HIV Medicine最新文献

{"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":"https://doi.org/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":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"https://doi.org/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":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual care pathways for people living with HIV: A mixed-methods systematic review.","authors":"Hamzah Z Farooq, Louise Whitton, Chikondi Mwendera, Pip Divall, Sophie J I M Spitters, Jane Anderson, John P Thornhill","doi":"10.1111/hiv.13701","DOIUrl":"https://doi.org/10.1111/hiv.13701","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic prompted an unprecedented surge in virtual services, necessitating a rapid shift to digital healthcare approaches. This review focuses on evaluating the evidence of virtual care (VC) in delivering HIV care, considering the complex nature of HIV and the need for tailored-approaches, especially for marginalized populations.</p><p><strong>Methods: </strong>A mixed-methods systematic review was performed with searches on five databases, covering studies from January 1946 to May 2022. Inclusion criteria involved two-way virtual consultations between healthcare workers and people living with HIV (PLHIV), with detailed descriptions and outcomes. Qualitative and quantitative studies were included, and the risk of bias was assessed using the Newcastle-Ottawa score and Stenfors' framework.</p><p><strong>Results: </strong>Among 4143 identified records, 26 studies met the criteria, with various models of care described. The majority of studies were observational, and videoconferencing was the primary mode of virtual consultation employed. Quantitative analysis revealed PLHIV generally accept VC, with high attendance rates (87%). Mean acceptability and satisfaction rates were 80% and 85%, respectively, while 87% achieved HIV viral suppression. The setting and models of VC implementation varied, with some introduced in response to COVID-19 while others were as part of trials.</p><p><strong>Conclusions: </strong>VC for PLHIV is deemed an acceptable and effective approach and is associated with good virological outcomes. Data on other health outcomes is lacking. The review underscores the importance of diverse models of care, patient choice and comprehensive training initiatives for both staff and patients. Establishing a 'gold standard' for VC models is crucial for ensuring appropriate and effective reviews of PLHIV in virtual settings.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286063","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":"Patient evaluation of Klick, a technology-enabled, nurse-delivered HIV outpatient pathway.","authors":"S Day, C Rae, A McOwan, R Wilkins, A Gray, A Harvey, C Casley, A Murungi, D Asboe","doi":"10.1111/hiv.13710","DOIUrl":"https://doi.org/10.1111/hiv.13710","url":null,"abstract":"<p><strong>Objectives: </strong>Klick is a clinic-specific, digitally supported outpatient pathway of care for people living with HIV (PLWH). It involves a smartphone application (app) for PLWH to self-manage their care, navigate access to the clinic and communicate with their healthcare provider. We present a patient evaluation of Klick.</p><p><strong>Methods: </strong>Patients use Klick to book/reschedule appointments, view laboratory results, request medication, access remote nurse-delivered consultations and communicate with clinicians. In October 2022, Klick was evaluated by PLWH through a questionnaire and interviews.</p><p><strong>Results: </strong>Between August 2020 and April 2024, 5859 patients had registered to use Klick; during April 2024 alone, 2509 (43%) used Klick. In October 2022, 1661 PLWH were invited to complete surveys, of whom 362 (22%) responded. These respondents were 95% (340/358) male and 84% (298/354) white, and 63% (227/359) were in the age range 41-60 years. Respondents felt Klick was easy to use (average score 4.3/5), and 92% thought having a clinic-specific app was important/very important. Respondents valued the following app features as important/very important - online booking (93%); viewable results (94%); prescription requests (90%) - and rated their experience of using them highly - 91% for e-booking and 91% for viewable results. A total of 93% said they would recommend Klick to friends and 82% rated Klick as above average/excellent.</p><p><strong>Conclusions: </strong>PLWH reported high levels of satisfaction using a clinic-specific mHealth app to manage their HIV care and demonstrated sustained active use. Klick was rated easy to use, as helping to meet healthcare needs and as providing a superior experience for some aspects of care. Other HIV clinics or services managing chronic conditions could benefit from the adoption of personalized digital solutions to enhance patient care.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286061","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":"Correction to “Severe haematologic toxicity is rare in high risk HIV-exposed infants receiving combination neonatal prophylaxis”","authors":"","doi":"10.1111/hiv.13713","DOIUrl":"10.1111/hiv.13713","url":null,"abstract":"<p>\u0000 <span>The European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord</span> and <span>Chiappini, E</span>. (<span>2019</span>), <span>Severe haematologic toxicity is rare in high risk HIV-exposed infants receiving combination neonatal prophylaxis</span>. <i>HIV Med</i>, <span>20</span>: <span>291</span>-<span>307</span>. https://doi.org/10.1111/hiv.12696\u0000 </p><p>The corresponding author Elena Chiappini was inadvertently removed from the authorship. The author byline should read:</p><p>The European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord* and Elena Chiappini¹</p><p>^<i>1</i><i>Anna Meyer University Hospital, University of Florence, Florence, Italy</i></p><p>The online version of the article has been corrected.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":"25 10","pages":"1179"},"PeriodicalIF":2.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hiv.13713","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203764","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}

{"title":"Long COVID among people with HIV: A systematic review and meta‐analysis","authors":"Xueying Yang, Fanghui Shi, Hao Zhang, William A. Giang, Amandeep Kaur, Hui Chen, Xiaoming Li","doi":"10.1111/hiv.13708","DOIUrl":"https://doi.org/10.1111/hiv.13708","url":null,"abstract":"BackgroundPeople with HIV might be at an increased risk of long COVID (LC) because of their immune dysfunction and chronic inflammation and alterations in immunological responses against severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2; coronavirus disease 2019 [COVID‐19]). This systematic review aimed to evaluate the association between HIV infection and LC and the prevalence and characteristics of and risk factors for LC among people with HIV.MethodsMultiple databases, including Embase, PubMed, PsycINFO, Web of Science, and Sociological s, were searched to identify articles published before June 2023. Published articles were included if they presented at least one LC outcome measure among people with HIV and used quantitative or mixed‐methods study designs. For effects reported in three or more studies, meta‐analyses using random‐effects models were performed using R software.ResultsWe pooled 39 405 people with HIV and COVID‐19 in 17 eligible studies out of 6158 publications in all the databases. It was estimated that 52% of people with HIV with SARS‐CoV‐2 infection developed at least one LC symptom. Results from the random‐effects model showed that HIV infection was associated with an increased risk of LC (odds ratio 2.20; 95% confidence interval 1.25–3.86). The most common LC symptoms among people with HIV were cough, fatigue, and asthenia. Risk factors associated with LC among people with HIV included a history of moderate–severe COVID‐19 illness, increased interferon‐gamma‐induced protein 10 or tumour necrosis factor‐α, and decreased interferon‐β, among others.ConclusionsThe COVID‐19 pandemic continues to exacerbate health inequities among people with HIV because of their higher risk of developing LC. Our review is informative for public health and clinical communities to develop tailored strategies to prevent aggravated LC among people with HIV.","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":"27 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203763","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":"CROI 2024 BHIVA working group summary","authors":"Tristan J. Barber,&nbsp;Amanda Clarke,&nbsp;Ashini Fox,&nbsp;Nicola E. Mackie,&nbsp;Caroline Sabin,&nbsp;Laura J. Waters","doi":"10.1111/hiv.13705","DOIUrl":"10.1111/hiv.13705","url":null,"abstract":"<p>The Conference on Retroviruses and Opportunistic Infections (CROI) is usually the most significant HIV conference of the year in terms of basic and clinical scientific output. CROI 2024 in Denver, USA, felt very much back to ‘business as usual’ following COVID-19 disruptions that had impacted preceding years, but also felt more global and outward- facing. The British HIV Association supports a working group to attend CROI annually and deliver feedback in the UK. This article summarizes the highlights from that meeting.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":"25 11","pages":"1183-1191"},"PeriodicalIF":2.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203761","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":"Real-world effectiveness and safety of switching to dolutegravir/lamivudine among people living with HIV-1 aged over 50 years who are virologically suppressed.","authors":"C Piñeiro, S Policarpo, C Caldas, L Santos, I Augusto, V P DiMondi, R Serrão","doi":"10.1111/hiv.13699","DOIUrl":"https://doi.org/10.1111/hiv.13699","url":null,"abstract":"<p><strong>Objectives: </strong>People living with HIV face several challenges as they age, including the potential for polypharmacy and increased susceptibility to drug-related adverse effects. Thus, effective and well-tolerated regimens with minimal or no drug interactions would be useful in this population. We present real-world effectiveness and safety data for individuals aged >50 years who achieved virological suppression (HIV-1 RNA <50 copies/mL) and switched to dolutegravir/lamivudine (DTG/3TC).</p><p><strong>Methods: </strong>This retrospective, observational, single-centre study conducted in Portugal included individuals aged >50 years who switched to DTG/3TC while virologically suppressed and had ≥12 months of follow-up. Proportions of individuals maintaining virological suppression were described at 12 months; CD4+ cell counts were described at baseline and 12 months. Descriptive subgroup analyses were performed based on age, sex assigned at birth, and availability of historical genotypic resistance results.</p><p><strong>Results: </strong>Overall, 538 individuals aged >50 years were included (74% male; mean age, 62 years; mean time on previous therapy, 160 months). High proportions (intention-to-treat population, 97%; on-treatment population, 98%) of individuals who switched to DTG/3TC maintained virological suppression through 12 months of follow-up. CD4+ cell counts remained stable (mean baseline: 727 cells/mm³ [range 94-2371]; mean month 12: 742 cells/mm³ [range 99-2659]). No individuals experienced virological failure. Nine (2%) individuals discontinued DTG/3TC for non-treatment-related reasons. Proportions with virological suppression at month 12 were similar between on-treatment subgroups by age, sex assigned at birth, and historical genotypic resistance results availability.</p><p><strong>Conclusions: </strong>DTG/3TC demonstrated robust effectiveness and a good safety profile in individuals aged >50 years with virological suppression in Portugal.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139930","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":"Evaluation of HIV antiretroviral treatment adherence in 2019 using anonymized data from the French national health insurance claims data base: The COCOVIH study","authors":"F. Prevoteau du Clary,&nbsp;C. Majerholc,&nbsp;D. Zucman,&nbsp;J.-M. Livrozet,&nbsp;A. Vallee,&nbsp;C. Laurendeau,&nbsp;S. Bouee","doi":"10.1111/hiv.13690","DOIUrl":"10.1111/hiv.13690","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Adherence to antiretroviral treatment (ART) plays a key role in achieving viral suppression in people living with HIV. We aimed to quantify ART adherence in the entire French HIV-infected population treated in 2019 and to determine factors of influence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>People living with HIV were identified using HIV diagnosis according to <i>International Statistical Classification of Diseases and Related Health Problems, Tenth Revision</i> criteria, HIV-specific laboratory tests, and prescription of antiretrovirals in 2019. Adherence was measured using the medication possession ratio (MPR; actual divided by theoretical number of tablets). Variables of interest included sex, age, type of ART, relevant comorbidities, and receiving supplementary universal health coverage for low-income citizens (CMUc).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of the <i>n</i> = 211 124 people living with HIV identified between 2006 and 2019, we included <i>n</i> = 140 607 on ART with two or more prescription fills in 2019 in this analysis. In total, 87.5% of people living with HIV were receiving ART in 2019. Mean ± standard deviation MPR was 82.5 ± 22.7%; 57% of people living with HIV had an MPR ≥90%, and 12.7% had an MPR &lt;50%. Those with an MPR ≥90% significantly differed between males and females (59.1% and 52.8%, respectively; <i>p</i> &lt; 0.001), and between CMUc recipients and non recipients (54.1% and 57.6%, respectively; <i>p</i> &lt; 0.001). MPR ≥90% rate was lower for those with chronic nephropathy (50.2%), renal failure (46.6%), and tuberculosis (50.1%), and for those using psychoactive substances (52.3%). Factors associated with MPR ≥90% in multivariable analysis were older age, male sex, not receiving CMUc, more recent HIV diagnosis, and triple (vs. dual) ART.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>In 2019, the average MPR in people living with HIV was 82.5% according to the comprehensive French health care database. Besides sociodemographic variables such as older age, male sex, and not being a CMUc recipient (i.e. of low socioeconomic status), more recent HIV diagnosis and triple therapy were independently associated with better adherence, possibly reflecting advances in ART tolerability and dosing.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":"25 11","pages":"1218-1226"},"PeriodicalIF":2.8,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hiv.13690","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132600","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}

{"title":"Therapeutic failure reported with HIV long-acting injectables: An analysis of the FDA Adverse Event Reporting System from 2021 to 2024.","authors":"Kenneth L McCall, Danielle L Cabral, Jamie F Coghlan, Ashante M Concepcion, Kristine E Denimarck, Shawn S Shalumov","doi":"10.1111/hiv.13709","DOIUrl":"https://doi.org/10.1111/hiv.13709","url":null,"abstract":"<p><strong>Objectives: </strong>We examined adverse event (AE) reports relating to cabotegravir/rilpivirine (CAB/RPV) in the US FDA Adverse Event Reporting System (FAERS), focusing on therapeutic failure (TF) and non-therapeutic failure (NTF) outcomes.</p><p><strong>Methods: </strong>FAERS is a database of AE and medication error reports from post-marketing surveillance. The study was granted exempt approval by the Binghamton University Institutional Review Board. We queried reports for CAB/RPV in the FAERS system from 1 January 2021 to 31 March 2024. TFs were defined as involving any of the following terms: viral load increased, virological failure, pathogen resistance, blood HIV RNA increased, treatment failure, drug ineffective, viral mutation identified, viraemia, and therapy non-responder. The top 20 most common AEs were also identified. Means, standard deviations, and percentages were used to characterize the sample.</p><p><strong>Results: </strong>The study cohort consisted of 2605 reports. The reported sex of the study cohort was 50% male (n = 1295), 19% female (n = 505), and 31% unspecified (n = 805), with a mean ± standard deviation (SD) age of 46.9 ± 12.4 years (n = 378). The top three most reported AEs were TFs, product dose omissions, and injection site pain, with 377 (14.5%), 354 (13.6%), and 331 (12.7%) cases, respectively. The mean ± SD weight of people with a report of TF versus NTF was 101.8 ± 33.4 kg and 87.7 ± 26.7 kg, respectively (p = 0.0175).</p><p><strong>Conclusion: </strong>Our findings suggest that healthcare professionals should have a heightened awareness of potential challenges with CAB/RPV administration, including TFs and dose omissions in real-world settings.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132601","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}