Lancet Hiv最新文献

{"title":"Funding concerns pervasive at IAS 2025.","authors":"Paul Adepoju","doi":"10.1016/s2352-3018(25)00225-5","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00225-5","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"7 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805737","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 clinical and economic impact of genotypic resistance testing for people diagnosed with persistent virological non-suppression on tenofovir-lamivudine-dolutegravir in South Africa: a modelling study.","authors":"Emily P Hyle,Linda-Gail Bekker,Suzanne M McCluskey,Wanyi Chen,Paul E Sax,Mahomed-Yunus Moosa,Munashe Machoko,Audrey Bangs,Kim Steegen,Mark J Siedner,David A M C van de Vijver,Stephen C Resch,Anne M Neilan,Andrew Phillips,Rochelle P Walensky,Richard J Lessells,Milton C Weinstein,Caitlin M Dugdale,Robin Wood,Kenneth A Freedberg","doi":"10.1016/s2352-3018(25)00164-x","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00164-x","url":null,"abstract":"BACKGROUNDPersistent virological non-suppression among people with HIV receiving tenofovir-lamivudine-dolutegravir (TLD) can result from poor adherence with or without resistance; however, genotypic resistance testing (GRT) is not recommended routinely in South Africa. We examined the clinical and economic effect of GRT for all South African adults diagnosed with persistent virological non-suppression on TLD.METHODSIn this modelling study, we used the previously validated Cost-Effectiveness of Preventing AIDS Complications-International microsimulation model to compare three strategies: (1) continued TLD (baseline); (2) immediate switch to tenofovir-lamivudine plus ritonavir-boosted darunavir; and (3) GRT prompting switch to tenofovir-lamivudine plus ritonavir-boosted darunavir for people with dolutegravir resistance or TLD continuation for people without dolutegravir resistance. We estimated that 2·3% and 28·5% of the baseline population have dolutegravir resistance and nucleoside reverse transcriptase inhibitor (NRTI) resistance, respectively. We also examined the effect of a low-cost, point-of-care urine tenofovir test in development to detect recent antiretroviral therapy use (84% sensitivity and 50% specificity), with GRT only when positive. Costs included GRT (US$157 per test), TLD ($45 per year), tenofovir-lamivudine plus ritonavir-boosted darunavir ($247 per year), and urine tenofovir testing ($2 per test). Outcomes included life-years, costs (provider perspective), and incremental cost-effectiveness ratios (ICERs; $ per disability-adjusted life-year [DALY]). We considered cost-effectiveness thresholds of less than $3310 per DALY (base case) and less than $1100 to $4250 per DALY.FINDINGSBased on our model, we estimated that continued TLD results in 14·11 undiscounted life-years and costs $5380 discounted at 3%; GRT results in 14·36 life-years and costs $5860 (0·14 discounted DALYs averted; ICER $3500 per DALY). Immediate switch results in fewer DALYs averted and higher costs. GRT has an ICER of $3310 per DALY or less when baseline dolutegravir resistance prevalence is ≥2·5% or genotypic resistance test costs ≤$147 per test. Urine tenofovir testing to identify GRT eligibility results in an ICER of $2300 per DALY; the ICER would be less than $1100 per DALY if urine test specificity is 0·87 or greater and costs $2 per test or test specificity is higher than 0·98 and costs $10 per test or less.INTERPRETATIONGRT could increase life expectancy for people with HIV and persistent virological non-suppression on TLD in South Africa and could be cost-effective, especially at lower test costs. At current effectiveness and costs of tenofovir-lamivudine plus ritonavir-boosted darunavir, an immediate switch would not be preferred.FUNDINGNational Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the MGH Jerome and Celia Reich Endowed Scholar in HIV/AIDS Research Award.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"33 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805735","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":"Elton John AIDS Foundation plugging gaps in HIV funding.","authors":"Ed Holt","doi":"10.1016/s2352-3018(25)00222-x","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00222-x","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"106 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144802619","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":"WHO recommends lenacapavir for HIV prevention.","authors":"Roger Pebody","doi":"10.1016/s2352-3018(25)00224-3","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00224-3","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"16 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144802602","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":"Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process.","authors":"Chloe Orkin,Amy Paterson,Alexa Elias,Melanie Smuk,Kyle Ring,Alain Volny-Anne,Alexandra Calmy,Aniruddha Hazra,Anna Maria Geretti,Asa Radix,Boghuma K Titanji,Bruno Spire,Carlos Del Rio,Caroline Foster,Carolyn Bolton Moore,Claudia P Cortes,Cristina Mussini,Daniel R Kuritzkes,Darrell H S Tan,Esteban Martinez,Ferdinand W N M Wit,Fiona Cresswell,W D Francois Venter,Itzchak Levy,Jason Zucker,Jean-Michel Molina,Jennifer Hoy,Jose Arribas,Josep M Llibre,Judith Currier,Juergen Rockstroh,Jussi Sutinen,Kelly Gebo,Laura Waters,Magnus Gisslen,Mark O'Reilly,Marta Boffito,Melanie Thompson,Milosz Parczewski,Mina John,Monica Gandhi,Nagalingeswaran Kumarasamy,Nicholas Paton,Nicola Mackie,Pedro Cahn,Rick Elion,Sebastian Noe,Sharon Walmsley,Simon Collins,Susan Cole-Haley,Vanessa Apea,William R Short,Yvonne Gilleece,Sara Paparini","doi":"10.1016/s2352-3018(25)00131-6","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00131-6","url":null,"abstract":"BACKGROUNDDefinitions of virological failure and treatment discontinuation for long-acting injectable (LAI) cabotegravir and rilpivirine antiretroviral therapy are inconsistent in clinical practice and observational studies, which complicates interpretation and implementation of findings. The CONSENSUS-LAI study aimed to establish consistent definitions of virological failure and treatment discontinuation to enhance evidence transferability and support optimal clinical outcomes.METHODSThe study had two phases. Phase 1 was an international online survey exploring existing definitions of virological and treatment discontinuation, conducted between April 25 and July 1, 2024. Eligible participants were health-care professionals working in infectious disease or sexual health services who had provided care to at least ten people living with HIV in the past 6 months, had prescribed LAI cabotegravir and rilpivirine in clinical trials or clinical practice, and were able to give informed consent. Participants were recruited via social media and mailing lists of medical specialist societies. Phase 2 was a Delphi process, in which a panel of experts, selected to ensure representation from all six WHO regions, scored leading definitions from phase 1 on a 9-point Likert scale. The proposed definitions were scored according to four validity criteria: clarity, usability in the expert's setting, appropriateness across clinical purposes, and applicability across relevant population groups. Revisions were suggested in iterative rounds until consensus was reached. Consensus was predefined as at least 75% of experts agreeing or strongly agreeing (scores 7-9) with the validity criteria.FINDINGS386 LAI cabotegravir and rilpivirine prescribers across 28 countries completed the survey, revealing 15 definitions for virological failure on LAI cabotegravir and rilpivirine and nine for treatment discontinuation. 52 experts participated in the Delphi process. Consensus agreement on both definitions was reached after two rounds for all validity criteria. For virological failure, the consensus definition was as follows: (a) viral load 200 copies or more per mL or more on two occasions 2-4 weeks apart, or (b) a single viral load of more than 1000 copies per mL, and/or (c) emergent resistance, in the context of timely injections and prior suppression of less than 200 copies per mL, OR (d) unable to suppress viral load to less than 200 copies per mL on continuous therapy. For treatment discontinuation the consensus definition was as follows: people on LAI cabotegravir and rilpivirine who have missed two consecutive injections and have not taken oral bridging in the interim, irrespective of reason for discontinuation.INTERPRETATIONThe consensus definitions provide a foundation for aligning practice and evaluating patient outcomes. Further validation of the viral load threshold for virological failure and the optimal viral load retesting window is required.FUNDINGViiV Healthcare.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"27 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144796908","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 immunogenicity of investigational tuberculosis vaccine M72/AS01_E-4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial.","authors":"Alemnew F Dagnew, Linda L Han, Kogieleum Naidoo, Lee Fairlie, James C Innes, Keren Middelkoop, Michele Tameris, Robert J Wilkinson, Jintanat Ananworanich, Daniel Bower, Lisa Schlehuber, Nicole Frahm, Amy Cinar, Michael Dunne, Alexander C Schmidt","doi":"10.1016/S2352-3018(25)00124-9","DOIUrl":"10.1016/S2352-3018(25)00124-9","url":null,"abstract":"<p><strong>Background: </strong>M72/AS01<sub>E-4</sub> is a recombinant fusion protein vaccine candidate derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A) and AS01<sub>E-4</sub> adjuvant. We evaluated safety and immunogenicity of M72/AS01<sub>E-4</sub> in people living with HIV in South Africa.</p><p><strong>Methods: </strong>In this observer-blinded, randomised, controlled, phase 2 trial, participants aged 16-35 years with well controlled HIV were enrolled from urban, semi-urban, and semi-rural settings in South Africa, including sites with high tuberculosis and HIV prevalence, as well as agricultural and mining communities. Participants were randomly assigned (1:1), stratified by site and interferon-gamma release assay (IGRA) status, to receive two intramuscular doses of M72/AS01<sub>E-4</sub> or placebo. Eligibility criteria included antiretroviral therapy for at least 3 months, HIV viral load of less than 200 copies per mL, CD4 counts of 200 cells per μL or higher, and previous completion of tuberculosis preventive therapy and no tuberculosis history. The sponsor and its delegates, the laboratory team, investigators, site staff, and participants were blinded to randomisation, whereas an unblinded pharmacist who was not involved in trial procedures prepared placebo and reconstituted M72/AS01<sub>E-4</sub> in unit-dose syringes covered with a blinding label. All participants who received at least one dose of either M72/AS01<sub>E-4</sub> or placebo were included in the safety population for safety analyses. Immunogenicity analyses were conducted using the per-protocol population, which included participants who received the intervention as planned and did not substantially deviate from the protocol procedures. Safety assessments included solicited adverse events in the first 7 days after each dose, unsolicited adverse events in the first 28 days after each dose, and serious adverse events. Humoral responses were measured with ELISA and cellular responses were assessed using multiparameter flow cytometry, in the per-protocol population. This study is complete and is registered with ClinicalTrials.gov, NCT04556981.</p><p><strong>Findings: </strong>Between Nov 17, 2020, and Aug 12, 2022, 402 eligible participants were assigned treatment, of whom 401 participants received at least one dose of M72/AS01<sub>E-4</sub> (n=201; 175 [87%] were female and 26 [13%] were male; 196 [98%] were Black) or placebo (n=200; [176 [88%] were female and 24 [12%] were male; 196 [98%] were Black) and followed for a median duration of 372 days (IQR 364-389). Among M72/AS01<sub>E-4</sub> recipients, solicited adverse events were more frequent, ranging from 17% (33 of 199) for gastrointestinal symptoms to 77% (140 of 183) for injection-site pain. Most events were mild to moderate, with severe events ranging from 0% (0 of 197) for swelling and (0 of 198) redness to 13% (24 of 183) for injection-site pain, resolving within 3 days. Unsolicited adverse ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e546-e555"},"PeriodicalIF":13.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12310912/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144565427","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":"Lenacapavir will not end the HIV epidemic in the current US political climate.","authors":"Steven A John,Michael G Curtis,Jennifer L Walsh,Katherine G Quinn","doi":"10.1016/s2352-3018(25)00188-2","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00188-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"8 1","pages":"e542"},"PeriodicalIF":16.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144763178","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":"Evaluation of antiretroviral regimen switching options in adults with HIV with sustained viral load non-suppression on dolutegravir, lamivudine, and tenofovir in eastern, central, southern, and western Africa: a modelling study.","authors":"Andrew N Phillips, Loveleen Bansi-Matharu, Joep J van Oosterhout, Emily Hyle, David van de Vijver, Roger Kouyos, Steven Y Hong, Helen Chun, Elliot Raizes, Rami Kantor, Michael R Jordan, Marco Vitoria, Nathan Ford, Owen Mugurungi, Tsitsi Apollo, Pugie Chimberengwa, Graeme Meintjes, Mark Siedner, Jens Lundgren, Jonathan Schapiro, Charles Flexner, Tom Loosli, Valentina Cambiano, Jennifer Smith, Ruisi Xia, Suzanne McCluskey, Sandrine Mewoabi, Alexandra Calmy, Serge Paul Eholie, Paul Revill","doi":"10.1016/S2352-3018(25)00068-2","DOIUrl":"10.1016/S2352-3018(25)00068-2","url":null,"abstract":"<p><strong>Background: </strong>In Africa, for people with HIV on a dolutegravir-based regimen with a viral load of more than 1000 copies per mL despite enhanced adherence counselling, the appropriate course of action is uncertain. We aimed to evaluate the predicted effects of alternative antiretroviral regimen switching options in this population, including consideration of cost-effectiveness.</p><p><strong>Methods: </strong>We used an existing individual-based model to simulate risk and experience of HIV in 100 000 adults alive between 1989 and 2076. Using sampling of parameter values, we created 1000 setting-scenarios, reflecting the uncertainty in assumptions and a range of settings similar to those seen in eastern, central, southern, and western Africa. For each setting-scenario, we predicted the outcomes from the three alternative policies for people with sustained viral load non-suppression on a dolutegravir-containing regimen from 2026: a switch to a protease inhibitor-based regimen (switch policy), a switch to a protease inhibitor-based regimen only if HIV drug resistance testing beforehand shows integrase inhibitor resistance (resistance test policy), and no switch with no HIV drug resistance test (no switch policy). We considered predicted outcomes over 10-year and 50-year periods from 2026, used a 3% discount rate, and a cost-effectiveness threshold of US$500 per disability-adjusted life-year (DALY) averted. Ritonavir-boosted darunavir costs $210 per year, and dolutegravir less than $20. We assumed a cost of HIV drug resistance testing of $200 and considered variations around this. For comparing policies, we calculated net DALYs, which account for the health consequences of differences in costs and provide a measure of the impact of a policy on overall population burden of disease.</p><p><strong>Findings: </strong>Across setting-scenarios, there was a mean of 14 480 deaths per year (95% CI 13 750-15 210) over 50 years with a mean annual discounted cost of $103·2 million (95·8-106·5) with the switch policy in the context of having scaled to a setting with an adult population of 10 million in 2024. Compared with the switch policy, the no switch policy was predicted to lead to an overall increased number of DALYs incurred (mean 4400 per year, 95% CI 3200-5500), although it resulted in the lowest overall cost, with a difference in annual discounted costs of $5·1 million (95% CI 4·6-5·6) lower than the switch policy. The resistance test policy led to a similar risk of death and DALYs to the switch policy at a lower overall cost (difference in annual discounted costs $3·5 million per year, 95% CI 3·1-3·9), leading to 6900 (95% CI 5500-8200) fewer net DALYs per year. Net DALYs for the resistance test versus no switch policies were similar (-1000 net DALYs, 95% CI 400 to -2300). The incremental cost-effectiveness ratio when comparing the resistance test policy with the no switch policy was $376 per DALY averted; the switch policy was dominate","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e578-e586"},"PeriodicalIF":13.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144512593","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":"Reflections from the frontline of the HIV/AIDS response.","authors":"Andrew Green","doi":"10.1016/S2352-3018(25)00015-3","DOIUrl":"10.1016/S2352-3018(25)00015-3","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e545"},"PeriodicalIF":13.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531056","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":"A SWING in the right direction for sex workers.","authors":"Sima Barmania","doi":"10.1016/S2352-3018(25)00097-9","DOIUrl":"10.1016/S2352-3018(25)00097-9","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e544"},"PeriodicalIF":13.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796355","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}