Lancet Hiv最新文献

{"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":"https://doi.org/10.1016/S2352-3018(25)00043-8","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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":""},"PeriodicalIF":12.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/10.1016/S2352-3018(25)00123-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":12.8,"publicationDate":"2025-06-04","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":"Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial.","authors":"Kelly E Seaton, Carmen A Paez, Chenchen Yu, Shelly T Karuna, Theresa Gamble, Maurine D Miner, Jack Heptinstall, Lu Zhang, Fei Gao, Margaret Yacovone, Hans Spiegel, Julie B Dumond, Maija Anderson, Estelle Piwowar-Manning, Bonnie Dye, India Tindale, Lori Proulx-Burns, Meg Trahey, Simbarashe Takuva, Azwidihwi Takalani, Veronique C Bailey, Spyros A Kalams, Hyman Scott, Nonhlanhla N Mkhize, Joshua A Weiner, Margaret E Ackerman, M Juliana McElrath, Michael Pensiero, Dan H Barouch, David Montefiori, Georgia D Tomaras, Lawrence Corey, Myron S Cohen, Yunda Huang, Sharana Mahomed, Marc Siegel, Colleen F Kelley","doi":"10.1016/S2352-3018(25)00012-8","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00012-8","url":null,"abstract":"<p><strong>Background: </strong>PGDM1400LS is a human monoclonal antibody targeting the HIV envelope V2 apex with a lysine-serine modification intended to enhance serum and tissue half-lives and is being considered for use in combination monoclonal antibody trials. We sought to test whether PGDM1400LS was safe and had favourable serum concentration, pharmacokinetics, and neutralising ability in healthy adults.</p><p><strong>Methods: </strong>HVTN 140/HPTN 101 part A is an open-label, dose escalation, first-in-human phase 1 trial of PGDM1400LS given intravenously or subcutaneously to healthy adults aged 18-50 years without HIV-1. The study enrolled participants at four sites in the USA, across five groups, each receiving one dose of PGDM1400-LS intravenously (group 1: 5 mg/kg; group 2: 20 mg/kg; and group 4: 40 mg/kg) or subcutaneously (group 3: 20 mg/kg; and group 5: 40 mg/kg). Participants in group 1 were enrolled sequentially without random assignment. Participants in groups 2 and 3 were block randomised and enrolled simultaneously after group 1 safety review. Groups 4 and 5 followed the same process, contingent on groups 2 and 3 safety review. The primary endpoints were safety and tolerability of PGDM1400LS, serum concentration of PGDM1400LS, and serum neutralising activity after single administration of PGDM1400LS. Serum PGDM1400LS concentrations collected at seven timepoints (day 0, day 3, day 6, day 28, day 56, day 112, and day 168) were assessed via an anti-idiotype binding assay and characterised via non-compartmental pharmacokinetic analysis. Serum neutralisation activity (ID₈₀) was assessed by a TZM-bl assay. The study is registered with ClinicalTrials.gov, NCT05184452.</p><p><strong>Findings: </strong>Between Nov 15, 2021, and March 4, 2022, 15 participants were enrolled into the five study groups (three participants per group) with 6 months of follow-up. Ten of 15 participants were female, 14 of 15 participants were non-Hispanic, and 11 of 15 participants were White, with a median age of 27 years (range 24-47). PGDM1400LS was safe and well tolerated, with mild to moderate solicited symptoms. Serum concentrations showed dose proportionality by administration route, with peak concentrations observed immediately after intravenous infusion (range 95·7-727·4 μg/mL) or on day 6 after subcutaneous infusion (205·6-547·1 μg/mL). The median elimination half-life was 55 days (range 48-59), representing a 2-to-3-times increase versus parental PDGM1400. Estimated subcutaneous (vs intravenous) bioavailability was 50-60%. ID₈₀ titres showed agreement with concentration-predicted ID₈₀ titres, indicating maintenance of neutralisation activity in vivo.</p><p><strong>Interpretation: </strong>PGDM1400LS is a promising candidate for combination monoclonal antibody efficacy trials going forward.</p><p><strong>Funding: </strong>National Institute of Allergy and Infectious Diseases-National Institutes of Health.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e405-e415"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182870","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":"Mortality risk in people with HIV and anal cancer - Authors' reply.","authors":"Raquel Martin-Iguacel, Jordi Aceiton, Georgia Escaramis, Josep M Llibre","doi":"10.1016/S2352-3018(25)00104-3","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00104-3","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e399-e400"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183201","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":"Association of state-level PrEP coverage and new HIV diagnoses in the USA from 2012 to 2022: an ecological analysis of the population impact of PrEP.","authors":"Patrick S Sullivan, Marta Juhasz, Stephanie N DuBose, Gordon Le, Kamaria Brisco, Duygu Islek, James Curran, Eli Rosenberg","doi":"10.1016/S2352-3018(25)00036-0","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00036-0","url":null,"abstract":"<p><strong>Background: </strong>Pre-exposure prophylaxis (PrEP) medications are highly efficacious for preventing new HIV infections, but the population impact of PrEP depends on whether prescribed PrEP reaches the people at greatest risk in a population, and adherence and persistence on PrEP over time. We sought to use ecological analysis methods to characterise the impact of PrEP on HIV infections at the population level, complementing data from efficacy trials and programmatic monitoring.</p><p><strong>Methods: </strong>We conducted an ecological analysis of US state-level data on PrEP use, HIV viral suppression, and trends in HIV diagnoses in all US states and the District of Columbia by using a nationwide commercial pharmacy database (IQVIA) to calculate PrEP coverage (PrEP users per 100 people with a PrEP indication) and public health surveillance data to document HIV diagnoses from Jan 1, 2012, to Dec 31, 2022, by state and year. States were assigned to quintiles of mean PrEP coverage over the 10-year period, and we calculated quintile-specific changes in HIV diagnoses from 2012 to 2022. We used generalised linear mixed modelling to assess the state-level and national-level associations of PrEP coverage with HIV diagnosis rates, controlling for state-specific viral suppression.</p><p><strong>Findings: </strong>From 2012 to 2022, mean PrEP coverage across the USA increased dramatically from 0·6% to 26·3%, and HIV diagnosis rates decreased modestly from 13·0 to 10·6 per 100 000 population. Proportionate decreases in HIV diagnoses were higher in states with higher PrEP coverage; a significant inverse dose-response relationship existed between PrEP coverage and HIV diagnoses, in that areas with higher PrEP coverage had progressively larger declines in HIV diagnoses.</p><p><strong>Interpretation: </strong>Ecological evidence supports the population-level impact of PrEP in the USA and suggests that higher levels of PrEP coverage are associated with larger reductions in HIV diagnoses, even accounting for effects of viral suppression on HIV transmission. To the extent that these relationships are causal, programmes and policies to lower barriers to PrEP use among people with indications are likely to be associated with subsequent population-level declines in new HIV diagnoses.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e440-e448"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183253","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":"Mortality risk in people with HIV and anal cancer.","authors":"Kirsten Rozemeijer, Sarah van Veelen, Catharina J Alberts, Maarten Schim van der Loeff","doi":"10.1016/S2352-3018(25)00103-1","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00103-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e399"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182040","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":"PrEP and its challenges for HIV elimination.","authors":"Eliã Pinheiro Botelho","doi":"10.1016/S2352-3018(25)00125-0","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00125-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e397-e398"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183716","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":"Supporting Poland's LGBT+ community through thick and thin.","authors":"Ed Holt","doi":"10.1016/S2352-3018(24)00261-3","DOIUrl":"10.1016/S2352-3018(24)00261-3","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e404"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142356514","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":"UK boosts HIV testing efforts.","authors":"Tony Kirby","doi":"10.1016/S2352-3018(25)00098-0","DOIUrl":"10.1016/S2352-3018(25)00098-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e402-e403"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991215","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":"Adapting the UK's HIV response to a changing epidemic.","authors":"","doi":"10.1016/S2352-3018(25)00136-5","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00136-5","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 6","pages":"e393"},"PeriodicalIF":12.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144180994","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}