Objectives: We aimed to describe health-related quality of life (HRQoL), overall and across its dimensions, identify associated factors, and assess changes over time among people with HIV (PWH) from the Spanish multicentre CoRIS cohort.
Methods: We developed a mobile app to collect HRQoL data every 3 months using the WHOQOL-HIV-BREF questionnaire (31 items across six domains), among PWH followed in CoRIS in 2021-2023. Factors associated with good/very good global HRQoL and with domain-specific mean scores were identified using multivariable logistic and linear regression, respectively.
Results: Of 414 PWH (94.2% on antiretroviral treatment, 91.1% virally suppressed), 51.2% reported good/very good HRQoL. Latin American migrants (adjusted OR: 0.60 [95% CI: 0.36; 1.00]), and participants with lower educational level (0.36 [0.21; 0.64]), a previous AIDS diagnosis (0.56 [0.29; 1.11]) and a history of non-AIDS-related cancers (0.40 [0.14; 1.14]) were less likely to report good/very good global HRQoL. The most affected items included sexual satisfaction, forgiveness and blame, sleep and rest, and concerns about the future, with spirituality, religion and personal beliefs as the most affected domain. Latin American origin, lower educational level and shorter (<2 years) or longer (>15 years) time since HIV diagnosis were associated with poorer HRQoL in specific domains. No significant changes in HRQoL were observed after 12 months except slightly higher scores in physical health.
Conclusions: Only half of PWH reported good/very good global HRQoL. This highlights the need to develop targeted strategies to improve HRQoL among PWH, focusing on addressing the most affected dimensions and supporting the most vulnerable groups.
{"title":"Health-related quality of life in people with HIV from the multicentre CoRIS cohort in Spain: Associated factors and short-term changes over time.","authors":"Rebeca Izquierdo, Inés Suárez-García, Cristina Marco-Sánchez, Leire Pérez-Latorre, Melchor Riera, Joanna Cano, Consuelo Viladés, Sergio Reus, Julián Olalla, Patricia González-Ruano, Eva Orviz, Asunción Díaz, Santiago Moreno, Inma Jarrín","doi":"10.1111/hiv.13762","DOIUrl":"https://doi.org/10.1111/hiv.13762","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to describe health-related quality of life (HRQoL), overall and across its dimensions, identify associated factors, and assess changes over time among people with HIV (PWH) from the Spanish multicentre CoRIS cohort.</p><p><strong>Methods: </strong>We developed a mobile app to collect HRQoL data every 3 months using the WHOQOL-HIV-BREF questionnaire (31 items across six domains), among PWH followed in CoRIS in 2021-2023. Factors associated with good/very good global HRQoL and with domain-specific mean scores were identified using multivariable logistic and linear regression, respectively.</p><p><strong>Results: </strong>Of 414 PWH (94.2% on antiretroviral treatment, 91.1% virally suppressed), 51.2% reported good/very good HRQoL. Latin American migrants (adjusted OR: 0.60 [95% CI: 0.36; 1.00]), and participants with lower educational level (0.36 [0.21; 0.64]), a previous AIDS diagnosis (0.56 [0.29; 1.11]) and a history of non-AIDS-related cancers (0.40 [0.14; 1.14]) were less likely to report good/very good global HRQoL. The most affected items included sexual satisfaction, forgiveness and blame, sleep and rest, and concerns about the future, with spirituality, religion and personal beliefs as the most affected domain. Latin American origin, lower educational level and shorter (<2 years) or longer (>15 years) time since HIV diagnosis were associated with poorer HRQoL in specific domains. No significant changes in HRQoL were observed after 12 months except slightly higher scores in physical health.</p><p><strong>Conclusions: </strong>Only half of PWH reported good/very good global HRQoL. This highlights the need to develop targeted strategies to improve HRQoL among PWH, focusing on addressing the most affected dimensions and supporting the most vulnerable groups.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004692","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}
Ntombenhle Mkhize, Jorge Garrido, Susan Cole-Haley, Dázon Dixon Diallo, Gabriel Maldonado, Stéphan Vernhes, YoYo Wu, Mario Cascio
Introduction: The Joint United Nations Programme on HIV/AIDS (UNAIDS) Global 2025 targets prioritize action to overcome the collective barriers affecting the people and communities sitting on the outer margins of HIV care. Addressing the social and structural disparities that drive greater HIV prevalence and burden requires well-resourced, community-led responses that are fully integrated into national and global HIV initiatives.
Methods: The HIV Community Council (HCC), composed of 10 leaders from diverse global communities, convened to share their insights, amplify the community's voice, and identify barriers and solutions to empower all to live well with HIV through a dynamic, stepwise process of preparative work, deep discussion, prioritization, and consensus.
Results: The HCC created six recommendations to address two important barriers to living well with HIV: stigma and poor mental wellbeing. These recommendations are informed by best practice and community experience. They include suggestions for developing and delivering actionable solutions at the community level to prompt opportunities for support from existing global and regional organizations.
Conclusion: The HCC calls for action to implement community-endorsed, culturally appropriate, and practical solutions to tackle stigma and poor mental wellbeing and improve the long-term health of people with HIV.
{"title":"Breaking down global barriers: A multinational and multi-community approach to combat stigma and enhance mental wellbeing in people with HIV.","authors":"Ntombenhle Mkhize, Jorge Garrido, Susan Cole-Haley, Dázon Dixon Diallo, Gabriel Maldonado, Stéphan Vernhes, YoYo Wu, Mario Cascio","doi":"10.1111/hiv.13763","DOIUrl":"https://doi.org/10.1111/hiv.13763","url":null,"abstract":"<p><strong>Introduction: </strong>The Joint United Nations Programme on HIV/AIDS (UNAIDS) Global 2025 targets prioritize action to overcome the collective barriers affecting the people and communities sitting on the outer margins of HIV care. Addressing the social and structural disparities that drive greater HIV prevalence and burden requires well-resourced, community-led responses that are fully integrated into national and global HIV initiatives.</p><p><strong>Methods: </strong>The HIV Community Council (HCC), composed of 10 leaders from diverse global communities, convened to share their insights, amplify the community's voice, and identify barriers and solutions to empower all to live well with HIV through a dynamic, stepwise process of preparative work, deep discussion, prioritization, and consensus.</p><p><strong>Results: </strong>The HCC created six recommendations to address two important barriers to living well with HIV: stigma and poor mental wellbeing. These recommendations are informed by best practice and community experience. They include suggestions for developing and delivering actionable solutions at the community level to prompt opportunities for support from existing global and regional organizations.</p><p><strong>Conclusion: </strong>The HCC calls for action to implement community-endorsed, culturally appropriate, and practical solutions to tackle stigma and poor mental wellbeing and improve the long-term health of people with HIV.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004689","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}
Matthew W McGarrity, Paul MacPherson, Abby Li, Mark Naccarato, Peter Anderson, Darrell H S Tan
Objective: To measure concentrations of tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) among individuals taking tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) or tenofovir alafenamide plus emtricitabine (TAF/FTC) who were scheduled to undergo or had already undergone bariatric surgery.
Methods: We enrolled pre-exposure prophylaxis (PrEP) users attending clinics in Toronto or Ottawa who were undergoing or had undergone bariatric surgery. After participants completed a minimum of 7 days of consecutive PrEP dosing, we collected DBS samples immediately before they administered their next daily dose of PrEP. Participants who had already undergone bariatric surgery before enrolment provided a single sample at baseline only. One participant undergoing planned bariatric surgery provided samples preoperatively and on postoperative days 7, 28 and 84. TFV-DP was measured by liquid chromatography tandem mass spectrometry. We compared results against the population range TFV-DP at varying degrees of adherence and stratified by chronology of bariatric surgery, type of bariatric surgery and PrEP regimen.
Results: Of seven eligible participants, all were gay, cis-gender men. Median age was 48 years (Q1-Q3: 44-51). Six participants underwent bariatric surgery before enrolment: four Roux-en-Y gastric bypass (RYGB) and two sleeve gastrectomy (SG). Four were taking TDF/FTC and two were taking TAF/FTC. All had therapeutic TFV-DP concentrations, except for one TDF/FTC participant who underwent SG. One participant taking TAF/FTC enrolled before receiving RYGB and displayed a slight decrease in TFV-DP over time, although all concentrations remained in the therapeutic range.
Conclusions: Tenofovir diphosphate concentrations were at or near therapeutic values in this small sample of men using oral PrEP who underwent RYGB or SG.
{"title":"Intracellular tenofovir-diphosphate concentrations in HIV pre-exposure prophylaxis users who underwent bariatric surgery.","authors":"Matthew W McGarrity, Paul MacPherson, Abby Li, Mark Naccarato, Peter Anderson, Darrell H S Tan","doi":"10.1111/hiv.13759","DOIUrl":"https://doi.org/10.1111/hiv.13759","url":null,"abstract":"<p><strong>Objective: </strong>To measure concentrations of tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) among individuals taking tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) or tenofovir alafenamide plus emtricitabine (TAF/FTC) who were scheduled to undergo or had already undergone bariatric surgery.</p><p><strong>Methods: </strong>We enrolled pre-exposure prophylaxis (PrEP) users attending clinics in Toronto or Ottawa who were undergoing or had undergone bariatric surgery. After participants completed a minimum of 7 days of consecutive PrEP dosing, we collected DBS samples immediately before they administered their next daily dose of PrEP. Participants who had already undergone bariatric surgery before enrolment provided a single sample at baseline only. One participant undergoing planned bariatric surgery provided samples preoperatively and on postoperative days 7, 28 and 84. TFV-DP was measured by liquid chromatography tandem mass spectrometry. We compared results against the population range TFV-DP at varying degrees of adherence and stratified by chronology of bariatric surgery, type of bariatric surgery and PrEP regimen.</p><p><strong>Results: </strong>Of seven eligible participants, all were gay, cis-gender men. Median age was 48 years (Q1-Q3: 44-51). Six participants underwent bariatric surgery before enrolment: four Roux-en-Y gastric bypass (RYGB) and two sleeve gastrectomy (SG). Four were taking TDF/FTC and two were taking TAF/FTC. All had therapeutic TFV-DP concentrations, except for one TDF/FTC participant who underwent SG. One participant taking TAF/FTC enrolled before receiving RYGB and displayed a slight decrease in TFV-DP over time, although all concentrations remained in the therapeutic range.</p><p><strong>Conclusions: </strong>Tenofovir diphosphate concentrations were at or near therapeutic values in this small sample of men using oral PrEP who underwent RYGB or SG.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983373","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}
Introduction: Antiretroviral treatment (ART) has significantly enhanced health outcomes for people living with HIV (PLWH). With the evolution of treatment options, there is an increasing interest in the development of long-acting injectable formulations of antiretroviral drugs. These formulations present a promising alternative to oral ART.
Methods: The methodology and reporting of this systematic review followed the guidance of the Joanna Briggs Institute Reviewer's Manual and Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ). The comprehensive searches involved multiple databases, including PubMed, MEDLINE (Ovid), Embase (Ovid), CINHAL (EBSCO), ProQuest Dissertations and Theses, Web of Science, Wanfang (Chinese), CNKI (Chinese), Google Scholar and Baidu Scholar (Chinese).
Results: In all, 142 studies were identified and 20 eligible studies were included in the meta-aggregation. A total of 141 findings, 20 categories and nine synthesized findings were extracted from 20 studies. The nine synthesized findings identified from the 20 studies focused on the following topics: benefits, flexibility and practicality of long-acting injectable (LAI) treatment; scepticism about the use of LAI treatment; management challenges; logistical challenges; potential for protecting marginalized populations; concerns about side effects; financial issue; suggestions for improvement. PLWH's geographical distribution, backgrounds, demographics and clinical characteristics were limited.
Conclusion: We recommend considering the needs and experiences of PLWH in the transition from oral ART to LAI treatment. For marginalized populations, it is crucial to maintain regular communication with healthcare providers and institutions. Additionally, at the community level, engaging diverse stakeholders with valuable insights is vital, as is enhancing health education programmes and intensifying efforts to combat discrimination. These measures will play a key role in addressing the needs of PLWH, enhancing public awareness and promoting better understanding of LAI treatment.
抗逆转录病毒治疗(ART)显著改善了艾滋病毒感染者(PLWH)的健康状况。随着治疗方案的发展,人们对开发长效抗逆转录病毒药物注射制剂越来越感兴趣。这些制剂是口服抗逆转录病毒治疗的一种有希望的替代方案。方法:本系统综述的方法和报告遵循乔安娜布里格斯研究所审稿人手册和提高定性研究综合报告透明度(ENTREQ)的指导。综合检索涉及PubMed、MEDLINE (Ovid)、Embase (Ovid)、CINHAL (EBSCO)、ProQuest Dissertations and Theses、Web of Science、万方(中文)、CNKI(中文)、谷歌Scholar和百度Scholar(中文)等多个数据库。结果:总共有142项研究被确定,20项符合条件的研究被纳入meta-aggregation。从20项研究中提取了141项研究结果、20个分类和9个综合研究结果。从20项研究中确定的9项综合发现集中在以下主题:长效注射(LAI)治疗的益处、灵活性和实用性;对使用LAI治疗持怀疑态度;管理的挑战;后勤挑战;保护边缘人口的潜力;对副作用的担忧;金融问题;改进建议。PLWH的地理分布、背景、人口统计学和临床特征是有限的。结论:我们建议在从口服抗逆转录病毒治疗过渡到LAI治疗时考虑PLWH的需求和经验。对于边缘化人群来说,与医疗保健提供者和机构保持定期沟通至关重要。此外,在社区一级,让不同的利益攸关方提供宝贵的见解至关重要,加强卫生教育方案和加强打击歧视的努力也至关重要。这些措施将在解决PLWH的需求,提高公众意识和促进更好地了解LAI治疗方面发挥关键作用。
{"title":"Transitions in treatment: A systematic review and meta-aggregation of preferences and barriers in switching from oral to long-acting injectable antiretroviral therapy among people living with HIV and stakeholders.","authors":"Tiantian Hu, Shuqi Yang, Junwen Yu, Zhongfang Yang, Yilin Jin, Zheng Zhu","doi":"10.1111/hiv.13756","DOIUrl":"https://doi.org/10.1111/hiv.13756","url":null,"abstract":"<p><strong>Introduction: </strong>Antiretroviral treatment (ART) has significantly enhanced health outcomes for people living with HIV (PLWH). With the evolution of treatment options, there is an increasing interest in the development of long-acting injectable formulations of antiretroviral drugs. These formulations present a promising alternative to oral ART.</p><p><strong>Methods: </strong>The methodology and reporting of this systematic review followed the guidance of the Joanna Briggs Institute Reviewer's Manual and Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ). The comprehensive searches involved multiple databases, including PubMed, MEDLINE (Ovid), Embase (Ovid), CINHAL (EBSCO), ProQuest Dissertations and Theses, Web of Science, Wanfang (Chinese), CNKI (Chinese), Google Scholar and Baidu Scholar (Chinese).</p><p><strong>Results: </strong>In all, 142 studies were identified and 20 eligible studies were included in the meta-aggregation. A total of 141 findings, 20 categories and nine synthesized findings were extracted from 20 studies. The nine synthesized findings identified from the 20 studies focused on the following topics: benefits, flexibility and practicality of long-acting injectable (LAI) treatment; scepticism about the use of LAI treatment; management challenges; logistical challenges; potential for protecting marginalized populations; concerns about side effects; financial issue; suggestions for improvement. PLWH's geographical distribution, backgrounds, demographics and clinical characteristics were limited.</p><p><strong>Conclusion: </strong>We recommend considering the needs and experiences of PLWH in the transition from oral ART to LAI treatment. For marginalized populations, it is crucial to maintain regular communication with healthcare providers and institutions. Additionally, at the community level, engaging diverse stakeholders with valuable insights is vital, as is enhancing health education programmes and intensifying efforts to combat discrimination. These measures will play a key role in addressing the needs of PLWH, enhancing public awareness and promoting better understanding of LAI treatment.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921544","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}
Pub Date : 2025-01-01Epub Date: 2024-09-20DOI: 10.1111/hiv.13716
Anthony Muchai Manyara, Tadios Manyanga, Anya Burton, Hannah Wilson, Joseph Chipanga, Tsitsi Bandason, Chris Grundy, Etheldreda I Yoliswa Madela, Kate A Ward, Bilkish Cassim, Rashida Abbas Ferrand, Celia L Gregson
Objectives: We investigated associations between HIV, frailty and health-related quality of life (HRQoL).
Methods: This cross-sectional study recruited men and women aged ≥40 years in Zimbabwe. A researcher collected clinical and HRQoL data, and performed physical assessments and HIV testing. Frailty was defined using five criteria: unintentional weight loss, exhaustion, low physical activity, low gait speed, low handgrip strength. The presence of three or more criteria defined frailty, one to two pre-frailty, and zero non-frail. Data analysis used adjusted regression modelling.
Results: Of 1034 adults (mean ± SD, 62.0 ± 14.0 years), 21.6% (n = 223) were living with HIV: 93.3% knew their status, of whom 96.2% were on antiretroviral therapy (ART) and 89.7% of these had a viral load <50 copies/mL. Mean age at HIV diagnosis was 44.6 ± 10.4 years (only 8.1% were ≥70 years), people had been living with HIV for 9.8 ± 5.0 years and had been on ART for 9.4 ± 5.2 years. Overall, HIV was not associated with frailty: adjusted odds ratio (aOR) was 0.99 [95% confidence interval (CI): 0.42-2.33] for frailty versus non-frailty. However, each 5 years lived with HIV was associated with twice the odds of frailty/pre-frailty (aOR = 2.03, 95% CI: 1.03-4.13), independent of age and ART duration. Furthermore, each 5 years of ART use was associated with 60% lower odds of frailty/pre-frailty (aOR = 0.39, 95% CI: 0.19-0.78), independent of age and years lived with HIV. Older age, minimal education and poverty were associated with frailty. Frailty was associated with lower HRQoL in people both with and without HIV.
Conclusion: Reduced survival and good viral suppression may explain the lack of association between HIV and frailty. Early ART initiation could reduce future risk of frailty.
{"title":"Prevalence, factors and quality of life associated with frailty and pre-frailty in middle-aged and older adults living with HIV in Zimbabwe: A cross-sectional study.","authors":"Anthony Muchai Manyara, Tadios Manyanga, Anya Burton, Hannah Wilson, Joseph Chipanga, Tsitsi Bandason, Chris Grundy, Etheldreda I Yoliswa Madela, Kate A Ward, Bilkish Cassim, Rashida Abbas Ferrand, Celia L Gregson","doi":"10.1111/hiv.13716","DOIUrl":"10.1111/hiv.13716","url":null,"abstract":"<p><strong>Objectives: </strong>We investigated associations between HIV, frailty and health-related quality of life (HRQoL).</p><p><strong>Methods: </strong>This cross-sectional study recruited men and women aged ≥40 years in Zimbabwe. A researcher collected clinical and HRQoL data, and performed physical assessments and HIV testing. Frailty was defined using five criteria: unintentional weight loss, exhaustion, low physical activity, low gait speed, low handgrip strength. The presence of three or more criteria defined frailty, one to two pre-frailty, and zero non-frail. Data analysis used adjusted regression modelling.</p><p><strong>Results: </strong>Of 1034 adults (mean ± SD, 62.0 ± 14.0 years), 21.6% (n = 223) were living with HIV: 93.3% knew their status, of whom 96.2% were on antiretroviral therapy (ART) and 89.7% of these had a viral load <50 copies/mL. Mean age at HIV diagnosis was 44.6 ± 10.4 years (only 8.1% were ≥70 years), people had been living with HIV for 9.8 ± 5.0 years and had been on ART for 9.4 ± 5.2 years. Overall, HIV was not associated with frailty: adjusted odds ratio (aOR) was 0.99 [95% confidence interval (CI): 0.42-2.33] for frailty versus non-frailty. However, each 5 years lived with HIV was associated with twice the odds of frailty/pre-frailty (aOR = 2.03, 95% CI: 1.03-4.13), independent of age and ART duration. Furthermore, each 5 years of ART use was associated with 60% lower odds of frailty/pre-frailty (aOR = 0.39, 95% CI: 0.19-0.78), independent of age and years lived with HIV. Older age, minimal education and poverty were associated with frailty. Frailty was associated with lower HRQoL in people both with and without HIV.</p><p><strong>Conclusion: </strong>Reduced survival and good viral suppression may explain the lack of association between HIV and frailty. Early ART initiation could reduce future risk of frailty.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"153-165"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11725409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-09-17DOI: 10.1111/hiv.13711
Joana Woods, Simiso Sokhela, Godspower Akpomiemie, Bronwyn Bosch, Karlien Möller, Esther Bhaskar, Chelsea Kruger, Ncomeka Manentsa, Noxolo Tom, Philadelphia Macholo, Nomathemba Chandiwana, Andrew Hill, Michelle Moorhouse, Willem D F Venter
Objectives: Treatment-related weight gain and metabolic complications with antiretroviral integrase-based regimens, especially among Black women, suggest the need for alternative options.
Methods: We conducted a 48-week, open-label, single-arm, single-centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz- or dolutegravir-based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women.
Results: The 101 participants enrolled (median age 35 years; interquartile range 31-40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir-based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0-6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50-3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9-7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93-5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8-7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26-3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol -8.4% (95% CI -11.3 to -5.5; p < 0.001), triglycerides -10.4% (95% CI -16.4 to -4.4; p < 0.001) and high-density lipoprotein -14.8% (95% CI -18.5 to -11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild.
Conclusions: Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.
{"title":"DORA: 48-week weight and metabolic changes in Black women with HIV, in a phase IIIb switch study from dolutegravir- or efavirenz- to doravirine-based first-line antiretroviral therapy.","authors":"Joana Woods, Simiso Sokhela, Godspower Akpomiemie, Bronwyn Bosch, Karlien Möller, Esther Bhaskar, Chelsea Kruger, Ncomeka Manentsa, Noxolo Tom, Philadelphia Macholo, Nomathemba Chandiwana, Andrew Hill, Michelle Moorhouse, Willem D F Venter","doi":"10.1111/hiv.13711","DOIUrl":"10.1111/hiv.13711","url":null,"abstract":"<p><strong>Objectives: </strong>Treatment-related weight gain and metabolic complications with antiretroviral integrase-based regimens, especially among Black women, suggest the need for alternative options.</p><p><strong>Methods: </strong>We conducted a 48-week, open-label, single-arm, single-centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz- or dolutegravir-based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women.</p><p><strong>Results: </strong>The 101 participants enrolled (median age 35 years; interquartile range 31-40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir-based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0-6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50-3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9-7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93-5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8-7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26-3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol -8.4% (95% CI -11.3 to -5.5; p < 0.001), triglycerides -10.4% (95% CI -16.4 to -4.4; p < 0.001) and high-density lipoprotein -14.8% (95% CI -18.5 to -11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild.</p><p><strong>Conclusions: </strong>Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"81-96"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11725414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-08-28DOI: 10.1111/hiv.13698
Axel Ursenbach, Antoine Sireyjol, Cyrille Delpierre, Claudine Duvivier, Laurent Hocqueloux, David Rey
Introduction: Prevention of cardiovascular disease is a major issue in the current management of people living with HIV. Concern is growing about the metabolic impact of integrase strand transfer inhibitors (INSTIs), which could lead to an increased risk of diabetes, but the data are conflicting. This is an updated version of our previous analysis, with longer follow-up and new molecules.
Methods: We retrospectively evaluated the incidence of new-onset diabetes in people living with HIV starting combined antiretroviral therapy with an INSTI compared with non-nucleoside reverse transcriptase inhibitors and protease inhibitors. Data were collected from the Dat'AIDS cohort study, a collaboration of 30 HIV treatment centres in France. We used a propensity score-based inverse probability of treatment weighting approach to adjust for baseline characteristics between the two groups (INSTI and non-INSTI).
Results: Between 2009 and 2021, a total of 12 150 people living with HIV were included. The incidence of diabetes was higher in the INSTI group than in the non-INSTI group (hazard ratio 1.38; 95% confidence interval 1.07-1.77; p = 0.012). Regardless of the third drug, but to a greater extent for INSTIs, we observed a peak of new-onset diabetes in the year following initiation of combined antiretroviral therapy.
Conclusions: The incidence of diabetes was higher in people treated with integrase inhibitors than in those receiving other third agents. This increased risk occurred both during the first year of treatment and in the longer term.
{"title":"Increased incidence of diabetes in people living with HIV treated with first-line integrase strand transfer inhibitors: A French multicentre retrospective study.","authors":"Axel Ursenbach, Antoine Sireyjol, Cyrille Delpierre, Claudine Duvivier, Laurent Hocqueloux, David Rey","doi":"10.1111/hiv.13698","DOIUrl":"10.1111/hiv.13698","url":null,"abstract":"<p><strong>Introduction: </strong>Prevention of cardiovascular disease is a major issue in the current management of people living with HIV. Concern is growing about the metabolic impact of integrase strand transfer inhibitors (INSTIs), which could lead to an increased risk of diabetes, but the data are conflicting. This is an updated version of our previous analysis, with longer follow-up and new molecules.</p><p><strong>Methods: </strong>We retrospectively evaluated the incidence of new-onset diabetes in people living with HIV starting combined antiretroviral therapy with an INSTI compared with non-nucleoside reverse transcriptase inhibitors and protease inhibitors. Data were collected from the Dat'AIDS cohort study, a collaboration of 30 HIV treatment centres in France. We used a propensity score-based inverse probability of treatment weighting approach to adjust for baseline characteristics between the two groups (INSTI and non-INSTI).</p><p><strong>Results: </strong>Between 2009 and 2021, a total of 12 150 people living with HIV were included. The incidence of diabetes was higher in the INSTI group than in the non-INSTI group (hazard ratio 1.38; 95% confidence interval 1.07-1.77; p = 0.012). Regardless of the third drug, but to a greater extent for INSTIs, we observed a peak of new-onset diabetes in the year following initiation of combined antiretroviral therapy.</p><p><strong>Conclusions: </strong>The incidence of diabetes was higher in people treated with integrase inhibitors than in those receiving other third agents. This increased risk occurred both during the first year of treatment and in the longer term.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"166-172"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11725413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142092817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Our objective was to evaluate the trajectory of immunology in patients with HIV with different baseline CD4 T-cell count strata after antiretroviral therapy (ART) under long-term viral suppression.
Methods: This was a sub-analysis focused on patients with virological suppression for at least 5 years after ART. Data were obtained from the Yunnan HIV cohort in China. Patients were categorized according to prespecified baseline CD4 T-cell counts. The trajectories of CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio changing over time were fitted using a B-spline regression model. The Cox proportional hazards regression model was used to assess the association of baseline CD4 T-cell count with the risk of both immunological responder (IR) and CD4/CD8 ratio normalization.
Results: A total of 2618 patients with a median follow-up of 7.25 years (interquartile range [IQR] 5.92-8.75) were included. Over a period of 12 years, the mean CD4 T-cell count remained above 500 cells/μL in all groups. The mean CD4/CD8 ratio was solely normalized in patients whose baseline CD4 T-cell counts were above 350 cells/μL. Patients with higher baseline CD4 T-cell counts showed higher risks of both IR and CD4/CD8 ratio normalization than those with the lowest (all p trend <0.001). A higher baseline CD4 T-cell count predicted a shorter time for both IR and CD4/CD8 ratio normalization.
Conclusions: Long-term, sustained viral suppression may not be able to fully normalize immunological functions in patients with HIV. A high baseline CD4 T-cell count benefits IR and CD4/CD8 ratio normalization.
目的我们的目的是评估在长期病毒抑制下接受抗逆转录病毒疗法(ART)后,不同基线CD4 T细胞计数分层的HIV患者的免疫学轨迹:这是一项子分析,主要针对抗逆转录病毒疗法后病毒学抑制至少 5 年的患者。数据来自中国云南艾滋病队列。根据预设的基线 CD4 T 细胞计数对患者进行分类。CD4 T细胞计数、CD8 T细胞计数和CD4/CD8比值随时间变化的轨迹采用B-样条回归模型进行拟合。Cox比例危险回归模型用于评估基线CD4 T细胞计数与免疫应答者(IR)和CD4/CD8比值正常化风险的相关性:共纳入了 2618 名患者,中位随访时间为 7.25 年(四分位数间距 [IQR] 5.92-8.75)。在长达 12 年的时间里,各组患者的 CD4 T 细胞平均数量均保持在 500 cells/μL 以上。基线 CD4 T 细胞计数高于 350 cells/μL 的患者的平均 CD4/CD8 比值完全正常。基线 CD4 T 细胞计数较高的患者出现 IR 和 CD4/CD8 比率正常化的风险均高于基线 CD4 T 细胞计数最低的患者(均为 p 趋势结论):长期、持续的病毒抑制可能无法使艾滋病患者的免疫功能完全正常化。高基线 CD4 T 细胞计数有利于 IR 和 CD4/CD8 比率正常化。
{"title":"Trajectories of CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio in patients with HIV and long-term virological suppression based on Yunnan HIV cohort.","authors":"Yuanlu Shu, Mi Zhang, Jianjian Li, Xuemei Deng, Jiafa Liu, Cuixian Yang, Xingqi Dong","doi":"10.1111/hiv.13707","DOIUrl":"10.1111/hiv.13707","url":null,"abstract":"<p><strong>Objective: </strong>Our objective was to evaluate the trajectory of immunology in patients with HIV with different baseline CD4 T-cell count strata after antiretroviral therapy (ART) under long-term viral suppression.</p><p><strong>Methods: </strong>This was a sub-analysis focused on patients with virological suppression for at least 5 years after ART. Data were obtained from the Yunnan HIV cohort in China. Patients were categorized according to prespecified baseline CD4 T-cell counts. The trajectories of CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio changing over time were fitted using a B-spline regression model. The Cox proportional hazards regression model was used to assess the association of baseline CD4 T-cell count with the risk of both immunological responder (IR) and CD4/CD8 ratio normalization.</p><p><strong>Results: </strong>A total of 2618 patients with a median follow-up of 7.25 years (interquartile range [IQR] 5.92-8.75) were included. Over a period of 12 years, the mean CD4 T-cell count remained above 500 cells/μL in all groups. The mean CD4/CD8 ratio was solely normalized in patients whose baseline CD4 T-cell counts were above 350 cells/μL. Patients with higher baseline CD4 T-cell counts showed higher risks of both IR and CD4/CD8 ratio normalization than those with the lowest (all p trend <0.001). A higher baseline CD4 T-cell count predicted a shorter time for both IR and CD4/CD8 ratio normalization.</p><p><strong>Conclusions: </strong>Long-term, sustained viral suppression may not be able to fully normalize immunological functions in patients with HIV. A high baseline CD4 T-cell count benefits IR and CD4/CD8 ratio normalization.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"70-80"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142106950","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}
Pub Date : 2025-01-01Epub Date: 2024-10-04DOI: 10.1111/hiv.13712
Kirsten M A Trayner, Norah E Palmateer, Andrew McAuley, Alan Yeung, Beth L Cullen, Lesley A Wallace, Kirsty Roy, Rebecca Metcalfe, Erica Peters, Julie Craik, Daniel Carter, John Campbell, Trina Ritchie, Samantha J Shepherd, Rory N Gunson, Sharon J Hutchinson
Background: In the context of an outbreak of HIV among people who inject drugs in Glasgow, Scotland, identified in 2015, our objectives were to: (1) develop epidemiological methods to estimate HIV incidence using data linkage, and (2) examine temporal changes in HIV incidence to inform public health responses.
Methods: This was a retrospective cohort study involving data linkage of laboratory HIV testing data to identify individuals with a history of drug use. Person-years (PY) and Poisson regression were used to estimate incidence by time period (pre-outbreak: 2000-2010 and 2011-2013; early outbreak: 2014-2016; ongoing outbreak: 2017-2019).
Results: Among 13 484 individuals tested for HIV, 144 incident HIV infections were observed from 2000 to 2019. Incidence rates increased from pre-outbreak periods (1.00/1000 PY (95% confidence interval, CI: 0.60-1.65) in 2000-2010 and 1.70/1000 PY (95% CI: 1.14-2.54) in 2011-2013) to 3.02/1000 PY (95% CI: 2.36-3.86) early outbreak (2014-2016) and 2.35 (95% CI 1.74-3.18) during the ongoing outbreak period (2017-2019). Compared with the pre-outbreak period (2000-2010), the incidence rates were significantly elevated during both the early outbreak (2014-16) (adjusted incidence rate ratio (aIRR) = 2.87, 95% CI: 1.62-5.09, p < 0.001) and the ongoing outbreak periods (2017-19) (aIRR = 2.12, 95% CI: 1.16-3.90, p = 0.015).
Conclusions: Public health responses helped to curb the rising incidence of HIV infection among people with a history of drug use in Glasgow, but further efforts are needed to reduce it to levels observed prior to the outbreak. Data linkage of routine diagnostic test data to assess and monitor incidence of HIV infection provided enhanced surveillance, which is important to inform outbreak investigations and guide national strategies on elimination of HIV transmission.
{"title":"Examining trends in the incidence of HIV infection among people with a history of drug use to inform an outbreak investigation and response: A retrospective cohort study.","authors":"Kirsten M A Trayner, Norah E Palmateer, Andrew McAuley, Alan Yeung, Beth L Cullen, Lesley A Wallace, Kirsty Roy, Rebecca Metcalfe, Erica Peters, Julie Craik, Daniel Carter, John Campbell, Trina Ritchie, Samantha J Shepherd, Rory N Gunson, Sharon J Hutchinson","doi":"10.1111/hiv.13712","DOIUrl":"10.1111/hiv.13712","url":null,"abstract":"<p><strong>Background: </strong>In the context of an outbreak of HIV among people who inject drugs in Glasgow, Scotland, identified in 2015, our objectives were to: (1) develop epidemiological methods to estimate HIV incidence using data linkage, and (2) examine temporal changes in HIV incidence to inform public health responses.</p><p><strong>Methods: </strong>This was a retrospective cohort study involving data linkage of laboratory HIV testing data to identify individuals with a history of drug use. Person-years (PY) and Poisson regression were used to estimate incidence by time period (pre-outbreak: 2000-2010 and 2011-2013; early outbreak: 2014-2016; ongoing outbreak: 2017-2019).</p><p><strong>Results: </strong>Among 13 484 individuals tested for HIV, 144 incident HIV infections were observed from 2000 to 2019. Incidence rates increased from pre-outbreak periods (1.00/1000 PY (95% confidence interval, CI: 0.60-1.65) in 2000-2010 and 1.70/1000 PY (95% CI: 1.14-2.54) in 2011-2013) to 3.02/1000 PY (95% CI: 2.36-3.86) early outbreak (2014-2016) and 2.35 (95% CI 1.74-3.18) during the ongoing outbreak period (2017-2019). Compared with the pre-outbreak period (2000-2010), the incidence rates were significantly elevated during both the early outbreak (2014-16) (adjusted incidence rate ratio (aIRR) = 2.87, 95% CI: 1.62-5.09, p < 0.001) and the ongoing outbreak periods (2017-19) (aIRR = 2.12, 95% CI: 1.16-3.90, p = 0.015).</p><p><strong>Conclusions: </strong>Public health responses helped to curb the rising incidence of HIV infection among people with a history of drug use in Glasgow, but further efforts are needed to reduce it to levels observed prior to the outbreak. Data linkage of routine diagnostic test data to assess and monitor incidence of HIV infection provided enhanced surveillance, which is important to inform outbreak investigations and guide national strategies on elimination of HIV transmission.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"97-114"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11725416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-09-27DOI: 10.1111/hiv.13719
Félix Gutiérrez
{"title":"\"Editorial comment on: Increased incidence of diabetes in people living with HIV treated with first-line integrase strand transfer inhibitors: A French multicentre retrospective study\".","authors":"Félix Gutiérrez","doi":"10.1111/hiv.13719","DOIUrl":"10.1111/hiv.13719","url":null,"abstract":"","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":"4-5"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345799","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}