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Dolutegravir in neonates: finally we are getting there! 新生儿使用多替格拉韦:我们终于实现了目标!
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-08 DOI: 10.1016/s2352-3018(25)00274-7
Kimesh Loganathan Naidoo,Moherndran Archary
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引用次数: 0
Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial. 多替格拉韦分散片和口服薄膜在南非暴露于HIV的足月新生儿中的安全性和药代动力学(PETITE-DTG研究):一项开放标签、随机、1/2期试验。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-08 DOI: 10.1016/s2352-3018(25)00239-5
Adrie Bekker,Nicolas Salvadori,Helena Rabie,Samantha du Toit,Kanchana Than-In-At,Maria Groenewald,Shaun Barnabas,Lindee Ganger,Thanchanok Luangcharoenkul,Sirikanya Pingkarawat,Edmund V Capparelli,Andrew Owen,Ratchada Cressey,Samantha Fry,Geraldine Le Roux,Yardpiroon Tawon,Jutatip Kaewmalee,Thamonphat Phitak,Marc Lallemant,Mark F Cotton,Tim R Cressey
{"title":"Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial.","authors":"Adrie Bekker,Nicolas Salvadori,Helena Rabie,Samantha du Toit,Kanchana Than-In-At,Maria Groenewald,Shaun Barnabas,Lindee Ganger,Thanchanok Luangcharoenkul,Sirikanya Pingkarawat,Edmund V Capparelli,Andrew Owen,Ratchada Cressey,Samantha Fry,Geraldine Le Roux,Yardpiroon Tawon,Jutatip Kaewmalee,Thamonphat Phitak,Marc Lallemant,Mark F Cotton,Tim R Cressey","doi":"10.1016/s2352-3018(25)00239-5","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00239-5","url":null,"abstract":"BACKGROUNDDolutegravir is not recommended for neonates (age 28 days or younger) due to the absence of dosing guidelines and safety information. We evaluated the multidose pharmacokinetics and safety of two paediatric dolutegravir formulations in neonates: a scored dispersible tablet and a novel oral dispersible film.METHODSWe did a phase 1/2, open-label, single-centre, two-stage, randomised trial in neonates at Tygerberg Hospital, South Africa, who were born at term (≥37 weeks gestational age, birthweights ≥2 kg) to pregnant women on dolutegravir-based antiretroviral therapy. Neonates in stage two were randomly assigned (1:1) to receive 5 mg dolutegravir either as half of a scored dispersible tablet (10 mg) or one oral dispersible film (5 mg), administered every 48 h for the first 2 weeks of life, followed by daily up to day 28 of life. Plasma pharmacokinetic samples were collected during three visits: at entry (before and 1-3 h after the first dolutegravir dose); at any time from the third dolutegravir dose but before week 4 of life (before and 1, 2, 4, 6, and 48 h after the dolutegravir dose); and during week 4 of life (before and 1-3 h after the dolutegravir dose). The primary outcomes were dolutegravir pharmacokinetic parameters of area under the concentration time curve (AUC), maximum plasma concentration (Cmax), apparent clearance (CL/F), and trough concentration (Ctrough) in participants who completed intensive pharmacokinetic sampling and occurrence of non-treatment-related and treatment-related adverse events of grade 3 or higher and any adverse events in participants who received at least one dose of dolutegravir. Target pharmacokinetic criteria were geometric mean Ctrough higher than 0·67 μg/mL and individual Cmax lower than 17·0 μg/mL. The trial is registered with ClinicalTrials.gov, NCT05590325.FINDINGSBetween Sept 15, 2023, and Nov 6, 2024, 41 neonates were enrolled, randomly assigned, and received dolutegravir (21 [51%] received dispersible tablets and 20 [49%] received dolutegravir films); 25 (61%) neonates were male and 16 (39%) were female. Median birthweight was 3235 g (range 2365-4330) and the first dolutegravir dose was administered at median 47 h (range 22-78) after birth. Intensive dolutegravir pharmacokinetic profiles sampled after at least three doses of dolutegravir (range 6-10 days of life) were similar between the dolutegravir dispersible tablet and the dolutegravir film and the dolutegravir geometric mean area under the concentration time curve (AUC0-48), and CL/F were 193·2 μg x h/mL and 0·026 L/h, respectively. Both formulations attained a dolutegravir geometric mean Ctrough higher than 0·67 μg/mL. All neonates had a dolutegravir Cmax lower than 17·0 μg/mL at every pharmacokinetic visit. No adverse events were related to dolutegravir. Two grade 3 adverse events, the highest severity observed, occurred in one neonate with pneumonia. A total of 22 adverse events occurred in 12 (57%) of the 21 neonates receiving dolute","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"105 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145261628","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-related outcomes among migrants living in Europe compared with the general population: a systematic review and meta-analysis. 生活在欧洲的移民与一般人群的hiv相关结果的比较:系统回顾和荟萃分析。
IF 13 1区 医学
Lancet Hiv Pub Date : 2025-10-06 DOI: 10.1016/S2352-3018(25)00301-7
Francesco Vladimiro Segala, Francesco Di Gennaro, Luisa Frallonardo, Elda De Vita, Valentina Petralia, Vitalba Sapienza, Stefano Di Gregorio, Mariangela Cormio, Roberta Novara, Giuseppina Rizzo, Mario Barbagallo, Nicola Veronese, Annalisa Saracino
{"title":"HIV-related outcomes among migrants living in Europe compared with the general population: a systematic review and meta-analysis.","authors":"Francesco Vladimiro Segala, Francesco Di Gennaro, Luisa Frallonardo, Elda De Vita, Valentina Petralia, Vitalba Sapienza, Stefano Di Gregorio, Mariangela Cormio, Roberta Novara, Giuseppina Rizzo, Mario Barbagallo, Nicola Veronese, Annalisa Saracino","doi":"10.1016/S2352-3018(25)00301-7","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00301-7","url":null,"abstract":"<p><strong>Background: </strong>Compared with the general population, international migrants arriving in Europe face severe socioeconomic challenges that result in higher HIV prevalence and limited access to health care, potentially leading to negative outcomes. In this systematic review and meta-analysis, we aimed to investigate the incidence of HIV-related outcomes among international migrants arriving in Europe compared with the incidence among the general population.</p><p><strong>Methods: </strong>We did a systematic review and meta-analysis to identify studies investigating HIV-related outcomes in migrants and the general population living with HIV in Europe. Six authors (EDV, VP, VS, SDG, MC, and RN) independently searched PubMed, Scopus, and Web of Science from database inception until July 22, 2023 (with an update on March 3, 2024), then screened titles and abstracts of all potentially eligible articles. Studies were included if they were observational studies; investigated clinical, virological, or immunological outcomes in migrants living with HIV; were conducted in Europe; had at least one control group of non-migrants living in a European country; and were in English. Titles and abstracts were screened for eligibility followed by a full-text assessment by two authors (EDV, VP, VS, SDG, MC, or RN). Data were extracted from articles using a structured Redcap form. Primary outcomes of our systematic review were (1) mortality, (2) AIDS-defining condition, (3) combined outcome of AIDS or death, (4) treatment discontinuation, (5) rate of loss to follow-up, (6) virological failure, and (7) immunological failure. Data were reported as relative risks (RRs) or odds ratios with their 95% CIs. The study is registered with PROSPERO, CRD42024501191.</p><p><strong>Findings: </strong>Of the 1316 articles identified (1297 in the initial search and 19 in the updated search), 18 were included in our systematic review, consisting of 104 597 participants who were followed up for a mean of 86·6 months. The meta-analysis, adjusted for potential confounders, showed that migrants present similar mortality risk (RR 0·88, 95% CI 0·75-1·04), but higher risk for AIDS-defining conditions (1·21, 1·11-1·31), treatment discontinuation (2·39, 1·49-3·29), loss to follow-up (2·53, 1·41-4·53), and virological failure (1·93, 1·34-2·52) compared with the general population. Subanalyses for WHO regions showed that risk was driven mainly by migrants from the African region.</p><p><strong>Interpretation: </strong>Compared with the non-migrant population, migrants living in Europe with HIV face higher risks for progression to AIDS, loss to follow-up, treatment discontinuation, and virological failure. Interventions aimed to improve HIV care among migrants living in Europe are urgently needed.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145259768","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
Retraction and republication-HIV-related outcomes among migrants living in Europe compared with the general population: a systematic review and meta-analysis. 与一般人群相比,生活在欧洲的移民撤回和共和与hiv相关的结果:一项系统回顾和荟萃分析。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-06 DOI: 10.1016/s2352-3018(25)00300-5
The Lancet Hiv Editors
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引用次数: 0
Correction to Lancet HIV 2024; 11: e793-94. 《柳叶刀HIV 2024》修正;11: e793 - 94。
IF 13 1区 医学
Lancet Hiv Pub Date : 2025-10-06 DOI: 10.1016/S2352-3018(25)00298-X
{"title":"Correction to Lancet HIV 2024; 11: e793-94.","authors":"","doi":"10.1016/S2352-3018(25)00298-X","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00298-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145259728","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
Iconic AIDS memorial on show. 标志性的艾滋病纪念馆展出。
IF 13 1区 医学
Lancet Hiv Pub Date : 2025-10-01 Epub Date: 2025-07-30 DOI: 10.1016/S2352-3018(25)00220-6
Talha Burki
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引用次数: 0
The imperative for increased investment for an HIV cure. 增加艾滋病治疗投资的必要性。
IF 13 1区 医学
Lancet Hiv Pub Date : 2025-10-01 Epub Date: 2025-07-22 DOI: 10.1016/S2352-3018(25)00193-6
Remko van Leeuwen, Françoise Barré-Sinoussi, Michaela Müller-Trutwin, Asier Sáez-Cirión, Monique Nijhuis, Sharon R Lewin, Thumbi Ndung'u, Florence Riako-Anam, Mitchell Warren, Izukanji Sikazwe, Birgit Poniatowski, Beatriz Grinsztejn, Cissy Kityo, Masen Davis, Ole S Søgaard, Marcus Altfeld, Javier Martinez-Picado, Linos Vandekerckhove, Andrea Gramatica, Devin Sok, Simon Collins, Yazdan Yazdanpanah
{"title":"The imperative for increased investment for an HIV cure.","authors":"Remko van Leeuwen, Françoise Barré-Sinoussi, Michaela Müller-Trutwin, Asier Sáez-Cirión, Monique Nijhuis, Sharon R Lewin, Thumbi Ndung'u, Florence Riako-Anam, Mitchell Warren, Izukanji Sikazwe, Birgit Poniatowski, Beatriz Grinsztejn, Cissy Kityo, Masen Davis, Ole S Søgaard, Marcus Altfeld, Javier Martinez-Picado, Linos Vandekerckhove, Andrea Gramatica, Devin Sok, Simon Collins, Yazdan Yazdanpanah","doi":"10.1016/S2352-3018(25)00193-6","DOIUrl":"10.1016/S2352-3018(25)00193-6","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e671-e673"},"PeriodicalIF":13.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144718935","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
The impact of cuts in the US President's Emergency Plan for AIDS Relief funding for HIV pre-exposure prophylaxis in sub-Saharan Africa: a modelling study. 削减美国总统艾滋病紧急救援计划对撒哈拉以南非洲艾滋病毒暴露前预防的供资的影响:一项模拟研究。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-01 DOI: 10.1016/s2352-3018(25)00192-4
Jack Stone,Kennedy Kipkoech Mutai,Adelina Artenie,Romain Silhol,Marie-Claude Boily,Jirair Ratevosian,Chris Beyrer,Peter Vickerman
{"title":"The impact of cuts in the US President's Emergency Plan for AIDS Relief funding for HIV pre-exposure prophylaxis in sub-Saharan Africa: a modelling study.","authors":"Jack Stone,Kennedy Kipkoech Mutai,Adelina Artenie,Romain Silhol,Marie-Claude Boily,Jirair Ratevosian,Chris Beyrer,Peter Vickerman","doi":"10.1016/s2352-3018(25)00192-4","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00192-4","url":null,"abstract":"BACKGROUNDIn January, 2025, the US Government issued a directive, pausing all foreign aid programmes. This directive included a 90-day pausing of all US President's Emergency Plan for AIDS Relief (PEPFAR) funding for HIV oral pre-exposure prophylaxis (PrEP) except for pregnant and breastfeeding women, with a return to funding for PrEP looking increasingly unlikely. We aimed to estimate the impact of a funding pause for PrEP on HIV infections in sub-Saharan Africa.METHODSIn this mathematical modelling study, we developed a static HIV transmission model incorporating PrEP, parameterised with estimates of population size, HIV prevalence and incidence, and PrEP effectiveness for different subpopulations (including key populations) in each PEPFAR-funded sub-Saharan African country. Key populations were men who have sex with men, female sex workers, transgender women, and people who inject drugs. We used PEPFAR reporting on numbers of people in different subpopulations returning for oral PrEP for each country in July to September, 2024, as the estimated number using oral PrEP provided by PEPFAR. For each country and subpopulation, we modelled the relative and absolute increase in new primary HIV infections resulting from removing this funded PrEP for a year and the number of secondary infections that could result from these primary infections during the next 5 years.FINDINGSTowards the end of 2024, 719 384 individuals who were not breastfeeding or pregnant, including 205 868 people from key populations, received PEPFAR-funded PrEP across 28 sub-Saharan African countries. The estimated proportion of HIV-negative key population individuals receiving PEPFAR-funded PrEP (ie, the coverage) ranged from 2·6% (95% uncertainty interval 2·0-3·4) in people who inject drugs to 5·0% (4·5-5·9) in female sex workers. Estimated coverage among non-key population men was less than 0·1% (&lt;0·1 to &lt;0·1) and in women was 0·1% (0·1 to 0·1). Stopping PEPFAR's provision of PrEP for a year could lead to 6671 (5032-8192) additional new primary HIV infections, including 5663 (4146-7074) in key populations. Within key populations, this absolute increase corresponds to relative increases in new HIV infections of 0·8% (0·3-1·5) in people who inject drugs, 1·4% (0·8-2·3) in transgender women, 2·2% (1·3-3·0) in men who have sex with men, and 2·9% (1·8-4·4) in female sex workers. In Zambia, the country with the highest PEPFAR coverage across all key populations, this increase ranges from 7·8% (2·5-17·1) in people who inject drugs to 18·1% (9·7-33·2) in men who have sex with men. When considering secondary transmissions, we estimated that a 1-year pause could lead to 10 313 (7796-12 921) additional infections during the next 5 years.INTERPRETATIONOur projections show the substantial detrimental impacts that cuts to PEPFAR funding could have. Mitigation measures, including funding through alternative international donors or domestic government budgets, are needed to maintain and increase","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"26 1","pages":"e712-e721"},"PeriodicalIF":16.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145215614","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
The promise and paradox of HIV self-testing in the era of twice-yearly PrEP. 在每年两次的PrEP时代,HIV自我检测的希望与矛盾。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-01 DOI: 10.1016/s2352-3018(25)00263-2
Victor Abiola Adepoju,Abdulrakib Abdulrahim,Shankar Biswas
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引用次数: 0
Russia spiralling into an HIV crisis. 俄罗斯陷入了艾滋病危机。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2025-10-01 DOI: 10.1016/s2352-3018(25)00272-3
The Lancet Hiv
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引用次数: 0
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