An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

开始日期2026-07-01

申办/合作机构

Gilead Sciences, Inc.

NCT07476339

/ Recruiting临床4期IIT

A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks

Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.
The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.
Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.

开始日期2026-06-17

申办/合作机构

Gilead Sciences, Inc.

[+1]

NCT07645287

/ Recruiting临床2期

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

开始日期2026-06-15

申办/合作机构

Gilead Sciences, Inc.

100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的临床结果

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100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的转化医学

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100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的专利（医药）

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170

项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的文献（医药）

2026-08-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Results of three multicenter observational studies of regimens containing tenofovir alafenamide among people with HIV in Japan

Article

作者: Ohwaki, Ichiro ; Ohnishi, Makiko ; Lee, KuanYeh ; Serejo, Margarida ; Ishizaki, Akinobu ; Peters, Jami ; Taguchi, Nao

BACKGROUND:

Safety data on tenofovir alafenamide (TAF)-containing regimens with >2 years' follow-up in large cohorts of people with HIV (PWH) in Japan are limited. We evaluated the safety of TAF-containing regimens among PWH in Japan, including combinations with emtricitabine (F/TAF), elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), and bictegravir/emtricitabine (B/F/TAF).

METHODS:

Data were collected from medical records for three separate single-arm studies from the HIV-Related Drugs multicenter observational joint cooperative surveillance. Data cut-off periods for each study were: F/TAF, January 2017-April 2025; E/C/F/TAF, July 2016-November 2024; and B/F/TAF, April 2019-February 2025. Each cohort was managed independently and analyzed descriptively as a separate observational cohort, without cross-cohort comparative analyses.

RESULTS:

Safety analyses for the studies included 1678 patients who received F/TAF, 659 who received E/C/F/TAF, and 1495 who received B/F/TAF; 22.2%-35.2% of patients were treatment-naïve across the three TAF-containing products. Median (quartile [Q]1, Q3) treatment duration was 5.12 (2.50, 6.89), 3.10 (2.38, 6.00), and 3.00 (1.28, 4.48) years. Adverse drug reactions (ADRs) occurred in 12.0%-18.6% of patients across studies. The most common ADRs by preferred term were: F/TAF, hypertension (23 [1.4%]) and hyperuricemia (22 [1.3%]); E/C/F/TAF, dyslipidemia (9 [1.4%]) and insomnia (6 [0.9%]); and B/F/TAF, weight increased (32 [2.1%]) and insomnia (18 [1.2%]). Most ADRs initially occurred within the first six months of treatment. The frequency of serious ADRs was <5%; 1.3%-2.9% discontinued treatment due to ADRs.

CONCLUSIONS:

The findings from these studies are consistent with the known safety profiles of the three TAF-containing products. No new safety issues emerged.

2026-07-01·ADVANCES IN THERAPY

The Safety and Effectiveness of B/F/TAF for HIV-1 in a Prospective Multicenter Observational Study in the Republic of Korea

Article

作者: Peters, Jami ; Suekawa-Pirrone, Kimberly ; Lee, Jeong-A ; Liu, Lauren ; Aizen, Keith ; Kim, Yeon-Jae ; Jung, Sook-In

INTRODUCTION:

This study aimed to evaluate the safety and the effectiveness of B/F/TAF in patients living with HIV-1 treated in real-world settings in the Republic of Korea (ROK).

METHODS:

This prospective, multicenter, observational study aimed to enroll all patients initiating B/F/TAF at 45 sites between July 2019 and November 2023. Safety was assessed up to 48 weeks post-treatment initiation. HIV-1 RNA and CD4 + T-cell were recorded at baseline, and then at approximately 48 weeks (i.e., between 36 and 64 weeks) post-treatment initiation.

RESULTS:

Of the 2844 patients enrolled, 2761 were analyzed (mean age 44 ± 14 years; 93.48% male; 81.53% treatment-experienced). Adverse events were reported in 37.16% of patients, adverse drug reactions (ADRs) in 5.40%, serious adverse events in 3.48%, and serious adverse drug reactions in 0.04%. No fatal ADRs were reported. Viral suppression rates (HIV-1 RNA < 50 copies/mL) were 97.83% for treatment-experienced patients, 93.84% for treatment-naïve, and 97.19% overall. CD4⁺ T-cell counts increased in both groups.

CONCLUSION:

In this large real-world cohort, B/F/TAF demonstrated a favorable safety profile and high effectiveness, consistent with prior studies. No new safety concerns were identified.

2026-07-01·HIV MEDICINE

Bictegravir/emtricitabine/tenofovir alafenamide in viremic people with HIV harbouring nucleos(t)ide reverse transcriptase inhibitor resistance‐associated mutations

Article

作者: Ge, You ; Chen, Yaling ; Liu, Anni ; Hu, Zhiliang ; Qin, Jiamin ; Chen, Wei ; Qian, Zheng ; Wei, Hongxia ; Yang, Jinjin ; Zhong, Yandan

Abstract:

Introduction:

Accumulating evidence supports switching virologically suppressed people with HIV (PWH) harbouring nucleoside reverse transcriptase inhibitor (NRTI) resistance‐associated mutations (RAMs) to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). However, real‐world data on initiating B/F/TAF in individuals with NRTI RAMs and ongoing viremia remain limited.

Methods:

We retrospectively included adult PWH treated at the Second Hospital of Nanjing between June 2020 and November 2024 who had at least one NRTI RAM and an HIV‐1 RNA ≥200 copies/mL at B/F/TAF initiation. The primary outcome was virological suppression at 12 months (HIV‐1 RNA <50 copies/mL). Laboratory adverse events were assessed.

Results:

A total of 45 participants were included (97.8% male). At baseline, the median HIV‐1 RNA was 36 800 copies/mL (interquartile range [IQR]: 5130–243 000), and the median CD4 cell count was 53 cells/μL (IQR: 18–307). AIDS‐defining illnesses were documented in 13 participants (28.9%). M184V/I was present in 71.1% and K65R/N in 8.9%. At 12 months, 41/45 (91.1%) participants achieved HIV‐1 RNA <50 copies/mL, and 44/45 (97.8%) achieved <200 copies/mL, with high suppression rates across resistance subgroups, including those with K65R/N or thymidine analogue mutations. All participants without suppression at 12 months achieved virological suppression with extended follow‐up. Grade 3–4 laboratory adverse events occurred in 10/45 (22.2%) participants, most commonly severe bone marrow suppression. These events were frequently attributable to comorbidities and concomitant medications, with no discontinuations of B/F/TAF.

Conclusions:

B/F/TAF demonstrated high virological suppression and acceptable laboratory safety in viremic PWH with pre‐existing NRTI RAMs, supporting its use in this challenging clinical setting.

692

项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的新闻（医药）

2026-08-06

·GBIHealth

礼来、诺和诺德等多家MNC发布财报

礼来2026Q2财报：收入增长48% 2026年8月5日，礼来（NYSE：LLY）发布2026年第二季度财务业绩。2026年第二季度，公司收入229.74亿美元，同比增长48%。这主要归因于产品销量增长60%，但部分被实现价格下降13%所抵消。以替尔泊肽（Mounjaro和Zepbound）为首的重点产品（Key Products）营收在第二季度增长至157.0亿美元。免疫学、肿瘤学和神经科学治疗领域的重点产品收入比2025年Q2增长了121%。按市场划分，美国市场收入增长33%至144亿美元，主要受销量增长37%的驱动，部分被实现价格下降3%所抵消。销量增长主要由Zepbound和Mounjaro推动。价格下降主要受Zepbound和Mounjaro影响，但部分被返利和折扣估计值的调整（主要由Trulicity、Zepbound和Mounjaro推动）所抵消。美国以外市场收入增长80%至86.0亿美元，主要受销量大幅增长113%驱动，部分被实现价格下降36%所抵消。海外实现价格下降主要归因于Mounjaro被纳入中国国家医保药品目录（NRDL）。海外销量增长由Mounjaro领跑。欧唐静（Jardiance）在海外市场的收入包含了与勃林格殷格翰（Boehringer Ingelheim）合作相关的2.50亿美元销售里程碑付款。按产品划分，Mounjaro第二季度销售额增长91%至99.0亿美元。该药在美国的销售额增长45%至48.0亿美元，反映出强劲的需求（部分被实现价格下降抵消）；在海外的销售额增长172%至52.0亿美元，主要受销量增长推动。Zepbound第二季度在美国的销售额增长44%至49亿美元，主要由强劲需求推动，部分被实现价格下降所抵消。鉴于核心产品的良好表现，公司将2026全年营收指引上调至850亿至870亿美元，业绩利润率达49.0%~50.5%。诺和诺德2026Q2财报：公司收入121亿美元，中国市场增长13% 2026年8月5日，诺和诺德（NYSE：NVO）发布公司2026年第二季度财务业绩。第二季度，公司净销售额784.88亿丹麦克朗（约121亿美元），同比增长7%（按固定汇率计算，下同）。2026年上半年，公司净销售额1485.51亿丹麦克朗（约229亿美元），同比增长2%。按市场划分，2026年第二季度，美国市场收入408.69亿丹麦克朗，同比增长4%（上半年收入762.54亿丹麦克朗，-4%）；欧洲和加拿大市场收入192.06亿丹麦克朗，同比增长17%（上半年收入371.24亿丹麦克朗，+8%）；新兴市场收入84.13亿丹麦克朗，同比增长5%（上半年收入152.74亿丹麦克朗，-7%）；亚太市场收入50.3亿丹麦克朗，同比下滑6%（上半年收入101.55亿丹麦克朗，+7%）；中国市场收入49.7亿丹麦克朗，同比增长13%（上半年收入97.44亿丹麦克朗，与去年同期持平）。业绩增长主要由司美格鲁肽销售额驱动。第二季度，肥胖症业务收入231.52亿丹麦克朗，同比增长16%，其中减重用司美格鲁肽注射液（Wegovy）销售额194.84亿丹麦克朗，同比增长1%；片剂销售额32.18亿丹麦克朗；GLP-1类降糖业务收入367.84亿丹麦克朗，同比增长2%，其中降糖用司美格鲁肽注射液（Ozempic）销售额313.75亿丹麦克朗，同比增长5%；Wegovy片剂和Rybelsus销售额52.28亿丹麦克朗，同比下滑4%。出于业务组合调整，诺和诺德终止了monlunabant的开发。该药是一种实验性化合物，靶向1型大麻素受体（CB1受体），2023年诺和诺德斥资11亿美元收购拿大生物技术公司Inversago Pharma获得该药。试验发现，该药较高剂量时减重效果有限，且出现轻中度神经精神副作用。吉利德2026Q2财报：收入增长10%至78亿美元 2026年8月5日，吉利德科学公司（Nasdaq: GILD）公布2026年第二季度财务业绩。报告期内，公司总收入达78亿美元，同比增长10%。产品销售额为76亿美元，同比增长8%。剔除Veklury（瑞德西韦）后，产品销售额增长10%，主要得益于HIV产品、拓达维（戈沙妥珠单抗）和Livdelzi（司拉德帕）的销售增长，但部分被细胞治疗产品和丙型肝炎（HCV）产品的销售下降所抵消。 2026年第二季度，吉利德的HIV产品销售额同比增长12%，达57亿美元。其中，必妥维（Biktarvy）销售额增长7%至38亿美元；达可挥（Descovy）销售额大幅增长48%至9.67亿美元。肝脏疾病产品组合销售额增长10%至8.77亿美元，主要由于Livdelzi、慢性乙型肝炎（HBV）产品及Hepcludex需求的增加，但部分被HCV产品销售额下降所抵消。细胞治疗产品销售额下降14%至4.17亿美元，其中奕凯达（阿基仑赛）销售额下降12%至3.46亿美元，Tecartus（布瑞基奥仑赛）销售额下降24%至7000万美元，主要受竞争压力影响。瑞德西韦销售额锐减81%至2300万美元，主要因COVID-19相关住院率持续走低。TROP2 ADC药物拓达维实现销售额4.57亿美元，同比增长26%，受需求增加所驱动。安斯泰来2026财年第一季度财报：收入增长26.7% 2026年8月5日，安斯泰来（TSE：4503）公布2026财年第一季度财务业绩，公司收入6409.14亿日元（约40.66亿美元），同比增长26.7%。战略品牌（Padcev，Izervay，Vyloy，Veozah，Xospata）销售收入1603亿日元，同比增长43.2%。按市场划分，第一季度美国市场收入2888亿日元，同比增长28.5%；日本市场收入796亿日元，同比增长15.5%；成熟市场（欧洲、加拿大等）收入1522亿日元，同比增长18.2%；中国市场（中国大陆和香港）收入321亿日元，同比增长8.9%；其他市场收入854亿日元，同比增长60.5%。公司预计，2026财年收入将达22200亿日元，同比增长3.8%；核心营业利润4600亿日元，同比增长8.4%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

2026-08-06

·医药观澜

默沙东抗艾滋病口服新药在中国申报上市丨产业新闻

8月5日，中国国家药监局药品审评中心（CDE）官网公示显示，默沙东（MSD）申报的多拉韦林伊拉曲韦片（doravirine/islatravir，DOR/ISL）上市申请已获得受理。根据CDE官网，该产品此前已经被纳入优先审评，拟定适应症为：作为治疗成人HIV-1感染的完整双药治疗方案，适用于正接受稳定抗逆转录病毒治疗方案达到病毒学抑制（HIV-1 RNA<50拷贝/ml）、无抗病毒治疗失败史且无已知与多拉韦林耐药相关突变的患者，替代其当前的抗逆转录病毒治疗方案。根据默沙东公开资料，这款双药单片方案（Idvynso）已经于今年4月获美国FDA批准治疗成人HIV-1感染，以替代当前的抗逆转录病毒治疗方案。公开I资料显示，多拉韦林是一种口服非核苷逆转录酶抑制剂。它通过与HIV-1病毒的逆转录酶结合，防止HIV-1病毒将RNA转化为DNA，从而阻断HIV-1病毒复制。它已在美国和中国获批用于治疗成年HIV-1感染患者。伊拉曲韦则是一种核苷类逆转录酶易位抑制剂（NRTTI），具有转录酶和易位抑制作用（可防止核苷酸结合和掺入DNA链，导致链立即终止）和延迟链终止作用（即使在易位的情况下也能防止核苷酸掺入）。美国FDA批准该产品主要基于两项关键3期临床试验（MK-8591A-051和MK-8591A-052）第48周的数据。在双盲的MK-8591A-052试验中，主要终点（HIV-1 RNA≥50拷贝/mL）结果显示，第48周时，转换至Idvynso治疗的受试者中有1%（n=342）病毒载量≥50拷贝/mL，而继续接受活性对照药物BIC/FTC/TAF治疗的受试者中为1%（n=171）。第48周次要终点结果显示，转换至Idvynso治疗的受试者中92%维持病毒学抑制（HIV-1 RNA<50拷贝/mL），继续接受活性对照药物治疗的受试者中为94%。在开放标签MK-8591A-051试验中，主要终点（HIV-1 RNA≥50拷贝/mL）结果显示，第48周时，转换至Idvynso治疗的受试者中有1%（n=366）患者的病毒载量≥50拷贝/mL，而继续接受基础抗逆转录病毒治疗方案（bART）治疗的受试者中为5%（n=185）。第48周次要终点结果显示，转换至Idvynso治疗的受试者中96%维持病毒学抑制（HIV-1 RNA<50拷贝/mL），继续接受bART治疗的受试者中为92%。在两项试验中，Idvynso的安全性特征总体与各自的活性对照药物相当。参考资料：[1] 中国国家药监局药品审评中心（CDE）官网. From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c [2]FDA Approves Merck’s Once-Daily IDVYNSO™ (doravirine/islatravir). Retrieved April 21, 2026 from https://www.merck.com/news/fda-approves-mercks-once-daily-idvynso-doravirine-islatravir/免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

2026-08-06

·抗体圈

210亿美元收购ADC，业绩增长26%！

当地时间8月5日，吉利德科学交出了一份令华尔街侧目的成绩单。 2026年第二季度，这家HIV巨头的基础业务收入同比增长10%，其中HIV产品销售额飙升12%至57亿美元，Biktarvy稳坐38亿美元宝座，Descovy更以48%的增速冲至9.67亿美元。但真正值得关注的，是那款曾被210亿美元天价收购押注的抗体偶联药物Trodelvy，交出4.57亿美元的业绩，同比增长26%。按照花旗银行32亿美元的峰值预测，这款全球首个获批的TROP-2 ADC，正在用实打实的临床数据与商业表现，向外界证明自己的重磅炸弹成色。从末线到一线：乳腺癌版图的“升维之战” 2026年6月，FDA正式批准Trodelvy两项一线转移性三阴性乳腺癌适应症。这不是简单的适应症扩增，而是一场治疗逻辑的根本重构。 ASCENT-03研究中，Trodelvy单药将不适合免疫治疗患者的中位无进展生存期从6.9个月推至9.7个月，疾病进展风险降低38%。而在ASCENT-04/KEYNOTE D-19研究中，联合帕博利珠单抗方案面对PD-L1高表达人群，将PFS从7.8个月提升至11.2个月，HR值0.65。三阴性乳腺癌，这个占乳腺癌总量15%、却攫取了半数以上死亡病例的“恶霸”，终于迎来了一线层面的精准打击武器。 Trodelvy也由此成为欧盟首个获批一线mTNBC适应症的ADC药物。在中国市场，戈沙妥珠单抗于2025年3月拿下HR+/HER2-乳腺癌适应症，并在2025版CSCO指南中跃升为三阴性乳腺癌二线治疗的1A类推荐。从后线到前线，从TNBC到HR+/HER2-，Trodelvy正在构筑一座难以逾越的乳腺癌护城河。失败的“体面”：聪明企业懂得何时放手然而，这款药物的研发并非一路高歌。 2025年，ASCENT-07研究在HR+/HER2-转移性乳腺癌前线治疗中折戟，未能达到PFS主要终点。同年，吉利德与默沙东合作的EVOKE-03研究在PD-L1高表达非小细胞肺癌领域被独立数据监查委员会叫停。肺癌战场的两次受挫，基本宣告Trodelvy在肺科领域的战略撤退。更早之前，吉利德主动撤回尿路上皮癌加速批准适应症，确证性III期TROPiCS-04研究未能达到OS终点。在制药行业，敢于主动撤回不是示弱，而是对科学最大的尊重。相较于某些企业硬撑无效适应症直至FDA强制叫停，吉利德的选择显得克制而专业。 32亿美元的想象力肺癌失守，尿路上皮癌退场，Trodelvy注定无法复刻Enhertu百亿美元的神话。但它在乳腺癌领域的统治力不容置疑。一线TNBC双适应症获批、HR+/HER2-后线巩固、MIBC新辅助治疗探索、SCLC III期研究推进，Trodelvy正在一条更窄但更深的赛道中构筑确定性。有时，伟大的药不在于覆盖多少癌种，而在于在正确的癌种中拯救多少生命。对于占乳腺癌15%的TNBC患者而言，Trodelvy带来的不仅是数月PFS延长，更是从无药可用到有药可选的时代跨越。 32亿美元的峰值预期，也许保守了。但在创新药的漫漫长路上，能够精准锚定自己的生态位、在进退之间保持清醒判断的产品，远比盲目追逐大适应症的“全能选手”更值得尊敬。吉利德用Q2数据告诉市场：Trodelvy不仅活下来了，而且正在成为乳腺癌ADC赛道上一座绕不开的灯塔。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。

100 项与富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	美国	Gilead Sciences, Inc.	2018-02-07

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
禁食	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
代谢综合征	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
肥胖	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
乙型肝炎	临床3期	美国	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	中国	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	日本	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	多米尼加共和国	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	法国	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	希腊	Gilead Sciences, Inc.	2018-05-30
乙型肝炎	临床3期	中国香港	Gilead Sciences, Inc.	2018-05-30

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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


NCT05405751 (SIMPLIFIED, CTgov)	临床4期	HIV感染	101	Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]	構鏇醖獵憲鏇築衊糧壓 = 願齋壓襯獵憲餘顧廠衊鑰鑰選願餘廠鹽鹹構淵 (窪遞鹽壓蓋觸築觸觸遞, 觸襯鑰網網膚襯鬱鬱衊 ~ 繭齋遞膚鏇壓餘鏇鹽淵) 更多	-	2026-06-30
NCT05648201 (PANNA-B PK, CTgov)	临床4期	HIV感染	20	Doravirine 100Mg Tab (Doravirine)	選繭選淵餘遞餘糧選鑰(憲選繭遞範鹹範餘襯廠) = 鑰網積築蓋積繭窪觸壓築壓範糧壓衊鑰淵窪鬱 (襯鑰選憲選衊鹽壓選遞, 21) 更多	-	2026-04-16
				Biktarvy 50/200/25 Tab (Biktarvy)	選繭選淵餘遞餘糧選鑰(憲選繭遞範鹹範餘襯廠) = 襯餘壓糧蓋憲繭範餘憲築壓範糧壓衊鑰淵窪鬱 (襯鑰選憲選衊鹽壓選遞, 19.4) 更多
NCT06104306 (CTgov)	临床4期	HIV感染	33	B/F/TAF	鑰鏇選製窪膚襯鏇構獵 = 窪構範鬱獵艱膚鏇憲築襯簾築餘鑰顧鏇顧觸積 (築鏇選餘繭齋齋襯網簾, 淵鏇夢鏇壓齋構繭築齋 ~ 憲觸艱鏇繭襯製鏇衊簾) 更多	-	2026-02-11
NCT04712058 (Pubmed \| Int J Infect Dis)	临床3期	HIV感染	225	Bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF)	窪壓醖蓋餘顧淵鹽鹹網(網窪襯範選繭鏇蓋願鏇) = 築積積蓋蓋憲憲選襯壓鬱鏇鹹餘夢鑰獵鏇衊顧 (齋憲膚獵淵夢範淵獵簾 ) 更多	积极	2025-12-01
NCT04734652 (INSIGHT, Pubmed \| Lancet HIV)	临床2期	HIV感染	122	Bictegravir-emtricitabine-tenofovir alafenamide	鏇餘淵簾膚選憲艱鬱鏇(憲網淵觸衊範顧觸衊觸) = 積廠齋糧餘獵膚顧選繭憲範夢鬱顧積簾窪鹹顧 (膚鏇鑰鏇窪廠餘範網糧, 86 ~ 98) 更多	积极	2025-12-01
				Dolutegravir + tenofovir + lamivudine	鏇餘淵簾膚選憲艱鬱鏇(憲網淵觸衊範顧觸衊觸) = 鑰膚夢繭壓蓋觸網獵繭憲範夢鬱顧積簾窪鹹顧 (膚鏇鑰鏇窪廠餘範網糧, 84 ~ 99) 更多
NCT05122754 (Pubmed \| Infect Dis Ther)	临床3期	HIV感染	150	Bictegravir/Emtricitabine/Tenofovir Alafenamide	願簾網鹽簾鏇鹹壓艱膚(醖齋範壓窪鏇鹹壓餘淵) = 簾餘製繭餘蓋遞鹹範鹹鹽獵鑰膚顧夢鹽積鬱窪 (鏇網膚獵餘鏇淵顧繭積, 0.20 ~ 4.12) 更多	积极	2025-11-21
				Tenofovir Disoproxil Fumarate-Based Regimens	願簾網鹽簾鏇鹹壓艱膚(醖齋範壓窪鏇鹹壓餘淵) = 鑰鹹齋憲遞衊鹽夢網繭鹽獵鑰膚顧夢鹽積鬱窪 (鏇網膚獵餘鏇淵顧繭積, −0.52 ~ 3.15) 更多
NCT04734652 (INSIGHT study \| INSIGHT, CTgov)	临床2期	获得性免疫缺陷综合征 \| 肺结核	122	Biktarvy® (BIC Arm)	壓鹽夢鹽選遞衊構簾簾 = 艱簾餘鑰製壓蓋築壓範衊鬱鹹窪鬱夢餘繭選齋 (鑰醖簾網壓願齋憲膚夢, 夢窪願築衊簾鹹鹹淵簾 ~ 構範夢齋繭獵衊淵憲鹽) 更多	-	2025-08-15
				Tenofovir+Dolutegravir+Lamivudine (DTG Arm)	壓鹽夢鹽選遞衊構簾簾 = 鹹願繭膚夢構壓獵膚廠衊鬱鹹窪鬱夢餘繭選齋 (鑰醖簾網壓願齋憲膚夢, 艱醖選遞衊鑰觸淵鑰淵 ~ 製顧簾遞淵衊憲範鑰範) 更多
NCT02607956 \| NCT02607930 (Pubmed \| AIDS Res Ther)	临床3期	HIV感染一线	1,268	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	鏇齋艱積構夢顧鹽餘夢(夢鬱窪積衊網鹹繭網選) = 糧獵醖鹽齋觸艱積餘積製觸窪窪膚醖鹹製糧艱 (夢糧襯鏇襯襯網鏇齋顧 ) 更多	积极	2025-04-07
				dolutegravir + emtricitabine/tenofovir alafenamide	鏇齋艱積構夢顧鹽餘夢(夢鬱窪積衊網鹹繭網選) = 廠範願網顧獵醖衊選鑰製觸窪窪膚醖鹹製糧艱 (夢糧襯鏇襯襯網鏇齋顧 ) 更多
NCT03547908 (ALLIANCE, BusinessWire) 人工标引	临床3期	乙型肝炎 \| HIV感染	-	Biktarvy	願遞簾齋構觸壓鑰衊齋(夢衊憲憲夢積遞積鑰憲) = 積襯夢淵獵鑰襯蓋選壓積鹽壓範願觸鏇鏇艱顧 (選願製構網觸膚餘選積 ) 更多	积极	2024-11-12
NCT03580668 (BICSTaR, BusinessWire) 人工标引	N/A	HIV感染	-	Biktarvy (treatment‐naïve)	獵鹽網鹹糧鏇壓糧觸獵(選蓋觸憲觸簾積艱艱網) = 範鬱獵餘廠積遞蓋鹹齋糧蓋艱衊鏇製窪糧壓築 (構顧鏇蓋蓋窪構網製鬱 ) 更多	积极	2024-11-12
				Biktarvy (treatment‐experienced)	獵鹽網鹹糧鏇壓糧觸獵(選蓋觸憲觸簾積艱艱網) = 繭積製壓壓齋築憲淵鑰糧蓋艱衊鏇製窪糧壓築 (構顧鏇蓋蓋窪構網製鬱 ) 更多