Lancet Hiv最新文献

{"title":"Correction to Lancet HIV 2025; 12: e473-84.","authors":"","doi":"10.1016/S2352-3018(25)00191-2","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00191-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144565426","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}

{"title":"Uzbekistan's progress in HIV care blighted by stigma.","authors":"Ed Holt","doi":"10.1016/S2352-3018(25)00160-2","DOIUrl":"10.1016/S2352-3018(25)00160-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e471-e472"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250471","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}

{"title":"Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults.","authors":"Richard L Wu, Katherine V Houser, Martin R Gaudinski, Alicia T Widge, Seemal F Awan, Cristina A Carter, LaSonji A Holman, Jamie Saunders, Cynthia S Hendel, Aba Eshun, William R Whalen, Xiaolin Wang, Anita Arthur, Jennifer E Cunningham, Allison Beck, Joseph P Casazza, Galina V Yamshchikov, Ro Shauna Rothwell, Larisa Strom, Tejaswi Dittakavi, Myra Happe, Somia P Hickman, Michelle Conan-Cibotti, Kevin Carlton, Lily Zhang, Yunda Huang, Edmund V Capparelli, Mike Castro, Bob C Lin, Sarah O'Connell, Britta S Flach, Robert T Bailer, Sandeep R Narpala, Leonid Serebryannyy, Adrian B McDermott, Frank J Arnold, Jason G Gall, Sandra Vazquez, Nina M Berkowitz, Ingelise J Gordon, Grace L Chen, Peter D Kwong, Jinghe Huang, Theodore C Pierson, Mark Connors, John R Mascola, Tongqing Zhou, Nicole A Doria-Rose, Richard A Koup, Lesia K Dropulic","doi":"10.1016/S2352-3018(25)00041-4","DOIUrl":"10.1016/S2352-3018(25)00041-4","url":null,"abstract":"<p><strong>Background: </strong>Broadly neutralising antibodies (bNAbs) have shown promise as both prevention and treatment strategies against HIV-1. The clinical effectiveness of bNAbs depends on enhancing their neutralisation breadth and extending their serum half-lives. In this study, we aimed to assess the safety, tolerability, pharmacokinetic profile, and neutralisation activity in serum of N6LS, a HIV-1 bNAb.</p><p><strong>Methods: </strong>In this first-in-human, dose-escalation, open-label, phase 1 trial, healthy adult participants (aged 18-50 years) who were HIV-1 negative were recruited to the National Institutes of Health Clinical Center (Bethesda, MD, USA). Three groups received one intravenous administration of N6LS at 5 mg/kg (n=3), 20 mg/kg (n=3), or 40 mg/kg (n=3); one group received one subcutaneous administration of 5 mg/kg N6LS (n=3); two groups received three administrations of either 5 mg/kg subcutaneous (n=5) or 20 mg/kg intravenous (n=5) N6LS every 12 weeks; and two groups received one subcutaneous administration of either 5 mg/kg (n=5) or 20 mg/kg (n=5) N6LS with ENHANZE drug product (EDP), recombinant human hyaluronidase PH20. The primary objectives were the safety and tolerability of N6LS with and without EDP. All participants who received N6LS were included in the primary safety analyses. This trial is registered at ClinicalTrials.gov, NCT03538626, and is complete.</p><p><strong>Findings: </strong>Between June 18, 2018, and April 11, 2022, we enrolled 33 healthy adults (19 female individuals and 14 male individuals). One participant did not receive N6LS and one participant was lost to follow-up after 8 weeks. N6LS had an encouraging safety profile similar to other HIV-1 bNAbs, with no serious adverse events. Local reactogenicity was observed after administration of N6LS, with the most common symptom being mild to moderate injection site pain or tenderness in subcutaneous groups, reported in six of eight participants. All ten participants who received N6LS with EDP had mild to severe injection site erythema, which, despite being graded as severe in size, was generally not noticed by participants or deemed bothersome, and resolved without intervention. Systemic reactogenicity was mild in all groups. N6LS had an overall mean serum half-life of 48·6 days and retained its broad and potent neutralisation characteristics in serum. EDP administration increased N6LS bioavailability. No functional anti-drug antibodies to N6LS were detected following administration.</p><p><strong>Interpretation: </strong>N6LS showed a promising safety and pharmacokinetics profile while retaining its potent neutralisation characteristics in serum, making it a promising candidate for inclusion in HIV-1 prevention and therapeutic combination strategies. The addition of EDP can enable safe subcutaneous administration of higher doses and larger volumes of N6LS, supporting additional methods for prophylactic and therapeutic bNAb administration.</p><p><s","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e485-e495"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of antiretrovirals on major adverse cardiovascular events in the REPRIEVE trial: a longitudinal cohort analysis.","authors":"Carl J Fichtenbaum, Carlos D Malvestutto, Maya G Watanabe, Emma Davies Smith, Heather J Ribaudo, Sara McCallum, Kathleen V Fitch, Judith S Currier, Marissa R Diggs, Sarah M Chu, Judith A Aberg, Michael T Lu, Javier Valencia, Cristina Gómez-Ayerbe, Indira Brar, Jose Valdez Madruga, Gerald S Bloomfield, Pamela S Douglas, Markella V Zanni, Steven K Grinspoon","doi":"10.1016/S2352-3018(25)00043-8","DOIUrl":"10.1016/S2352-3018(25)00043-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In the REPRIEVE trial of statin therapy in people with HIV, pitavastatin reduced major adverse cardiovascular events (MACE) among those with low-to-moderate risk of cardiovascular disease (CVD). We aimed to investigate associations between former and current use of antiretroviral therapy (ART) on entry into the REPRIEVE trial and the development of MACE.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This longitudinal cohort analysis was a prespecified secondary analysis of the REPRIEVE trial, a double-blind, placebo-controlled, multicentre, phase 3 randomised trial conducted at 137 sites in 12 countries. REPRIEVE enrolled people with HIV aged 40-75 years, currently on ART, with a CD4 count of more than 100 cells per μL and low-to-moderate CVD risk, and randomly assigned them to receive pitavastatin or placebo. For this secondary analysis, participants' history of ART use, including lifetime exposure to selected agents, was collected at baseline. The primary outcome of interest was time-to-first MACE. Stratified Cox proportional hazards models were used to estimate the relative hazards of MACE associated with ART exposures. Effects of no previous exposure, former exposure, and current exposure to ART at entry to the study were compared using models unadjusted and adjusted for entry risk factors and ART regimen at entry. All analyses were conducted in the intention-to-treat population. The REPRIEVE trial is registered at ClinicalTrials.gov, NCT02344290, and is complete.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between March 26, 2015, and July 31, 2019, 7769 participants were enrolled into the REPRIEVE trial. 2419 (31·1%) of 7769 participants were assigned female at birth and 5350 (68·9%) were assigned male at birth. 3208 (41·3%) of 7769 participants were Black or African American, 2704 (34·8%) were White, 1138 (14·6%) were Asian, and 719 (9·3%) were of other races. Participants had a median age of 50·0 years (IQR 45·0-55·0), LDL cholesterol concentration of 106 mg/dL (86-128), 10-year atherosclerotic cardiovascular disease risk score of 4·5% (2·1-7·0), and CD4 cell count of 621 cells per μL (448-827). 5867 (97·8%) of 5997 participants for whom data on this measure were available had an HIV-1 viral load of less than 400 copies per mL. The median duration of ART use at entry was 9·6 years (5·3-14·8). Overall, 1702 (21·9%) of 7769 participants reported previous exposure to abacavir, 6681 (86·0%) to tenofovir disoproxil fumarate, 3832 (49·3%) to thymidine analogues (zidovudine or stavudine), and 3683 (47·4%) to protease inhibitors. At study entry, 984 (12·6%) participants were using abacavir, 4743 (61·0%) were using tenofovir disoproxil fumarate, 756 (9·7%) were using thymidine analogues, and 1990 (25·6%) were using protease inhibitors. In adjusted analyses, former exposure (hazard ratio 1·62, 95% CI 1·14-2·30) and current exposure (1·41, 1·01-1·96) to abacavir was associated with a higher hazard of MACE than in participants who were never ex","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e496-e505"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12244172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maintenance therapy with dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV (PASO-DOBLE): 48-week results from a randomised, multicentre, open-label, non-inferiority trial.","authors":"Pablo Ryan, José L Blanco, Mar Masia, Lucio Garcia-Fraile, Maria J Crusells, Pere Domingo, Adrian Curran, Roberto Guerri-Fernandez, Enrique Bernal, Joaquin Bravo, Boris Revollo, Juan Macias, Juan M Tiraboschi, Rocio Montejano, Concepción Amador, Miguel Torralba, Dolores Merino, Vicens Diaz-Brito, M J Galindo, Sergio Ferra, Aroa Villoslada, Juan Emilio Losa, Francisco J Fanjul, Xavier Perez-Stachowski, Joaquim Peraire, Joaquin Portilla, Sara de la Fuente, Carlos Dueñas, Maria J Vazquez, Silvana Di Gregorio, Herminia Esteban, Pedro Gil, Marta de Miguel, Belen Alejos, Esteban Martínez","doi":"10.1016/S2352-3018(25)00105-5","DOIUrl":"10.1016/S2352-3018(25)00105-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Although single-tablet, oral bictegravir, emtricitabine, and tenofovir alafenamide or dolutegravir and lamivudine are preferred regimens in several major guidelines and are widely used in many countries, they have not been compared in a fully powered trial. This study aimed to prospectively compare the 48-week results of dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide as maintenance therapies for people with HIV.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;PASO-DOBLE is a randomised, multicentre, open-label, non-inferiority trial done over 48 weeks at 30 sites in Spain. Adults (aged ≥18 years) with HIV-1, without previous viral failure, who had reached virological suppression on oral regimens containing at least one pill a day, cobicistat, efavirenz, or tenofovir disoproxil fumarate and no previous use of dolutegravir or bictegravir, and plasma HIV-1 RNA &lt;50 copies per mL for at least 24 weeks were eligible. Participants were randomly assigned (1:1) to switch regimens to dolutegravir 50 mg and lamivudine 300 mg or bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg once daily, using random block permutation, stratified by tenofovir alafenamide presence at baseline and sex assigned at birth. The primary endpoint was the proportion of participants with HIV RNA ≥50 copies per mL at week 48 in the intention-to-treat exposed population (ie, all participants who received at least one dose of study medication). The primary and safety analysis was done in the intention-to-treat exposed population. The non-inferiority margin was 4%. This trial is registered with ClinicalTrials.govNCT04884139 and is incomplete.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between July 14, 2021, and March 24, 2023, 553 participants initiated dolutegravir and lamivudine (n=277) or bictegravir, emtricitabine, and tenofovir alafenamide (n=276). The difference in the proportion of participants with HIV RNA ≥50 copies per mL between the dolutegravir and lamivudine group (six [2%] of 277) and bictegravir, emtricitabine, and tenofovir alafenamide group (two [1%] of 276) was 1·4% (95% CI -0·5 to 3·4; p=0·16), showing non-inferiority. The most common adverse events occurring in at least 10% of participants in either group were infections, musculoskeletal, gastrointestinal, metabolic, and psychiatric events. Adverse events were usually mild or moderate and considered unrelated to the study drugs. More grade 3-4 adverse events occurred in the bictegravir group (ten [3%]) than in the dolutegravir group (three [1%]; p=0·049). Very few participants discontinued dolutegravir and lamivudine (n=1) or bictegravir, emtricitabine, and tenofovir alafenamide (n=2) due to adverse events. There were no deaths in either group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;These results provide further evidence that might be useful in shared decision-making between physicians and people living with HIV regarding switching oral antiretrov","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e473-e484"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259166","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}

{"title":"The future of HIV diagnostics: an exemplar in infectious diseases.","authors":"Nitika Pant Pai, Rigveda Kadam, Ilesh Jani, George Alemnji, Ruslan Malyuta, Trevor Peter","doi":"10.1016/S2352-3018(25)00078-5","DOIUrl":"10.1016/S2352-3018(25)00078-5","url":null,"abstract":"<p><p>Over the past 40 years, diagnostics have become the backbone of HIV prevention, treatment, and retention in care, and are central to the achievement of UNAIDS 95-95-95 targets. Over the next decade, the global HIV response will face difficult challenges. In addition to sustaining gains achieved in prevention and treatment, substantial gaps in care need to be addressed for underserved populations. Diagnostics will play an important role in control and prevention of HIV infection through novel technologies, digital solutions, and integrated service delivery innovations. The integration of diagnostics with digital health, machine learning, and generative artificial intelligence provides opportunities for more effective individual and public health disease control. These diagnostics and other futuristic innovations such as wearable technologies, omics, metaverse-based solutions, and quantum diagnostics could enable the achievement of the UNAIDS 95-95-95 targets; however, their use will face barriers related to health-care system financing, infrastructure, technological readiness and skills, and long-term sustainability. This Review highlights diagnostic strategies and innovations that could catalyse a new era in the management of the HIV pandemic.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e522-e531"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144053635","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}

{"title":"How can Africa sustain its HIV response amid US aid cuts?","authors":"Wilbroad Mutale, Aggrey Semeere, Elizabeth A Bukusi, Dike Ojji, Francois Venter, Thomas Odeny, Roma Chilengi, Mosepele Mosepele, Elvin Geng, Izukanji Sikazwe, Samuel Bosomprah, Llyod Mulenga, Fred Simitala","doi":"10.1016/S2352-3018(25)00071-2","DOIUrl":"10.1016/S2352-3018(25)00071-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e468-e470"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694136","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}

{"title":"Antiretroviral therapy and obesity risk: a weighty question.","authors":"Jennifer Manne-Goehler, Nomathemba Chandiwana","doi":"10.1016/S2352-3018(25)00157-2","DOIUrl":"10.1016/S2352-3018(25)00157-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e464-e465"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259165","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}

{"title":"Time to say farewell to abacavir?","authors":"Laura Waters, Nicola Mackie","doi":"10.1016/S2352-3018(25)00123-7","DOIUrl":"10.1016/S2352-3018(25)00123-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e467-e468"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250470","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}

{"title":"Expanding PrEP treatment options with a potent anti-HIV antibody.","authors":"Giacomo Schmidt Frattari, Ole Schmelz Søgaard","doi":"10.1016/S2352-3018(25)00072-4","DOIUrl":"10.1016/S2352-3018(25)00072-4","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e465-e467"},"PeriodicalIF":12.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144133323","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}