Lancet Hiv最新文献

{"title":"Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial.","authors":"Anthony M Mills, Giuliano Rizzardini, Moti N Ramgopal, Olayemi O Osiyemi, Johannes R Bogner, Debbie P Hagins, Roger Paredes, Jacques Reynes, Jürgen K Rockstroh, Andrew Carr, Feng-Hsiu Su, Stephanie O Klopfer, Karen Eves, Rebeca M Plank, Todd Correll, Michelle C Fox","doi":"10.1016/S2352-3018(24)00030-4","DOIUrl":"10.1016/S2352-3018(24)00030-4","url":null,"abstract":"<p><strong>Background: </strong>Doravirine and islatravir is an investigational, once-daily regimen with high antiviral potency, favourable safety and tolerability, and a low propensity for resistance. We investigated a switch from bictegravir, emtricitabine, and tenofovir alafenamide to doravirine (100 mg) and islatravir (0·75 mg) in virologically suppressed adults with HIV-1.</p><p><strong>Methods: </strong>We conducted a phase 3, multicentre, randomised, active-controlled, double-blind, double-dummy, non-inferiority trial at 89 research, community, and hospital-based clinics in 11 countries. Adults aged 18 years or older with fewer than 50 HIV-1 RNA copies per mL for at least 3 months on bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) and no history of previous virological failure on any past or current regimen were randomly assigned (1:1) by a computer-generated randomisation allocation schedule, with block randomisation based on a block size of four, to switch to doravirine (100 mg) and islatravir (0·75 mg) or continue bictegravir, emtricitabine, and tenofovir alafenamide orally once daily, with matching placebos taken by all participants. Participants, investigators, study staff, and sponsor personnel involved in study drug administration or clinical evaluation of participants were masked to treatment assignment until week 48. Participants were instructed at each visit to take one tablet from each of the two bottles received, one of study drug and one of placebo, once daily, and participants were assessed at baseline and weeks 4, 12, 24, 36, and 48. The primary endpoint was the proportion of participants with greater than or equal to 50 HIV-1 RNA copies per mL at week 48 in the full analysis set (ie, all participants who received at least one dose of study drug; US Food and Drug Administration snapshot; prespecified non-inferiority margin 4%). The study is ongoing, with all remaining participants in post-treatment follow-up, and is registered with ClinicalTrials.gov, NCT04223791.</p><p><strong>Findings: </strong>We screened 726 individuals for eligibility between Feb 18 and Sept 3, 2020, of whom 643 (88·6%) participants were randomly assigned to a treatment group (183 [28·5%] women and 460 [71·5%] men). 322 participants were switched to doravirine (100 mg) and islatravir (0·75 mg) and 321 continued bictegravir, emtricitabine, and tenofovir alafenamide (two participants [one with a protocol deviation and one who withdrew] assigned to bictegravir, emtricitabine, and tenofovir alafenamide did not receive treatment). The last follow-up visit for the week 48 analysis occurred on Aug 26, 2021. At week 48, two (0·6%) of 322 participants in the doravirine and islatravir group compared with one (0·3%) of 319 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group had greater than or equal to 50 HIV-1 RNA copies per mL (difference 0·3%, 95% CI -1·2 to 2·0). The per-protocol analysis showed consis","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e357-e368"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140909680","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":"Sex workers are a key population in society.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(24)00129-2","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00129-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 6","pages":"e345"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181067","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":"Dynamics of virological and immunological markers of HIV persistence after allogeneic haematopoietic stem-cell transplantation in the IciStem cohort: a prospective observational cohort study.","authors":"Maria Salgado, Cristina Gálvez, Monique Nijhuis, Mi Kwon, E Fabian Cardozo-Ojeda, Jon Badiola, Matthew J Gorman, Laura E P Huyveneers, Victor Urrea, Alessandra Bandera, Björn-Erik Ole Jensen, Linos Vandekerckhove, Manuel Jurado, Kavita Raj, Julian Schulze Zur Wiesch, Rebeca Bailén, Johanna M Eberhard, Mitja Nabergoj, Gero Hütter, Raquel Saldaña-Moreno, Sharon Oldford, Lisa Barrett, Maria Luisa Montes Ramirez, Salisu Garba, Ravi Kumar Gupta, Boris Revollo, Christelle Ferra-Coll, Jurgen Kuball, Galit Alter, Asier Sáez-Cirión, Jose Luis Diez-Martin, Elizabeth R Duke, Joshua T Schiffer, Annemarie Wensing, Javier Martinez-Picado","doi":"10.1016/S2352-3018(24)00090-0","DOIUrl":"10.1016/S2352-3018(24)00090-0","url":null,"abstract":"<p><strong>Background: </strong>Allogeneic haematopoietic stem-cell transplantation (allo-HSCT) markedly reduces HIV reservoirs, but the mechanisms by which this occurs are only partly understood. In this study, we aimed to describe the dynamics of virological and immunological markers of HIV persistence after allo-HSCT.</p><p><strong>Methods: </strong>In this prospective observational cohort study, we analysed the viral reservoir and serological dynamics in IciStem cohort participants with HIV who had undergone allo-HSCT and were receiving antiretroviral therapy, ten of whom had received cells from donors with the CCR5Δ32 mutation. Participants from Belgium, Canada, Germany, Italy, the Netherlands, Spain, Switzerland, and the UK were included in the cohort both prospectively and retrospectively between June 1, 2014 and April 30, 2019. In the first 6 months after allo-HSCT, participants had monthly assessments, with annual assessments thereafter, with the protocol tailored to accommodate for the individual health status of each participant. HIV reservoirs were measured in blood and tissues and HIV-specific antibodies were measured in plasma. We used the Wilcoxon signed-rank test to compare data collected before and after allo-HSCT in participants for whom longitudinal data were available. When the paired test was not possible, we used the Mann-Whitney U test. We developed a mathematical model to study the factors influencing HIV reservoir reduction in people with HIV after allo-HSCT.</p><p><strong>Findings: </strong>We included 30 people with HIV with haematological malignancies who received a transplant between Sept 1, 2009 and April 30, 2019 and were enrolled within the IciStem cohort and included in this analysis. HIV reservoirs in peripheral blood were reduced immediately after full donor chimerism was achieved, generally accompanied by undetectable HIV-DNA in bone marrow, ileum, lymph nodes, and cerebrospinal fluid, regardless of donor CCR5 genotype. HIV-specific antibody levels and functionality values declined more slowly than direct HIV reservoir values, decaying significantly only months after full donor chimerism. Mathematical modelling suggests that allogeneic immunity mediated by donor cells is the main viral reservoir depletion mechanism after massive reservoir reduction during conditioning chemotherapy before allo-HSCT (half-life of latently infected replication-competent cells decreased from 44 months to 1·5 months).</p><p><strong>Interpretation: </strong>Our work provides, for the first time, data on the effects of allo-HSCT in the context of HIV infection. Additionally, we raise the question of which marker can serve as the last reporter of the residual viraemia, postulating that the absence of T-cell immune responses might be a more reliable marker than antibody decline after allo-HSCT.</p><p><strong>Funding: </strong>amfAR (American Foundation for AIDS Research; ARCHE Program), National Institutes of Health, National Institute ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 6","pages":"e389-e405"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181060","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":"Tajikistan's tentative steps to tackling HIV.","authors":"Ed Holt","doi":"10.1016/S2352-3018(24)00088-2","DOIUrl":"10.1016/S2352-3018(24)00088-2","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e354-e355"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140330236","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":"Critical illness due to infection in people living with HIV.","authors":"Guy A Richards, Jarrod Zamparini, Ismail Kalla, Abdullah Laher, Lyle W Murray, Erica J Shaddock, Sarah Stacey, Wd Francois Venter, Charles Feldman","doi":"10.1016/S2352-3018(24)00096-1","DOIUrl":"10.1016/S2352-3018(24)00096-1","url":null,"abstract":"<p><p>People living with HIV comprise a substantial number of the patients admitted to intensive care. This number varies according to geography, but all areas of the world are affected. In lower-income and middle-income countries, the majority of intensive care unit (ICU) admissions relate to infections, whereas in high-income countries, they often involve HIV-associated non-communicable diseases diagnoses. Management of infections potentially resulting in admission to the ICU in people living with HIV include sepsis, respiratory infections, COVID-19, cytomegalovirus infection, and CNS infections, both opportunistic and non-opportunistic. It is crucial to know which antiretroviral therapy (ART) is appropriate, when is the correct time to administer it, and to be aware of any safety concerns and potential drug interactions with ART. Although ART is necessary for controlling HIV infections, it can also cause difficulties relevant to the ICU such as immune reconstitution inflammatory syndrome, and issues associated with ART administration in patients with gastrointestinal dysfunction on mechanical ventilation. Managing infection in people with HIV in the ICU is complex, requiring collaboration from a multidisciplinary team knowledgeable in both the management of the specific infection and the use of ART. This team should include intensivists, infectious disease specialists, pharmacists, and microbiologists to ensure optimal outcomes for patients.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 6","pages":"e406-e418"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181058","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":"Context-specific estimates of vertical transmission.","authors":"Souleymane Tassembedo, Isidore Tiandiogo Traore, Abdoul-Salam Ouedraogo, Nicolas Meda, Philippe Van de Perre, Nicolas Nagot, Fati Kirakoya-Samadoulougou","doi":"10.1016/S2352-3018(24)00095-X","DOIUrl":"10.1016/S2352-3018(24)00095-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e353"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855602","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":"Two-drug regimens for the treatment of HIV in Africa.","authors":"Ivan Mambule, Claire Norcross, Loice Achieng Ombajo, Simiso Sokhela, Eva Agnes Laker Odongpiny, Noela Owarwo, David S Lawrence, Eugene Ruzagira, Fiona V Cresswell","doi":"10.1016/S2352-3018(24)00061-4","DOIUrl":"10.1016/S2352-3018(24)00061-4","url":null,"abstract":"<p><p>Two-drug regimens for the treatment of HIV are increasingly available. The oral regimen of dolutegravir plus lamivudine is recommended as a preferred option in multiple national guidelines but is not currently included in WHO HIV treatment guidelines nor widely used in Africa. Long-acting injectable cabotegravir and rilpivirine is being rolled out in the USA, Europe, and Australia but its use in sub-Saharan Africa is currently restricted to clinical trials. Given the increasing life expectancy, rising prevalence of non-communicable diseases, and resulting polypharmacy among people living with HIV, there are potential advantages to the use of two-drug regimens, particularly in African women, adolescents, and older adults. This Viewpoint reviews existing evidence and highlights the risks, benefits, and key knowledge gaps for the use of two-drug regimens in settings using the public health approach in Africa. We suggest that a two-drug regimen of dolutegravir and lamivudine can be safely used as a switch option for virologically suppressed individuals in settings using the public health approach once chronic hepatitis B has been excluded. Individuals with HIV who are switched to two-drug regimens should receive a full course of hepatitis B vaccinations. More efficacy data is needed to support dolutegravir plus lamivudine combination in the test and treat approach, and long-acting cabotegravir and rilpivirine in the public health system in sub-Saharan Africa.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e419-e426"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872331","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":"Correction to Lancet HIV 2024; 11: e285-99.","authors":"","doi":"10.1016/S2352-3018(24)00152-8","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00152-8","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":16.1,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141238478","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":"Another crackdown on LGBTQ+ people in Africa.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(24)00100-0","DOIUrl":"10.1016/S2352-3018(24)00100-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 5","pages":"e273"},"PeriodicalIF":12.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140865520","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":"Collective antiretroviral protection: new dimensions of community HIV prevention practices at the intersection of U=U and PrEP.","authors":"Julien B Brisson, Daniel Grace, Amaya G Perez-Brumer","doi":"10.1016/S2352-3018(24)00034-1","DOIUrl":"10.1016/S2352-3018(24)00034-1","url":null,"abstract":"<p><p>Collective antiretroviral protection is an evolving sexual health strategy in HIV prevention, used in particular by gay, bisexual, and other men who have sex with men. The strategy involves HIV-negative individuals who engage in condomless sexual activities but, instead of using pre-exposure prophylaxis (PrEP) themselves, choose partners who either have undetectable viral loads or are on PrEP. This biomedical-sorting practice, rooted in the scientific principles of undetectable equals untransmittable (U=U) and PrEP, relies on an indirect protection strategy. Collective antiretroviral protection allows for HIV-negative individuals not on PrEP to benefit from their partner's antiretroviral use, without directly consuming antiretrovirals themselves for HIV prevention, during condomless sex. Empirical research is needed to evaluate the public health implications of this emerging sexual health approach. Research and public health initiatives should adopt a non-stigmatising approach to individuals engaging in collective antiretroviral protection and look beyond individual behaviour to understand the broader community-level effects of this innovative HIV prevention strategy.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e341-e344"},"PeriodicalIF":16.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186015","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}