Summary: Background: Data on cancer incidence and associated risk factors among women with HIV are limited. We investigated cancer burden among women with HIV. Methods: We included all women ≥18 years from the two large multicentre observational cohort collaborations (D:A:D and RESPOND). The primary outcomes were incidence of all cancers, HPV-related and common individual cancers including breast cancer, lung cancer, and non-Hodgkin lymphoma (NHL) from 2006 to 2021. Baseline was defined as the latest date of entry into local cohort enrolment and 1st January 2006 for D:A:D and 1st January 2012 for RESPOND. Participants were followed from baseline until the date of first cancer, final follow-up or administrative censoring—whichever occurred first. We assessed risk factors using multivariable Poisson regression by applying robust standard errors and determined a population attributable fraction (PAF) for key risk factors for cancers. Findings: Among 17,512 women included, median age at baseline was 39.5 years (interquartile range, IQR 32.5–46.0). Over 141,404 person-years (PYS) and a median 9.2 (5.5–10.1) years of follow-up, 832 women were diagnosed with any cancer; incidence rate 5.9 (95% CI 5.5–6.4)/1000 PYS, 163 HPV-related cancers (1.1 [1.0–1.3]/1000 PYS), 150 breast cancers (1.1 [0.9–1.2]/1000 PYS), 94 lung cancers (0.7 [0.5–0.8]/1000 PYS) and 72 NHL (0.5 [0.4–0.6]/1000 PYS). Older age (≥45 vs. <45 years), Southern Europe (vs. Western Europe) and smoking were associated with an increased risk of overall cancers. Lower pre-ART nadir CD4, time-updated CD4, and a prior AIDS diagnosis were associated with lung- and HPV-related cancer. In PAF analysis, smoking and HIV-related factors such as lower current CD4, nadir CD4 and HIV viremia significantly contributed to cancer risk. Interpretation: Our findings suggest that women with HIV older than 45 years, past or current immunosuppressed or current smokers could be candidates for intensified cancer screening and prevention. Funding: The Highly Active Antiretroviral Therapy Oversight Committee, The CHU St Pierre Brussels HIV Cohort, The Austrian HIV Cohort Study, The Australian HIV Observational Database, The AIDS Therapy Evaluation in the Netherlands national observational HIV cohort, The Brighton HIV Cohort, The National Croatian HIV Cohort, The EuroSIDA cohort, The Frankfurt HIV Cohort Study, The Georgian National AIDS Health Information System, The Nice HIV Cohort, The Isabel Foundation, The Modena HIV Cohort, The PISCIS Cohort Study, The Swiss HIV Cohort Study, The Swedish InfCare HIV Cohort, The Royal Free HIV Cohort Study, The San Raffaele Scientific Institute, The University Hospital Bonn HIV Cohort, The University of Cologne HIV Cohort, Merck Life Sciences, ViiV Healthcare, and Gilead Sciences.

Background:Data on cancer incidence and associated risk factors among women with HIV are limited. We investigated cancer burden among women with HIV. Methods:We included all women ≥18 years from the two large multicentre observational cohort collaborations (D:A:D and RESPOND). The primary outcomes were incidence of all cancers, HPV-related and common individual cancers including breast cancer, lung cancer, and non-Hodgkin lymphoma (NHL) from 2006 to 2021. Baseline was defined as the latest date of entry into local cohort enrolment and 1st January 2006 for D:A:D and 1st January 2012 for RESPOND. Participants were followed from baseline until the date of first cancer, final follow-up or administrative censoring-whichever occurred first. We assessed risk factors using multivariable Poisson regression by applying robust standard errors and determined a population attributable fraction (PAF) for key risk factors for cancers. Findings:Among 17,512 women included, median age at baseline was 39.5 years (interquartile range, IQR 32.5-46.0). Over 141,404 person-years (PYS) and a median 9.2 (5.5-10.1) years of follow-up, 832 women were diagnosed with any cancer; incidence rate 5.9 (95% CI 5.5-6.4)/1000 PYS, 163 HPV-related cancers (1.1 [1.0-1.3]/1000 PYS), 150 breast cancers (1.1 [0.9-1.2]/1000 PYS), 94 lung cancers (0.7 [0.5-0.8]/1000 PYS) and 72 NHL (0.5 [0.4-0.6]/1000 PYS). Older age (≥45 vs. <45 years), Southern Europe (vs. Western Europe) and smoking were associated with an increased risk of overall cancers. Lower pre-ART nadir CD4, time-updated CD4, and a prior AIDS diagnosis were associated with lung- and HPV-related cancer. In PAF analysis, smoking and HIV-related factors such as lower current CD4, nadir CD4 and HIV viremia significantly contributed to cancer risk. Interpretation:Our findings suggest that women with HIV older than 45 years, past or current immunosuppressed or current smokers could be candidates for intensified cancer screening and prevention. Funding:The Highly Active Antiretroviral Therapy Oversight Committee, The CHU St Pierre Brussels HIV Cohort, The Austrian HIV Cohort Study, The Australian HIV Observational Database, The AIDS Therapy Evaluation in the Netherlands national observational HIV cohort, The Brighton HIV Cohort, The National Croatian HIV Cohort, The EuroSIDA cohort, The Frankfurt HIV Cohort Study, The Georgian National AIDS Health Information System, The Nice HIV Cohort, The Isabel Foundation, The Modena HIV Cohort, The PISCIS Cohort Study, The Swiss HIV Cohort Study, The Swedish InfCare HIV Cohort, The Royal Free HIV Cohort Study, The San Raffaele Scientific Institute, The University Hospital Bonn HIV Cohort, The University of Cologne HIV Cohort, Merck Life Sciences, ViiV Healthcare, and Gilead Sciences.

The optimal positioning and sequencing of sodium-glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in adults with chronic kidney disease (CKD) with type 2 diabetes (T2D) and overweight/obesity is unclear. This Delphi panel aimed to establish expert consensus on the foundational versus adjunctive role of SGLT2is and GLP-1 RAs in this adult population. A total of 114 participants across 10 countries participated in a two-round Delphi panel (9.7

OBJECTIVE:To assess outcomes of heavily treatment experienced people with HIV (PWH) who received the antiretroviral therapy salvage regimen containing raltegravir, etravirine, and darunavir/ritonavir (known as TRIO). METHODS:Data were from the ART Cohort Collaboration, which is a collaboration of European and North American HIV cohort studies. Adult PWH were eligible if they had a history of virologic failure while receiving nonnucleoside reverse-transcriptase inhibitors; three or more primary protease inhibitor and nucleoside reverse transcriptase inhibitor mutations; three or fewer darunavir and nonnucleoside reverse-transcriptase inhibitor mutations; received TRIO between 2007 and 2018; virologic failure at TRIO start; and did not receive any TRIO drugs previously. Follow-up began at TRIO start. We examined rates of virologic suppression on TRIO, AIDS/death, receipt of drug-reducing regimens post-TRIO in those virologically suppressed, and subsequent virologic response. We used a competing risks framework to estimate 5-y cumulative incidence of outcomes. RESULTS:Among 126 eligible PWH, 24% were female, and median age was 46 y (IQR: 41-50). Median follow-up was 7.9 y (IQR: 5.1-9.3). A total of 94 (74.6%) were virologically suppressed on TRIO. Of these, 26 (28%) subsequently switched to a drug-reducing regimen, of whom 19 of 26 (73.1%) were virologically suppressed at their next viral load measure. The 5-y cumulative incidence of outcomes was stop TRIO and start another three or more drug regimen (39.1%); simplify (16.0%); stop TRIO without switching (8.8%); and death on TRIO (7.2%). CONCLUSIONS:Although the most common outcome after TRIO was switch to another three or more drug regimen, almost one third of virologically suppressed PWH under TRIO (with a history of multidrug resistance) switched to a drug-reducing regimen, the majority of whom maintained suppression.

INTRODUCTION:Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects. METHODS AND ANALYSIS:This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-naïve PLHIV (HIV RNA≥1000 copies/mL at screening) across six countries (Brazil, Cameroon, France, Côte d'Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age ≥18 years, confirmed HIV-1 infection with plasma RNA levels ≥1000 copies/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by screening HIV-1 RNA load (≤100 000 or >100 000 copies/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA <50 copies/mL at week 48 on the assigned treatment (FDA Snapshot algorithm). Secondary outcomes include cardiometabolic safety endpoints (ie, weight gain, insulin resistance, hypertension, diabetes, waist and hip circumferences, waist-to-hip ratio, fasting glycaemia, insulin and fasting serum lipids), along with mental health, quality of life, virological and immunological parameters. Final data collection is expected by July 2028. ETHICS AND DISSEMINATION:Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024/09/1717/CE/CNERSH/SP)/Ministry of Public Health (D30-1464/AAR/MINSANTE/SG/DROS/CRC); Côte d'Ivoire: (CNESVS (0018224/MSHPCMU/CNESVS-km)/AIRP (1329/AIRP/DISMP/Om/kbaag); France (CTIS CPP/ANSM (2023-508626-10-00)); Mozambique (CNBS (20/CNBS/25)/ANARME (4635/380/ANARME)); Thailand: (IHRP (08/1944)/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924 302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms. TRIAL REGISTRATION NUMBERS:NCT06203132; EU-CT, 2023-508626-10-00.

Background:The LENAddOn study aimed to characterize people with HIV (PWH) initiating injectable lenacapavir (LEN) post-early access program in France, assess LEN continuation rates at W26 and W52, and describe reasons for LEN discontinuation. Methods:Observational, retrospective study across 19 centers, including people with HIV-1 who initiated LEN between 20 June 2023 and 30 June 2024. Sociodemographic, clinical, and laboratory data were extracted from medical records. The primary outcome was the proportion of PWH receiving a second and third set of LEN injections at W26 and W52. Results:Seventy-seven PWH were included (median age, 57 years [IQR, 44-63]; duration of antiretroviral therapy (ART), 25 years [17-29]), with a history of frequent adherence issues and vulnerability factors. At LEN initiation, 22 (28.6%) had a plasma HIV-1 viral load (pVL) ≥200 copies/mL, and 43 (55.8%) had a pVL <50 copies/mL; 42 (54.6%) had viral resistance to ≥2 drugs in ≥3 classes. Twenty-one participants (27.3%) received injectable ART associating LEN plus cabotegravir ± rilpivirine. Lenacapavir continuation rate was 94.8% (95% CI, 87.2-98.6) at W26 and 81.8% (71.4-89.7) at W52, with 4 LEN discontinuations between D0 and W26 and 10 between W26 and W52. Main reasons for LEN discontinuation were death unrelated to LEN/lost-to-follow-up (n = 5), persistence of viral replication (n = 3), and injection site reactions (n = 2). Last measured pVL during the study period was <200 cp/mL in 72/77 participants (93.5%) and <50 cp/mL in 61/77 (79.2%). Conclusions:Lenacapavir use allowed simplification of antiretroviral regimens, with the maintenance or achievement of virological suppression. Continuation of LEN at W26 and W52 remained high among a population with extensive treatment history.

Objectives The COVID-19 pandemic threatened global HIV Test and Treat Efforts. We assessed whether it affected (1) the number of antiretroviral therapy (ART) initiations and (2) the proportion of timely ART initiations in people living with HIV (PLWH) globally.Design Quasi-experimental, regression discontinuity design using routinely collected data from HIV clinics.Setting 360 HIV care clinics across primary and secondary levels of care, participating in the International epidemiology Databases to Evaluate AIDS consortium, in 31 countries in Asia, Africa and the Americas.Participants 177 391 PLWH (≥18 years old) who initiated ART 2 years before and 1 year after the onset of the COVID-19 pandemic in their country.Primary and secondary outcome measures The primary outcome was the number of ART initiations per week; the secondary outcome was the proportion of timely ART initiations (ie, ART initiated within 7 days of enrolment). We assessed changes in these outcomes in the 52 weeks after compared to the 104 weeks before the pandemic onset, defined using each country’s peak Oxford Stringency Index score between January and June 2020.Results Among 177 391 newly enrolled PLWH, 129 743 initiated during the pre-pandemic and 47 648 post-pandemic onset. 72.5% of ART initiations were timely pre-pandemic whereas 82.3% were during the pandemic. Absolute number of ART initiations remained stable during the pandemic period in 25 of 31 countries but decreased significantly in six countries: India (−5.0 p, 95% CI −9.2 to −0.7), Rwanda (−10.0 p, −18.6 to −1.4), Malawi (−33.4 p, −54.1 to −12.3), South Africa (−130.8 p, −188.6 to −73.1), Zimbabwe (−12.9 p, −20.0 to −5.8) and Togo (−19.6 p, −39.1 to −0.1). The proportion of timely initiations was stable in all countries except in Kenya (+4.2 pp, 95% CI +0.3 to +8.1) and in Mozambique (+2.7 pp, +0.5 to +4.9), where it increased significantly.Conclusions A deeper understanding of the factors that contributed to sustaining ART initiations, particularly in settings with stringent public health and social measures, is needed. These insights should inform preparedness strategies, resource allocation and policy development to ensure continuity of HIV services during future health emergencies, in line with World Health Organisation recommendations.

OBJECTIVES:We investigated, in a real-world setting, virological factors associated with virological failure (VF) after bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) initiation in people with HIV (PWH) with and without pre-existing drug resistance mutation (PRM) and the emergence of new resistance mutations at virological failure. METHODS:Treatment-experienced PWH from ANRS-CO3-AquiVIH-NA cohort starting B/F/TAF between 2018 and 2021 were stratified depending on their baseline viral load (VL): virologically suppressed (VS; VL <50 copies/mL) and virologically unsuppressed (VU; VL >50 copies/mL). PRM were identified using cumulative genotypic resistance tests (GRT) according to the ANRS algorithm. Factors associated with VF were analysed using a Cox proportional hazards model and survival curves. RESULTS:Among the 636 PWH with available GRT results, 82.7% were VS at B/F/TAF initiation. PRMs to at least one component of B/F/TAF were present for 23.1% of participants (20.9% VS and 33.6% VU), with the M184I/V mutation identified in 89.1% of cases (88.2% in VS and 91.9% in VU). Virological success was higher for those with no PRMs (92.8% no PRM vs 86.4% with PRM). VU PWH had a higher risk of VF [HR 9.53 (5.54-16.40)]. Among the 66 PWH with baseline GRT experiencing VF, new resistance mutations were selected for six (two VU and four VS). After VF, B/F/TAF was maintained for 56/66 (84.8%) participants, of whom 40/56 (71.4%) had a VL <50 copies/mL at their last visit. CONCLUSIONS:Virological suppression was maintained in VS PWH regardless PRMs but to a less extent in VU PWH. Emergence of new resistance mutation occurred rarely in the case of VF.

INTRODUCTION:As people living with HIV age, frailty has emerged as a determinant of adverse health outcomes. We evaluated four frailty assessment tools in their ability to predict adverse health outcomes and mortality in people living with HIV. METHODS:We enrolled 508 people living with HIV aged ≥70 years. At baseline, frailty was assessed using the Fried frailty phenotype, the FRAIL scale, the Study of Osteoporotic Fractures (SOF) score and the French Health Authority (HAS) questionnaire. The primary outcome was adverse health events (serious or recurrent falls, emergency department visits, unscheduled hospitalizations, nursing home admission or death) over 36 months. Log-binomial regression models estimated relative risks (RRs) for adverse outcomes in the 355 participants with a 36 months visit follow-up or death. Cox proportional hazards models assessed mortality in all enrolled people living with HIV. RESULTS:Over 36 months, 204 participants (40.2%) experienced our primary outcome, including 40 deaths. Frailty was associated with a higher risk of adverse outcomes with all tools: Fried phenotype [RR 1.41, 95% confidence interval (CI) 1.06-1.86], FRAIL scale (RR 1.88, 95% CI 1.54-2.29), SOF score (RR 1.45, 95% CI 1.05-2.00) and HAS questionnaire (RR 1.64, 95% CI 1.40-1.92). All tools were strongly associated with mortality, except the SOF score. CONCLUSIONS:In people living with HIV aged ≥70 years, all four frailty tools predicted adverse health outcomes, whilst mortality was best predicted by the Fried phenotype, FRAIL scale and HAS questionnaire. Simple, questionnaire-based tools such as the FRAIL scale and the HAS questionnaire offer practical and effective frailty screening tools in routine HIV care for older adults.

BACKGROUND:Statins are among the most widely used drugs; however, their benefits for primary prevention of atherosclerotic cardiovascular disease (ASCVD) in individuals aged 75 years or older without the disease remain uncertain. We aimed to assess the non-inferiority of statin cessation in terms of all-cause mortality under real-life conditions in individuals aged 75 years or older who were prescribed statins for the primary prevention of ASCVD. METHODS:We performed a multicentre, open-label, parallel-group, phase 3 randomised controlled trial in 297 primary care offices. Individuals who were aged 75 years or older, were prescribed any statin for at least 1 year for the primary prevention of ASCVD, had no history of ASCVD, and could provide informed consent were randomly assigned (in an unbalanced 5:4 ratio) to continue or stop their statin treatment and were followed up for 36 months. Participants were excluded if they had a progressive disease with a life expectancy of 3 months or less, were diagnosed with dementia, had known homozygous or double heterozygous familial hypercholesterolaemia, or were unable to provide informed consent. Randomisation was computer-generated and implemented via a central electronic system; masking was not done. The primary endpoint was all-cause mortality at 3 years, analysed in participants according to the primary estimand (participants who met all key eligibility criteria and were randomly assigned to statin discontinuation or continuation less than 90 days after inclusion). Missing data were handled using multiple imputation. The non-inferiority margin was 5% for the absolute between-group difference in mortality. This trial is registered with ClinicalTrials.gov, NCT02547883 (completed). FINDINGS:Between June 15, 2016, and Jan 7, 2020, 1180 participants were randomly assigned, and 1160 participants were included in the analysis of the primary estimand. 639 participants were randomly assigned to the statin continuation group, and 521 participants were assigned to the statin discontinuation group. The median age was 80 years (IQR: 78-84), and 775 (66·8%) of 1160 participants were women; 342 (29·5%) of 1160 participants had diabetes, and 896 (77·2%) of them had hypertension. At 36 months, 48 (7·9%) of 604 participants in the statin continuation group and 35 (7·2%) of 484 participants in the statin discontinuation group had died. The absolute difference in all-cause mortality between groups was -0·68% (95% CI -3·95 to 2·60). Statin discontinuation was non-inferior to continuation for 3-year all-cause mortality as the upper bound of the between group difference 95% CI did not exceed the prespecified non-inferiority margin. Adverse events occurred in 461 (73·1%) of 631 participants in the continuation group, and in 390 (74·0%) of 527 in the discontinuation group. Non-cardiovascular adverse events occurred in 456 (72·3%) of 631 participants in the continuation group and 383 (72·7%) of 527 in the discontinuation group. INTERPRETATION:In persons aged 75 years or older receiving statins for primary prevention and with no previous history of ASCVD, discontinuation of statins was non-inferior to continuation in terms of all-cause mortality over 3 years. These findings support individualised decision-making regarding statin discontinuation in older adults. FUNDING:French Ministry of Health within the framework of the Medico Economical Research Program (PRME) 2014.

Background Extrapulmonary tuberculosis (EPTB) is a leading cause of death among people living with HIV (PLHIV) in sub-Saharan Africa, yet site-specific mortality patterns and risk factors remain poorly characterised. We aimed to describe EPTB localisations and assess mortality rates and determinants of death among HIV-infected adults with EPTB in Abidjan, Côte d’Ivoire. Methods We conducted a retrospective cohort study including all HIV-infected adults (≥ 18 years) treated for presumptive or confirmed EPTB at the Infectious and Tropical Diseases Department of Treichville University Hospital between January 1, 2010, and March 31, 2019. Data were extracted from medical records. Survival was estimated using Kaplan–Meier methods. Risk factors for death were identified using a stratified Cox proportional hazards model. Results Of 2,046 TB/HIV co-infected patients, 1,240 (60.6%) had EPTB. The most frequent localisations were lymph nodes (32.0%), miliary tuberculosis (23.6%), and tuberculous meningitis (TBM, 16.4%). Overall mortality was 38% (470/1,240), reaching 58% for TBM, 49% for serous membrane TB, and 43% for miliary TB. Most deaths occurred within the first 60 days of anti-tuberculosis treatment. In multivariable analysis, independent risk factors for death were TBM (adjusted hazard ratio [aHR] 2.20; 95% confidence interval [CI] 1.28–3.74) and serous membrane TB (aHR 1.77; 95% CI 1.02–3.09). Miliary TB showed a trend toward increased mortality (aHR 1.66; 95% CI 0.98–2.82). Protective factors included cotrimoxazole prophylaxis (aHR 0.65; 95% CI 0.53–0.80) and a CD4 count ≥ 100 cells/mm³ (aHR 0.26; 95% CI 0.18–0.36). Conclusions EPTB is frequent and highly lethal among HIV-infected patients in Côte d’Ivoire, particularly TBM and serous membrane TB. The first two months of treatment are a critical period for survival. Cotrimoxazole prophylaxis and preserved CD4 counts are strongly protective. These findings support earlier HIV diagnosis, prompt ART initiation, and strengthened diagnostic algorithms for disseminated EPTB in resource-limited settings.

OBJECTIVE:Limited data exist regarding the incidence of glucocorticoid-induced adrenal insufficiency (AI). The incidence of hospitalization for AI remains poorly characterized. In a retrospective propensity score-matched cohort study, we assessed the incidence of AI and hospitalization for AI in patients receiving long-term systemic or inhaled corticosteroids compared with those receiving nonsteroidal anti-inflammatory drugs (NSAIDs). DESIGN/METHODS:Participants were recruited from the TriNetX Research Collaborative network. Using propensity score matching (1:1), we compared adults receiving long-term (>3 months) systemic or inhaled corticosteroids with those treated with NSAIDs. We assessed the rates of AI diagnosis and hospitalization for AI in the two groups. RESULTS:After matching, 243 430 patients on systemic corticosteroids and 315 237 patients on inhaled corticosteroids were compared with corresponding NSAID-treated controls. Mean age was 56.5 ± 18 years. Over a mean follow-up of 2.4 ± 1.9 years, long-term systemic corticosteroid use was associated with higher rates of AI diagnosis (0.20% vs 0.04% per year; HR 6.32, 95% CI 5.50-7.26, P < .001) and hospitalization for AI (0.02% vs 0.008% per year; HR 3.52, 95% CI 2.57-4.84, P < .001). Inhaled corticosteroid use was associated with increased AI diagnosis (0.05% vs 0.04% per year; HR 1.55, 95% CI 1.34-1.80, P < .001) but not with hospitalization for AI (HR 1.26, 95% CI 0.91-1.76, P = .17). CONCLUSIONS:Long-term systemic corticosteroid use substantially increases the risk of both AI diagnosis and hospitalization for AI. Inhaled corticosteroids confer a modest increase in AI diagnosis without significantly elevating hospitalization risk.

OBJECTIVE:While the cardiovascular safety of testosterone therapy in men remains controversial, limited data exist for trans men treated with testosterone. We assessed cardiovascular events, mortality, and suicide attempts under testosterone therapy in both cis men with hypogonadism and trans men. METHODS:Participants were recruited from the TriNetX Research network. We compared 117 908 cis men with hypogonadism treated with testosterone with 1:1 propensity score matched cis men not treated. We compared 6251 trans men treated with 6251 trans men not treated with testosterone and 6986 trans men treated to 6986 cis men not treated with testosterone. RESULTS:After 5 years of follow-up, cis men with testosterone therapy had a lower risk of myocardial infarction (HR [hazard ratio]: 0.94, 95% confidence interval [CI] [0.89-0.99], P = .01) with no difference for stroke or mortality, but higher risks of atrial fibrillation (1.27 [1.22-1.32], P < .0001) and acute pulmonary embolism/deep vein thrombosis (1.26 [1.18-1.34], P < .0001). Trans men treated with testosterone had no significant increase in the rate of cardiovascular outcomes as compared to both untreated trans and cis men. There was a lower rate of suicide attempts for trans men treated with testosterone as compared to untreated trans men (0.52 [0.35-0.78], P = .001), without significant differences when compared to untreated cis men. CONCLUSIONS:Testosterone treatment in cis men with hypogonadism was associated with a lower risk of myocardial infarction but a higher risk of atrial fibrillation and venous thromboembolism. Testosterone therapy in trans men was not associated with an increased risk of cardiovascular events when compared to untreated trans men or cis men.

Patient-reported outcomes (PROs) provide important insights into individuals’ health and well-being. We report PROs from six observational cohort studies in treatment-experienced people with HIV switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical practice. Data were pooled from the BICtegravir Single Tablet Regimen (BICSTaR) cohort studies (Asia/Canada/EU/Israel/Japan) and a similarly designed Chinese cohort study (GS-CN-380-5759). Quality of life (QoL; mental/physical health) and HIV treatment satisfaction were self-reported by participants using the generic (non-HIV-specific) 36-item Short Form Health Survey questionnaire and HIV Treatment Satisfaction Questionnaire (HIVTSQ; status [s]/change), respectively. Descriptive statistics and linear mixed models adjusted for potential confounders and interactions, with bootstrapped confidence intervals, were used to analyse PROs through 24 months (12 months for treatment satisfaction). Of 3724 treatment-experienced participants included, 64.2

Objectives BICSTaR is a multinational, prospective, observational study that aimed to evaluate bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV treatment-naïve (TN) and treatment-experienced (TE) participants in routine clinical practice. Methods Month 12 analysis of the French cohort with respect to virologic effectiveness, drug-related adverse events (DRAEs), emergence of resistance, body weight, and patient-reported outcomes using the HIV Symptom Index and the HIV Treatment Satisfaction Questionnaire. Results A total of 240 participants initiated B/F/TAF in January-July 2019 (56 TN, 184 TE), 79% of whom were male, with a median age of 50 years. At baseline, 63% (TN: 46%, TE: 68%) presented with comorbidities. At month 12, HIV-1 RNA was <50 cp/mL in 92% (43/47) of TN and 96% (134 of 139) of TE in missing = excluded analysis (discontinuation = failure analysis: TN: 92% [43 of 47], TE: 92% [134 of 146]). No major mutations associated with B/F/TAF resistance emerged. A total of 7% (16 of 240) discontinued B/F/TAF, including 4% (10 of 240) due to DRAEs and none for virologic reasons. DRAEs were reported in 13% (30 of 240) (no renal DRAE). The median changes in body weight were +6.5 kg in TN and +1.0 kg in TE. The number of bothersome symptoms decreased in the TN group, and treatment satisfaction significantly increased in the TE group. Conclusions These French real-world data confirm the effectiveness, safety, and tolerability of B/F/TAF in TN and TE participants with a high prevalence of comorbidities.