Lancet HivPub Date : 2026-07-01Epub Date: 2026-06-19DOI: 10.1016/S2352-3018(26)00150-5
The Lancet Hiv
{"title":"Global HIV response requires global political support.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(26)00150-5","DOIUrl":"10.1016/S2352-3018(26)00150-5","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e429"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284216","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}
Lancet HivPub Date : 2026-07-01Epub Date: 2026-05-26DOI: 10.1016/S2352-3018(26)00052-4
Wendy P Bannister, Joanne Reekie, Lars Peters, Cristiana Oprea, Raimonda Matulionytė, Marie-Angélique De Scheerder, Alina Kryshchuk, Line Dahlerup Rasmussen, Fiona Burns, Kai Zilmer, Elżbieta Jablonowska, Christoph Boesecke, Alexandra Zagalo, Esteban Martinez, Marcel Stoeckle, János Szlávik, Jasna Topalovic Cetkovic, Georgios Adamis, Justyna D Kowalska, Daria Podlekareva
{"title":"Trends in AIDS-defining illnesses among people living with HIV in clinical care in Europe: results from the EuroSIDA multicentre cohort study (2003-24).","authors":"Wendy P Bannister, Joanne Reekie, Lars Peters, Cristiana Oprea, Raimonda Matulionytė, Marie-Angélique De Scheerder, Alina Kryshchuk, Line Dahlerup Rasmussen, Fiona Burns, Kai Zilmer, Elżbieta Jablonowska, Christoph Boesecke, Alexandra Zagalo, Esteban Martinez, Marcel Stoeckle, János Szlávik, Jasna Topalovic Cetkovic, Georgios Adamis, Justyna D Kowalska, Daria Podlekareva","doi":"10.1016/S2352-3018(26)00052-4","DOIUrl":"10.1016/S2352-3018(26)00052-4","url":null,"abstract":"<p><strong>Background: </strong>Despite substantial declines in AIDS-defining illnesses following implementation of treat-all policies across Europe, these conditions remain a substantial cause of morbidity and mortality among people with HIV. This study aimed to describe temporal trends in AIDS-defining illnesses across Europe, including trends in the incidences of specific illnesses, and to investigate associated risk factors.</p><p><strong>Methods: </strong>Adults with HIV in clinical care were enrolled consecutively at 113 collaborating clinics in EuroSIDA, a prospective longitudinal cohort study, with data collected annually from routine clinical visits. Participants under follow-up in the WHO European region during 2003-24 were included in analyses. AIDS-defining illnesses were defined using the clinical conditions from the US Centers for Disease Control 1993 AIDS case definition. AIDS-related deaths were identified using the Coding Causes of Death in HIV methodology. In the primary analysis, we included all initial AIDS-defining illnesses that occurred during prospective follow-up, with follow-up censored after diagnosis of an AIDS-defining illness. Incidence rates of AIDS-defining illnesses and AIDS-related deaths were calculated as number of events per 1000 person-years of follow-up. Multivariable Poisson regression was used to compare incidence of AIDS-defining illnesses across regions, calendar time periods, and clinical and demographic factors.</p><p><strong>Findings: </strong>22 119 adults with HIV who contributed follow-up between Jan 1, 2003, and Dec 31, 2024 (16 086 [72·7%] male and 6017 [27·2%] female participants, median age 41 years [IQR 34-49]) were included in this cohort. 4787 (21·6%) participants were in southern Europe, 4866 (22·0%) were in central-western Europe, 3925 (17·7%) were in northern Europe, 3090 (13·9%) were in central-eastern Europe, and 5451 (24·6%) were in eastern Europe. During 222 402 person-years of follow-up, 1705 (7·7%) participants had at least one AIDS-defining illness, including 480 (28·2%) who died of an AIDS-related cause. The overall incidence rate of initial AIDS-defining illnesses was 7·7 per 1000 person-years of follow-up (95% CI 7·3-8·0). The incidence of AIDS-defining illnesses declined across all regions, with the largest absolute decline observed in eastern Europe, where the incidence rate fell from 115·1 (75·8-174·9) per 1000 person-years of follow-up in 2003 to 15·7 (10·5-23·4) per 1000 person-years of follow-up in 2013. In multivariable analysis, the incidence rate ratio of AIDS-defining illnesses over the observation period was 2·59 (95% CI 2·13-3·15) in eastern Europe versus central-western Europe. Other factors associated with AIDS-defining illnesses were HIV acquisition via injecting drug use, CD4 count less than 500 cells per μL, more recent CD4 cell nadir, interrupted or discontinued antiretroviral therapy (ART), previous AIDS-defining illnesses, non-AIDS-defining malignancies, and ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e465-e477"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148036693","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}
Lancet HivPub Date : 2026-07-01Epub Date: 2026-02-25DOI: 10.1016/S2352-3018(26)00033-0
Jürgen K Rockstroh, Sheetal Kassim, Roger Paredes, Christopher Bettacchi, Gary Sinclair, Anchalee Avihingsanon, Nelly Mugo, Jean-Michel Molina, Brenda Crabtree Ramírez, Hiroyuki Gatanaga, Yayun Xu, Stephanie O Klopfer, Tracy L Diamond, Mary Vesnesky, Luisa M Stamm, Michelle C Fox, Mary L Pisculli
{"title":"Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial.","authors":"Jürgen K Rockstroh, Sheetal Kassim, Roger Paredes, Christopher Bettacchi, Gary Sinclair, Anchalee Avihingsanon, Nelly Mugo, Jean-Michel Molina, Brenda Crabtree Ramírez, Hiroyuki Gatanaga, Yayun Xu, Stephanie O Klopfer, Tracy L Diamond, Mary Vesnesky, Luisa M Stamm, Michelle C Fox, Mary L Pisculli","doi":"10.1016/S2352-3018(26)00033-0","DOIUrl":"10.1016/S2352-3018(26)00033-0","url":null,"abstract":"<p><strong>Background: </strong>Doravirine and islatravir is a two-drug regimen being investigated for the treatment of HIV-1. This study evaluated efficacy and safety of once daily doravirine and islatravir versus bictegravir, emtricitabine, and tenofovir alafenamide in adults with HIV-1 who were treatment-naive.</p><p><strong>Methods: </strong>MK-8591A-053 is a phase 3, randomised, double-blind, active-controlled, non-inferiority study being done at 116 research, community, and hospital-based clinics across 20 countries. Adults aged at least 18 years with HIV-1 RNA of 500 copies per mL or more never previously treated for HIV-1 were randomly assigned (1:1), stratified by screening HIV-1 RNA viral load and CD4-cell count, to received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily. The primary endpoint was percentage of participants with HIV-1 RNA less than 50 copies per mL at week 48 (FDA snapshot; prespecified non-inferiority margin -10%). Participants who received at least one dose of study intervention were analysed for safety. This trial is ongoing and is registered with ClinicalTrials.govNCT05705349.</p><p><strong>Findings: </strong>We screened 756 participants for eligibility between March 8, 2023, and Oct 11, 2024. 269 participants were treated with doravirine-islatravir and 267 with bictegravir-emtricitabine-tenofovir. The last study visit for this analysis occurred on Oct 13, 2025. Median age was 32 years (IQR 26-40), 134 (25%) participants were assigned female at birth, 225 (42%) were White, 92 (17%) had CD4 counts less than 200 cells per μL, 197 (37%) had an HIV-1 RNA greater than 100 000 copies per mL, and 314 (59%) had pre-existing resistance-associated mutations. At week 48, doravirine-islatravir was non-inferior to bictegravir-emtricitabine-tenofovir: 247 (91·8%) of 269 versus 242 (90·6%) of 267 had HIV-1 RNA less than 50 copies per mL (estimated difference 1·2%, 95% CI -3·7 to 6·2). Mean increase in CD4 count was 218 cells per μL in the doravirine-islatravir group and 226 cells per μL in the bictegravir-emtricitabine-tenofovir group (estimated difference -6·8, 95% CI -35·8 to 22·2). Two participants in the doravirine-islatravir group and one in the bictegravir-emtricitabine-tenofovir group with pretreatment HIV-1 RNA greater than 1 million copies per mL and CD4 counts less than 200 cells per μL acquired treatment-emergent mutations. Phenotypic analysis revealed resistance to doravirine in two participants treated with doravirine-islatravir. 38 (14%) of 269 participants in the doravirine-islatravir group and 48 (18%) of 267 in the bictegravir-emtricitabine-tenofovir group had treatment-related adverse events: the most common were increased weight (7, 3%), headache (6, 2%), and dizziness (5, 2%) in the doravirine-islatravir group and increased weight (9, 3%), headache (9, 3%), and decreased estimated glomerular filtration rate (","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e440-e451"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322359","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}
Lancet HivPub Date : 2026-07-01Epub Date: 2026-05-08DOI: 10.1016/S2352-3018(26)00105-0
Irma Kirtadze, Lynn M Madden, David Otiashvili, David Oliveros, Tamar Mgebrishvili, Mariam Sherozia, Frederick L Altice
{"title":"Drug policy changes threaten HIV and HCV control in Georgia.","authors":"Irma Kirtadze, Lynn M Madden, David Otiashvili, David Oliveros, Tamar Mgebrishvili, Mariam Sherozia, Frederick L Altice","doi":"10.1016/S2352-3018(26)00105-0","DOIUrl":"10.1016/S2352-3018(26)00105-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e430-e431"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876170","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}
Lancet HivPub Date : 2026-07-01Epub Date: 2026-05-14DOI: 10.1016/S2352-3018(26)00117-7
Talha Burki
{"title":"The Soviet response to the AIDS crisis.","authors":"Talha Burki","doi":"10.1016/S2352-3018(26)00117-7","DOIUrl":"10.1016/S2352-3018(26)00117-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e439"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943396","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}
Lancet HivPub Date : 2026-07-01DOI: 10.1016/s2352-3018(26)00121-9
Eleanor J Ong,Rena Janamnuaysook,Danvic Rosadiño,Rayner Kay Jin Tan
{"title":"Risk of donor-driven stigma in scale-up of long-acting PrEP.","authors":"Eleanor J Ong,Rena Janamnuaysook,Danvic Rosadiño,Rayner Kay Jin Tan","doi":"10.1016/s2352-3018(26)00121-9","DOIUrl":"https://doi.org/10.1016/s2352-3018(26)00121-9","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"39 1","pages":"e436"},"PeriodicalIF":16.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148365369","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}
Lancet HivPub Date : 2026-07-01Epub Date: 2026-05-11DOI: 10.1016/S2352-3018(25)00356-X
Sharana Mahomed, Carmen A Paez, Yunda Huang, Kelly E Seaton, Chenchen Yu, Kevin Gillespie, Maurine D Miner, Shelly T Karuna, Theresa Gamble, Jack Heptinstall, Elize Domin, Haili Tang, Lu Zhang, Fei Gao, Margaret Yacovone, Hans M L Spiegel, Julie Dumond, Maija A Anderson, Estelle Piwowar-Manning, Bonnie J Dye, India Tindale, Lori Proulx-Burns, Meg Trahey, Simbarashe Takuva, Azwidihwi Takalani, Veronique C Bailey, Spyros A Kalams, Hyman Scott, Josphat Kosgei, Sinéad Delany-Moretlwe, Sheetal Kassim, Fatima Laher, Z Mike Chirenje, Yeukai Musodza, Felix Mhlanga, Nonhlanhla Mkhize, Joshua A Weiner, Margaret E Ackerman, M Juliana McElrath, Michael N Pensiero, Lucio Gama, Dan H Barouch, Lawrence Corey, Myron S Cohen, David C Montefiori, Georgia D Tomaras, Marc Siegel, Colleen F Kelley
{"title":"Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, VRC07-523LS, and PGT121.414.LS infused intravenously or subcutaneously (HVTN 140/HPTN 101 part B): a phase 1, randomised trial.","authors":"Sharana Mahomed, Carmen A Paez, Yunda Huang, Kelly E Seaton, Chenchen Yu, Kevin Gillespie, Maurine D Miner, Shelly T Karuna, Theresa Gamble, Jack Heptinstall, Elize Domin, Haili Tang, Lu Zhang, Fei Gao, Margaret Yacovone, Hans M L Spiegel, Julie Dumond, Maija A Anderson, Estelle Piwowar-Manning, Bonnie J Dye, India Tindale, Lori Proulx-Burns, Meg Trahey, Simbarashe Takuva, Azwidihwi Takalani, Veronique C Bailey, Spyros A Kalams, Hyman Scott, Josphat Kosgei, Sinéad Delany-Moretlwe, Sheetal Kassim, Fatima Laher, Z Mike Chirenje, Yeukai Musodza, Felix Mhlanga, Nonhlanhla Mkhize, Joshua A Weiner, Margaret E Ackerman, M Juliana McElrath, Michael N Pensiero, Lucio Gama, Dan H Barouch, Lawrence Corey, Myron S Cohen, David C Montefiori, Georgia D Tomaras, Marc Siegel, Colleen F Kelley","doi":"10.1016/S2352-3018(25)00356-X","DOIUrl":"10.1016/S2352-3018(25)00356-X","url":null,"abstract":"<p><strong>Background: </strong>Passive immunisation with a combination of broadly neutralising monoclonal antibodies (mAbs) presents a potential HIV-1 prevention modality. This study (HVTN 140/HPTN 101) sought to evaluate PGDM1400LS (targeting V3-glycan) administered alone (part A, previously reported), and in combination (part B) with VRC07-523LS (targeting CD4 binding site) and PGT121.414.LS (targeting V2-apex) in healthy adults without HIV-1.</p><p><strong>Methods: </strong>The study was a phase 1, multicentre, randomised, open-label trial done across the USA (five sites), Kenya (one site), South Africa (four sites), and Zimbabwe (three sites). Part B participants were randomly assigned to five groups (n=16 each), all receiving the three mAbs at months 0 and 4: infusion group T6 (20 mg/kg each mAb intravenously), T7 (20 mg/kg each mAb subcutaneously), T8 (1·4 g each mAb intravenously), T9 (1·4 g each mAb subcutaneously), and T10 (40 mg/kg each mAb intravenously). Primary endpoints were safety and tolerability throughout the study, and pharmacokinetics and neutralising activity on days 0, 3, 6, 28, 56, 112, 168, 224, and 280. Serum mAb concentrations over time were assessed via a validated anti-idiotype binding assay and analysed with two-compartment population pharmacokinetics models. Serum neutralisation titres were assessed by a validated TZM-bl assay. The study is registered at ClinicalTrials.gov (NCT05184452) and is complete.</p><p><strong>Findings: </strong>For the 80 part B participants enrolled from March 21 to Oct 5, 2022, the median age was 27·0 years, with 47·5% females. Most participants had mild-to-moderate solicited local and systemic symptoms. No serious adverse events were reported. On the basis of pharmacokinetics data from part A and part B combined, the estimated elimination half-life of PGDM1400LS was 53 days (51·4-55·3). Subcutaneous administration of PGDM1400LS exhibited bioavailability of 73·0% (67·5-78·5%) relative to intravenous administration of the same dose. PGT121.414.LS had an estimated elimination half-life of 65 days (61·8-68·1) with subcutaneous bioavailability of 77·7% (71·2-84·1), and VRC07-523LS had an estimated elimination half-life of 44 days (41·6-45·7) with a subcutaneous bioavailability of 80·1% (71·4-88·8). Both weight-based and fixed-dose regimens showed similar pharmacokinetic profiles. Observed neutralisation titres were consistent with those predicted on the basis of concentrations and in vitro neutralisation. No treatment-induced anti-drug antibody responses were detected.</p><p><strong>Interpretation: </strong>The mAb combination of PGDM1400LS, PGT121.414.LS, and VRC07-523LS was safe and well tolerated, with no antagonistic pharmacokinetic interactions or loss of neutralisation activity. These findings support further evaluation of this combination in future efficacy trials.</p><p><strong>Funding: </strong>National Institute of Allergy and Infectious Diseases-National Institutes of Health.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e452-e464"},"PeriodicalIF":14.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13537269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876227","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}
Lancet HivPub Date : 2026-07-01DOI: 10.1016/s2352-3018(26)00149-9
Anna Grimsrud,Florence Riako Anam,Cheryl Case Johnson,Ingrid T Katz,Izukanji Sikazwe,Maaya Sundaram,Lynne S Wilkinson
{"title":"Differentiated service delivery and self-care in HIV.","authors":"Anna Grimsrud,Florence Riako Anam,Cheryl Case Johnson,Ingrid T Katz,Izukanji Sikazwe,Maaya Sundaram,Lynne S Wilkinson","doi":"10.1016/s2352-3018(26)00149-9","DOIUrl":"https://doi.org/10.1016/s2352-3018(26)00149-9","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"15 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148365368","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}