Pub Date : 2025-09-26DOI: 10.1016/s2352-3018(25)00237-1
Peter Ranscombe
{"title":"Nostalgic throwbacks in Sad Gay AIDS Play parody.","authors":"Peter Ranscombe","doi":"10.1016/s2352-3018(25)00237-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00237-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"327 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145188799","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}
Pub Date : 2025-09-26DOI: 10.1016/s2352-3018(25)00267-x
Roger Pebody
{"title":"Creating a space where young people with HIV can be free.","authors":"Roger Pebody","doi":"10.1016/s2352-3018(25)00267-x","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00267-x","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"65 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145188800","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}
Pub Date : 2025-09-24DOI: 10.1016/s2352-3018(25)00189-4
Deborah Persaud,Anne Coletti,Bryan S Nelson,Jennifer Jao,Edmund V Capparelli,Diane Costello,Camlin Tierney,Adeodata R Kekitiinwa,Teacler Nematadzira,Boniface N Njau,John Moye,Patrick Jean-Philippe,Violet Korutaro,Annet Nalugo,Tapiwa Mbengeranwa,Tinashe Chidemo,Blandina T Mmbaga,Philoteus A Sakasaka,Mark Cotton,Cheryl Jennings,Carly Hoffmann,Laura Hovind,Yvonne Bryson,Ellen G Chadwick,
BACKGROUNDWe hypothesised that initiating antiretroviral therapy (ART) soon after birth could limit HIV-1 reservoirs and promote ART-free remission. This study aims to assess remission in children with in-utero HIV-1 infection who received very early ART as neonates by performing analytical treatment interruption (ATI).METHODSIMPAACT P1115 is an ongoing, open-label, proof-of-concept study at 30 research sites in 11 countries across Africa, Asia, and the Americas. Neonates (≥34 weeks gestational age) at high risk for in-utero HIV-1 were eligible. Neonates born to mothers with untreated HIV-1 (cohort 1) or mothers who might have been on ART (cohort 2) initiated three-drug oral nevirapine-based ART (6mg/kg per dose orally twice a day) within 48 h of birth (cohort 1), three-drug nevirapine-based prophylaxis (≥8 mg/kg per dose orally once a day), or nevirapine-based ART after HIV-1 diagnosis by age 10 days (cohort 2). Coformulated ritonavir 75 mg/m2 and lopinavir 300 mg/m2 orally twice a day was added when age appropriate for those with confirmed in-utero HIV-1. Nevirapine was discontinued 12 weeks after two consecutive plasma viral loads were below the assay limit. Children at least 2 years of age maintaining undetectable HIV-1 RNA since week 48 and who tested HIV-1 antibody negative, HIV-1 DNA not detected, and normal CD4 count and percentage qualified for ATI. The primary outcome was ART-free remission, defined as no HIV-1 RNA in plasma for 48 weeks or more off ART. A two-sided exact 95% CI was calculated to estimate the probability of remission. This study is registered with ClinicalTrials.gov (NCT02140255).FINDINGSAmong 54 children with in-utero HIV-1 enrolled between Jan 23, 2015, and Dec 14, 2017, six (11%) children (four girls, two boys; one in cohort 1, five in cohort 2) met criteria and underwent ATI at a median age of 5·5 years. Two children had early rebound at 3·4 weeks and 9·4 weeks. Four reached ART-free remission (67%; exact 95% CI 22-96), one of whom had late viral rebound at 79·3 weeks. All three children with viral rebound successfully resuppressed HIV-1 RNA below the assay limit on ART. Mild symptoms of acute retroviral syndrome occurred in two participants during rebound and resolved with ART resumption.INTERPRETATIONThis study shows that ART-free remission for 48 weeks or longer is achievable with very early ART in children with in-utero HIV-1, but close monitoring for viral rebound and acute retroviral syndrome during ATI is needed. These findings, observed in resource-constrained countries, exhibit the feasibility of testing at birth and initiating very early ART, show the potential to limit HIV-1 reservoirs for ART-free remission, and inform future remission strategies.FUNDINGThe US National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the US National Institute of Mental Health.
{"title":"ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept study.","authors":"Deborah Persaud,Anne Coletti,Bryan S Nelson,Jennifer Jao,Edmund V Capparelli,Diane Costello,Camlin Tierney,Adeodata R Kekitiinwa,Teacler Nematadzira,Boniface N Njau,John Moye,Patrick Jean-Philippe,Violet Korutaro,Annet Nalugo,Tapiwa Mbengeranwa,Tinashe Chidemo,Blandina T Mmbaga,Philoteus A Sakasaka,Mark Cotton,Cheryl Jennings,Carly Hoffmann,Laura Hovind,Yvonne Bryson,Ellen G Chadwick, ","doi":"10.1016/s2352-3018(25)00189-4","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00189-4","url":null,"abstract":"BACKGROUNDWe hypothesised that initiating antiretroviral therapy (ART) soon after birth could limit HIV-1 reservoirs and promote ART-free remission. This study aims to assess remission in children with in-utero HIV-1 infection who received very early ART as neonates by performing analytical treatment interruption (ATI).METHODSIMPAACT P1115 is an ongoing, open-label, proof-of-concept study at 30 research sites in 11 countries across Africa, Asia, and the Americas. Neonates (≥34 weeks gestational age) at high risk for in-utero HIV-1 were eligible. Neonates born to mothers with untreated HIV-1 (cohort 1) or mothers who might have been on ART (cohort 2) initiated three-drug oral nevirapine-based ART (6mg/kg per dose orally twice a day) within 48 h of birth (cohort 1), three-drug nevirapine-based prophylaxis (≥8 mg/kg per dose orally once a day), or nevirapine-based ART after HIV-1 diagnosis by age 10 days (cohort 2). Coformulated ritonavir 75 mg/m2 and lopinavir 300 mg/m2 orally twice a day was added when age appropriate for those with confirmed in-utero HIV-1. Nevirapine was discontinued 12 weeks after two consecutive plasma viral loads were below the assay limit. Children at least 2 years of age maintaining undetectable HIV-1 RNA since week 48 and who tested HIV-1 antibody negative, HIV-1 DNA not detected, and normal CD4 count and percentage qualified for ATI. The primary outcome was ART-free remission, defined as no HIV-1 RNA in plasma for 48 weeks or more off ART. A two-sided exact 95% CI was calculated to estimate the probability of remission. This study is registered with ClinicalTrials.gov (NCT02140255).FINDINGSAmong 54 children with in-utero HIV-1 enrolled between Jan 23, 2015, and Dec 14, 2017, six (11%) children (four girls, two boys; one in cohort 1, five in cohort 2) met criteria and underwent ATI at a median age of 5·5 years. Two children had early rebound at 3·4 weeks and 9·4 weeks. Four reached ART-free remission (67%; exact 95% CI 22-96), one of whom had late viral rebound at 79·3 weeks. All three children with viral rebound successfully resuppressed HIV-1 RNA below the assay limit on ART. Mild symptoms of acute retroviral syndrome occurred in two participants during rebound and resolved with ART resumption.INTERPRETATIONThis study shows that ART-free remission for 48 weeks or longer is achievable with very early ART in children with in-utero HIV-1, but close monitoring for viral rebound and acute retroviral syndrome during ATI is needed. These findings, observed in resource-constrained countries, exhibit the feasibility of testing at birth and initiating very early ART, show the potential to limit HIV-1 reservoirs for ART-free remission, and inform future remission strategies.FUNDINGThe US National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the US National Institute of Mental Health.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"61 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181175","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}
Pub Date : 2025-09-24DOI: 10.1016/s2352-3018(25)00190-0
Marie-Claude C Lavoie,Elvin H Geng
Globally, in 2024, 87% of all people living with HIV knew their HIV status, and among people aware of their status and on treatment, 94% were virally suppressed. As progress is being made to reach the UNAIDS 95-95-95 targets, one of the key public health challenges for HIV lies in optimising continuity of care and effectively re-engaging people out of care. Across settings, up to 40-50% of individuals diagnosed with HIV are disengaged from HIV care. Delaying or discontinuing HIV treatment can negatively affect health outcomes at the individual level, including increasing viraemia and mortality, and increases the risk for ongoing HIV transmission at the community level. In addition to the scarcity of HIV research focusing on continuous retention and re-engagement, there are also methodological gaps interfering with our ability to better understand and intervene. This Viewpoint emphasises the importance of more nuanced distinctions of concepts related to disengagement and re-engagement, balancing data harmonisation with flexibility to facilitate evidence generation and collaboration, and identifying and testing re-engagement interventions. Developing a global research agenda, along with methodological guidance, would assist in moving synergistically and intentionally towards a comprehensive approach to re-engagement.
{"title":"A research framework to support re-engagement and continuous engagement in HIV care.","authors":"Marie-Claude C Lavoie,Elvin H Geng","doi":"10.1016/s2352-3018(25)00190-0","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00190-0","url":null,"abstract":"Globally, in 2024, 87% of all people living with HIV knew their HIV status, and among people aware of their status and on treatment, 94% were virally suppressed. As progress is being made to reach the UNAIDS 95-95-95 targets, one of the key public health challenges for HIV lies in optimising continuity of care and effectively re-engaging people out of care. Across settings, up to 40-50% of individuals diagnosed with HIV are disengaged from HIV care. Delaying or discontinuing HIV treatment can negatively affect health outcomes at the individual level, including increasing viraemia and mortality, and increases the risk for ongoing HIV transmission at the community level. In addition to the scarcity of HIV research focusing on continuous retention and re-engagement, there are also methodological gaps interfering with our ability to better understand and intervene. This Viewpoint emphasises the importance of more nuanced distinctions of concepts related to disengagement and re-engagement, balancing data harmonisation with flexibility to facilitate evidence generation and collaboration, and identifying and testing re-engagement interventions. Developing a global research agenda, along with methodological guidance, would assist in moving synergistically and intentionally towards a comprehensive approach to re-engagement.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"62 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181169","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}
Pub Date : 2025-09-24DOI: 10.1016/s2352-3018(25)00231-0
Maria C Puertas
{"title":"Hope for treatment-free remission in children born with HIV.","authors":"Maria C Puertas","doi":"10.1016/s2352-3018(25)00231-0","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00231-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"2 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181174","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}
Pub Date : 2025-09-23DOI: 10.1016/s2352-3018(25)00221-8
Luxsena Sukumaran,Karine Scheuermaier,Caroline A Sabin,Nomathemba Chandiwana,Francesc Xavier Gómez-Olivé,Malcolm von Schantz,Dale E Rae,Alan Winston
People with HIV experience higher burden of cardiometabolic, mood, and cognitive disorders. Poor-quality and insufficient sleep are both associated with increased risk for these comorbidities and are more common in people with HIV. Although previous reviews have explored the prevalence and risk factors for sleep complaints in people with HIV, few have differentiated these complaints by potential underlying causes. Disordered sleep in people with HIV might arise from HIV-specific sleep disruptors, including direct effects of the virus, chronic inflammation, and antiretroviral treatment. There is also evidence that sleep is more fragile in people with HIV and some common sleep disorders, such as obstructive sleep apnoea, chronic insomnia, and circadian rhythm disorders, might be particularly problematic in people with HIV. Understanding how HIV uniquely disrupts sleep physiology could inform the development of tailored, mechanism-based management strategies to improve sleep health in people with HIV.
{"title":"Understanding and managing disordered sleep in people with HIV.","authors":"Luxsena Sukumaran,Karine Scheuermaier,Caroline A Sabin,Nomathemba Chandiwana,Francesc Xavier Gómez-Olivé,Malcolm von Schantz,Dale E Rae,Alan Winston","doi":"10.1016/s2352-3018(25)00221-8","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00221-8","url":null,"abstract":"People with HIV experience higher burden of cardiometabolic, mood, and cognitive disorders. Poor-quality and insufficient sleep are both associated with increased risk for these comorbidities and are more common in people with HIV. Although previous reviews have explored the prevalence and risk factors for sleep complaints in people with HIV, few have differentiated these complaints by potential underlying causes. Disordered sleep in people with HIV might arise from HIV-specific sleep disruptors, including direct effects of the virus, chronic inflammation, and antiretroviral treatment. There is also evidence that sleep is more fragile in people with HIV and some common sleep disorders, such as obstructive sleep apnoea, chronic insomnia, and circadian rhythm disorders, might be particularly problematic in people with HIV. Understanding how HIV uniquely disrupts sleep physiology could inform the development of tailored, mechanism-based management strategies to improve sleep health in people with HIV.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"52 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145153301","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}
BACKGROUNDPeople living with HIV are at high risk of pneumococcal disease, and evidence of pneumococcal conjugate vaccine (PCV) safety and efficacy is needed. We aimed to evaluate the safety, tolerability, and immunogenicity of V116 (an adult-specific 21-valent PCV) in this population.METHODSThis two-part phase 3 trial was conducted at 20 centres in Belgium, Chile, France, South Africa, Thailand, and the USA. Part A was a randomised, active comparator-controlled, parallel-group, multicentre, double-blind trial in adults aged 18 years or older living with HIV (CD4 counts ≥50 cells per μL, plasma HIV RNA load <50 000 copies per mL, and combination antiretroviral therapy for ≥6 weeks). In part A, participants were randomly assigned (1:1), using an interactive response technology system, to receive V116 followed by placebo 8 weeks later or 15-valent PCV (PCV15) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later. Part B was an open-label trial of PCV15 after receiving V116 in part A (once all participants completed follow-up). Unmasked study personnel administered a 0·5 mL intramuscular dose of each vaccine. The funder, site staff, data management team, and participants were masked. Blood samples were collected on day 1 and at 30 days and 12 weeks post-vaccination in part A and on days 1 and 30 in part B. The primary outcome in part A, assessed in the per-protocol population, was serotype-specific opsonophagocytic activity geometric mean titres 30 days post-vaccination for the 13 serotypes common to V116 and PCV15 plus PPSV23 and for the eight serotypes unique to V116. Part B was exploratory. Immunogenicity was assessed using descriptive statistics. This study is registered with ClinicalTrials.gov, NCT05393037, and EudraCT, 2021-006710-36 (completed).FINDINGSAdults were enrolled and followed up in part A between July 13, 2022, and July 13, 2023, and in part B between Oct 18, 2023, and Jan 25, 2024. 313 participants were randomly assigned (156 in the V116 plus placebo group and 157 in the PCV15 plus PPSV23 group) and 304 (97%) completed part A (152 in each group). 126 (81%) of 155 participants in the V116 plus placebo group as-treated population from part A received PCV15 in part B (administration interval median 11·4 months [range 9·5-16·9]). 221 (71%) participants were male and 91 (29%) were female. The mean age was 45 years (SD 13). V116 was immunogenic for all 21 serotypes contained in the vaccine, and immune responses on day 30 were generally similar to those seen with PCV15 plus PPSV23 at week 12 for the 13 common serotypes and higher for the eight serotypes unique to V116. In part A, fewer participants had at least one adverse event in the V116 plus placebo group (111 [72%] of 155 vs 141 [91%] of 155 in the PCV15 plus PPSV23 group) with a lower frequency of injection-site adverse events (79 [51%] vs 130 [84%]); serious adverse events were low (four [3%] vs six [4%]) and none were vaccine related. One non-vaccine-rel
{"title":"Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial.","authors":"Jayani Pathirana,Moti Ramgopal,Charlotte Martin,Johannes J Lombaard,Carolina Chahin,Odile Launay,Winai Ratanasuwan,David Greenberg,Carlos G Grijalva,Walter A Orenstein,Angelika Shenkerman,Lori Hall,Doreen Fernsler,Yeonil Kim,Jianing Li,Heather Loryn Platt, ","doi":"10.1016/s2352-3018(25)00165-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00165-1","url":null,"abstract":"BACKGROUNDPeople living with HIV are at high risk of pneumococcal disease, and evidence of pneumococcal conjugate vaccine (PCV) safety and efficacy is needed. We aimed to evaluate the safety, tolerability, and immunogenicity of V116 (an adult-specific 21-valent PCV) in this population.METHODSThis two-part phase 3 trial was conducted at 20 centres in Belgium, Chile, France, South Africa, Thailand, and the USA. Part A was a randomised, active comparator-controlled, parallel-group, multicentre, double-blind trial in adults aged 18 years or older living with HIV (CD4 counts ≥50 cells per μL, plasma HIV RNA load <50 000 copies per mL, and combination antiretroviral therapy for ≥6 weeks). In part A, participants were randomly assigned (1:1), using an interactive response technology system, to receive V116 followed by placebo 8 weeks later or 15-valent PCV (PCV15) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later. Part B was an open-label trial of PCV15 after receiving V116 in part A (once all participants completed follow-up). Unmasked study personnel administered a 0·5 mL intramuscular dose of each vaccine. The funder, site staff, data management team, and participants were masked. Blood samples were collected on day 1 and at 30 days and 12 weeks post-vaccination in part A and on days 1 and 30 in part B. The primary outcome in part A, assessed in the per-protocol population, was serotype-specific opsonophagocytic activity geometric mean titres 30 days post-vaccination for the 13 serotypes common to V116 and PCV15 plus PPSV23 and for the eight serotypes unique to V116. Part B was exploratory. Immunogenicity was assessed using descriptive statistics. This study is registered with ClinicalTrials.gov, NCT05393037, and EudraCT, 2021-006710-36 (completed).FINDINGSAdults were enrolled and followed up in part A between July 13, 2022, and July 13, 2023, and in part B between Oct 18, 2023, and Jan 25, 2024. 313 participants were randomly assigned (156 in the V116 plus placebo group and 157 in the PCV15 plus PPSV23 group) and 304 (97%) completed part A (152 in each group). 126 (81%) of 155 participants in the V116 plus placebo group as-treated population from part A received PCV15 in part B (administration interval median 11·4 months [range 9·5-16·9]). 221 (71%) participants were male and 91 (29%) were female. The mean age was 45 years (SD 13). V116 was immunogenic for all 21 serotypes contained in the vaccine, and immune responses on day 30 were generally similar to those seen with PCV15 plus PPSV23 at week 12 for the 13 common serotypes and higher for the eight serotypes unique to V116. In part A, fewer participants had at least one adverse event in the V116 plus placebo group (111 [72%] of 155 vs 141 [91%] of 155 in the PCV15 plus PPSV23 group) with a lower frequency of injection-site adverse events (79 [51%] vs 130 [84%]); serious adverse events were low (four [3%] vs six [4%]) and none were vaccine related. One non-vaccine-rel","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"72 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145068318","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}
Pub Date : 2025-09-11DOI: 10.1016/s2352-3018(25)00169-9
Andrew N Phillips,Matthew D Hickey,Starley B Shade,Jane Kabami,James Ayieko,Paul Revill,Elijah Kakande,Laura B Balzer,Nicole Sutter,Loveleen Bansi-Matharu,Jennifer Smith,Gabriel Chamie,Diane V Havlir,Moses R Kamya,Maya Petersen
BACKGROUNDIn randomised controlled trials in Kenya and Uganda, a dynamic choice HIV prevention (DCP) intervention that offered structured choice of biomedical prevention product and opportunity to change products over time substantially improved prevention coverage; incident HIV infections were eliminated when long-acting cabotegravir was included as an option. We aimed to assess the potential cost-effectiveness of the intervention regimen in east, central, southern, and west Africa.METHODSWe used the existing individual-based HIV Synthesis model. Through sampling of parameter values at the start of each model run of a simulated population of adults, we created 1000 setting-scenarios, reflecting uncertainty in assumptions and a range of characteristics similar to those seen in east, central, southern, and west Africa. For each setting-scenario, we simulated predicted outcomes including disability-adjusted life-years (DALYs) and costs up to 50 years resulting from (1) continuing with the status quo (ie, no DCP); (2) introduction of the DCP intervention with oral pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and condoms without long-acting cabotegravir PrEP (ie, DCP without cabotegravir); and (3) introduction of the DCP intervention and including long-acting cabotegravir PrEP (ie, DCP including cabotegravir). We used a cost-effectiveness threshold of US$500 per DALY averted, and a discount rate of 3% per year. The annual cost of DCP including cabotegravir was assumed to be $190 per person. Net DALYs averted was calculated by DALYs averted plus the difference in costs divided by the cost-effectiveness threshold.FINDINGSReflecting the trial results, among people with a PrEP indication (ie, having an HIV acquisition risk) and an HIV test in the past 3 months, the median proportion of people on PrEP was 14% (90% range 4-43) with no DCP, 54% (23-74) with DCP without cabotegravir, and 71% (35-83) with DCP including cabotegravir. These increases in PrEP use led to HIV incidence reductions, with incidence rate ratios of 0·89 (0·67-1·17) for DCP without cabotegravir and 0·64 (0·44-0·97) for DCP including cabotegravir, relative to no DCP. Across setting-scenarios, both DCP policies led to DALYs being averted: 18 400 DALYs per year (95% CI 16 700-20 100) for DCP including cabotegravir and 56 400 DALYs per year (52 300-60 500) for DCP without cabotegravir in 10 million adults. Compared with no DCP, there was a mean increase in annual discounted costs over 50 years: $8·6 million (7·7-9·4) for DCP without cabotegravir and $13·2 million (11·6-14·8) for DCP including cabotegravir. Addition of long-acting cabotegravir PrEP to DCP was cost-effective (vs DCP without cabotegravir); the incremental cost-effectiveness ratio for DCP including cabotegravir (vs no DCP) was $234 per DALY averted. There was substantial variation across setting-scenarios and we found that DCP was more likely to be the cost-effective choice in settings with high prevalence
{"title":"Dynamic choice HIV prevention with long-acting injectable cabotegravir pre-exposure prophylaxis in east, central, southern, and west Africa: a cost-effectiveness modelling analysis.","authors":"Andrew N Phillips,Matthew D Hickey,Starley B Shade,Jane Kabami,James Ayieko,Paul Revill,Elijah Kakande,Laura B Balzer,Nicole Sutter,Loveleen Bansi-Matharu,Jennifer Smith,Gabriel Chamie,Diane V Havlir,Moses R Kamya,Maya Petersen","doi":"10.1016/s2352-3018(25)00169-9","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00169-9","url":null,"abstract":"BACKGROUNDIn randomised controlled trials in Kenya and Uganda, a dynamic choice HIV prevention (DCP) intervention that offered structured choice of biomedical prevention product and opportunity to change products over time substantially improved prevention coverage; incident HIV infections were eliminated when long-acting cabotegravir was included as an option. We aimed to assess the potential cost-effectiveness of the intervention regimen in east, central, southern, and west Africa.METHODSWe used the existing individual-based HIV Synthesis model. Through sampling of parameter values at the start of each model run of a simulated population of adults, we created 1000 setting-scenarios, reflecting uncertainty in assumptions and a range of characteristics similar to those seen in east, central, southern, and west Africa. For each setting-scenario, we simulated predicted outcomes including disability-adjusted life-years (DALYs) and costs up to 50 years resulting from (1) continuing with the status quo (ie, no DCP); (2) introduction of the DCP intervention with oral pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and condoms without long-acting cabotegravir PrEP (ie, DCP without cabotegravir); and (3) introduction of the DCP intervention and including long-acting cabotegravir PrEP (ie, DCP including cabotegravir). We used a cost-effectiveness threshold of US$500 per DALY averted, and a discount rate of 3% per year. The annual cost of DCP including cabotegravir was assumed to be $190 per person. Net DALYs averted was calculated by DALYs averted plus the difference in costs divided by the cost-effectiveness threshold.FINDINGSReflecting the trial results, among people with a PrEP indication (ie, having an HIV acquisition risk) and an HIV test in the past 3 months, the median proportion of people on PrEP was 14% (90% range 4-43) with no DCP, 54% (23-74) with DCP without cabotegravir, and 71% (35-83) with DCP including cabotegravir. These increases in PrEP use led to HIV incidence reductions, with incidence rate ratios of 0·89 (0·67-1·17) for DCP without cabotegravir and 0·64 (0·44-0·97) for DCP including cabotegravir, relative to no DCP. Across setting-scenarios, both DCP policies led to DALYs being averted: 18 400 DALYs per year (95% CI 16 700-20 100) for DCP including cabotegravir and 56 400 DALYs per year (52 300-60 500) for DCP without cabotegravir in 10 million adults. Compared with no DCP, there was a mean increase in annual discounted costs over 50 years: $8·6 million (7·7-9·4) for DCP without cabotegravir and $13·2 million (11·6-14·8) for DCP including cabotegravir. Addition of long-acting cabotegravir PrEP to DCP was cost-effective (vs DCP without cabotegravir); the incremental cost-effectiveness ratio for DCP including cabotegravir (vs no DCP) was $234 per DALY averted. There was substantial variation across setting-scenarios and we found that DCP was more likely to be the cost-effective choice in settings with high prevalence ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"9 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058892","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}
Pub Date : 2025-09-05DOI: 10.1016/s2352-3018(25)00266-8
{"title":"Correction to Lancet HIV 2025; published online June 11. https://doi.org/10.1016/S2352-3018(25)00158-4.","authors":"","doi":"10.1016/s2352-3018(25)00266-8","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00266-8","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"35 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145018251","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}
Pub Date : 2025-09-04DOI: 10.1016/s2352-3018(25)00163-8
Jayne Ellis,Elisabetta Groppelli,Ronan Doyle,David S Lawrence,David B Meya,David R Boulware,Henry C Mwandumba,Cecilia Kanyama,Mina C Hosseinipour,Graeme Meintjes,Conrad Muzoora,Mosepele Mosepele,Chiratidzo E Ndhlovu,Thomas S Harrison,Joseph N Jarvis,
BACKGROUNDHIV-associated cryptococcal meningitis case fatality remains greater than 25%. Co-prevalent infections might contribute to poor outcomes. We aimed to ascertain the prevalence and the clinical significance of Epstein-Barr virus (EBV) and cytomegalovirus co-infections in patients with cryptococcal meningitis to guide potential therapeutic interventions.METHODSWe conducted a post-hoc analysis of a prospective cohort using plasma and cerebrospinal fluid (CSF) samples collected in the AMBITION-cm randomised trial. AMBITION-cm was done at seven hospital sites across five African countries (Botswana, Malawi, South Africa, Uganda, and Zimbabwe). The primary endpoint of the trial was all-cause mortality at 10 weeks. Quantitative PCR (qPCR) was used to measure baseline cytomegalovirus and EBV viral loads in these samples. Baseline demographic and clinical data including antiretroviral therapy status, and laboratory data including CD4 cell count, CSF white cell count, protein, glucose, and quantitative cryptococcal culture were captured in real time via an electronic medical records system. We assessed the prevalence of cytomegalovirus plasma viraemia and EBV plasma viraemia, and CNS co-infections, associations between cytomegalovirus and EBV co-infection status and baseline covariates, and associations with 2-week and 10-week mortality.FINDINGSBetween Jan 31, 2018, and Feb 18, 2021, among 811 participants enrolled, 60% were male, median age was 37 years (IQR 32-43), and median baseline CD4 count was 27 cells per μL (IQR 10-58). Cytomegalovirus plasma viraemia was present in 395 (49%) of 804 participants and EBV plasma viraemia was present in 585 (73%) participants. 39 (5%) of 707 participants had detectable cytomegalovirus in the CSF and 191 (27%) of 708 participants had detectable EBV. Cytomegalovirus plasma viraemia was associated with lower CD4 cell counts, less CSF inflammation, and higher CSF fungal burdens. Conversely, EBV plasma viraemia was associated with higher CD4 cell counts and more CSF inflammation. At 2 and 10 weeks, the risk of mortality was two times higher in participants with high-level cytomegalovirus plasma viraemia (≥1000 copies per mL) than in participants without cytomegalovirus plasma viraemia (adjusted odds ratio 2·31 [95% CI 1·12-4·75] at 2 weeks; 2·44 [1·33-4·45] at 10 weeks). EBV coinfections were not associated with increased mortality.INTERPRETATIONThese data indicate that cytomegalovirus might be an important copathogen in this context, and that cytomegalovirus viraemia represents a potentially modifiable risk factor to reduce mortality among adults with HIV-associated cryptococcal meningitis. Interventional trials are now required and planned to determine whether treatment of cytomegalovirus viraemia improves outcomes in advanced HIV disease.FUNDINGNational Institute for Health and Care Research, European and Developing Countries Clinical Trials Partnership, Medical Research Council, and Wellcome Trust.
{"title":"Epstein-Barr virus and cytomegalovirus co-infections and mortality risk in patients with HIV-associated cryptococcal meningitis: a post-hoc analysis of a prospective nested cohort in the AMBITION-cm randomised controlled trial.","authors":"Jayne Ellis,Elisabetta Groppelli,Ronan Doyle,David S Lawrence,David B Meya,David R Boulware,Henry C Mwandumba,Cecilia Kanyama,Mina C Hosseinipour,Graeme Meintjes,Conrad Muzoora,Mosepele Mosepele,Chiratidzo E Ndhlovu,Thomas S Harrison,Joseph N Jarvis, ","doi":"10.1016/s2352-3018(25)00163-8","DOIUrl":"https://doi.org/10.1016/s2352-3018(25)00163-8","url":null,"abstract":"BACKGROUNDHIV-associated cryptococcal meningitis case fatality remains greater than 25%. Co-prevalent infections might contribute to poor outcomes. We aimed to ascertain the prevalence and the clinical significance of Epstein-Barr virus (EBV) and cytomegalovirus co-infections in patients with cryptococcal meningitis to guide potential therapeutic interventions.METHODSWe conducted a post-hoc analysis of a prospective cohort using plasma and cerebrospinal fluid (CSF) samples collected in the AMBITION-cm randomised trial. AMBITION-cm was done at seven hospital sites across five African countries (Botswana, Malawi, South Africa, Uganda, and Zimbabwe). The primary endpoint of the trial was all-cause mortality at 10 weeks. Quantitative PCR (qPCR) was used to measure baseline cytomegalovirus and EBV viral loads in these samples. Baseline demographic and clinical data including antiretroviral therapy status, and laboratory data including CD4 cell count, CSF white cell count, protein, glucose, and quantitative cryptococcal culture were captured in real time via an electronic medical records system. We assessed the prevalence of cytomegalovirus plasma viraemia and EBV plasma viraemia, and CNS co-infections, associations between cytomegalovirus and EBV co-infection status and baseline covariates, and associations with 2-week and 10-week mortality.FINDINGSBetween Jan 31, 2018, and Feb 18, 2021, among 811 participants enrolled, 60% were male, median age was 37 years (IQR 32-43), and median baseline CD4 count was 27 cells per μL (IQR 10-58). Cytomegalovirus plasma viraemia was present in 395 (49%) of 804 participants and EBV plasma viraemia was present in 585 (73%) participants. 39 (5%) of 707 participants had detectable cytomegalovirus in the CSF and 191 (27%) of 708 participants had detectable EBV. Cytomegalovirus plasma viraemia was associated with lower CD4 cell counts, less CSF inflammation, and higher CSF fungal burdens. Conversely, EBV plasma viraemia was associated with higher CD4 cell counts and more CSF inflammation. At 2 and 10 weeks, the risk of mortality was two times higher in participants with high-level cytomegalovirus plasma viraemia (≥1000 copies per mL) than in participants without cytomegalovirus plasma viraemia (adjusted odds ratio 2·31 [95% CI 1·12-4·75] at 2 weeks; 2·44 [1·33-4·45] at 10 weeks). EBV coinfections were not associated with increased mortality.INTERPRETATIONThese data indicate that cytomegalovirus might be an important copathogen in this context, and that cytomegalovirus viraemia represents a potentially modifiable risk factor to reduce mortality among adults with HIV-associated cryptococcal meningitis. Interventional trials are now required and planned to determine whether treatment of cytomegalovirus viraemia improves outcomes in advanced HIV disease.FUNDINGNational Institute for Health and Care Research, European and Developing Countries Clinical Trials Partnership, Medical Research Council, and Wellcome Trust.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"21 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008832","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}
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