HIV Medicine最新文献

Objectives: Our objective was to evaluate bone mineral density (BMD) among older people living with HIV at the time of enrolment into a clinical trial in Kenya.

Methods: The bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) Elderly Study is a clinical trial among virally suppressed people living with HIV aged ≥60 years randomized to switch to BFTAF or continue their pre-enrolment regimen. At enrolment, dual-energy x-ray absorptiometry (DXA) of the lumbar spine, total hip, and femoral neck was performed and T-scores calculated for BMD. Osteoporosis was defined as T-score -2.5 or lower and osteopenia as T-score between -1 and -2.5. Fracture risk was calculated based on clinical risk factors (not including BMD), considering HIV as a secondary cause of osteoporosis, and the correlation between FRAX®-HIV and BMD assessed.

Results: Between February and May 2022, a total of 296 participants were enrolled. All were Black African, 147 (49.7%) were female, the median age was 64 years (range 60-77), and 280 (94.6%) were on tenofovir disoproxil fumarate. The median BMD of lumbar spine, total hip, and femoral neck was 0.87 g/cm² (interquartile range [IQR] 0.78-0.99), 0.89 g/cm² (IQR 0.79-1.01), and 0.75 g/cm² (IQR 0.67-0.84), respectively, with median T-scores of -1.9 (IQR -2.8 to -0.7), -1.0 (IQR -1.9 to -0.3), and -1.5 (IQR -2.2 to -0.9), respectively. Osteoporosis and osteopenia were found in 37.5% and 47.3% of participants, respectively. Major osteoporotic fracture and hip fracture 10-year median probabilities using FRAX®-HIV were 3.4% (IQR 2.8-4.6) and 1.0% (IQR 0.7-1.3). Correlation coefficients between these FRAX®-HIV probabilities and femoral neck BMD were -0.204 for major osteoporotic fracture and -0.338 for hip fracture.

Conclusions: The prevalence of osteoporosis is high among older people living with HIV in Kenya, where DXA is not readily available and risk calculation without BMD had low correlation with measured BMD values. Additional data are required on the impact of investment in fracture risk assessment and treatment, including population-specific risk calculators.

Objectives: The survival rate of people with HIV admitted to intensive care units (ICUs) is approaching that of people without HIV. We conducted a matched-cohort study of people with and without HIV admitted to ICU at a large hospital to compare short-term mortality, during 2000-2019.

Methods: People with HIV were matched to people without HIV (1:2) on age, sex, admission year and Acute Physiology and Chronic Health Evaluation (APACHE)-II score. Applying logistic regression models fitted using independence estimating equations, we describe population-averaged associations of HIV with short-term (in-ICU, in-hospital) mortality during a patient's first admission to ICU, and explore whether these varied by year.

Results: A total of 177 people with HIV were matched to 354 people without HIV (71.2% vs. 71.2% male; median age: 47 vs. 48 years, median APACHE-II: 18 vs. 17, median admission year: 2013 vs. 2013). Among people with HIV, 73.4% were on antiretroviral therapy, 51.2% had HIV-RNA ≤50 copies/mL and median CD4 T-cell count was 132 cells/ $\mu$ L. People with HIV had higher in-ICU (24.3% vs. 15.3%) and in-hospital (31.6% vs. 20.1%) mortality. People with HIV had 1.69-fold higher odds (95% confidence interval: 1.03-2.76) of in-ICU mortality and 1.86 (1.19-2.91) higher odds of in-hospital mortality than people without HIV, adjusted for age, sex, year and APACHE-II. There was no evidence that these associations varied by year (p-interaction-in-ICU = 0.90; p-interaction-in-hospital = 0.46).

Conclusions: Our findings suggest that although outcomes have improved over time, people with HIV continue to have higher short-term in-ICU and in-hospital mortality following ICU admission compared with people without HIV with similar characteristics.

Objectives: Our aim was to examine mortality trends in the era of antiretroviral therapy, among people who inject drugs (PWID) who are living with HIV. The study objectives were to assess and quantify mortality among PWID diagnosed with HIV over time in Scotland, in the context of a recent outbreak of HIV and rise in drug-related mortality.

Methods: This was a retrospective cohort study of those diagnosed with HIV in Scotland between January 2000 and February 2020, with acquisition related to injecting drug use, linked to mortality data. Factors associated with all-cause mortality were examined using Cox proportional hazards regression.

Results: Among 430 individuals with 3143 person-years (py) of follow-up, 88 (20.5%) died. Drug-related deaths accounted for 45.5% of all deaths, rising to 60% among those diagnosed in 2015-2020. The crude all-cause mortality was 28.00 per 1000 py overall and 37.62 per 1000 py within 5 years of diagnosis. Mortality risk was markedly higher among PWID diagnosed in 2015-2020 [adjusted hazard ratio (aHR) = 3.53], relative to those diagnosed in 2000-2004. Among those diagnosed in 2015-2020 (as part of the HIV outbreak), the mortality risk was higher among those not on, compared with those on, opioid agonist therapy (aHR = 3.87).

Conclusion: Mortality among PWID living with HIV in Scotland has risen substantially in the 21st century. Our findings highlight the important role of opioid-agonist therapy, alongside other prevention and treatment measures to address high levels of drug-related mortality for PWID living with HIV, including within HIV outbreaks in this population group.

Introduction: People with HIV currently face a tenfold higher risk of developing cardiovascular disease (CVD) than those without HIV. Studies have shown various off-target effects of antiretroviral treatment (ART) on the cardiovascular system, but little is known about the effects of currently used integrase strand transfer inhibitors (INSTIs) on platelets. Platelet activation is associated with increased CVD, thrombus formation, and release of proinflammatory mediators, so exploring platelet effects from currently prescribed ART may contribute to the understanding of CVD etiopathogenesis in people with HIV.

Methods: We aimed to identify potential effects of INSTIs on platelet aggregation and activation markers from individuals without HIV after in vitro treatment with clinically relevant drug concentrations. We used bictegravir (BIC) and dolutegravir (DTG) individually or in the therapeutic drug combinations BIC/emtricitabine (FTC)/tenofovir alafenamide fumarate (TAF) or DTG/lamivudine (3TC). Additionally, we conducted a pilot study to compare platelet activity profiles from people with HIV on BIC/FTC/TAF and DTG/3TC.

Results: Changes to in vitro platelet aggregation responses upon exposure to different INSTIs were observed both upon individual drug application and when using therapeutic combinations. However, these effects were not reflected in flow-cytometric evaluation of platelet degranulation. A pilot study in eight people with HIV and eight without HIV revealed no significant effects but established protocols for future patient studies.

Conclusion: There is currently no consistent evidence of an effect of INSTIs on platelet activation. Further study is warranted, focusing on models with more pathophysiological relevance, including extensive studies in people with HIV.

Objective: Opt-out screening for blood-borne viruses (BBVs) in emergency departments (EDs) has been established in areas with a high prevalence of HIV diagnoses in England. This multi-site study explored the attitudes of healthcare workers (HCWs) towards BBV screening in EDs post-implementation.

Design: This was a cross-sectional electronic survey of HCWs.

Methods: Between November 2023 and February 2024, HCWs across 33 EDs in England participating in opt-out BBV screening were invited to complete a survey about the feasibility and acceptability of screening, including the opt-out consent process. Factors independently associated with acceptability of opt-out screening were identified using multivariable logistic regression. Free-text responses were analysed thematically.

Results: Responses from 610 HCWs in 19 EDs were provided: 50.4% were nurses, 43.1% doctors, and 6.5% other healthcare professionals. Acceptability of the screening programme and opt-out consent was high (90.3% and 77.7%, respectively), with some variation between EDs. Acceptability of opt-out consent was greater among doctors than among other HCWs, and among HCWs who proactively discussed screening further with patients who opted out. However, 50.8% of HCWs felt that patients should be verbally reminded at blood draw, and 44.3% of HCWs wanted more training in discussing opt-out screening with patients. Free-text answers suggested changes to test-ordering systems, including simple integration of tick boxes to document whether patients opted out and to block repeated testing.

Conclusions: There was substantial support from ED HCWs for routine opt-out ED BBV screening, including opt-out consent. Key areas suggested for improvement included changes to test-ordering systems and additional training for HCWs. Frequent preference for verbal reminders at the point of blood draw suggests continued HIV testing exceptionalism.

Objectives: Patient-reported outcomes (PROs) have emerged as a valuable tool for aligning HIV care with patient needs and priorities. This study aimed to explore patient and healthcare provider (HCP) experiences of integrating a PRO solution into standard clinical care for HIV in a Danish outpatient clinic.

Methods: A tailored PRO solution for people living with HIV was developed in a Danish outpatient clinic. Patients were eligible if they were aged >18 years, spoke Danish, had been on effective antiretroviral therapy for 2 years, and had no additional health issues. Patients completed an electronic questionnaire 14 days before in-clinic consultations. HCPs reviewed patients' responses before these consultations. We assessed the usability, acceptability, and relevance of the PRO solution by conducting semi-structured interviews with 24 patients (12 responders and 12 non-responders) and six HCPs. A further 95 non-responders were interviewed over the phone. Data were analysed using thematic analysis.

Results: Respondents found that PROs improved patient-provider communication, treatment planning, and self-management. Non-respondents faced barriers such as health literacy, cultural beliefs, and access to technology, necessitating alternative delivery methods. HCPs found that PROs facilitated person-centred care and symptom management, but HCPs faced challenges such as insufficient training, resources, and organizational support.

Conclusions: Implementing PROs in HIV care is challenging because of the patient diversity, clinician training needs, and organizational adaptations. Nevertheless, the use of PROs is associated with enhanced person-centred care. Future recommendations include tailored use of PROs, better understanding of the impact on patient groups, on-site questionnaire completion, and emphasis on shared decision-making between patients and HCPs.

Background: Liver steatosis (LS) and liver fibrosis (LF) can increase the risk of cardiovascular disease in people with HIV, but their prevalence and associated factors are poorly understood. This study aimed to assess the prevalence of and factors associated with LS and LF in a large cohort of people with HIV.

Methods: We conducted a cross-sectional study of consecutive people with HIV attending the Clinic of Barcelona from September 2022 to September 2023, excluding those with chronic B or/and C hepatitis virus coinfection. LS was assessed using the Hepatic Steatosis Index (HSI) and Fatty Liver Index (FLI), and LF was assessed using the Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS), Fibrosis-4 score (FIB-4), and the European AIDS Clinical Society (EACS) algorithm in both the whole cohort (cohort 1) and in a specific cohort more susceptible to liver disease (cohort 2). We identified independent variables associated with LS and LF using logistic regression.

Results: Cohort 1 included 4664 people with HIV; 76% and 37% of them had available HSI and FLI data, LS was present in 28% and 19%, respectively. LF risk was present in 1%, 2%, and 1% of people with HIV according to NFS, FIB-4, and EACS algorithm scores, respectively. Cohort 2 included 1345 people with HIV; 60% and 30% of them had available HSI and FLI data, LS affected 55% and 43% and LF 2%, 5%, or 3%, respectively. Factors associated with LS included current CD4 cell count, diabetes, and hypertension, whereas LF was associated with previous exposure to dideoxynucleoside drugs and current CD4 to LF. Current integrase strand transfer inhibitor (INSTI) therapy appeared protective for LF in cohort 1.

Conclusions: In this study, one in four people with HIV had LS, and the prevalence rose to one in two in those with cardiovascular risk factors. The prevalence of LF was low, but it should be considered in older people with HIV with low CD4 counts or high aspartate transaminase levels. A possible protective effect from INSTIs deserves further investigation.

Background: Assessing the potential increased risk of viral rebound (VR) in migrants requires adequate control for sex and acquisition risk groups.

Methods: People living with HIV1, enrolled in the ANRS CO4-French Hospital Database on HIV, who achieved virological suppression with antiretroviral therapy (ART) initiated between 2006 and 2016 were included. We first compared the risk of VR, with loss to follow-up and death considered as competing events, across origin among the HIV acquisition groups, then across acquisition groups among the different origins, and finally across modality of a variable combining sex, acquisition group, and origin. Models were adjusted for clinical and biological confounding factors.

Results: We included 21 571 French natives (FRA), 10 148 migrants from sub-Saharan Africa (SSA), 1137 migrants from the non-French West Indies (NFWI), and 4205 other migrants (OTHER). The 5-year probability of VR was 19% (95% confidence interval [CI] 19-20) overall, 15% in FRA, 21% in OTHER, 26% in SSA, and 34% in NFWI (p < 0.0001). It was 14% in men who have sex with men (MSM), 23% in heterosexual men, and 23% in women (p < 0.0001). After adjustment, all acquisition groups had a higher risk of VR than MSM from FRA, with men and women from NFWI having the highest risk (adjusted hazard ratio [aHR] 2.46; 95% CI 2.12-2.86 and aHR 2.59; 95% CI 2.20-3.04, respectively). Within each acquisition group, all groups of origin had a higher risk of VR than FRA. Within each region of origin, except the NFWI, heterosexual men had a higher risk of VR than MSM.

Conclusions: After accounting for sex and acquisition group, migration, especially from NFWI, remains prognostic of VR.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.