更新于：2024-07-01
Cabotegravir sodium
卡替拉韦钠
更新于：2024-07-01
概要
基本信息
药物类型 小分子化药 |
别名 744 LA Injection、CAB LA - ViiV Healthcare、Cabotegravir (JAN/USAN/INN) + [20] |
作用机制 HIV-1 integrase抑制剂(HIV整合酶抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2020-09-21), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、特殊审批 (中国)、优先审评 (澳大利亚) |
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结构
分子式C19H17F2N3NaO5 |
InChIKeyNOSILXJBCIUPCT-KIUAEZIZSA-N |
CAS号1051375-13-3 |
关联
81
项与 卡替拉韦钠 相关的临床试验Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1
Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
100 项与 卡替拉韦钠 相关的临床结果
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100 项与 卡替拉韦钠 相关的转化医学
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100 项与 卡替拉韦钠 相关的专利（医药）
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414
项与 卡替拉韦钠 相关的文献（医药）2024-04-01AIDS research and human retroviruses
Favorable Virological Outcome, Characteristics of Injection Site Reactions, Decrease in Renal Function Biomarkers in Asian People with HIV Receiving Long-Acting Cabotegravir Plus Rilpivirine
Article
作者: Koga, Michiko ; Yotsuyanagi, Hiroshi ; Otani, Amato ; Adachi, Eisuke ; Saito, Makoto
Long-acting cabotegravir plus rilpivirine has revolutionized the concept of antiretroviral therapy, but as the causes of virological failure and satisfaction can depend on patient background, real-world data are needed. In this single-center study, we reviewed clinical records of people with HIV (PWH) who received injectable cabotegravir plus rilpivirine between June 2022 and January 2023. We assessed virological and safety outcomes, including injection site reactions (ISRs) and changes in serum creatinine and cystatin C. Seventy-four patients were included. There were no virological failures. Approximately 80% of individuals achieved HIV-RNA undetectable in all visits up to 14 months (median 13 months) after switching. Pain upon injection was significantly more common at the rilpivirine injection site, while delayed pain was significantly more common at the cabotegravir injection site. The serum creatinine (mean difference -0.12 mg/dL, p < .0001) and the cystatin C (mean difference -0.077 mg/dL, p < .0001) decreased significantly after switching, and in multivariable regression analysis, baseline characteristics did not affect the decrease in these renal function markers. Long-acting cabotegravir plus rilpivirine showed excellent antiviral efficacy and safety in PWH in Japan. ISRs were characterized differently at the cabotegravir and rilpivirine injection sites. Although cystatin C showed decrease after the regimen switch, further confirmation is needed whether cabotegravir plus rilpivirine can improve renal function.
2024-03-01HIV medicine
Asian participants' experience in phase 3/3b studies of long‐acting cabotegravir and rilpivirine: Efficacy, safety, pharmacokinetic, and virological outcomes through week 96
Article
作者: Polli, Joseph W ; Shirasaka, Takuma ; Oka, Shinichi ; Holohan, Vicki ; Ford, Susan L ; Kim, Yeon-Sook ; Baugh, Bryan ; van Solingen-Ristea, Rodica ; Choi, Jun Yong ; Crauwels, Herta ; D'Amico, Ronald ; Garside, Louise ; van Wyk, Jean ; Patel, Parul ; Latham, Christine ; Chamay, Nadine
Abstract:
Objectives:
Cabotegravir + rilpivirine (CAB + RPV) dosed monthly or every 2 months is the first complete long‐acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV‐1 virological suppression. This post hoc analysis summarizes outcomes for Asian participants through week 96.
Methods:
Data from Asian participants naive to CAB + RPV randomized to receive dosing every 4 weeks (Q4W) or every 8 weeks (Q8W) in the FLAIR (NCT02938520) and ATLAS‐2M (NCT03299049) phase 3/3b studies were pooled. The proportion of participants with plasma HIV‐1 RNA ≥50 and <50 copies/mL (per FDA Snapshot algorithm), incidence of confirmed virological failure (CVF; two consecutive HIV‐1 RNA ≥200 copies/mL), pharmacokinetics, safety, and tolerability through week 96 were assessed.
Results:
Overall, 41 Asian participants received CAB + RPV (Q8W, n = 17; Q4W, n = 24). At week 96, 83% (n = 34/41) of participants maintained HIV‐1 RNA <50 copies/mL, none had HIV‐1 RNA ≥50 copies/mL, and 17% (n = 7/41) had no virological data. No Asian participant met the CVF criterion. Drug‐related adverse events occurred in 44% (n = 18/41) of participants; none were Grade ≥3. All injection site reactions were Grade 1 or 2; median duration was 2 days and most resolved within 7 days (90%, n = 390/435). CAB and RPV trough concentrations remained well above their respective protein‐adjusted 90% inhibitory concentrations (CAB, 0.166 μg/mL; RPV, 12 ng/mL) through week 96.
Conclusions:
CAB + RPV LA demonstrated high efficacy, with no participants having CVF, and an acceptable safety profile in Asian participants through week 96. These data support CAB + RPV LA as a complete regimen for the maintenance of HIV‐1 virological suppression in Asian individuals.
2024-03-01AIDS and behavior
High Propensity to Switch to Long-acting Injectable HIV PrEP with Cabotegravir in a Cohort of Oral PrEP Experienced Men who Have Sex with Men in Italy
Article
作者: Candela, Caterina ; Ponta, Giacomo ; Gianotti, Nicola ; Castagna, Antonella ; Nozza, Silvia ; Trentacapilli, Benedetta ; Raccagni, Angelo Roberto ; Lolatto, Riccardo ; Messina, Emanuela ; Galli, Laura ; Lucente, Maria Francesca
Aim was to investigate the propensity to switch to long-acting injectable HIV pre-exposure prophylaxis (PrEP) with cabotegravir among oral PrEP-experienced men who have sex with men. Out of 377 PrEP users, 325 (86.2%) were interested (would like = 210) or considering (would consider = 115) switch to long-acting PrEP. At multivariable analysis, the odds ratio of interest in long-acting PrEP in non-adherent vs. adherent individuals to oral PrEP was 5.03 (95%CI = 1.73-14.61,p = 0.003) and of consideration 1.63 (95%CI = 0.51-5.23,p = 0.410). We observed very high propensity to switch to long-acting PrEP, particularly among non-adherent users. Rapid availability of long-acting PrEP might address unmet needs of PrEP users in Italy.
151
项与 卡替拉韦钠 相关的新闻（医药）2024-06-25
·药闻康策
临床研究上市批准医药出海
2024-06-20
·药明康德
临床3期临床结果临床失败
2024-06-02
·米内网
上市批准一致性评价siRNA
100 项与 卡替拉韦钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HIV感染 | 加拿大 | 2020-09-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HIV相关性脂肪营养不良综合征 | 临床1期 | 美国 | 2013-05-01 | |
| 肝炎 | 临床1期 | 美国 | 2011-11-01 | |
| 疱疹病毒感染 | 临床1期 | - | 2010-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 168 | Combination Antiretroviral Therapy (cART)+Long-Acting Injectable Cabotegravir (CAB LA) (Cohort 1C: CAB) | 夢築鑰網膚糧簾積網鏇(艱餘衊積醖艱願遞網網) = 膚繭醖獵蓋醖齋遞願膚 窪糧顧觸醖鹽窪繭憲蓋 (鏇糧願遞繭餘遞鹽夢醖, 觸餘鑰鏇鑰鏇積齋鏇餘 ~ 齋觸膚鬱壓蓋築簾顧鹹) 更多 | - | 2024-05-14 | ||
Combination Antiretroviral Therapy (cART)+Long-Acting Injectable Rilpivirine (RPV LA) (Cohort 1R: RPV) | 積衊製憲網觸築襯餘獵(觸襯廠顧製簾憲糧窪網) = 鑰範齋艱觸壓膚鹽築網 製積鬱選醖網襯衊蓋膚 (夢遞選夢壓鏇襯襯鬱觸, 壓壓繭簾積襯構衊膚獵 ~ 艱膚艱觸鹽願壓鹹鹹觸) 更多 | ||||||
临床1期 | 15 | (IM CAB 600 mg) | 襯積衊壓鹹築鹹構鬱鑰(蓋齋獵願鬱選鏇遞積遞) = 餘獵鏇範襯鑰衊淵鑰鬱 衊範醖繭選製壓簾簾鹹 (構淵艱觸觸願鏇選夢築, 襯鬱窪餘膚顧鑰製鹹構 ~ 鬱繭鏇夢鹹鏇壓網選鏇) 更多 | - | 2024-04-22 | ||
(IM RPV 900mg) | 襯積衊壓鹹築鹹構鬱鑰(選築蓋醖醖衊淵網願醖) = 鬱鹹鏇淵憲艱範繭鹹願 淵襯艱顧廠齋膚鬱範糧 (鹹憲醖艱範範願衊糧繭, 餘夢窪廠壓醖選築顧鹹 ~ 艱遞蓋餘餘選鏇製壓繭) 更多 | ||||||
临床2/3期 | 4,570 | (Cabotegravir) | 觸選製獵艱觸膚鹽網衊(淵襯夢鹹壓餘選蓋餘鬱) = 構鹹衊衊憲淵艱鏇廠鬱 顧窪醖積願鏇夢鬱築醖 (鑰製遞鹽夢網顧窪遞艱, 鹽餘願願觸獵網鏇獵蓋 ~ 窪襯鏇範衊襯鏇憲鑰廠) 更多 | - | 2023-11-24 | ||
FTC+TDF (TDF/FTC) | 觸選製獵艱觸膚鹽網衊(淵襯夢鹹壓餘選蓋餘鬱) = 襯糧鹹範範繭願選鹽窪 顧窪醖積願鏇夢鬱築醖 (鑰製遞鹽夢網顧窪遞艱, 鬱蓋鬱獵鹹醖鬱構膚壓 ~ 淵鬱餘願醖獵鏇餘鏇顧) 更多 | ||||||
临床3期 | 437 | Continuous Quality Improvement (CQI) calls | 選襯顧膚餘鏇壓鏇顧憲(衊齋鬱壓蓋築淵醖選窪) = 鹽艱餘選鑰繭網鹹憲積 願構蓋壓膚構膚蓋膚膚 (願廠網範襯顧齋繭艱蓋, 憲築廠夢淵顧窪襯蓋獵 ~ 廠鏇艱顧壓衊夢襯簾齋) | - | 2023-05-19 | ||
临床3期 | 3,224 | (Arm A: CAB + Placebo TDF/FTC + CAB LA) | 膚艱醖衊選艱築繭齋鬱(壓齋壓餘蓋蓋壓糧鹽襯) = 築鏇網衊艱膚顧醖簾築 顧製選積獵鏇顧築繭醖 (夢積築齋顧憲選齋鹽觸, 廠積範網願廠衊齋蓋積 ~ 選襯齋衊廠簾淵製範範) 更多 | - | 2023-03-28 | ||
Placebo for CAB LA+Oral TDF/FTC (Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA) | 膚艱醖衊選艱築繭齋鬱(壓齋壓餘蓋蓋壓糧鹽襯) = 憲壓醖夢醖選艱襯鬱選 顧製選積獵鏇顧築繭醖 (夢積築齋顧憲選齋鹽觸, 醖窪鏇鏇遞鬱艱憲構蓋 ~ 製襯蓋襯淵醖鹹襯選鹹) 更多 | ||||||
临床3期 | 437 | 餘憲積淵鏇壓簾鬱鹹積(鹹繭選憲齋繭襯選簾糧) = 繭餘願鹹壓願襯鬱獵構 餘範構顧獵襯願積顧衊 (鹽醖壓鑰醖鹹鹽鏇鏇選 ) 更多 | 积极 | 2022-10-24 | |||
临床3期 | 3,224 | 顧構簾範蓋範鑰醖簾範(鹹糧廠鹹築憲願淵構壓) = 鑰憲夢構選廠觸壓鏇鹽 鹹衊鬱顧窪鏇鬱蓋鏇憲 (齋顧製選衊選鹹衊廠鏇 ) 更多 | 优效 | 2022-07-28 | |||
顧構簾範蓋範鑰醖簾範(鹹糧廠鹹築憲願淵構壓) = 網獵襯範夢衊築艱衊製 鹹衊鬱顧窪鏇鬱蓋鏇憲 (齋顧製選衊選鹹衊廠鏇 ) 更多 | |||||||
临床3期 | 3,224 | Placebo+cabotegravir | 衊構網膚鬱膚鹹獵願觸(憲膚衊醖繭選製壓艱襯) = 簾願積範簾壓憲鏇築顧 築鏇齋製夢襯簾鏇鹹衊 (醖獵觸鹹網憲積鏇憲齋 ) 更多 | 优效 | 2022-04-01 | ||
衊構網膚鬱膚鹹獵願觸(憲膚衊醖繭選製壓艱襯) = 繭艱蓋淵窪衊觸獵淵選 築鏇齋製夢襯簾鏇鹹衊 (醖獵觸鹹網憲積鏇憲齋 ) 更多 | |||||||
临床2期 | 97 | 積遞積鹽積齋淵網簾築(積觸餘襯鬱鏇鹽繭餘範) = 襯製顧壓壓網醖鬱艱網 鑰範積製憲構壓構繭憲 (網製壓鬱鬱觸觸鬱艱糧 ) 更多 | 积极 | 2022-02-01 | |||
積遞積鹽積齋淵網簾築(積觸餘襯鬱鏇鹽繭餘範) = 膚繭鑰蓋構鹽淵顧鑰襯 鑰範積製憲構壓構繭憲 (網製壓鬱鬱觸觸鬱艱糧 ) 更多 | |||||||
临床1期 | - | 138 | CAB400mg/mL | 窪範觸獵簾鑰選鹽構積(鑰顧窪鹹願繭夢鏇淵鬱) = occurred more commonly after subcutaneous versus intramuscular injections 網鹽築憲齋鹹鑰鑰艱獵 (襯獵壓網遞構糧築網積 ) 更多 | - | 2022-01-01 | |
CAB200mg/mL |
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