HIV Medicine最新文献

{"title":"Impact of omission of routine blood monitoring of stable patients living with HIV during the coronavirus pandemic.","authors":"Eleanor Swift, George Upton, Colin Fitzpatrick, Jonathan Roberts, Yvonne Gilleece, Amanda Clarke","doi":"10.1111/hiv.13696","DOIUrl":"10.1111/hiv.13696","url":null,"abstract":"<p><strong>Introduction: </strong>The British HIV Association (BHIVA) guidelines were amended during the coronavirus (COVID-19) pandemic, allowing for less frequent monitoring of routine bloods. We assessed the impact of this on patient outcomes.</p><p><strong>Methods: </strong>Between April 2020 and March 2021, routine blood appointments at our HIV clinic were replaced by virtual consultations in 'stable' people living with HIV (PLWH), defined using standard operating procedure (SOP) criteria. All had an undetectable HIV viral load (VL) (<50 copies/mL). Demographic, HIV clinical information, and antiretroviral treatment (ART) data were collated using the electronic patient record (EPR). Blood results from before (baseline) and after (follow-up) the omitted appointment were analysed for each parameter.</p><p><strong>Results: </strong>In all, 791/2395 PLWH were scheduled to have blood tests omitted; 381 were excluded for reasons including not fitting the SOP criteria or presenting to clinic early, and 410 were included in analysis. The demographics of the group were consistent with our whole HIV cohort. HIV VL became detectable in 8/410 individuals (1.95%, range 51-730 copies/mL). VL resuppressed in 6/8 after a median of 29 days. VL remained detectable in two individuals, both of whom remain in care. Routine blood monitoring revealed baseline and follow-up blood parameters that were largely within normal range. Four out of 12 parameters had statistically significant changes but were not considered clinically significant; 59/410 (14.4%) changed ART, most commonly for simplification.</p><p><strong>Conclusion: </strong>For the majority of stable PLWH included in our evaluation, the omission of routine blood monitoring during the pandemic did not have a negative impact on HIV suppression or blood monitoring outcomes. ART switch was uncommon.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.","authors":"Christoph Stephan, Christoph D Spinner, Ansgar Rieke, Stefan Christensen, Stefan Mauss, Sandra Schreiber, Boris Albuquerque, Marion Heinzkill, Heribert Ramroth, Hans-Jürgen Stellbrink","doi":"10.1111/hiv.13728","DOIUrl":"https://doi.org/10.1111/hiv.13728","url":null,"abstract":"<p><strong>Background: </strong>Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence.</p><p><strong>Methods: </strong>Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires.</p><p><strong>Results: </strong>The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE.</p><p><strong>Conclusion: </strong>Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular prevention: Statins and beyond-A message from the editors of the special issue of HIV medicine.","authors":"Laura Waters, Esteban Martinez","doi":"10.1111/hiv.13731","DOIUrl":"https://doi.org/10.1111/hiv.13731","url":null,"abstract":"","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of risk factors and mortality in veterans with HIV and those without HIV suffering first major acute cardiovascular events.","authors":"William L Hicks, Suzan Khalil, Floyd W Burke, Minh Quang Ho, Ishak Mansi","doi":"10.1111/hiv.13724","DOIUrl":"https://doi.org/10.1111/hiv.13724","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have demonstrated that people with HIV have an increased atherosclerotic plaque vulnerability, making them more susceptible to severe cardiovascular complications. This study aimed to examine the clinical characteristics of people with HIV in comparison to people without HIV admitted to Veterans Health Administration (VHA) with their first major acute cardiovascular events (MACE) and compare their total mortality.</p><p><strong>Methods: </strong>We used national VHA data to extract data of those admitted to VHA hospitals with MACE defined as acute myocardial infarction (AMI), acute cerebrovascular accident (CVA) or cardiac arrest during the fiscal years 2003-2021. The hazard ratio (HR) of mortality for people with HIV versus people without HIV was estimated using Cox proportional hazard regression analysis.</p><p><strong>Results: </strong>Out of 280 311 veterans, 2510 people with HIV and 277 801 people without HIV had their first MACE during the study period. People with HIV were younger, more likely to be African American, had a lower prevalence of diabetes mellitus and hypertension, similar total cholesterol levels and a lower mean 10-year cardiovascular risk score (25.4 in people with HIV vs. 28.7 in people without HIV). Among MACE components, people with HIV had a higher proportion of CVA (27% vs. 21.3%, p < 0.001) and cardiac arrest (13.0% vs. 8.4%, p < 0.001) but a lower incidence of AMI (62.4% vs. 72.5%, p < 0.001) than people without HIV. Additionally, people with HIV had a higher risk of total mortality (adjusted HR: 2.05, 95% confidence interval: 1.90-2.22) compared with people without HIV.</p><p><strong>Conclusion: </strong>People with HIV experience MACE at younger ages despite lower cardiovascular risks and similar baseline cholesterol and blood pressure levels. People with HIV had higher mortality and a higher risk of having ventricular fibrillation arrest and stroke as their first MACE.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Should we measure quality of life among people with HIV? A multicentre survey of physicians' opinions in Spain.","authors":"Rebeca Izquierdo, Inés Suárez-García, Teresa Gómez-García, Cristina Marco-Sánchez, Julián Puente-Ferreiro, Cristina Moreno, Asunción Diaz, Noemí Cabello-Clotet, David Vinuesa, José Luis Blanco, Estrella Melús, Cristina Gómez-Ayerbe, Julián Olalla, Melchor Riera, José Ignacio Bernardino, Juan Carlos de López Bernaldo de Quirós, Santiago Moreno, Inma Jarrín","doi":"10.1111/hiv.13726","DOIUrl":"https://doi.org/10.1111/hiv.13726","url":null,"abstract":"<p><strong>Objectives: </strong>We assessed the opinions of physicians caring for people with HIV (PWH) from the multicentre Spanish CoRIS cohort regarding the assessment of health-related quality of life (HRQoL).</p><p><strong>Methods: </strong>We designed an online self-administered questionnaire comprising 27 structured questions across four domains: (i) sociodemographic and clinical data; (ii) usefulness of measuring HRQoL; (iii) information, training and resource needed; and (iv) whether and how HRQoL should be measured. Physicians completed the questionnaire between April and June 2023.</p><p><strong>Results: </strong>Of 131 physicians surveyed [53.8% men, median age 52 years (interquartile range: 42-60)], 90.9% and 88.6% agreed that measuring HRQoL is useful for both PWH and medical decision-making, respectively. However, 67.2% needed training on what HRQoL is and how to measure it, 79.4% required information on validated tools, and 80.9% felt that clinical guidelines are needed. Overall, 90.1% of physicians agreed that HRQoL should be measured among PWH. Most physicians (82.8%) supported using specific scales for PWH, with 74.1% recommending annual measurement, 49.1% suggesting that nurses from HIV units conduct the assessments, and 43.1% favouring personal interviews during medical visits. At the time of the survey, 55.3% of physicians did not measure HRQoL in any patients due to time or resource constraints (75.8%).</p><p><strong>Conclusions: </strong>Despite the recognized importance of HRQoL measurement in PWH, Spanish physicians encounter barriers such as time constraints and limited resources. Developing clear guidelines, using tailored scales, and integrating digital tools along with multidisciplinary support could enhance routine HRQoL assessments and improve patient-centred care.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HIV postnatal prophylaxis and infant feeding policies vary across Europe: results of a Penta survey.","authors":"Georgina Fernandes, Elizabeth Chappell, Tessa Goetghebuer, Christian R Kahlert, Santa Ansone, Stefania Bernardi, Guido Castelli Gattinara, Elena Chiappini, Catherine Dollfus, Pierre Frange, Bridget Freyne, Luisa Galli, Vania Giacomet, Galia Grisaru-Soen, Christoph Königs, Hermione Lyall, Magdalena Marczynska, Mariana Mardarescu, Lars Naver, Tim Niehues, Antoni Noguera-Julian, Kim Stol, Alla Volokha, Steven B Welch, Claire Thorne, Alasdair Bamford","doi":"10.1111/hiv.13723","DOIUrl":"https://doi.org/10.1111/hiv.13723","url":null,"abstract":"<p><strong>Objectives: </strong>This survey was conducted to describe current European postnatal prophylaxis (PNP) and infant feeding policies with the aim of informing future harmonized guidelines.</p><p><strong>Methods: </strong>A total of 32 senior clinicians with relevant expertise, working in 20 countries within the European Region, were invited to complete a REDCap questionnaire between July and September 2023.</p><p><strong>Results: </strong>Twenty-three of the 32 invited paediatricians responded, representing 16/20 countries. There were multiple respondents from the same country for Italy (n = 5), the UK (n = 2), Germany (n = 2) and France (n = 2). All countries use risk stratification to guide PNP regimen selection. Nine out of 16 countries reported three risk categories, six out of 16 reported two, and one country reported differences in categorization. Criteria used to stratify risk varied between and within countries. For the lowest risk category, the PNP regimen reported ranged from no PNP to up to four weeks of one drug; the drug of choice reported was zidovudine, apart from one country which reported nevirapine. For the highest risk category, the most common regimen was zidovudine/lamivudine/nevirapine (20/23 respondents); regimen duration varied from two to six weeks with variation in recommended dosing. Guidelines support breastfeeding for infants born to people living with HIV in eight out of 16 countries; in the other eight, guidelines do not support/specify.</p><p><strong>Conclusions: </strong>Guidelines and practice for PNP and infant feeding vary substantially across Europe and within some countries, reflecting the lack of robust evidence. Effort is needed to align policies and practice to reflect up-to-date knowledge to ensure the vertical transmission risk is minimized and unnecessary infant HIV testing and PNP avoided, while simultaneously supporting families to make informed decisions on infant feeding choice.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Are people with HIV at advanced disease stages being left behind? A global survey.","authors":"Fernanda Fonseca, Vivian I Avelino-Silva, Wilfred Odoke, Jan van den Hombergh, Adele Schwartz Benzaken","doi":"10.1111/hiv.13725","DOIUrl":"https://doi.org/10.1111/hiv.13725","url":null,"abstract":"<p><strong>Introduction: </strong>A substantial percentage of people with HIV are still admitted for care at advanced disease stages. Here, we investigate the availability of the supplies and infrastructure required to provide care for this population in healthcare facilities and explore correlations with local demand.</p><p><strong>Methods: </strong>AIDS Healthcare Foundation's partner facilities were invited to respond to a survey addressing the availability of services to support clients with advanced HIV. We present results per continent and according to gross national income per capita using frequencies and percentages. We generated country-level scores taking the average percentage of facilities with available resources on 10 key items and used Spearman's correlation to investigate relationships between country scores and local demand, depicted by the percentages of people with HIV newly enrolled in care with a CD4 T-cell count <200/mm³ in 2022.</p><p><strong>Results: </strong>A total of 643 facilities from 37 countries responded to the survey between September and December 2021. Overall, services requiring more costly equipment and/or supplies were less frequently available. Facilities in Africa, Asia, and Latin America/Caribbean and those with lower gross national income had a somewhat lower availability of diagnostic and therapeutic resources. Availability of services was not correlated with local demand: 14 countries (42%) had scores below the 50% percentile despite having >20% of newly enrolled people with HIV with a CD4 T-cell count <200/mm³.</p><p><strong>Conclusion: </strong>Appropriate care can mitigate the morbidity and mortality associated with advanced HIV. We found that the healthcare services recommended by the World Health Organization as essential to support clients with advanced HIV are often unavailable in facilities providing HIV care, despite high local demand.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"'We are fragile, but we are strong': A qualitative study of perspectives, experiences and priority outcomes for people living with HIV and frailty.","authors":"Natalie St Clair-Sullivan, Jaime H Vera, Matthew Maddocks, Richard Harding, Thomas Levett, Jonathan Roberts, Zoe Adler, Stephen Bremner, Gary Pargeter, Katherine Bristowe","doi":"10.1111/hiv.13722","DOIUrl":"https://doi.org/10.1111/hiv.13722","url":null,"abstract":"<p><strong>Objectives: </strong>Advances in antiretroviral therapy have meant that the focus of HIV care has shifted to chronic disease management. The HIV population is ageing, and the prevalence of frailty is increasing. This study aimed to explore the perspectives and experiences of the impact of living with HIV and frailty and priority outcomes in relation to wellbeing and ageing.</p><p><strong>Methods: </strong>In-depth qualitative interviews were undertaken with older people living with HIV who screened positive for frailty using the FRAIL scale. Participants were recruited from a UK outpatient HIV clinic. Interviews were analysed using reflexive thematic analysis.</p><p><strong>Results: </strong>In total, 24 people living with HIV were interviewed. Frailty was described as not being able to do the things you could and living with limitations that impacted physical, psychological and social wellbeing. Being identified as frail was not always surprising, but acceptance of this diagnosis required an understanding of what frailty means and what they can do to address it. For people living with HIV, the word 'frail' was largely acceptable when its clinical meaning was explained. However, participants questioned whether a different term is needed if this is a new 'HIV-associated frailty'. Priority outcomes were slowing the progression of frailty, retaining independence and being treated holistically.</p><p><strong>Conclusion: </strong>When talking about frailty with people living with HIV, professionals need to balance honesty and sensitivity and provide clear information about the meaning and impact for the person. Holistic management plans must recognize the physical and psycho-social impact of frailty and prioritize slowing its progression and reducing its impact on independence.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The first AI-based Chatbot to promote HIV self-management: A mixed methods usability study.","authors":"Yuanchao Ma, Sofiane Achiche, Gavin Tu, Serge Vicente, David Lessard, Kim Engler, Benoît Lemire, Moustafa Laymouna, Alexandra de Pokomandy, Joseph Cox, Bertrand Lebouché","doi":"10.1111/hiv.13720","DOIUrl":"https://doi.org/10.1111/hiv.13720","url":null,"abstract":"<p><strong>Background: </strong>We developed MARVIN, an artificial intelligence (AI)-based chatbot that provides 24/7 expert-validated information on self-management-related topics for people with HIV. This study assessed (1) the feasibility of using MARVIN, (2) its usability and acceptability, and (3) four usability subconstructs (perceived ease of use, perceived usefulness, attitude towards use, and behavioural intention to use).</p><p><strong>Methods: </strong>In a mixed-methods study conducted at the McGill University Health Centre, enrolled participants were asked to have 20 conversations within 3 weeks with MARVIN on predetermined topics and to complete a usability questionnaire. Feasibility, usability, acceptability, and usability subconstructs were examined against predetermined success thresholds. Qualitatively, randomly selected participants were invited to semi-structured focus groups/interviews to discuss their experiences with MARVIN. Barriers and facilitators were identified according to the four usability subconstructs.</p><p><strong>Results: </strong>From March 2021 to April 2022, 28 participants were surveyed after a 3-week testing period, and nine were interviewed. Study retention was 70% (28/40). Mean usability exceeded the threshold (69.9/68), whereas mean acceptability was very close to target (23.8/24). Ratings of attitude towards MARVIN's use were positive (+14%), with the remaining subconstructs exceeding the target (5/7). Facilitators included MARVIN's reliable and useful real-time information support, its easy accessibility, provision of convivial conversations, confidentiality, and perception as being emotionally safe. However, MARVIN's limited comprehension and the use of Facebook as an implementation platform were identified as barriers, along with the need for more conversation topics and new features (e.g., memorization).</p><p><strong>Conclusions: </strong>The study demonstrated MARVIN's global usability. Our findings show its potential for HIV self-management and provide direction for further development.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysis.","authors":"Joseph J Eron, Moti Ramgopal, Olayemi Osiyemi, Mehri Mckellar, Jihad Slim, Edwin Dejesus, Priyanka Arora, Christiana Blair, Jason T Hindman, Aimee Wilkin","doi":"10.1111/hiv.13721","DOIUrl":"https://doi.org/10.1111/hiv.13721","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment for people with HIV-1 and end-stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose-adjusted regimens, with limited data on the use of a single-tablet regimen in this population. Our aim was to assess the efficacy and safety of once-daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and to evaluate the pharmacokinetics of bictegravir (BIC) in adults with HIV-1 and ESKD on HD.</p><p><strong>Methods: </strong>We performed an open-label extension (OLE) of an open-label, multicentre, single-group phase 3b study (NCT02600819) of adults with ESKD on HD and HIV-1 with virological suppression. Participants switched to elvitegravir/cobicistat/F/TAF (E/C/F/TAF) 150/150/200/10 mg for 96 weeks, following which a subgroup of US participants entered an OLE phase in which they switched to B/F/TAF 50/200/25 mg for 48 weeks, returning for study visits at weeks 4 and 12, and every 12 weeks thereafter. Study assessments included virological response, safety and pharmacokinetic analysis of BIC.</p><p><strong>Results: </strong>Ten participants entered the OLE (median age, 55 years). Virological suppression (HIV-1 RNA <50 copies/mL) was maintained in all participants over 48 weeks of B/F/TAF treatment. B/F/TAF was well tolerated, with no treatment discontinuations. Mean BIC trough concentrations were lower than those previously reported for people with HIV-1 with normal kidney function, but remained four- to seven-fold higher than the established protein-adjusted 95% effective concentration against wild-type HIV-1.</p><p><strong>Conclusion: </strong>These findings support the use of the once-daily B/F/TAF single-tablet regimen for people with HIV-1 and ESKD on HD. This regimen offers a convenient treatment option for this population as it reduces the need for dose adjustment, eases pill burden and avoids potential drug-drug interactions associated with alternatives that may impact individuals on multiple medications or awaiting transplantation.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}