首页 > 最新文献

Lancet Hiv最新文献

英文 中文
Using art to promote HIV prevention and highlight inequalities 利用艺术促进艾滋病毒预防和突出不平等现象
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-27 DOI: 10.1016/s2352-3018(26)00011-1
Tony Kirby
{"title":"Using art to promote HIV prevention and highlight inequalities","authors":"Tony Kirby","doi":"10.1016/s2352-3018(26)00011-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(26)00011-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"36 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146071544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing the effectiveness of a depression-integrated model in adult HIV care in Uganda (the HIV+D trial): a cluster-randomised controlled trial. 评估乌干达成人艾滋病毒治疗中抑郁症综合模式的有效性(HIV+D试验):一项聚类随机对照试验。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-15 DOI: 10.1016/s2352-3018(25)00232-2
Eugene Kinyanda,Leticia Kyohangirwe,Richard S Mpango,Isaac Sekitoleko,Wilber Ssembajjwe,Christine Tusiime,Joshua Ssebunnya,Kenneth Katumba,Barbra Elsa Kiconco,Yoko Laurence,Patrick Tenya,Joy Turyahabwa,Patrick Katana,Ian Ross,Anna Vassall,Giulia Greco,James Mugisha,Geoffrey Taasi,Hafsa Sentongo,Dickens Akena,Wilson W Muhwezi,Helen A Weiss,Melissa Neuman,Birthe L Knizek,Jonathan Levin,Pontiano Kaleebu,Ricardo Araya,Vikram Patel
BACKGROUNDAlthough depression is common in people with HIV, mental health interventions are not available to the vast majority of people with HIV in Africa. We aimed to test the effectiveness of the HIV+D collaborative stepped care depression intervention in adult HIV care in Uganda.METHODSA cluster-randomised controlled trial was done at 40 randomly selected primary HIV care centres (clusters) at public health-care facilities in three districts in Uganda. The 40 clusters were randomly allocated (1:1) to enhanced usual care only (EUC arm) or to HIV+D intervention plus EUC, with the randomisation stratified by level of health facility. We recruited adults (aged 18 years or older) with HIV with depression, defined by the locally validated version of the Patient Health Questionnaire 9 (PHQ-9). Participants were consecutively recruited into the study clinics until there was a maximum of 30 participants per cluster. HIV+D was coordinated by a lay counsellor and involved four sequential steps of psychoeducation, behavioural activation, antidepressant medication, and referral. EUC comprised sharing screening results with the HIV clinic physician and training on the WHO guidelines for depression management in routine care. The primary outcome was PHQ-9 scores at 3 months. The trial is registered with the ISRCTN registry (ISRCTN86760765) and is completed.FINDINGS8441 people with HIV were referred to the trial, and 1115 (13%) were enrolled between May 3 and Dec 31, 2021. The mean age was 38 years, 859 (77%) were female, 535 were enrolled in the EUC group, and 580 were enrolled in the HIV+D plus EUC group. Primary outcome data were available for 1097 (98%) participants. We observed high levels of fidelity, with 290 (92%) of 316 participants in the HIV+D plus EUC intervention group receiving the recommended 4-10 sessions of behavioural activation. At 3 months, the mean PHQ-9 scores were lower in the HIV+D plus EUC group, at 3middot;0 (SD 3middot;2) compared with the EUC group, at 7middot;6 (SD 4middot;2; adjusted mean difference 4middot;4; 95% CI 3middot;4-5middot;5; p<0middot;0001; effect size [d]=1middot;34). This effect was sustained, although attenuated, at 12 months (adjusted mean difference 1middot;9; 95% CI 1middot;0-2middot;8; p<0middot;0001; d=0middot;81). Baseline depression severity scores moderated the HIV+D plus EUC intervention effect, with the intervention having stronger effects for those with baseline scores in the severe range (≥20) than for those whose scores were in the moderate range (10-19) both at 3 and 12 months (p values for effect modification were <0middot;001 and 0middot;005, respectively). There was no evidence of effect modification by sex nor baseline HIV viral load. One participant in the HIV+D plus EUC group was hospitalised because of severe depression.INTERPRETATIONThe HIV+D plus EUC intervention had a significant and sustained effect on depression compared with EUC. This intervention offers a scalable approach to integrate
背景:尽管抑郁症在艾滋病毒感染者中很常见,但非洲绝大多数艾滋病毒感染者无法获得心理健康干预措施。我们的目的是测试艾滋病毒+D合作阶梯式护理抑郁症干预在乌干达成人艾滋病毒护理的有效性。方法在乌干达3个地区的40个随机选择的公共卫生保健机构的初级艾滋病毒护理中心(组)进行整群随机对照试验。这40个组随机分配(1:1)至仅强化常规护理组(EUC组)或HIV+D干预加EUC组,并按卫生设施水平进行随机分层。我们招募了成年(18岁或以上)艾滋病毒伴抑郁症患者,由患者健康问卷9 (PHQ-9)的本地验证版本定义。参与者被连续招募到研究诊所,直到每组最多有30名参与者。HIV+D由一名外行顾问协调,包括心理教育、行为激活、抗抑郁药物治疗和转诊四个连续步骤。EUC包括与艾滋病毒诊所医生分享筛查结果,并就世卫组织日常护理中抑郁症管理指南进行培训。主要观察指标为3个月时PHQ-9评分。该试验在ISRCTN注册中心(ISRCTN86760765)注册并完成。在2021年5月3日至12月31日期间,8441名艾滋病毒感染者被纳入试验,1115人(13%)入组。平均年龄38岁,女性859例(77%),EUC组535例,HIV+D + EUC组580例。1097名(98%)参与者可获得主要结局数据。我们观察到高水平的保真度,在HIV+D + EUC干预组的316名参与者中,有290名(92%)接受了推荐的4-10次行为激活。在3个月时,HIV+D + EUC组的PHQ-9平均得分较低,为3点;0 (SD 3middot;2)与EUC组比较,在7middot;6(标准差4middot;2;校正平均差4middot;4; 95% CI 3middot;4-5middot;5; p<0middot;0001;效应量[d]=1middot;34)。这种效果持续了12个月,虽然减弱了(调整后的平均差1middot;9; 95% CI 1middot;0-2middot;8; p<0middot;0001; d=0middot;81)。基线抑郁严重程度评分调节HIV+D + EUC干预效果,在3个月和12个月时,基线评分在严重范围(≥20)的干预效果强于基线评分在中等范围(10-19)的干预效果(影响修改的p值分别为<0点;001和0点;005)没有证据表明性别或基线HIV病毒载量改变了效果。HIV+D + EUC组中一名参与者因严重抑郁而住院。与EUC相比,HIV+D + EUC干预对抑郁症有显著且持续的影响。这一干预措施提供了一种可扩展的方法,将精神卫生保健纳入成人艾滋病毒护理机构。威康信托基金会公共卫生和热带医学高级研究奖学金。
{"title":"Assessing the effectiveness of a depression-integrated model in adult HIV care in Uganda (the HIV+D trial): a cluster-randomised controlled trial.","authors":"Eugene Kinyanda,Leticia Kyohangirwe,Richard S Mpango,Isaac Sekitoleko,Wilber Ssembajjwe,Christine Tusiime,Joshua Ssebunnya,Kenneth Katumba,Barbra Elsa Kiconco,Yoko Laurence,Patrick Tenya,Joy Turyahabwa,Patrick Katana,Ian Ross,Anna Vassall,Giulia Greco,James Mugisha,Geoffrey Taasi,Hafsa Sentongo,Dickens Akena,Wilson W Muhwezi,Helen A Weiss,Melissa Neuman,Birthe L Knizek,Jonathan Levin,Pontiano Kaleebu,Ricardo Araya,Vikram Patel","doi":"10.1016/s2352-3018(25)00232-2","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00232-2","url":null,"abstract":"BACKGROUNDAlthough depression is common in people with HIV, mental health interventions are not available to the vast majority of people with HIV in Africa. We aimed to test the effectiveness of the HIV+D collaborative stepped care depression intervention in adult HIV care in Uganda.METHODSA cluster-randomised controlled trial was done at 40 randomly selected primary HIV care centres (clusters) at public health-care facilities in three districts in Uganda. The 40 clusters were randomly allocated (1:1) to enhanced usual care only (EUC arm) or to HIV+D intervention plus EUC, with the randomisation stratified by level of health facility. We recruited adults (aged 18 years or older) with HIV with depression, defined by the locally validated version of the Patient Health Questionnaire 9 (PHQ-9). Participants were consecutively recruited into the study clinics until there was a maximum of 30 participants per cluster. HIV+D was coordinated by a lay counsellor and involved four sequential steps of psychoeducation, behavioural activation, antidepressant medication, and referral. EUC comprised sharing screening results with the HIV clinic physician and training on the WHO guidelines for depression management in routine care. The primary outcome was PHQ-9 scores at 3 months. The trial is registered with the ISRCTN registry (ISRCTN86760765) and is completed.FINDINGS8441 people with HIV were referred to the trial, and 1115 (13%) were enrolled between May 3 and Dec 31, 2021. The mean age was 38 years, 859 (77%) were female, 535 were enrolled in the EUC group, and 580 were enrolled in the HIV+D plus EUC group. Primary outcome data were available for 1097 (98%) participants. We observed high levels of fidelity, with 290 (92%) of 316 participants in the HIV+D plus EUC intervention group receiving the recommended 4-10 sessions of behavioural activation. At 3 months, the mean PHQ-9 scores were lower in the HIV+D plus EUC group, at 3middot;0 (SD 3middot;2) compared with the EUC group, at 7middot;6 (SD 4middot;2; adjusted mean difference 4middot;4; 95% CI 3middot;4-5middot;5; p&lt;0middot;0001; effect size [d]=1middot;34). This effect was sustained, although attenuated, at 12 months (adjusted mean difference 1middot;9; 95% CI 1middot;0-2middot;8; p&lt;0middot;0001; d=0middot;81). Baseline depression severity scores moderated the HIV+D plus EUC intervention effect, with the intervention having stronger effects for those with baseline scores in the severe range (≥20) than for those whose scores were in the moderate range (10-19) both at 3 and 12 months (p values for effect modification were &lt;0middot;001 and 0middot;005, respectively). There was no evidence of effect modification by sex nor baseline HIV viral load. One participant in the HIV+D plus EUC group was hospitalised because of severe depression.INTERPRETATIONThe HIV+D plus EUC intervention had a significant and sustained effect on depression compared with EUC. This intervention offers a scalable approach to integrate","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"85 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145994976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
25 years of the Alliance for Public Health in Ukraine. 乌克兰公共卫生联盟成立25周年。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-15 DOI: 10.1016/s2352-3018(26)00007-x
Ed Holt
{"title":"25 years of the Alliance for Public Health in Ukraine.","authors":"Ed Holt","doi":"10.1016/s2352-3018(26)00007-x","DOIUrl":"https://doi.org/10.1016/s2352-3018(26)00007-x","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"15 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145994977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lessons from Brazil's elimination of vertical HIV transmission. 巴西消除艾滋病毒垂直传播的经验教训。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-14 DOI: 10.1016/s2352-3018(26)00002-0
Mauer Alexandre da Ascensão Gonçalves,Humberto Morais,Pedro Dos Reis Sousa E Almeida,Howard Lopes Ribeiro Junior
{"title":"Lessons from Brazil's elimination of vertical HIV transmission.","authors":"Mauer Alexandre da Ascensão Gonçalves,Humberto Morais,Pedro Dos Reis Sousa E Almeida,Howard Lopes Ribeiro Junior","doi":"10.1016/s2352-3018(26)00002-0","DOIUrl":"https://doi.org/10.1016/s2352-3018(26)00002-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"83 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145993048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. 长效注射cabotegravir-rilpivirine在病毒学抑制的HIV-1青少年中的安全性、抗病毒活性和药代动力学(IMPAACT 2017/MOCHA):一项为期48周的多国1/2期单臂研究结果。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-14 DOI: 10.1016/s2352-3018(25)00242-5
Aditya H Gaur,Kristin Baltrusaitis,Edmund V Capparelli,John H Moye,Dwight E Yin,Gaerolwe Masheto,Sarah Buisson,Conn M Harrington,Mark A Marzinke,Elizabeth D Lowenthal,Rachel Scheckter,Andi Ace,Shawn Ward,Ryan Milligan,Kyle Whitson,Jenny Huang,S Y Amy Cheung,Brookie M Best,Ellen Townley,Gilly Roberts,Thomas N Kakuda,Eileen Birmingham,Sisinyana Ruth Mathiba,Linda Aurpibul,Violet Korutaro,Christiana Smith,Faeezah Patel,Evette Moodley,Carolyn Bolton-Moore, ,
BACKGROUNDCombined intramuscular long-acting cabotegravir-rilpivirine is the first long-acting combination antiretroviral therapy regimen approved for adults with HIV. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT 2017)-More Options for Children and Adolescents (MOCHA) study assessed safety, acceptability, tolerability, antiviral activity, and pharmacokinetics of these drugs in adolescents with HIV-1. Here we present secondary outcome data up to week 48.METHODSIn this phase 1/2, open-label, non-comparative, dose-finding trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, virologically suppressed (HIV-1 RNA <50 copies per mL) adolescents (aged 12-17 years; weight ≥35 kg) with HIV-1 switched prestudy antiretrovirals to 4 weeks of daily oral 30 mg cabotegravir and 25 mg rilpivirine, followed by 600 mg cabotegravir and 900 mg rilpivirine long-acting intramuscular (3 mL each) injections in the contralateral gluteus medius at week 4 and week 8, and then every 8 weeks. Secondary outcomes assessed here were grade 3 or worse adverse event, virological failure (including HIV-1 RNA ≥50 copies per mL and ≥200 copies per mL per the US Food and Drug Administration snapshot algorithm), and pharmacokinetic measures including cabotegravir and rilpivirine predose concentration assessment. This trial is registered with ClinicalTrials.gov, NCT03497676.FINDINGSBetween July 26, 2021, and Aug 27, 2022, 44 of 55 participants who had participated in cohort 1 and 100 of 115 screened study-naive participants were enrolled into cohort 2 of the study. 74 (51%) of 144 participants were female and 70 (49%) male, median age was 15 years (range 12-17), BMI 19·5 kg/m2 (16·0-34·3), weight 48·5 kg (35·2-100·9). 132 (92%) had vertical HIV acquisition. Of 144 enrolled participants, 142 received at least one injection, 140 completed week 48, and 140 received the expected seven injections through to week 48. Of 142 participants with at least one injection, 48 (34%) experienced injection-site reaction, mostly grade 1 resolving within 7 days. 43 (38%) of 140 participants experienced drug-related adverse events; two experienced grade 3 or worse adverse events (one abscess with pain 3 days after injection; one abscess 6 weeks after injection). The most common drug-related non-injection-site reaction adverse events were headache (three), rash (three), and nausea (two). After week 48, one participant experienced a grade 4 adverse event (anaphylaxis per site; post-injection reaction per Clinical Management Committee) that resolved but led to study drug discontinuation. No virological failures occurred through to week 48. Median week 48 observed predose concentrations were 2·77 μg/mL for cabotegravir (IQR 1·99-3·55) and 67·9 ng/mL for rilpivirine (52·8-82·4), approximating those in adults and exceeding the protein-adjusted IC90 of 0·166 μg/mL and 12 ng/mL, respectively.INTERPRETATIONWeek 48 data from the first virolo
背景:肌肉联合长效cabotegravil -rilpivirine是首个被批准用于成人HIV患者的长效抗逆转录病毒联合治疗方案。国际母婴青少年艾滋病临床试验网络(IMPAACT 2017)-儿童和青少年更多选择(MOCHA)研究评估了这些药物在感染HIV-1的青少年中的安全性、可接受性、耐受性、抗病毒活性和药代动力学。在这里,我们给出了第48周的次要结局数据。方法:在博茨瓦纳、南非、泰国、乌干达和美国的18个地点进行的这项开放标签、非比较、剂量寻找的1/2期试验中,病毒学抑制(HIV-1 RNA <50拷贝/ mL)青少年(12-17岁;体重≥35 kg)的HIV-1患者将研究前抗逆转录病毒药物转换为4周每日口服30 mg卡博特重力韦和25 mg利匹韦林,随后在第4周和第8周对侧臀中肌注射600 mg卡博特重力韦和900 mg利匹韦林长效肌内注射(各3 mL),然后每8周注射一次。这里评估的次要结局是3级或更严重的不良事件、病毒学失败(包括HIV-1 RNA≥50拷贝/ mL和≥200拷贝/ mL(根据美国食品和药物管理局的快照算法),以及药代动力学测量,包括卡波特韦和利匹韦林的剂量前浓度评估。该试验已在ClinicalTrials.gov注册,注册号为NCT03497676。研究结果:在2021年7月26日至2022年8月27日期间,参加队列1的55名参与者中有44名和115名筛选的研究新手参与者中有100名被纳入该研究的队列2。144名参与者中,女性74人(51%),男性70人(49%),年龄中位数为15岁(12-17岁),BMI 19.5 kg/m2(16.0 - 34.3),体重48.5 kg(35.2 -100·9)。132人(92%)垂直感染艾滋病毒。在144名参与者中,142名至少接受了一次注射,140名完成了第48周,140名接受了预期的7次注射,直到第48周。在142名至少注射一次的参与者中,48名(34%)经历了注射部位反应,大多数在7天内消退。140名参与者中有43名(38%)经历过药物相关不良事件;2例出现3级或更严重的不良事件(1例在注射后3天出现脓肿并伴有疼痛;1例在注射后6周出现脓肿)。最常见的药物相关非注射部位反应不良事件是头痛(3例)、皮疹(3例)和恶心(2例)。48周后,一名参与者经历了4级不良事件(每个部位过敏反应;临床管理委员会的注射后反应),该事件得到解决,但导致研究药物停药。到第48周均未发生病毒学失败。48周观察到的中位给药前浓度,卡波特韦(IQR为1.99 ~ 3.55)为2.77 μg/mL,利匹韦林(IQR为52.8 ~ 82.4)为67.9 ng/mL,与成人接近,分别超过蛋白调节IC90 (0.166 μg/mL和12 ng/mL)。第48周的数据来自第一批病毒学抑制的HIV-1青少年患者,他们从每日口服改为每8周肌肉注射卡博特韦和肌肉注射利匹韦林,显示出良好的安全性、药代动力学和病毒学抑制,这为实际使用(已获批准)和正在进行的监管申请(尚在审批中)提供了信息。美国国立卫生研究院和ViiV医疗保健。
{"title":"Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study.","authors":"Aditya H Gaur,Kristin Baltrusaitis,Edmund V Capparelli,John H Moye,Dwight E Yin,Gaerolwe Masheto,Sarah Buisson,Conn M Harrington,Mark A Marzinke,Elizabeth D Lowenthal,Rachel Scheckter,Andi Ace,Shawn Ward,Ryan Milligan,Kyle Whitson,Jenny Huang,S Y Amy Cheung,Brookie M Best,Ellen Townley,Gilly Roberts,Thomas N Kakuda,Eileen Birmingham,Sisinyana Ruth Mathiba,Linda Aurpibul,Violet Korutaro,Christiana Smith,Faeezah Patel,Evette Moodley,Carolyn Bolton-Moore, , ","doi":"10.1016/s2352-3018(25)00242-5","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00242-5","url":null,"abstract":"BACKGROUNDCombined intramuscular long-acting cabotegravir-rilpivirine is the first long-acting combination antiretroviral therapy regimen approved for adults with HIV. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT 2017)-More Options for Children and Adolescents (MOCHA) study assessed safety, acceptability, tolerability, antiviral activity, and pharmacokinetics of these drugs in adolescents with HIV-1. Here we present secondary outcome data up to week 48.METHODSIn this phase 1/2, open-label, non-comparative, dose-finding trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, virologically suppressed (HIV-1 RNA &lt;50 copies per mL) adolescents (aged 12-17 years; weight ≥35 kg) with HIV-1 switched prestudy antiretrovirals to 4 weeks of daily oral 30 mg cabotegravir and 25 mg rilpivirine, followed by 600 mg cabotegravir and 900 mg rilpivirine long-acting intramuscular (3 mL each) injections in the contralateral gluteus medius at week 4 and week 8, and then every 8 weeks. Secondary outcomes assessed here were grade 3 or worse adverse event, virological failure (including HIV-1 RNA ≥50 copies per mL and ≥200 copies per mL per the US Food and Drug Administration snapshot algorithm), and pharmacokinetic measures including cabotegravir and rilpivirine predose concentration assessment. This trial is registered with ClinicalTrials.gov, NCT03497676.FINDINGSBetween July 26, 2021, and Aug 27, 2022, 44 of 55 participants who had participated in cohort 1 and 100 of 115 screened study-naive participants were enrolled into cohort 2 of the study. 74 (51%) of 144 participants were female and 70 (49%) male, median age was 15 years (range 12-17), BMI 19·5 kg/m2 (16·0-34·3), weight 48·5 kg (35·2-100·9). 132 (92%) had vertical HIV acquisition. Of 144 enrolled participants, 142 received at least one injection, 140 completed week 48, and 140 received the expected seven injections through to week 48. Of 142 participants with at least one injection, 48 (34%) experienced injection-site reaction, mostly grade 1 resolving within 7 days. 43 (38%) of 140 participants experienced drug-related adverse events; two experienced grade 3 or worse adverse events (one abscess with pain 3 days after injection; one abscess 6 weeks after injection). The most common drug-related non-injection-site reaction adverse events were headache (three), rash (three), and nausea (two). After week 48, one participant experienced a grade 4 adverse event (anaphylaxis per site; post-injection reaction per Clinical Management Committee) that resolved but led to study drug discontinuation. No virological failures occurred through to week 48. Median week 48 observed predose concentrations were 2·77 μg/mL for cabotegravir (IQR 1·99-3·55) and 67·9 ng/mL for rilpivirine (52·8-82·4), approximating those in adults and exceeding the protein-adjusted IC90 of 0·166 μg/mL and 12 ng/mL, respectively.INTERPRETATIONWeek 48 data from the first virolo","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"269 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145993046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. 长效注射cabotegravil -rilpivirine在青少年HIV-1患者中的可接受性和耐受性(IMPAACT 2017/MOCHA):一项为期48周的多中心、开放标签、非比较1/2期试验结果。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-14 DOI: 10.1016/s2352-3018(25)00241-3
Elizabeth D Lowenthal,Jennifer Chapman,Kristin Baltrusaitis,Grace Kovic,Sanjna Merchant,Kaleb Branch,Chermiqua Tsosie,Martina Zapata Vaca,Barbara Heckman,Rodica M Van Solingen-Ristea,Conn M Harrington,Dwight E Yin,Ellen Townley,Michael Whitton,Allison L Agwu,Christiana Smith,Mary E Paul,Avy Violari,Evette Moodley,Maxensia Owor,Kulkanya Chokephaibulkit,Samantha Fry,Jennifer Jao,Charles D Mitchell,Sarah Buisson,Andi Ace,Irina Kolobova,Carolyn Bolton-Moore,Aditya H Gaur, ,
BACKGROUNDLong-acting cabotegravir and rilpivirine is the first intramuscular injectable antiretroviral treatment regimen recommended for maintenance of virological suppression in adults living with HIV-1. We report acceptability and tolerability outcomes in adolescents during 48 weeks of treatment with this regimen.METHODSIn this analysis of the phase 1/2, multicentre, open-label, non-comparative trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, 144 adolescents (weight ≥35 kg) with HIV-1 were enrolled to receive long-acting intramuscular cabotegravir and rilpivirine and 140 completed 48 weeks of treatment. Participant-reported acceptability and tolerability outcomes were a Faces Scale assessment of pain at each injection, preferred treatment method, and Quality of Life Inventory (PedsQL) at baseline and across 48 weeks of treatment for participants in Botswana, South Africa, Thailand, Uganda, and the USA. USA-based participants completed a Medication Satisfaction Questionnaire (SMSQc-Teen; after week 24), assessing their satisfaction with the all-intramuscular versus their previous oral regimen. A subset of eight adolescents and three parents or caregivers in the USA underwent in-depth interviews after a minimum of 24 weeks on study. This study is registered with ClinicalTrials.gov, NCT03497676.FINDINGSBetween July 26, 2021, and Aug 27, 2022, 44 of 55 adolescents who participated in cohort 1 and 100 of 115 screened study-naive adolescents were enrolled in cohort 2. 70 (49%) participants were male and 74 (51%) were female. 144 adolescents completed study questionnaires; 11 adolescents and parents completed in-depth interviews. At weeks 8, 24, and 48, 138 (97%) of 142, 139 (99%) of 141, and 140 (100%) of 140 participants, respectively, preferred intramuscular injections over oral treatment. Pain was more frequent with intramuscular rilpivirine than with cabotegravir (more pain than "hurts little bit" at all timepoints: 51-62% for rilpivirine vs 12-14% for cabotegravir). Health-related quality of life was high across all timepoints (overall median 94·6 [IQR 84·8-97·8] at baseline vs 93·5 [82·6-97·8] at 48 weeks). The 19 (100%) participants who completed the SMSQc-Teen reported higher satisfaction with the all-intramuscular regimen than with previous oral regimen. In the subset of individuals who underwent in-depth interviews, a prominent theme was reduced stress between parents and adolescents with the initiation of intramuscular antiretrovirals.INTERPRETATIONAcceptability and tolerability of intramuscular cabotegravir-rilpivirine remained high through to 48 weeks of treatment, suggesting that this long-acting intramuscular treatment approach is well received by diverse populations of adolescents with HIV across multiple settings.FUNDINGNational Institutes of Health and ViiV Healthcare.
长效卡博特韦和利匹韦林是推荐用于维持成年HIV-1感染者病毒学抑制的第一种肌内注射抗逆转录病毒治疗方案。我们报告了青少年在48周治疗期间的可接受性和耐受性结果。在博茨瓦纳、南非、泰国、乌干达和美国的18个地点进行的1/2期、多中心、开放标签、非比较试验的分析中,144名患有HIV-1的青少年(体重≥35 kg)入组接受长效卡博特韦和利匹韦林肌注治疗,140名完成了48周的治疗。在博茨瓦纳、南非、泰国、乌干达和美国,参与者报告的可接受性和耐受性结果是每次注射时疼痛的面部量表评估、首选治疗方法和基线和48周治疗期间的生活质量量表(PedsQL)。美国的参与者在24周后完成了一份药物满意度问卷(SMSQc-Teen),评估他们对全肌肉注射与之前口服方案的满意度。在至少24周的研究后,美国的8名青少年和3名父母或照顾者接受了深度访谈。本研究已在ClinicalTrials.gov注册,编号NCT03497676。研究结果:在2021年7月26日至2022年8月27日期间,参加队列1的55名青少年中有44名和115名筛选的研究初期青少年中有100名被纳入队列2。70人(49%)为男性,74人(51%)为女性。144名青少年完成了研究问卷;11名青少年和家长完成了深度访谈。在第8周、第24周和第48周,142人中有138人(97%)、141人中139人(99%)和140人中140人(100%)分别倾向于肌肉注射而不是口服治疗。肌内注射利匹韦林的疼痛比卡博特重力韦更频繁(在所有时间点疼痛比“有点疼”更严重:利匹韦林为51-62%,卡博特重力韦为12-14%)。与健康相关的生活质量在所有时间点都很高(基线时的总体中位数为94.6 [IQR为88.4 - 97.8],而48周时的中位数为93.5[86.2 - 97.8])。完成SMSQc-Teen的19名(100%)参与者报告对全肌肉注射方案的满意度高于先前的口服方案。在接受深度访谈的个体子集中,一个突出的主题是通过开始肌肉注射抗逆转录病毒药物减少父母和青少年之间的压力。在48周的治疗中,肌肉注射cabotegravr -rilpivirine的可接受性和耐受性仍然很高,这表明这种长效肌肉注射治疗方法在不同环境下的青少年艾滋病毒感染者中得到了很好的接受。美国国立卫生研究院和ViiV医疗保健。
{"title":"Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial.","authors":"Elizabeth D Lowenthal,Jennifer Chapman,Kristin Baltrusaitis,Grace Kovic,Sanjna Merchant,Kaleb Branch,Chermiqua Tsosie,Martina Zapata Vaca,Barbara Heckman,Rodica M Van Solingen-Ristea,Conn M Harrington,Dwight E Yin,Ellen Townley,Michael Whitton,Allison L Agwu,Christiana Smith,Mary E Paul,Avy Violari,Evette Moodley,Maxensia Owor,Kulkanya Chokephaibulkit,Samantha Fry,Jennifer Jao,Charles D Mitchell,Sarah Buisson,Andi Ace,Irina Kolobova,Carolyn Bolton-Moore,Aditya H Gaur, , ","doi":"10.1016/s2352-3018(25)00241-3","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00241-3","url":null,"abstract":"BACKGROUNDLong-acting cabotegravir and rilpivirine is the first intramuscular injectable antiretroviral treatment regimen recommended for maintenance of virological suppression in adults living with HIV-1. We report acceptability and tolerability outcomes in adolescents during 48 weeks of treatment with this regimen.METHODSIn this analysis of the phase 1/2, multicentre, open-label, non-comparative trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, 144 adolescents (weight ≥35 kg) with HIV-1 were enrolled to receive long-acting intramuscular cabotegravir and rilpivirine and 140 completed 48 weeks of treatment. Participant-reported acceptability and tolerability outcomes were a Faces Scale assessment of pain at each injection, preferred treatment method, and Quality of Life Inventory (PedsQL) at baseline and across 48 weeks of treatment for participants in Botswana, South Africa, Thailand, Uganda, and the USA. USA-based participants completed a Medication Satisfaction Questionnaire (SMSQc-Teen; after week 24), assessing their satisfaction with the all-intramuscular versus their previous oral regimen. A subset of eight adolescents and three parents or caregivers in the USA underwent in-depth interviews after a minimum of 24 weeks on study. This study is registered with ClinicalTrials.gov, NCT03497676.FINDINGSBetween July 26, 2021, and Aug 27, 2022, 44 of 55 adolescents who participated in cohort 1 and 100 of 115 screened study-naive adolescents were enrolled in cohort 2. 70 (49%) participants were male and 74 (51%) were female. 144 adolescents completed study questionnaires; 11 adolescents and parents completed in-depth interviews. At weeks 8, 24, and 48, 138 (97%) of 142, 139 (99%) of 141, and 140 (100%) of 140 participants, respectively, preferred intramuscular injections over oral treatment. Pain was more frequent with intramuscular rilpivirine than with cabotegravir (more pain than \"hurts little bit\" at all timepoints: 51-62% for rilpivirine vs 12-14% for cabotegravir). Health-related quality of life was high across all timepoints (overall median 94·6 [IQR 84·8-97·8] at baseline vs 93·5 [82·6-97·8] at 48 weeks). The 19 (100%) participants who completed the SMSQc-Teen reported higher satisfaction with the all-intramuscular regimen than with previous oral regimen. In the subset of individuals who underwent in-depth interviews, a prominent theme was reduced stress between parents and adolescents with the initiation of intramuscular antiretrovirals.INTERPRETATIONAcceptability and tolerability of intramuscular cabotegravir-rilpivirine remained high through to 48 weeks of treatment, suggesting that this long-acting intramuscular treatment approach is well received by diverse populations of adolescents with HIV across multiple settings.FUNDINGNational Institutes of Health and ViiV Healthcare.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"144 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145993060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A sustainable future for HIV prevention. 艾滋病毒预防的可持续未来。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/s2352-3018(25)00360-1
The Lancet Hiv
{"title":"A sustainable future for HIV prevention.","authors":" The Lancet Hiv","doi":"10.1016/s2352-3018(25)00360-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00360-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"19 1","pages":"e1"},"PeriodicalIF":16.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145830347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
HIV in Sudan's war: a silent emergency amid a protracted conflict 苏丹战争中的艾滋病毒:长期冲突中无声的紧急情况
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-22 DOI: 10.1016/s2352-3018(25)00374-1
Elbushra Ali Mohamed Herieka, Maisoon Abdalla Mohamed Abdelrahman, Nadia Ahmed, Zahir Osman Eltahir Babiker
{"title":"HIV in Sudan's war: a silent emergency amid a protracted conflict","authors":"Elbushra Ali Mohamed Herieka, Maisoon Abdalla Mohamed Abdelrahman, Nadia Ahmed, Zahir Osman Eltahir Babiker","doi":"10.1016/s2352-3018(25)00374-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00374-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"14 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145814017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Love, loss, and urban disillusionment in dystopian London 反乌托邦伦敦的爱情、失落和城市幻灭
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-20 DOI: 10.1016/s2352-3018(25)00305-4
Talha Burki
{"title":"Love, loss, and urban disillusionment in dystopian London","authors":"Talha Burki","doi":"10.1016/s2352-3018(25)00305-4","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00305-4","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"80 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Standardisation of monitoring routines for new long-acting antiretrovirals in development 正在开发的新型长效抗逆转录病毒药物监测程序的标准化
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-20 DOI: 10.1016/s2352-3018(25)00329-7
Christian Hoffmann, Jürgen K Rockstroh
{"title":"Standardisation of monitoring routines for new long-acting antiretrovirals in development","authors":"Christian Hoffmann, Jürgen K Rockstroh","doi":"10.1016/s2352-3018(25)00329-7","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00329-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"29 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Lancet Hiv
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1