地区高风险成人因呼吸道合胞病毒、流感或人偏肺病毒感染就诊时的门诊抗生素处方情况 Sarah C J Jorgensen and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf412, https://doi.org/10.1093/jac/dkaf412 29 Omadacycline as a drug candidate for Mycobacterium avium infections: in vitro insights on single and combination therapies 奥马环素作为鸟分枝杆菌感染候选药物：单药及联合治疗的体外研究 Saskia E Mudde and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf413, https://doi.org/10.1093/jac/dkaf413 30 Post-pandemic trends in Streptococcus pneumoniae serotype epidemiology and antibiotic susceptibility in adults with invasive and non-invasive pneumococcal disease in the USA (2022–2023) 后疫情时代美国成人侵袭性与非侵袭性肺炎链球菌病血清型流行病学及抗生素敏感性趋势（2022-2023） Mekki F Bensaci and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf414, https://doi.org/10.1093/jac/dkaf414 31 Benznidazole pharmacokinetics in patients with chronic Chagas disease: association with demographic factors and adverse drug reactions 慢性恰加斯病患者苯芴醇药代动力学：与人口统计学因素及药物不良反应的关联 Gabriel P E Silveira and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf416, https://doi.org/10.1093/jac/dkaf416 32 Acquired antimicrobial resistance genes in Bordetella Species: a global genomic analysis 博德特氏菌属中获得的抗菌药物耐药基因：全球基因组分析 Biao Tang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf418, https://doi.org/10.1093/jac/dkaf418 33 Machine learning for personalized antimicrobial susceptibility breakpoints: (Adaptive clinical breakpoint interpretation) 基于机器学习的个性化抗菌药物敏感性折点制定（自适应临床折点解释） Yinzheng Zhong and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf419, https://doi.org/10.1093/jac/dkaf419 34 Multicentre investigation of Wickerhamomyces anomalus fungemia in India: emerging resistance and mechanistic insights 印度异常威克汉姆酵母菌血症的多中心研究：新发耐药性及机制洞察 Shristi Verma and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf420, https://doi.org/10.1093/jac/dkaf420 35 Reducing aztreonam/avibactam waste: insights from Monte Carlo simulations 减少氨曲南/阿维巴坦浪费：蒙特卡洛模拟的启示 Yeleen Fromage and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf421, https://doi.org/10.1093/jac/dkaf421 36 Nanoparticle-based co-delivery of ciprofloxacin and meropenem enhances synergistic activity against multidrug-resistant hypervirulent Klebsiella pneumoniae clinical isolates 基于纳米颗粒的环丙沙星与美罗培南共递送可增强对多重耐药高毒力肺炎克雷伯菌临床分离株的协同活性 Reham Mostafa and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf422, https://doi.org/10.1093/jac/dkaf422 37 Development of population pharmacokinetic models of total and free piperacillin in critically ill children and young adults for Monte Carlo simulations and model-informed precision dosing 危重症儿童及青年总游离哌拉西林群体药代动力学模型开发：用于蒙特卡洛模拟及模型引导的精准给药 Sonya Tang Girdwood and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf423, https://doi.org/10.1093/jac/dkaf423 38 Reaching the target: time and dose required to achieve target vancomycin plasma concentrations in admitted patients 达标分析：住院患者达到目标万古霉素血浆浓度所需的时间与剂量 W Töpfer and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf424, https://doi.org/10.1093/jac/dkaf424 39 Notable transmitted HIV drug resistance among people who inject drugs in Pakistan 巴基斯坦注射毒品人群中显著传播的HIV耐药性 Stephanie Melnychuk and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf425, https://doi.org/10.1093/jac/dkaf425 40 Synergistic but clinically unattainable: amoxicillin/ceftriaxone combination against ampicillin-susceptible Enterococcus faecium 协同但临床难以实现：阿莫西林/头孢曲松联合对氨苄西林敏感粪肠球菌的体外活性 Ahmed Ashrin and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf426, https://doi.org/10.1093/jac/dkaf426 41 Pharmacodynamic studies of taniborbactam (VNRX-5133) combined with cefepime against β-lactamase–producing Gram-negative bacteria in a neutropenic murine thigh infection model 中性粒细胞减少小鼠大腿感染模型中他尼硼巴坦（VNRX-5133）联合头孢吡肟对产β-内酰胺酶革兰氏阴性菌的药效动力学研究 Panagiota-Christina Georgiou and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf431, https://doi.org/10.1093/jac/dkaf431 42 Epidemiology and treatment of endocarditis secondary to Enterobacterales other than Serratia spp. 非塞拉蒂亚属肠杆菌目细菌所致心内膜炎的流行病学及治疗 Clayton F Hausberger and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf432, https://doi.org/10.1093/jac/dkaf432 43 Enhanced activity of apramycin and apramycin-based combinations against Mycobacteroides abscessus 阿普拉霉素及其组合对脓肿分枝杆菌的增强活性 Yanqin Huang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf433, https://doi.org/10.1093/jac/dkaf433 44 Efflux-mediated multidrug resistance mechanism in Trichophyton indotineae and Trichophyton rubrum; role of ABC transporters and MFS gene 印度毛癣菌与红色毛癣菌中由ABC转运蛋白和MFS基因介导的流出泵型多重耐药机制 Dipika Shaw and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf434, https://doi.org/10.1093/jac/dkaf434 45 Sphingobacterium spp. as intrinsic producers of SPI Ambler class B metallo-β-lactamases 鞘氨醇杆菌属作为SPI Ambler B类金属β-内酰胺酶的固有产生者 Delphine Girlich and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf436, https://doi.org/10.1093/jac/dkaf436 46 Global phylogeography and genomic characterization of blaNDM-1-positive carbapenem-resistant Acinetobacter soli blaNDM-1阳性碳青霉烯耐药溶胶阿卡净菌的全球系统发育地理学及基因组特征 Pengpeng Min and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf437, https://doi.org/10.1093/jac/dkaf437 47 Pharmacokinetics and tolerability of one-month daily rifapentine for latent tuberculosis treatment in haemodialysis patients 血液透析患者潜伏性结核治疗中每月一次每日利福喷丁的药代动力学及耐受性 Thornthun Ueaphongsukkit and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf439, https://doi.org/10.1093/jac/dkaf439 48 In vitro susceptibility of cefepime-enmetazobactam, cefepime-taniborbactam and cefepime-zidebactam towards carbapenemase-producing Enterobacterales 头孢吡肟-恩美他唑巴坦、头孢吡肟-他尼硼巴坦及头孢吡肟-齐德巴坦对产碳青霉烯酶肠杆菌目的体外敏感性 Marion Dutkiewicz and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf440, https://doi.org/10.1093/jac/dkaf440 49 In vitro efficacy of sulbactam/durlobactam combined with β-lactam antibiotics in Australian Mycobacterium abscessus isolates 舒巴坦/杜洛巴坦联合β-内酰胺类抗生素对澳大利亚脓肿分枝杆菌分离株的体外疗效 Kirby Patterson-Fahy and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf441, https://doi.org/10.1093/jac/dkaf441 50 Harnessing CRISPR–Cas9 and CRISPRi systems to reverse antibiotic resistance in a clinical multidrug-resistant Escherichia coli isolate 利用CRISPR-Cas9及CRISPRi系统逆转临床多重耐药大肠杆菌分离株的抗生素耐药性 Ruonan Zhao and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf442, https://doi.org/10.1093/jac/dkaf442 51 Cotrimoxazole in the intensive care unit: an impossible task for the fixed association in real life? 重症监护室中复方磺胺甲噁唑的应用：固定组合在现实中的不可行性？ Manon Launay and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf443, https://doi.org/10.1093/jac/dkaf443 52 National representative survey of pretreatment HIV drug resistance in Colombia: analysis of antiretroviral resistance-associated mutations using next-generation sequencing 哥伦比亚全国代表性调查：基于下一代测序的抗逆转录病毒耐药相关突变分析 Ernesto Martínez-Buitrago and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf444, https://doi.org/10.1093/jac/dkaf444 53 A model-based comparison of dose reduction strategies for fixed-dose dolutegravir-containing regimens 基于模型的含固定剂量多替拉韦方案减量策略比较 Laura Dickinson and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf445, https://doi.org/10.1093/jac/dkaf445 54 Therapeutic drug monitoring and target attainment of unbound flucloxacillin in hospitalized patients with measured MICs (FLUTE) 住院患者中游离氟氯西林的治疗药物监测及目标达成情况（基于实测最低抑菌浓度的FLUTE研究） Pjotr P Temme and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf447, https://doi.org/10.1093/jac/dkaf447 55 Nirmatrelvir-ritonavir addition to acute care formulary: a retrospective, multi-centre evaluation of quantitative economic and qualitative clinical outcomes 奈玛特韦/利托那韦纳入急症治疗目录：一项多中心回顾性评估定量经济与定性临床结果的研究 Jose Valdes Ledesma and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf448, https://doi.org/10.1093/jac/dkaf448 56 Local antibiotic resistance surveillance in nursing homes using lot quality assurance sampling: a feasibility study 采用批量质量保证抽样法对养老院进行本地抗生素耐药性监测的可行性研究 Sacha Kuil and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf451, https://doi.org/10.1093/jac/dkaf451 57 High in vitro activity of the novel antimicrobial gepotidacin against Neisseria gonorrhoeae isolates in eight WHO Enhanced Gonococcal Antimicrobial Surveillance Programme countries in three WHO regions, 2021–24 2021-2024年，在世卫组织三个区域的八个世卫组织增强淋球菌抗菌药物监测计划国家中，新型抗菌药物吉皮达星对淋病奈瑟菌分离株的体外活性较高 Josefine Ahlstrand and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf452, https://doi.org/10.1093/jac/dkaf452 58 Despite increasing use of integrase inhibitors to treat HIV infection, resistance to this class remains stable 尽管整合酶抑制剂用于治疗HIV感染的使用量不断增加，但此类药物的耐药性仍保持稳定 Cathia Soulie and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf454, https://doi.org/10.1093/jac/dkaf454 59 Fine-needle aspiration in infected necrotizing pancreatitis in the delayed intervention era: a post hoc analysis of safety, microbiological yield and therapeutic implications 延迟干预时代感染性坏死性胰腺炎的细针穿刺抽吸术：安全性、微生物学检出率及治疗意义的事后分析 Hannah S Pauw and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf455, https://doi.org/10.1093/jac/dkaf455 60 β-Lactam dosing in critically ill children: predictors for target non-attainment 危重症儿童β-内酰胺类药物给药：未达目标浓度的预测因素 Stef Schouwenburg and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf457, https://doi.org/10.1093/jac/dkaf457 61 Co-administration of triazoles with calcineurin or mammalian target of rapamycin inhibitors in solid organ transplant patients hospitalized with invasive aspergillosis 实体器官移植患者合并侵袭性曲霉病住院时三唑类药物与钙调磷酸酶抑制剂或哺乳动物雷帕霉素靶蛋白抑制剂的联合用药情况 Barbara Alexander and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf461, https://doi.org/10.1093/jac/dkaf461 62 In vitro selection of cefiderocol-resistant mutants in Acinetobacter baumannii harbouring the most common carbapenemase genes 携带最常见碳青霉烯酶基因的鲍曼不动杆菌中头孢地尔耐药突变体的体外筛选 Otávio Hallal Ferreira Raro and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf462, https://doi.org/10.1093/jac/dkaf462 63 Preventing resistance development in infections by OXA β-lactamase-producing Pseudomonas aeruginosa: correlating clinical outcomes with hollow-fibre model input 预防产OXA β-内酰胺酶铜绿假单胞菌感染耐药性的产生：将临床结局与中空纤维模型输入相关联 María M Montero and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf464, https://doi.org/10.1093/jac/dkaf464 64 A national pilot community pharmacy–led urinary tract infection service: clinical and patient-reported outcomes from 9077 consultations 全国社区药房主导的尿路感染服务试点项目：9077次咨询的临床结局和患者报告结局 Efi Mantzourani and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf466, https://doi.org/10.1093/jac/dkaf466 65 Towards enhanced translational value: preclinical drug activity testing against actively multiplying, nutrient-starved and pellicle biofilm-embedded Mycobacterium abscessus 提高转化价值：针对活跃增殖、营养匮乏和生物膜包裹的脓肿分枝杆菌进行临床前药物活性测试 Henriëtte M Meliefste and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf468, https://doi.org/10.1093/jac/dkaf468 Research Letters（研究快报） 66 Novel multiresistance transposon Tn7731 in bovine Pasteurella multocida from Germany 德国牛源多杀性巴氏杆菌中新型多重耐药转座子Tn7731 Henrike Krüger-Haker and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf336, https://doi.org/10.1093/jac/dkaf336 67 Efficacy of eravacycline in difficult-to-treat (DTR) Acinetobacter baumannii bacteraemia in ICU: a case report 厄他培南治疗重症监护病房难治性鲍曼不动杆菌菌血症的疗效：一例病例报告 Monica Melchio and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf347, https://doi.org/10.1093/jac/dkaf347 68 Possible increased risk of Epstein–Barr virus (EBV) infection and post-transplant lymphoproliferative disease (PTLD) in letermovir-exposed haematopoietic cell transplantation recipients 来特莫韦暴露的造血细胞移植受者中EB病毒感染和移植后淋巴增殖性疾病风险可能增加 Jose F Camargo and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf348, https://doi.org/10.1093/jac/dkaf348 69 Dalbavancin dosing in a severely underweight woman with prosthetic valve endocarditis: the critical role of proactive therapeutic drug monitoring 达巴万星在严重体重不足人工瓣膜心内膜炎女性患者中的给药：主动治疗药物监测的关键作用 Ambra Barco and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf365, https://doi.org/10.1093/jac/dkaf365 70 Cefazolin-induced seizures in a haemodialysis patient with elevated serum and cerebrospinal fluid concentrations: a case report 血液透析患者头孢唑林血清和脑脊液浓度升高诱发癫痫：一例病例报告 Kohei Hasegawa and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf373, https://doi.org/10.1093/jac/dkaf373 71 Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes 使用聚丙烯腈膜进行连续性肾脏替代治疗的患者中卡泊芬净药代动力学治疗监测的回顾性分析 Antoine Hérault and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf390, https://doi.org/10.1093/jac/dkaf390 72 Diffusion of OXA-48- and NDM-5-producing Klebsiella pneumoniae ST383 clone in Central Italy 产OXA-48和NDM-5的肺炎克雷伯菌ST383克隆在意大利中部的传播 Gloria D’Achille and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf397, https://doi.org/10.1093/jac/dkaf397 73 Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry 来那卡帕韦在病毒载量阳性且接受过大量抗逆转录病毒治疗的HIV感染者中的持久性：来自PRESTIGIO登记处的现实数据 Tommaso Clemente and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf415, https://doi.org/10.1093/jac/dkaf415 74 Co-carriage of the oxazolidinone resistance genes cfr and optrA in a linezolid-resistant Staphylococcus rostri isolate from a pig-farm worker 猪场工人利奈唑胺耐药猪鼻支原体分离株中噁唑烷酮类耐药基因cfr和optrA的共携带情况 Gi Yong Lee and Soo-Jin Yang Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf428, https://doi.org/10.1093/jac/dkaf428 75 Importance of reviewing the package insert from gradient strip manufacturers 梯度扩散法药敏纸片生产商说明书审阅的重要性 Mandy Wootton and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf429, https://doi.org/10.1093/jac/dkaf429 76 One resistance gene, many transposons: repeated formation of compound and pseudo-compound transposons carrying the aphA1 kanamycin and neomycin resistance gene 一个耐药基因，多个转座子：携带aphA1卡那霉素和新霉素耐药基因的复合及假复合转座子的重复形成 Christopher J Harmer and Ruth M Hall Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf450, https://doi.org/10.1093/jac/dkaf450 77 Absence of lymphogranuloma venereum among men who have sex with men on PrEP receiving doxycycline postexposure prophylaxis 接受暴露后多西环素预防性治疗的暴露前预防用药男男性行为者中未发现性病淋巴肉芽肿 Cristina Gómez-Ayerbe and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf456, https://doi.org/10.1093/jac/dkaf456 78 In vitro activity of gepotidacin against Chlamydia trachomatis 吉皮达星对沙眼衣原体的体外活性 Arabella Touati and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf460, https://doi.org/10.1093/jac/dkaf460 Journal of Antimicrobial Chemotherapy Volume 81, Issue 2抗菌化疗杂志 81卷 2期 https://academic.oup.com/jac/issue Viewpoints（观点） 1 Long-acting glycopeptides: what are the barriers to access in patients who need them most, and how can they be overcome? 长效糖肽类：最需要它们的患者获取药物的障碍有哪些，如何克服？ Aleece MacPhail and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf471, https://doi.org/10.1093/jac/dkaf471 2 Redefining antifungal prophylaxis in acute leukaemia in the era of targeted therapies 靶向治疗时代急性白血病抗真菌预防的重新定义 Marcio Nucci and Johan Maertens Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag010, https://doi.org/10.1093/jac/dkag010 Reviews（综述） 3 Research progress on resistance mechanisms and clinical efficacy of tigecycline against Klebsiella pneumoniae 替加环素对肺炎克雷伯菌的耐药机制及临床疗效研究进展 Meilin Wu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf504, https://doi.org/10.1093/jac/dkaf504 4 Liposomal amphotericin B and renal safety: review of the evidence and clinical considerations 两性霉素B脂质体与肾脏安全性：证据回顾及临床考量 Johan Maertens and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf473, https://doi.org/10.1093/jac/dkaf473 5 Strategies for mitigating severe COVID-19 in patients with haematological malignancy during the omicron era 奥密克戎时代减轻血液系统恶性肿瘤患者严重新冠肺炎的策略 Keiji Okinaka and Joshua T Schiffer Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf489, https://doi.org/10.1093/jac/dkaf489 Systematic Reviews（系统综述） 6 Safety and efficacy of gepotidacin in urinary tract infection: a GRADE-assessed systematic review and meta-analysis 吉泊替达辛治疗尿路感染的安全性和有效性：一项基于GRADE评估的系统综述和荟萃分析 Taha Ibrahim and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf469, https://doi.org/10.1093/jac/dkaf469 7 The emerging clinical relevance and antimicrobial resistance of Pluralibacter gergoviae: a systematic review 产吲哚金黄杆菌日益凸显的临床相关性和抗菌药物耐药性：一项系统综述 Bruna Abdul Ahad Saad and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf476, https://doi.org/10.1093/jac/dkaf476 8 A comprehensive analysis of the mutational landscape determining polymyxin resistance in Klebsiella pneumoniae 决定肺炎克雷伯菌多粘菌素耐药性的突变谱综合分析 Sambit Kumar Dwibedy and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf503, https://doi.org/10.1093/jac/dkaf503 9 Factors promoting or hindering self-administered outpatient parenteral antimicrobial therapy: a systematic literature review 促进或阻碍自我给药门诊静脉注射抗菌药物治疗的因素：一项系统文献综述 Hester H Stoorvogel and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf490, https://doi.org/10.1093/jac/dkaf490 Original Research（论著） 10 Cefepime/enmetazobactam for Gram-negative periprosthetic joint infections? A randomized porcine study on target tissue pharmacokinetics 头孢吡肟/恩美唑巴坦治疗革兰氏阴性假体周围关节感染？一项关于猪的靶组织药代动力学的随机研究 M B D Nielsen and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf487, https://doi.org/10.1093/jac/dkaf487 11 Impact of extracorporeal membrane oxygenation modes on voriconazole exposure in critically ill patients 体外膜肺氧合模式对危重患者伏立康唑暴露的影响 Xinrui Wang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf501, https://doi.org/10.1093/jac/dkaf501 12 Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic -pharmacodynamic modelling in adults and infants 基于模型通过成人和婴儿群体药代动力学-药效学模型评估VRC07-523LS在婴儿中的给药方案 Dustin Huynh and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf449, https://doi.org/10.1093/jac/dkaf449 13 Antibiotic resistance of Pseudomonas aeruginosa strains—intracellular metabolomics analysis 铜绿假单胞菌菌株的抗生素耐药性——细胞内代谢组学分析 Karolina Anna Mielko-Niziałek and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf453, https://doi.org/10.1093/jac/dkaf453 14 In vitro activity of cefepime/zidebactam against sulbactam/durlobactam-susceptible and -resistant Acinetobacter baumannii clinical isolates 头孢吡肟/齐多巴坦对舒巴坦/杜洛巴坦敏感和耐药鲍曼不动杆菌临床分离株的体外活性 Carlo Tascini and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf467, https://doi.org/10.1093/jac/dkaf467 15 Prevalence of macrolide resistance in Mycoplasma pneumoniae in The Netherlands 荷兰肺炎支原体大环内酯类抗生素耐药性的流行情况 Patrick D J Sturm and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf475, https://doi.org/10.1093/jac/dkaf475 16 Simulated lung exposure in pneumonia patients to evaluate the antibacterial capacity and resistance suppression of clinical tigecycline regimens against carbapenem-resistant Acinetobacter baumannii 模拟肺炎患者肺部暴露情况以评估临床替加环素方案对碳青霉烯类耐药鲍曼不动杆菌的抗菌能力和耐药抑制作用 Xiaonan Zhang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf477, https://doi.org/10.1093/jac/dkaf477 17 Enterococcus faecium harbouring vanA, optrA and cfr(D) on a linear plasmid in Canada: a CANWARD surveillance case 加拿大发现携带vanA、optrA和cfr(D)的粪肠球菌线性质粒：一项CANWARD监测病例 Melissa McCracken and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf478, https://doi.org/10.1093/jac/dkaf478 18 The effect of intrauterine exposure to aminoglycosides on neonatal hearing 宫内暴露于氨基糖苷类抗生素对新生儿听力的影响 Daniel Leshin-Carmel and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf483, https://doi.org/10.1093/jac/dkaf483 19 Ceftazidime/avibactam: a potent arsenal against multidrug-resistant Pseudomonas aeruginosa-unveiling in vitro and in vivo strategies 头孢他啶/阿维巴坦：对抗多重耐药铜绿假单胞菌的有力武器——揭示体内外策略 Jiaju Zhuo and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf495, https://doi.org/10.1093/jac/dkaf495 20 Comparison of disk diffusion, MIC test strip and broth microdilution for eravacycline susceptibility testing of 422 Staphylococcus aureus isolates using ChinaCAST breakpoints 采用中国CAST折点，比较422株金黄色葡萄球菌对依拉环素的纸片扩散法、最低抑菌浓度测试条法和肉汤微量稀释法的敏感性测试结果 Xinying Wang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf502, https://doi.org/10.1093/jac/dkaf502 21 Penetration of daptomycin in cerebrospinal fluid during pneumococcal meningitis 肺炎链球菌性脑膜炎期间达托霉素在脑脊液中的渗透情况 Pascal Chavanet and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf474, https://doi.org/10.1093/jac/dkaf474 22 Rapid molecular diagnostics for detection of extensively drug-resistant Salmonella Typhi 用于检测广泛耐药伤寒沙门菌的快速分子诊断技术 Emma L Sweeney and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf481, https://doi.org/10.1093/jac/dkaf481 23 Gender inequality and antibiotic consumption: analysis of pharmaceutical sales data from 70 countries, 2000–22 性别不平等与抗生素消费：基于2000 - 2022年70个国家药品销售数据的分析 Deepshikha Batheja and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag002, https://doi.org/10.1093/jac/dkag002 24 Real-world evaluation of isavuconazole in children with cancer 伊沙康唑在儿童癌症患者中的现实应用评估 Janine Nijhuis and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf485, https://doi.org/10.1093/jac/dkaf485 25 Assessing antimicrobial susceptibility testing guideline adherence by laboratories providing bacteriology services in Ghana: a pilot study 加纳提供细菌学服务的实验室对抗菌药物敏感性试验指南依从性的评估：一项试点研究 Joseph Elikem Efui Acolatse and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag003, https://doi.org/10.1093/jac/dkag003 26 Resistance to second-generation integrase inhibitors in people with HIV following treatment failure on dolutegravir- or bictegravir-based ART in Taiwan 台湾地区基于多替拉韦或比克替拉韦的抗逆转录病毒治疗失败后，HIV感染者对第二代整合酶抑制剂的耐药性 Guan-Jhou Chen and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf488, https://doi.org/10.1093/jac/dkaf488 27 In vitro activity of gepotidacin against a challenging panel of multidrug-resistant Neisseria gonorrhoeae isolates 吉泊西汀对一组具有挑战性的多重耐药淋病奈瑟菌分离株的体外活性 Michelle Jayne Cole and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag001, https://doi.org/10.1093/jac/dkag001 28 A disproportionality analysis of adverse events associated with omadacycline based on the FDA adverse event reporting system database 基于美国食品药品监督管理局（FDA）不良事件报告系统数据库的奥马环素相关不良事件比例失衡分析 Ye-Lei Zhao and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag006, https://doi.org/10.1093/jac/dkag006 29 Weight-band-based simplification of oral allometric miltefosine dosing in paediatric patients with visceral leishmaniasis 基于体重范围的口服异速缩放米替福新给药方案在儿童内脏利什曼病患者中的简化应用 Andres Mazariegos Herrera and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag014, https://doi.org/10.1093/jac/dkag014 30 evelopment of a capability framework for antimicrobial stewardship specialist health professionals working in the NHS in England: utilizing Delphi methodology 运用德尔菲法为在英国国家医疗服务体系（NHS）中工作的抗菌药物管理专业人员制定能力框架 Ryan A Hamilton and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf438, https://doi.org/10.1093/jac/dkaf438 31 First characterization of insertions in the HIV-1 integrase-coding region from people with HIV 首次对来自艾滋病病毒感染者的HIV-1整合酶编码区插入情况进行特征分析 Nhat Quang Tu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf491, https://doi.org/10.1093/jac/dkaf491 32 Development of an impedance-based fast antimicrobial susceptibility test for Neisseria gonorrhoeae 开发一种基于阻抗的淋病奈瑟菌快速抗菌药物敏感性检测方法 Caitlin N Daniels and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf493, https://doi.org/10.1093/jac/dkaf493 33 Juvenile toxicity and developmental safety of Zintrodiazine, a novel antimalarial candidate, in Wistar rats 新型抗疟候选药物Zintrodiazine在Wistar大鼠中的幼年毒性和发育安全性研究 Hitesh A Kadu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag008, https://doi.org/10.1093/jac/dkag008 34 Do the redefined EUCAST susceptibility categories warrant adjustment of paediatric antibiotic dosages? Pragmatic physiologically based pharmacokinetic modelling of four commonly used agents 欧洲抗微生物药物敏感性试验委员会（EUCAST）重新定义的敏感性分类是否需要调整儿童抗生素剂量？——对四种常用药物的实用生理药代动力学建模研究 Marika A de Hoop-Sommen and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf463, https://doi.org/10.1093/jac/dkaf463 35 Exploring the opportunity for therapeutic drug monitoring (TDM) and precision dose antimicrobials in an outpatient antimicrobial therapy (OPAT) service: a prospective observational study 门诊抗菌治疗（OPAT）服务中开展治疗药物监测（TDM）和精准剂量抗菌治疗的机遇：一项前瞻性观察研究 R C Wilson and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf484, https://doi.org/10.1093/jac/dkaf484 36 Impact of sex, age and body composition on rilpivirine and cabotegravir trough concentrations in people with HIV receiving long-acting injectable antiretroviral therapy 性别、年龄和身体成分对接受长效注射用抗逆转录病毒治疗的HIV感染者利匹韦林和卡博特韦谷浓度的影响 Maria Vittoria Cossu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag024, https://doi.org/10.1093/jac/dkag024 37 Pharmacokinetics of cefiderocol during prolonged intermittent kidney replacement therapy in two patients with septic shock 头孢地尔在两例感染性休克患者长时间间歇性肾脏替代治疗期间的药代动力学 Julius J Schmidt and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf496, https://doi.org/10.1093/jac/dkaf496 38 Understanding mechanisms of reduced cefiderocol susceptibility in pvdS and fecI mutants of Pseudomonas aeruginosa 了解铜绿假单胞菌pvdS和fecI突变体对头孢地尔敏感性降低的机制 Yoshinori Yamano and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag004, https://doi.org/10.1093/jac/dkag004 39 Biomarker-informed PBPK modelling of meropenem in paediatric severe pneumonia: implications for target-site PK/PD 基于生物标志物的美罗培南在儿童重症肺炎中的生理药动学模型构建：对靶部位药代动力学/药效学的影响 Yao Liu and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf500, https://doi.org/10.1093/jac/dkaf500 40 Evaluating hypoalbuminaemia thresholds associated with delayed blood sterilization among patients receiving cefazolin or antistaphylococcal penicillins for MSSA bacteraemia 评估接受头孢唑林或抗葡萄球菌青霉素治疗甲氧西林敏感金黄色葡萄球菌（MSSA）菌血症患者中，与血液延迟灭菌相关的低白蛋白血症阈值 Sunish Shah and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf498, https://doi.org/10.1093/jac/dkaf498 Research Letters（研究快讯） 41 False-negative result in fourth-generation HIV screening tests after weak detection of p24 antigen in the context of inappropriate post-exposure prophylaxis use: a case report 不当使用暴露后预防用药导致第四代HIV筛查试验p24抗原弱检出后出现假阴性结果：一例病例报告 J Kimmerlin and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf459, https://doi.org/10.1093/jac/dkaf459 42 Proposal for the nomenclature of tmexCD-toprJ-like gene clusters 关于tmexCD-toprJ样基因簇命名的建议 Chengzhen Wang and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf482, https://doi.org/10.1093/jac/dkaf482 43 IS26-mediated chromosomal integration of virulence plasmid fragments in ST2237 carbapenem-resistant Klebsiella pneumoniae IS26介导的毒力质粒片段在ST2237型碳青霉烯耐药肺炎克雷伯菌染色体中的整合 Yan Li and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag018, https://doi.org/10.1093/jac/dkag018 Letter to the Editor（致编辑的信） 44 Comment on: Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes 对“采用聚丙烯腈膜对接受连续性肾脏替代治疗的患者进行卡泊芬净药代动力学监测的回顾性分析”的评论 Gwénola Marais and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf465, https://doi.org/10.1093/jac/dkaf465 45 Antimicrobial use for the treatment of bacterial sexually transmitted infections among doxycycline post-exposure prophylaxis (DoxyPEP) users in Milan, Italy-right-to-reply 意大利米兰地区使用多西环素暴露后预防（DoxyPEP）人群中，用于治疗细菌性传播感染的抗菌药物使用情况——回应说明 Angelo Roberto Raccagni and others Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag027, https://doi.org/10.1093/jac/dkag027 ACKNOWLEDGEMENT OF REFEREES（鸣谢审稿专家） 46 Acknowledgement of Referees 鸣谢审稿专家 Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf417, https://doi.org/10.1093/jac/dkaf417 CORRECTION（更正） 47 Correction to: Comment on: Antiviral effect of Evusheld in COVID-19 hospitalized patients infected with pre-Omicron or Omicron variants: a modelling analysis of the randomized DisCoVeRy trial 更正：关于Evusheld在感染奥密克戎变异株前或奥密克戎变异株的新冠住院患者中的抗病毒效果：对随机DisCoVeRy试验的建模分析的评论 Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf492, https://doi.org/10.1093/jac/dkaf492

临床结果临床1期

2026-02-02

·小左学习录

艾迪药业的抗艾创新药

艾迪药业是一个朋友推荐的，说对口我的专业，让我关注一下。于是看了一下这个公司，还真是我的老本行，说明我是一个不太善于发现并且非常懒的人，都没把它挖出来。艾迪药业成立于2009 年，2020年7月20日上市。上市第一年2020年报公司的业务描述是主要围绕人源蛋白领域和抗病毒等创新药物研发领域展开。当时的创新药管线有抗病毒类，抗炎及脑卒中类以及抗肿瘤类，但是到目前为止，公司的抗病毒药进展不错，而抗炎及脑卒中类几乎停滞不前，抗肿瘤药物的研发已于2024年停止。所以这家公司目前主要业务聚焦于抗HIV 及人源蛋白领域两条赛道。本篇主要看抗HIV药物。一、已上市药物： AC007:艾诺韦林（艾邦德®），2021年6月上市，首个国产抗HIV口服1类新药。 AC008: 艾诺米替（复邦德®），2022年12月上市，国内首个三联复方抗HIV1类新药。要看懂HIV药物，需要一点简单的背景知识：抗HIV的药物主要有7类： 1、核苷类反转录酶抑制剂NRTI 2、非核苷类反转录酶抑制剂NNRTI 3、蛋白酶抑制剂 PI 4、整合酶抑制剂INSTI 5、融合抑制剂FI 6、CCR5 抑制剂 7、衣壳抑制剂（capsidinhibitor）。目前抗HIV主流方案：2个NRTI+1个NNRTI /或者1个PI/ 或者1个INSTI。为什么要这么用，因为这个病需要终身服药，单药容易耐药，所以要联用，联合用药也叫鸡尾酒疗法。因为联用，所以病人服药片数会比较多，所以现在流行用三合一的复方制剂，一天一片更方便，联合用药可以提高依从性。 HIV有一个大单品，叫必妥维，2018年在美国上市，2020年在中国上市，2024年全球销售额134.23亿美元，排第五。必妥维为什么能够这么牛？说说我们国家，2006年，我国艾滋病防治开始执行四免一关怀政策，艾滋病是可以免费治疗的，一线方案是替诺福韦+拉米夫定+依非韦伦（2个NRTI+1个NNRTI），到现在20年过去了，一线主流方案还是这个，在当年，这个方案可以说是让艾滋病患者起死回生，病毒得到了抑制，生命得到了延续，解决了活下来的问题。但是这个方案也有它的缺陷，替诺福韦长期服用会有骨质疏松的问题，而且对肾功能不太友好，依非韦伦有神经毒性，服药后头昏、睡眠不佳、恶梦、皮疹、肝功能损害等等，免费药虽然种类也不少，但一线方案以外的药都有不同的用药限制，所以有很多患者其实是为了活着，不得不忍受药物副反应。 2016年左右，整合酶抑制剂上市了，但是价格没有打下来，一个月的费用大概在三四千左右，限制了长期使用，一般是治疗初期使用，病情平稳后更换为免费药。直到必妥维的出现，其实它的出现就意味着它很快就会迎来巅峰。必妥维的成分是比克替拉韦+恩曲他滨+丙酚替诺福韦（BIC 50mg/FTC 200mg /TAF 25mg），这里面包含了两个升级的核苷类反转录酶抑制剂和一个整合酶抑制剂。它解决了几大痛点： 1、副作用少：丙酚替诺福韦对骨骼和肾脏的毒性显著降低，且有效抗病毒所需剂量更小，25mg的就相当于300mg的替诺福韦的抗病毒效果。 2、单片制剂服用方便，没有使用限制：单片药物较多片药物服用更方便，在必妥维之前还有其它复方单片制剂在中国上市，比如捷芙康需要随餐服，绥美凯需要进行HLA-B5701筛查，这些限制必妥维都没有，大大提高用药便捷性。 3、价格合理：必妥维的商业化做得很成功，推广特别给力，到中国后很快就进了国谈药，一个月的费用医保报销后自付大概四五百，这是一个很容易被能接受的价格。 4、耐药屏障高：对于对非核苷类反转录酶抑制剂和蛋白酶抑制剂耐药的都有用，治疗效果不好的，没有耐药监测条件的都可以直接换。在能用必妥维之前，面对患者的副反应或者耐药无药可换的时候，其实医生也很痛苦，必妥维像根救命稻草一样，拯救了这部分患者。现在回到艾迪的抗HIV药物这部分，已上市的两款药艾诺韦林和艾诺米替。艾诺韦林2021年6月上市，上市后销量： 2021年3407盒， 2022年88914盒， 2023年59386盒， 2024年56150盒，上市后第二年销量狂飙，但是2023年和2024年就下滑了，为什么？因为2022年底艾诺米替上市了，艾诺米替是一个复方制剂，艾诺米替=替诺福韦+拉米夫定+艾诺韦林。艾诺米替上市后销量： 2023年98587盒， 2024年223863盒。复方制剂更受欢迎，公司重点推广艾诺米替了。所以目前艾诺米替是这个公司最大的看点，2024年艾迪收缩了战线，放弃了肿瘤业务，选择聚焦，但是艾诺米替能不能成为一个大单品，能不能持续高增长呢？说到底，还是要看产品够不够硬核。艾诺米替属于一个经典的组合，2个NRTI+1个NNRTI ，上市时的适应症为用于治疗HIV-1感染初治患者，2024年适应症扩展为：（1）无抗逆转录病毒治疗史的患者；（2）作为替代治疗方案，用于接受稳定抗逆转录病毒治疗达到病毒学抑制（HIV-1 RNA＜50 拷贝/mL）且无治疗失败史的患者。它相比目前的一线方案免费药是有优势的，首先它是个复方制剂，依从性会更好，有效性得到了验证，且耐药风险低，相比依非韦伦神经毒性更低，但是替诺福韦的局限还在。从艾诺米替上市后的销量来看，还是挺受市场欢迎的，放量很快，根据2025的业绩预告，艾诺米替2025的销量较2024年差不多是翻倍的，但是未来还能高增长多久呢？关于艾滋病的治疗我看一了篇预测有几个点： 1、2025年3月，国产诺拉依（依非米替）被纳入免费药目录，国免方案演进可能从替拉依到替拉依复方单片。 2、2026年4月20日，多替拉韦DTG核心专利正式到期，仿制药上市。首选方案可能变为2个NRTI+1个INRSTI。 3、多替拉韦进入国免方案的路径：多替拉韦已被纳入免费目录，但需耐药报告。27年后可能全面进入一线。 4、2026年1月1日，首个国际完整长效方案卡替拉韦CAB（7918降到3878）+利匹韦林RPV（1882降至922）正式降价，降幅超50%（9800降至4800），从每天服药到每年注射6次。 5、全球首个周服方案：ISL / LEN（伊斯拉曲韦+来那帕韦）三期临床试验疗效与必妥维相当，可能于2027年上市。根据这个预测，可以看出一些端倪，用长效针剂和周口服方案的人群跟用艾诺米替的不是一个人群，艾诺米替可能替代部分用替拉依的，但是如果多替拉韦仿制药全面进入一线不要求耐药报告的话，花钱选择艾诺米替意义也不是那么大，不过这还有几年时间，在这之前，患者如果用上一个方案没有明显副反应、没有耐药一般是不会换方案的，会一直用。根据弗若斯特沙利文报告，全球抗HIV 病毒药物市场规模2017 年为325 亿美元，至2021 年为380 亿美元，复合年增长率为4.0%。预计2025 年将达到479 亿美元，2030 年将达到575 亿美元，2021 年至2025 年的复合年增长率为6.0%，2025 年至2030 年的复合年增长率为3.7%。所以艾诺米替还是有些想象空间的，毕竟目前一年的销售额还不到3亿。目前的商业化进程看起来还可以。在国内市场运营方面，公司通过医学、市场、销售“三驾马车”紧密协作、齐头并进，通过专业化营销体系持续推进产品品牌建设。国际业务方面，公司加速推进抗艾创新产品的海外市场商业化布局，重点聚焦在非洲、东南亚等目标市场，积极开展产品注册及准入相关工作，2025 年 7 月 25 日，艾诺米替在桑给巴尔（非洲坦桑尼亚联合共和国的组成部分）上市，标志着公司抗 HIV 创新药首次实现海外注册上市。二、在研管线：关于艾滋病药物的研发方向，年报有一段是这样描述的：早期抗艾药研究主要集中在三个关键酶（即逆转录酶、蛋白酶、整合酶），药物核苷类反转录酶抑制剂、非核苷类反转录酶抑制剂和蛋白酶抑制剂仍是当前的主要用药。随着研究的愈发深入，整合酶抑制剂、融合抑制剂、辅助受体拮抗剂等药物的出现为鸡尾酒组合提供了更多的可能性。鸡尾酒疗法的不断完善使得治疗效果逐渐提升、副作用得到一定控制、用药费用逐步降低，患者能接受更好的治疗、拥有更多的用药选择。未来，全球抗艾滋病研发方向将主要集中在以下几个方向：1）现有已知作用靶点下开发具有更优疗效、更佳安全性、更好用药便捷性的新药，目前绝大部分研究属于此类范畴；2）探索新的潜在药物靶点（如衣壳蛋白、中性鞘磷脂酶-2 等），寻求更加强效、改善耐药的新化合物；3）探索新的治疗方式（如基因治疗、免疫治疗等），寻求能够治愈艾滋病的疗法；4）开发艾滋病疫苗或药物，实现预防感染。公司目前在研的药物主要有三个，一个是整合酶抑制剂，一个是基于整合酶抑制剂的复方制剂，一个是长效药物。 ACC017: HIV 整合酶抑制剂，临床Ⅱ期阶段。 2024年8月30日完成Ⅰ期临床，包括首次人体试验（FIH）、单剂量递增试验（SAD）、食物影响试验（FE）、与联合抗逆转录药物相互作用试验（DDI），结果显示：所有剂量组别参研者的安全性良好，未发生 2 级或以上不良事件；药物口服吸收暴露水平良好，可支持每日给药一次。截至2025年第二季度，已完成一项初治 HIV 感染者Ⅰb/Ⅱa 期临床研究，包括多剂量递增试验（MAD）、概念验证试验（POC）、药动学/药效学研究（PK/PD）以及初治人群联合给药剂量探索试验（Dose-finding），该项临床试验结果显示：初治 HIV 感染的参研者经 ACC017 片（40mg）单药治疗10天，病毒载量较基线平均下降 2.34 Log10拷贝/mL；联合核苷骨干药物（FTC/TAF，200/25mg）继续治疗 18 天，超过 90%的参研者实现病毒学完全抑制（HIV-RNA＜50 拷贝/mL）；此外，所有剂量组在经 ACC017 片单药治疗 10 天后继续联合核苷骨干药物治疗 18 天，100%的参研者HIV-RNA 均＜200 拷贝/mL。综合现有的研究结果，ACC017 片安全性良好，单药治疗药效明确，与 FTC/TAF 联合组成完整方案达到病毒学抑制水平高且快。截至2025年第二季度，在进行的一项经治耐药人群Ⅱ期临床研究已完成所有受试者的入组工作，正在积极有序推进。看起来是一个有希望的药，可以持续跟踪。 ADC118:ACC017 （Asuptegravir，ASU）+恩曲他滨+丙酚替诺福韦的三联复方制剂，2025年10月28通过IND申请。长效药物：临床前研究阶段。 ACC018: 2021年的时候年报提到是ANV+3TC+TAF的复方制剂，2023年没了，应该是有了ACC017，放弃了这个药。三、仿制药： ADC201:第二代整合酶抑制剂多替拉韦钠片仿制药，已递交 ANDA 申请并获受理。整合酶抑制剂疗效较为显著，可以较快降低病毒数量且一般都有较好的耐受性，2019 年世界卫生组织推荐 DTG 为治疗所有 HIV 患者的首要治疗选择之一。 ADC202:达芦那韦片仿制研发，已完成原料药上市登记和制剂ANDA 申请并获受理。 ADC205: 多替拉韦拉米夫定替诺福韦三联片，报告期内已完成小试开发，正在进行小试放大和工程批准备工作。仿制药是2023年在年报中开始出现的，估计是公司一不小心真弄出来两个HIV上市新药，打算往抗艾领域深度发展而拓宽的产品种类，但是仿制药造出来也不赚钱，没有多大的关注价值。根据2025的业绩预告，HIV创新药的收入占到了总营收的40%左右，这还是在并表了南大药业的情况下，不然占比会更高。而公司的产品中毛利率最高的就是HIV创新药。所以如果艾诺米替持续放量的话，公司会很快实现营收平衡，扭转亏损，如果ACC017进展顺利的话，未来的前景将会更加光明。

100 项与多替拉韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10113	多替拉韦钠	J05AX12	DB08930

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	ViiV Healthcare Co.	2013-08-12

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
肺结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
怀孕	临床3期	南非	ViiV Healthcare Ltd.	2017-03-14
怀孕	临床3期	乌干达	ViiV Healthcare Ltd.	2017-03-14
潜伏性结核	临床2期	美国	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	博茨瓦纳	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	海地	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	马拉维	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	南非	ViiV Healthcare Ltd.	2021-02-27
潜伏性结核	临床2期	泰国	ViiV Healthcare Ltd.	2021-02-27

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临床结果

适应症

分期

评价

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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


GS-US-380-1844，ALLIANCE (Pubmed)	-	HIV感染	2,622	多替拉韦+恩曲他滨+丙酚替诺福韦	壓築構範夢艱餘構蓋網(糧簾鏇製鏇築鏇夢觸鏇) = 獵願膚築蓋襯淵鑰憲鬱鏇夢鹽簾鑰衊齋範觸顧 (膚選廠醖選壓醖鏇顧艱 ) 更多	积极	2024-11-18
				多替拉韦	壓築構範夢艱餘構蓋網(糧簾鏇製鏇築鏇夢觸鏇) = 夢餘艱願夢廠鏇糧壓範鏇夢鹽簾鑰衊齋範觸顧 (膚選廠醖選壓醖鏇顧艱 ) 更多
NCT03048422 (IMPAACT 2010 (VESTED), Pubmed \| J Acquir Immune Defic Syndr)	临床3期	bone mineral density \| creatinine clearance	-	Dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)	糧膚構遞製鑰簾鏇鑰遞(鏇鏇簾壓顧製築夢遞網) = 選廠壓餘願範網窪積齋築獵製顧顧膚蓋願遞鏇 (餘積鏇憲鹹壓獵壓糧窪 )	积极	2024-10-01
				Dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF)	糧膚構遞製鑰簾鏇鑰遞(鏇鏇簾壓顧製築夢遞網) = 顧構網範餘壓鑰壓鬱築築獵製顧顧膚蓋願遞鏇 (餘積鏇憲鹹壓獵壓糧窪 )
NCT03249181 (DolPHIN-2, Pubmed \| J Antimicrob Chemother)	临床3期	HIV感染	268	Dolutegravir-based regimen	淵醖網衊糧壓願襯廠鑰(範鹽憲鏇鏇積鬱顧構顧) = 觸製觸簾憲積醖構壓鹹蓋糧鹹觸窪夢衊鑰築遞 (淵繭顧繭衊廠鹹淵衊顧 ) 更多	不佳	2024-09-03
NCT04272242 (CTgov)	临床2期	潜伏性结核 \| HIV感染	37	Antiretroviral Therapy (ART)+Dolutegravir (DTG)+Rifapentine (RPT)+Isoniazid (INH)	遞構夢範獵簾範鹹衊遞(廠選簾憲壓觸網鹹夢窪) = 繭糧膚鹹鹹顧夢夢網憲醖鑰壓壓淵觸淵觸憲鹹 (淵鹹廠夢築夢醖艱糧築, 艱艱鹹襯廠鹹顧網壓簾 ~ 構壓艱簾築願憲繭選鑰) 更多	-	2024-08-09
NCT03991013 (ARTIST, CTgov)	临床2期	HIV感染	192	tenofovir+Dolutegravir+lamivudine (Stage 2: Supplementary Dose)	獵淵膚構築獵獵艱製艱 = 齋鏇鑰鹽鹽範餘糧簾憲糧鏇壓糧餘鬱範鹹鏇獵 (鬱範壓製淵製餘鏇網餘, 獵鹽觸顧觸膚鑰艱積鹽 ~ 鹽齋膚繭糧艱獵淵膚選) 更多	-	2024-08-09
				Placebo (Stage 2: Placebo Dose)	獵淵膚構築獵獵艱製艱 = 鏇蓋衊窪廠壓鏇選醖夢糧鏇壓糧餘鬱範鹹鏇獵 (鬱範壓製淵製餘鏇網餘, 遞積繭鬱餘願餘構艱糧 ~ 鏇壓鹹壓艱齋獵製夢顧) 更多
NCT03017872 (D2EFT, Pubmed)	临床4期	HIV感染二线 HIV RNA load	828	ritonavir-boosted darunavir plus two NRTIs	蓋膚範觸壓築艱獵構艱(構繭網遞憲壓網繭願淵) = 遞膚襯壓齋顧網製襯願遞襯壓選遞鏇繭壓願膚 (構觸構觸繭選衊願鬱壓 )	积极	2024-07-01
				ritonavir-boosted darunavir plus dolutegravir	蓋膚範觸壓築艱獵構艱(構繭網遞憲壓網繭願淵) = 衊繭鹹選窪廠選齋築鏇遞襯壓選遞鏇繭壓願膚 (構觸構觸繭選衊願鬱壓 )
NCT04857892 (CTgov)	临床1期	HIV感染	41	GSK3640254+DTG (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)	鑰膚選糧簾醖築鏇鹽窪(簾夢選醖選齋獵憲鬱蓋) = 範廠淵顧壓廠鹹繭繭鬱網蓋願鹽獵膚鬱鏇獵顧 (艱壓鑰廠壓積艱廠餘夢, 46.8) 更多	-	2024-03-12
				GSK3640254+DTG (Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))	鑰膚選糧簾醖築鏇鹽窪(簾夢選醖選齋獵憲鬱蓋) = 網齋窪壓壓製鏇製鬱獵網蓋願鹽獵膚鬱鏇獵顧 (艱壓鑰廠壓積艱廠餘夢, 36.6) 更多
NCT01837277 (IDEA, CTgov)	临床2/3期	获得性免疫缺陷综合征	186	Dolutegravir 50 mg (Dolutegravir)	鏇餘選製構淵餘繭憲簾 = 構獵憲齋鏇壓齋願構襯簾繭獵淵襯顧蓋窪齋遞 (衊網製築獵夢鏇醖鏇襯, 鏇鏇鬱觸築鏇鬱壓鏇壓 ~ 網構壓鏇選繭鏇製齋鏇) 更多	-	2023-12-14
				Efavirenz (Efavirenz)	鏇餘選製構淵餘繭憲簾 = 鏇窪壓鑰鑰鹽襯淵製醖簾繭獵淵襯顧蓋窪齋遞 (衊網製築獵夢鏇醖鏇襯, 鹽廠壓醖鹹餘鹹艱餘憲 ~ 淵廠築淵廠構積窪鑰願) 更多
NCT02777229 (NAMSAL-ANRS-12313, Pubmed \| Open Forum Infect Dis)	临床3期	HIV感染一线	613	Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	築製廠積廠淵襯齋蓋顧(鏇醖襯憲淵襯憲鹹範膚) = 鑰願顧鏇窪鑰膚網築廠艱獵淵醖鬱蓋範鬱積鹹 (願衊製衊鑰簾構繭遞憲 ) 更多	积极	2023-12-01
				Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	築製廠積廠淵襯齋蓋顧(鏇醖襯憲淵襯憲鹹範膚) = 醖鹽窪選餘築衊觸鑰衊艱獵淵醖鬱蓋範鬱積鹹 (願衊製衊鑰簾構繭遞憲 ) 更多
NCT02777229 (NAMSAL ANRS 12313, Pubmed \| J Acquir Immune Defic Syndr)	临床3期	HIV感染一线	613	Dolutegravir 50 mg (DTG)	簾蓋鏇範鑰壓鏇蓋齋範(簾築蓋鏇壓鏇餘鹽夢獵) = 齋簾憲襯艱膚遞築繭蓋簾衊憲構淵膚網鏇餘襯 (構鏇製壓網遞繭鏇廠醖 ) 更多	积极	2023-11-01
				Low-dose Efavirenz (EFV400)	簾蓋鏇範鑰壓鏇蓋齋範(簾築蓋鏇壓鏇餘鹽夢獵) = 艱鏇顧憲蓋齋遞顧廠齋簾衊憲構淵膚網鏇餘襯 (構鏇製壓網遞繭鏇廠醖 ) 更多