Lancet HivPub Date : 2026-10-16DOI: 10.1016/S2352-3018(26)00265-1
The Lancet Hiv
{"title":"Fiji's national HIV emergency.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(26)00265-1","DOIUrl":"https://doi.org/10.1016/S2352-3018(26)00265-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":14.6,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149208079","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 : 2026-10-07DOI: 10.1016/S2352-3018(26)00180-3
Elphas Okango, Margot Otto, Khai Hoan Tram, Adrian Dobra, Hae-Young Kim, Paul Mee, Maxime Inghels, Diego Cuadros, Anna Bershteyn, Dickman Gareta, Till Bärnighausen, Andrew Tomita, Henry Mwambi, Kobus Herbst, Frank Courteney Tanser
{"title":"Epidemiological trends of HIV among individuals aged 15-54 years in South Africa from 2004 to 2025: a population-based, longitudinal cohort study.","authors":"Elphas Okango, Margot Otto, Khai Hoan Tram, Adrian Dobra, Hae-Young Kim, Paul Mee, Maxime Inghels, Diego Cuadros, Anna Bershteyn, Dickman Gareta, Till Bärnighausen, Andrew Tomita, Henry Mwambi, Kobus Herbst, Frank Courteney Tanser","doi":"10.1016/S2352-3018(26)00180-3","DOIUrl":"10.1016/S2352-3018(26)00180-3","url":null,"abstract":"<p><strong>Background: </strong>South Africa has mounted the largest HIV prevention and treatment programme in history, delivering substantial gains in survival and prevention of new HIV infections; however, service disruptions and recent funding losses might jeopardise these successes. There is a scarcity of high-quality, population-based empirical evidence on key epidemic metrics needed to accurately gauge recent progress towards epidemic control in South Africa. We aimed to evaluate recent progress towards HIV epidemic control in South Africa by quantifying long-term trends in key epidemic control metrics in a large population-based cohort in rural KwaZulu-Natal, South Africa.</p><p><strong>Methods: </strong>In this population-based, longitudinal cohort study, we used prospectively collected HIV testing, sociodemographic, behavioural, and population viral load data from the Africa Health Research Institute (AHRI) health and demographic surveillance system in rural KwaZulu-Natal from 2003 to 2025. Population-based HIV surveys (encompassing individual health interview and HIV testing) take place annually in all consenting resident individuals aged 15 years or older. We used Poisson regression models to quantify trends in directly observed HIV incidence in repeat testers (aged 15-54 years) who had initially tested negative for HIV and subsequently received at least one valid HIV test result. We further analysed 11 rounds of population viral load testing conducted between 2011 and 2025. We used generalised estimating equations to quantify population viral suppression metrics and calculated trends in the incidence-to-prevalence ratio, a key metric for evaluating progress towards epidemic control.</p><p><strong>Findings: </strong>Between June 24, 2003, and May 22, 2025, across the population cohort, 59 806 (65·4%) of 91 367 contacted individuals aged 15-54 years consented to participate at least once in population-based HIV testing. Of those tested, 33 754 (56·4%) were female and 26 052 (43·6%) were male, with a median age of 26·7 years (IQR 19·3-39·1) at testing date. Among 42 662 participants who initially tested HIV negative and were recontacted, 29 702 (69·6%) underwent repeat HIV testing and were included in the incidence analysis. In this group, over 182 112 person-years of observation, we observed 4852 HIV seroconversions. From 2013 to 2018, overall annual HIV incidence rates declined by 52·2% in males and 36·9% in females. We found no evidence of a continued downward trend in HIV incidence between 2019 and 2025 among either females or males. After a period of substantial decline (from 2011 to 2018), population detectable viraemia increased significantly from 2019 to 2025 by 9·6 percentage points (95% CI 5·4-13·8), remaining an estimated 30·7 percentage points (95% CI 27·2-34·3) below the UNAIDS 95-95-95 population viral suppression target. The incidence-to-prevalence ratio decreased substantially across consecutive survey rounds, from 0·132 ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":14.6,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149128826","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 : 2026-10-01Epub Date: 2026-08-07DOI: 10.1016/S2352-3018(26)00118-9
Cécile Tremblay, Innocent Valea, Birahim Pierre Ndiaye, Houreratou Barry, May ElSherif, Curtis Cooper, Janis L Breeze, Yun Cai, Lingyun Ye, Tosin Omole, Scott A Halperin, Souleymane Mboup, Joanne M Langley
{"title":"Safety and immunogenicity of one or two doses of the rVSVΔG-ZEBOV-GP Ebola virus vaccine in adults and adolescents living with HIV: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial.","authors":"Cécile Tremblay, Innocent Valea, Birahim Pierre Ndiaye, Houreratou Barry, May ElSherif, Curtis Cooper, Janis L Breeze, Yun Cai, Lingyun Ye, Tosin Omole, Scott A Halperin, Souleymane Mboup, Joanne M Langley","doi":"10.1016/S2352-3018(26)00118-9","DOIUrl":"10.1016/S2352-3018(26)00118-9","url":null,"abstract":"<p><strong>Background: </strong>A single dose of the replication-competent rVSVΔG-ZEBOV-GP vaccine is recommended by the WHO Strategic Advisory Group of Experts on Immunization during Ebola virus disease outbreaks. We aimed to assess the immunogenicity, safety, and tolerability of this vaccine in adults and adolescents with HIV.</p><p><strong>Methods: </strong>In this phase 2, multicentre, double-blind, randomised, placebo-controlled trial, we enrolled participants aged 13-70 years who had laboratory-confirmed HIV infection, were on antiretroviral therapy (ART), had an undetectable viral load (<40 copies per mL), and had a CD4 count of 200 cells per μL or more at four ambulatory settings in Montreal and Ottawa (Canada), Dakar (Senegal), and Bobo-Dioulasso (Burkina Faso). Sequential enrolment of five study cohorts occurred over time at each study site according to CD4 counts: cohort 1 (adults [age 18-70 years] with a CD4 count ≥500 cells per μL), cohort 2 (adults with a CD4 count of >350 and <500 cells per μL), cohort 3 (adults with a CD4 count of 200-350 cells per μL), cohort 4 (adolescents [age 13-17 years] with a CD4 count ≥200 cells per μL), and cohort 5 (adults and adolescents with a CD4 count ≥200 cells per μL). Participants were randomly assigned 4:1 to receive one dose (cohorts 1-4) or two doses (56 days apart; cohort 5) of rVSVΔG-ZEBOV-GP or placebo, administered at day 0. An unmasked staff member at each site prepared the vaccine or placebo; all other study personnel and participants were masked to group assignments. Participants were followed up to day 365. The primary immunogenicity endpoints, assessed in the per-protocol population, were Ebola virus-specific antibody responses measured by glycoprotein ELISA (GP-ELISA; geometric mean titre ratio [GMTR]) and neutralisation (geometric mean fold increase [GMFI] of plaque reduction neutralisation test [PRNT]) on day 28 in cohorts 1-5 combined (combined cohort), and 28 days after the second dose of vaccine or placebo in cohort 5. The primary safety endpoints, assessed in the as-treated population, were: the occurrence of each solicited local and systemic adverse event during a 14-day follow-up period after each vaccination; fever, joint pain (arthralgia), joint swelling (arthritis), rash, and blisters or vesicular lesions during a 42-day follow-up period after vaccination; any haematological and biochemical laboratory abnormality at 0, 3, 7, 14, and 28 days after each vaccine; occurrence of any unsolicited adverse event during a 42-day follow-up period after each vaccination; and occurrence of vaccine-related serious adverse events up to day 365 of the study. The trial is registered at ClinicalTrials.gov (NCT03031912) and is complete.</p><p><strong>Findings: </strong>Between Aug 1, 2017, and March 3, 2022, we assessed 647 individuals for eligibility, 251 of whom were enrolled. 120 (48%) participants were male, 130 (52%) were female, 225 (90%) were Black (Black African or African Canadian), ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e689-e701"},"PeriodicalIF":14.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148690049","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 : 2026-10-01Epub Date: 2026-09-08DOI: 10.1016/S2352-3018(26)00172-4
Giada Sebastiani, Tzu-Hao Lee, Ahmed Cordie, Felice Cinque, Jordan E Lake, Jeffrey V Lazarus, Jürgen K Rockstroh, Giovanni Guaraldi
{"title":"Metabolic dysfunction-associated steatotic liver disease in people living with HIV: a framework for integrated screening and care.","authors":"Giada Sebastiani, Tzu-Hao Lee, Ahmed Cordie, Felice Cinque, Jordan E Lake, Jeffrey V Lazarus, Jürgen K Rockstroh, Giovanni Guaraldi","doi":"10.1016/S2352-3018(26)00172-4","DOIUrl":"10.1016/S2352-3018(26)00172-4","url":null,"abstract":"<p><p>Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as a major cause of liver-related and cardiometabolic morbidity and mortality among people living with HIV, driven by ageing, obesity, type 2 diabetes, and long-term antiretroviral therapy. Approximately 20-41% of people living with HIV have MASLD, and significant liver fibrosis affects 12-20% of all people living with HIV, suggesting a fibrosis burden that exceeds that of the general population. HIV-specific mechanisms, including chronic immune activation, altered adipose distribution, and historical exposure to older antiretroviral agents, contribute to a more severe metabolic liver phenotype. Sex, gender, and social determinants of health-including menopause, food insecurity, and material deprivation-further influence fibrosis risk and access to care. International guidelines now recommend routine fibrosis screening in at-risk people living with HIV with the use of non-invasive tools such as transient elastography and serum biomarkers. Lifestyle interventions, optimisation of metabolic comorbidities, and emerging therapies including glucagon-like peptide-1 receptor agonists are reshaping management. Inclusion of people living with HIV in MASLD therapeutic trials remains a major, unmet research priority.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e745-e756"},"PeriodicalIF":14.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148913881","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 : 2026-10-01Epub Date: 2026-09-07DOI: 10.1016/S2352-3018(26)00199-2
Sharon Nachman
{"title":"Advancing a fixed-dose combination for children with HIV.","authors":"Sharon Nachman","doi":"10.1016/S2352-3018(26)00199-2","DOIUrl":"10.1016/S2352-3018(26)00199-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e681-e682"},"PeriodicalIF":14.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148907859","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 : 2026-10-01Epub Date: 2026-09-07DOI: 10.1016/S2352-3018(26)00168-2
Anne E M Kamphuis, Nicolas Salvadori, Hilda Angela Mujuru, Mutsawashe Bwakura-Dangarembizi, Grace Paul Kisitu, Frank Matovu, Elizabeth Kaudha, Alice Mulindwa, Tom G Jacobs, Kanchana Than-In-At, Tim R Cressey, Alessandra Nardone, Marc Lallemant, Angela Colbers, David M Burger
{"title":"Expediting a UNIVERSAL first-line regimen of a dolutegravir-emtricitabine-tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity trial.","authors":"Anne E M Kamphuis, Nicolas Salvadori, Hilda Angela Mujuru, Mutsawashe Bwakura-Dangarembizi, Grace Paul Kisitu, Frank Matovu, Elizabeth Kaudha, Alice Mulindwa, Tom G Jacobs, Kanchana Than-In-At, Tim R Cressey, Alessandra Nardone, Marc Lallemant, Angela Colbers, David M Burger","doi":"10.1016/S2352-3018(26)00168-2","DOIUrl":"10.1016/S2352-3018(26)00168-2","url":null,"abstract":"<p><strong>Background: </strong>Paediatric antiretroviral fixed-dose combination tablets remain limited. UNIVERSAL1 evaluated pharmacokinetics, short-term safety, and antiviral activity of novel fixed-dose ratios of dolutegravir, emtricitabine, and tenofovir alafenamide in children with HIV.</p><p><strong>Methods: </strong>UNIVERSAL1 was an open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity study. Children with HIV aged between 28 days and 10 years with a bodyweight between 3 kg and less than 25 kg were enrolled at three clinical research centres (one in Harare, Zimbabwe, and two in Kampala, Uganda). Children were enrolled across five WHO bodyweight bands (ten children per weight band) and received dolutegravir, emtricitabine, and tenofovir alafenamide at the following respective doses according to weight band: 5 mg, 15 mg, 1·88 mg (3 kg to <6 kg band); 15 mg, 45 mg, 5·64 mg (6 kg to <10 kg band); 20 mg, 60 mg, 7·52 mg (10 kg to <14 kg band); 25 mg, 75 mg, 9·4 mg (14 kg to <20 kg band); and 50 mg, 200 mg, 25 mg (20 kg to <25 kg band). Children weighing 3 kg to less than 20 kg received dispersible tablets with 10 mg dolutegravir and tablets for oral suspension with emtricitabine (15 mg)-tenofovir alafenamide (1·88 mg); children weighing 20 kg to less than 25 kg received film-coated tablets containing 50 mg dolutegravir and emtricitabine (200 mg)-tenofovir alafenamide (25 mg). Primary pharmacokinetic outcomes were the areas under the concentration time curve over the dosing interval from time 0 h to 24 h (AUC<sub>0-24h</sub>) for dolutegravir, emtricitabine, and tenofovir, and from time 0 h to time of the last measurable concentration of the dosing interval (AUC<sub>0-last</sub>) for tenofovir alafenamide; maximum plasma concentration (C<sub>max</sub>) for all four compounds; and concentration at the end of the dosing interval (C<sub>trough</sub> for dolutegravir, emtricitabine, and tenofovir and C<sub>last</sub> for tenofovir alafenamide). Primary safety outcomes were the occurrence of serious adverse events; new clinical and laboratory grade 3 and 4 adverse events; and adverse events of any grade leading to treatment interruption, discontinuation, or modification. Pharmacokinetic parameters were determined by non-compartmental analysis. The number of children with dolutegravir C<sub>trough</sub> lower than 0·32 mg/L (EC<sub>90</sub>), tenofovir alafenamide AUC<sub>0-last</sub> lower than 55 h × ng/mL (antiviral activity target), and tenofovir AUC<sub>0-24h</sub> higher than 2586 h × ng/mL (toxicity target) is reported. The trial is completed and registered with ClinicalTrials.gov, NCT05993767.</p><p><strong>Findings: </strong>Between Jan 7 and June 5, 2025, 53 participants were enrolled (51 included in pharmacokinetic analysis, 53 included in safety analysis). Of these 53 children, 28 (53%) were female and 25 (47%) were male. Median age was 37 months (IQR 10-64), and median weight was 11·6 kg (7·9-16·8). Dolutegrav","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e702-e712"},"PeriodicalIF":14.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148907908","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}