Effectiveness and Safety of Postoperative Hospital at Home for Surgical Patients: A Cohort Study.

OBJECTIVE: To determine the feasibility and effectiveness of a Hospital at Home (HaH) enabled early transfer pathways for surgical patients. BACKGROUND: HaH serves as a safe alternative to traditional hospitalization by providing acute care to patients in their homes through a comprehensive range of hospital-level interventions. To our knowledge, no studies have been published to date reporting a large cohort of early home-transferred patients after surgery through a HaH unit. METHODS: Cohort study enrolling every patient admitted to the HaH unit of a tertiary hospital who underwent any of 6 surgeries with a predefined early transfer pathway and fitting both general and surgery inclusion criteria (clinical and hemodynamic stability, uncomplicated surgery, presence of a caregiver, among others) from November 2021 to May 2023. Protocols were developed for each pathway between surgical services and HaH to deliver the usual postoperative care in the home setting. Discharge was decided according to protocol. An urgent escalation pathway was also established. RESULTS: During the study period, 325 patients were included: 141 were bariatric surgeries, 85 kidney transplants, 45 thoracic surgeries, 37 cystectomies, 10 appendicectomies, and 7 ventral hernia repairs. The overall escalation of care during HaH occurred in 7.3% of patients and 30-day readmissions in 7%. Most adverse events were managed at home and the overall mortality was zero. The total mean length of stay was 8 days (interquartile range 2-14), and patients with HaH were transferred home 3 days (interquartile range 1-6) earlier than the usual pathway; a total of 1551 bed-days were saved. CONCLUSIONS: The implementation of early home transfer pathways for surgical patients through HaH is feasible and effective, with favorable safety outcomes.

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP).

Background: New regimens may provide better tolerability, convenience, and safety for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). For this reason, we evaluated the single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for 28 days. Methods: This was a prospective, open-label, single-arm trial including individuals with potential HIV-1 exposure within 72 hours. The primary endpoint was noncompletion of PEP at day 28. Secondary endpoints were adverse effects, adherence, and rate of seroconversion. We performed follow-up at day 7, week 4, and week 12. Results: Between September 2019 and March 2022, the study enrolled 399 individuals. Median age was 30 (interquartile range [IQR], 27-36) years, and 91% (n = 364) were male. The mode of exposure was sex between men in 84% (n = 331) of cases; risk assessment for HIV-1 transmission was considered as "high" in 97% (n = 385) of the participants. Median time from exposure to consultation was 24 (IQR, 13-40) hours. Noncompletion of PEP was 29% (n = 114) (95% confidence interval [CI], 24%-33%) and 20% (n = 72) (95% CI, 16%-25%) per modified intention-to-treat. Main reasons for noncompletion were loss to follow-up (n = 104 [91%]) and intolerance (n = 8 [7%]). Older age was associated with a lower risk of premature discontinuation (OR, 0.94; P < .001). One hundred twenty-three (31%) participants reported adverse events, mostly mild and self-limited (82%); discontinuation occurred in 8 cases (2%). Adherence to PEP in the assessed users was 96%. There were no HIV seroconversions. Conclusions: DOR/3TC/TDF is a well-tolerated option for nonoccupational PEP. Clinical Trials Registration. NCT04233372.

Increasing of New CA-MRSA Infections Detected in people living with HIV Who Engage in Chemsex in Barcelona: An Ambispective Study.

INTRODUCTION: There are no data on community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections in the context of the chemsex phenomenon. This study aimed to characterize CA-MRSA-related infections in a cohort of people living with HIV (PLWH) who engage in chemsex. METHODS: At the Hospital Clinic of Barcelona, from February 2018 to January 2022, we analyzed CA-MRSA infections diagnosed in a cohort of PLWH who engage in chemsex. Epidemiological, behavioral and clinical variables were assessed. Mass spectrometry identification and antimicrobial susceptibility testing were performed on MRSA isolates. Pulse field electrophoresis was used to assess the clonality of the MRSA strains. The presence of Panton-Valentine leukocidin was also investigated. RESULTS: Among the cohort of 299 participants who engage in chemsex, 25 (8%) with CA-MRSA infections were identified, 9 at baseline and 16 with incident cases; the cumulative incidence was 5.5% (95% CI: 3.2%, 8.8%). The most common drugs were methamphetamine (96%) and GHB/GBL (92%). Poly-consumption and slamming were reported by 32% and 46%, respectively. CA-MRSA was isolated from the infection sites of 20 participants, and CA-MRSA colonization was confirmed in the remaining 5 persons. Seventy-one percent had used antibiotics in the previous year. All participants presented with skin and soft tissue infections, 28% required hospitalization, and 48% had recurrence. Of the 23 MRSA isolates further studied, 19 (82,6%) belonged to the same clone. Panton-Valentine leukocidin was detected in all isolates. CONCLUSION: PLWH who engage in chemsex may present with CA-MRSA infections. Clinical suspicion and microbiological diagnosis are required to provide adequate therapy, and CA-MRSA prevention interventions should be designed.

Safety and efficiency of discharge to home hospitalization directly after emergency department care of patients with acute heart failure. / Análisis de seguridad y eficiencia de la hospitalización a domicilio directamente desde urgencias en pacientes con insuficiencia cardiaca aguda.

OBJECTIVES: To analyze whether discharge to home hospitalization (HHosp) directly from emergency departments (EDs) after care for acute heart failure (AHF) is efficient and if there are short-term differences in outcomes between patients in HHosp vs those admitted to a conventional hospital ward (CHosp). MATERIAL AND METHODS: Secondary analysis of cases from the EAHFE registry (Epidemiology of Acute Heart Failure in Emergency Departments). The EAHFE is a multicenter, multipurpose, analytical, noninterventionist registry of consecutive AHF patients after treatment in EDs. Cases were included retrospectively and registered to facilitate prospective follow-up. Included were all patients diagnosed with AHF and discharged to HHosp from 2 EDs between March 2016 and February 2019 (3 years). Cases from 6 months were analyzed in 3 periods: March-April 2016 (corresponding to EAHFE-5), January-February 2018 (EAHFE-6), and January-February 2019 (EAHFE-7). The findings were adjusted for characteristics at baseline and during the AHF decompensation episode. RESULTS: A total of 370 patients were discharged to HHosp and 646 to CHosp. Patients in the HHosp group were older and had more comorbidities and worse baseline functional status. However, the decompensation episode was less severe, triggered more often by anemia and less often by a hypertensive crisis or acute coronary syndrome. The HHosp patients were in care longer (median [interquartile range], 9 [7-14] days vs 7 [5-11] days for CHosp patients, P .001), but there were no differences in mortality during hospital care (7.0% vs. 8.0%, P = .56), 30-day adverse events after discharge from the ED (30.9% vs. 32.9%, P = .31), or 1-year mortality (41.6% vs. 41.4%, P = .84). Risks associated with HHosp care did not differ from those of CHosp. The odds ratios (ORs) for HHosp care were as follows for mortality while in care, OR 0.90 (95% CI, 0.41-1.97); adverse events within 30 days of ED discharge, OR 0.88 (95% CI, 0.62-1.26); and 1-year mortality, OR 1.03 (95% CI, 0.76-1.39). Direct costs of HHosp and CHosp averaged €1309 and €5433, respectively. CONCLUSION: After ED treatment of AHF, discharge to HHosp requires longer care than CHosp, but short- and longterm outcomes are the same and at a lower cost.

OBJETIVO: Analizar si la hospitalización domiciliaria (HDom) directamente desde los servicios de urgencias (SU) de pacientes con insuficiencia cardiaca aguda (ICA) resulta eficiente y si se asocia con diferencias en evolución a corto y largo plazo comparada con hospitalización convencional (HCon). METODO: Análisis secundario del registro Epidemiology Acute Heart Failure in Emergency departments (EAHFE), que es un registro multicéntrico, multiporpósito, analítico no intervencionista, con seguimiento prospectivo que incluye de forma consecutiva a los pacientes que acuden por episodio de ICA al SU. Se incluyeron, retrospectivamente, todos los pacientes diagnosticados de ICA en dos SU ingresados directamente en HDom entre marzo de 2016 y febrero de 2019 (3 años) y se compararon sus resultados con los pacientes diagnosticados de ICA incluidos en el registro EAHFE por esos 2 SU e ingresados en HCon durante los periodos marzo-abril 2016 (EAHFE-5), enero-febrero 2018 (EAHFE-6), y enero-febrero 2019 (EAHFE-7) (6 meses). Los resultados se ajustaron por las características basales y clínicas del episodio de descompensación. RESULTADOS: Se incluyeron 370 pacientes en HDom y 646 en HCon. El grupo HDom tenía mayor edad, mayor comorbilidad y peor situación funcional basal, pero menor gravedad del episodio de descompensación, más frecuentemente desencadenado por anemia y menos por crisis hipertensiva y síndrome coronario agudo. La duración del ingreso fue mayor [mediana (RIC) 9 (7-14) días frente a 7 (5-11) días, p 0,001], pero no hubo diferencias en mortalidad intrahospitalaria (7,0% frente a 8,0%, p = 0,56), eventos adversos a 30 días posalta (30,9% frente a 32,9%, p = 0,31) ni mortalidad al año (41,6% frente a 41,4%, p = 0,84). En el modelo ajustado, el riesgo asociado a HDom tampoco difirió significativamente en mortalidad intrahospitalaria (OR = 0,90, IC 95% = 0,41-1,97), eventos adversos posalta a 30m días (HR = 0,88, IC95% = 0,62-1,26) ni mortalidad al año (HR = 1,03, IC 95% = 0,76-1,39). El coste directo promedio del episodio en HDom y HCon fue 1.309 y 5.433 euros, respectivamente. CONCLUSIONES: En la ICA, la HDom directamente desde el SU es más prolongada que la HCon, pero consigue los mismos resultados a corto y largo plazo, y su coste es inferior.

Hospital at home treatment with remdesivir for patients with COVID-19: real-life experience.

OBJECTIVES: Access and appropriateness of therapeutics for COVID-19 vary because of access or regulatory barriers, the severity of the disease, and for some therapies, the stage of the pandemic and circulating variants. Remdesivir has shown benefits in clinical recovery and is the treatment of choice for selected patients, both hospitalized and nonhospitalized, in main international guidelines. The use of remdesivir in alternatives to conventional hospitalization such as hospital at home (HaH) units remains incompletely explored. In this study, we aim to describe the real-life experience of outpatient remdesivir infusion for COVID-19 in a HaH unit. METHODS: We selected all the consecutive patients receiving remdesivir from a prospective cohort of 507 COVID-19 patients admitted at a HaH unit. Admission criteria included COVID-19 with a fraction of inspired oxygen requirement under 0.35 and respiratory rate under 22 rpm. Patients were daily assessed in person by a nurse and a physician. RESULTS: A total of 236 patients admitted at the HaH unit received remdesivir, 172 of whom were treated at home. Only 2% presented any adverse event related to the infusion, all of them mild. HaH saved 1416 day-beds, with only 5% of the patients requiring transfer back to the hospital. CONCLUSION: Remdesivir infusion in HaH units seems to be a safe and efficient alternative to conventional hospitalization for treating patients with nonsevere COVID-19.

PrEP program experience in a hospital HIV unit. Description of baseline user profile and identification of opportunities for improvement.

INTRODUCTION: Pre-Exposure Prophylaxis (PrEP) is a biomedical intervention to prevent HIV infection in seronegative people at high risk of becoming infected. This strategy was endorsed in October 2019 by the Spanish Ministry of Health. OBJECTIVE: To present the PrEP initial experience in the HIV Unit of the Hospital Clínic of Barcelona, paying special attention to the analysis of the vulnerability factors in the cohort. MATERIALS AND METHODS: Retrospective, descriptive study. The epidemiological, sociodemographic, and clinical characteristics of the users included in the program during the first year are analyzed, paying particular attention to Infections, risky practices, and substance use. RESULTS: 190 individuals were included, 177 men and 12 trans women with a mean age of 35 years (8 SD). 70% had higher education, and half had Spanish nationality. An average of 10 couples per trimester and 60% reported unprotected anal sex. 31% had at least one positive PCR for STIs, with N. gonorrhoeae being the most prevalent microorganism (51%) and the rectal sample the most affected (21%). 63% reported chemsex use, 19% polydrug use, and 8% "slamming". Half expressed concern about consumption and/or sexual practices and 25% the need for help. CONCLUSIONS: The PrEP user profile attended in our Hospital Unit justifies the creation of multidisciplinary teams that allow us to provide holistic attention to the sexual life of these people.

Evolution of Risk Behaviors, Sexually Transmitted Infections and PrEP Care Continuum in a Hospital-Based PrEP Program in Barcelona, Spain: A Descriptive Study of the First 2 Years' Experience.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) is effective for HIV prevention, but the PrEP care continuum also involves improving PrEP awareness, uptake, adherence, and retention in care. Users' awareness is often compromised because of vulnerability factors and risk behaviors, such as chemsex practice or specific substance use, which could lead to risk compensation. Correct adherence and retention in care are essential to achieve the full effectiveness of PrEP. This study describes changes in users' risk behaviors and sexually transmitted infections (STIs), as well also PrEP care continuum details. METHODS: This was a descriptive single-center retrospective study including adults at high HIV risk screened between November 2019 and June 2021 in the PrEP program of our hospital. Demographic, behavioral, STI, adherence, and retention in care variables were assessed. Data were collected from medical records and self-report questionnaires. RESULTS: A total of 295 people were included, 94% men and 5% transgender women, with a mean age of 34 years (SD 10) and 10% sex workers. At baseline, 55% disclosed chemsex practice and 3% slamming. During follow-up, condom use for anal intercourse decreased from 41% to 13% (p ≤ 0.0001) and one HIV infection was detected; other risk behaviors and STIs remained stable. Chemsex, group sex, fluid exchange, and condomless anal intercourse were related to STI risk. Adherence was correct in 80% of users, and retention in care was 57%. Discontinuations and loss to follow-up were high, mainly affecting transgender women, sex workers, and people practicing fisting. CONCLUSION: PrEP program implementation in our hospital was adequate, since it allowed, in a population at high HIV risk, overall users' risk behaviors and STIs to remain stable, with only one HIV diagnosis during the follow-up. We should target specific strategies to improve adherence and retention in care, as vulnerable subgroups at higher risk of loss to follow-up are identified.

Do ART and Chemsex Drugs Get Along? Potential Drug-Drug Interactions in a Cohort of People Living with HIV Who Engaged in Chemsex: A Retrospective Observational Study.

INTRODUCTION: People living with HIV (PLWH) who engaged in chemsex are at risk of potential drug-drug interactions (pDDIs) with recreational drugs. This study aimed to characterize pDDIs between antiretroviral treatment (ART) and chemsex drugs and evaluate their association with unscheduled relevant hospital consultations. METHODS: We conducted a single-center, retrospective, observational study in a series of gay, bisexual, and other men who have sex with men (gbMSM) living with HIV who engaged in chemsex and who attended a tertiary hospital in Barcelona, Spain, from February 2018 through August 2019. Associations between all recorded pDDIs and relevant unscheduled consultations were estimated using the incidence rate (IR) per 100 person-years of those events compared between patients with no pDDI (green flag) or moderate severity pDDI (orange flag) with patients with high severity pDDI (red flag) using the incidence rate ratio (IRR). RESULTS: Among 172 PLWH engaged in chemsex, 249 ART regimens were prescribed: 44% based on integrase inhibitors, 30% on boosted ART, and 26% based on non-nucleoside reverse transcriptase inhibitors. The substances and recreational drugs most frequently used were erectile dysfunction agents (83%), methamphetamine (79%), GHB (77%), and alkyl nitrites (71%). Polydrug use was reported in 52%. We observed 2048 pDDIs. Of these, 23% were orange flag pDDIs; 88% related to boosted ARTs. The IR of the 285 unscheduled relevant episodes in patients with orange flag pDDIs was 64.67 (95% CI 40.07-89.28). The IRR of green flag pDDIs was 1.05 (95% CI 0.60-1.8; p = 0.876). CONCLUSION: One in four pDDIs were of moderate severity but no significant increase in the incidence of unscheduled relevant consultations was observed. A high number of unscheduled consultations, predominantly for psychiatric events and intoxication, were observed. Beyond using non-boosted ART to minimize pDDIs, other factors related to the practice of chemsex must be addressed, in order to offer a better approach.

Chemsex Practices in PrEP: Beyond Addiction and Risk Toward a Healthy Sex Life-Baseline Experiences from a Hospital-Based PrEP Program in Barcelona, Spain.

Pre-exposure prophylaxis (PrEP) is a biomedical intervention that has demonstrated efficacy in HIV prevention in individuals at high-risk, among them chemsex users. Out of 190 PrEP users followed at Hospital Clinic of Barcelona until October 2020, 89% reported drug use, and 63% disclosed that they had engaged in chemsex practices, initiated in 64% of cases within the past year. Twenty-one percent used 3 or more drugs simultaneously, being GHB/GBL, nitrites, sildenafil, and methamphetamine the most prevalent combination. Eight percent reported slamming. Forty-one percent described having had negative experiences and 8% did not remember the last time they had sober sex. Methamphetamine, mephedrone, GHB/GBL, and having had open relationships, group sex, double penetration, and fisting were significantly more prevalent. Forty-nine percent admitted being worried about chemsex use, and 18% said they needed help. A comprehensive, interdisciplinary approach is mandatory to enable the attainment of a healthy approach to one's sex life.

RESUMEN: La PrEP es una intervención biomédica eficaz en la prevención del VIH en personas con alto riesgo, entre ellas las personas que practican chemsex. De los 190 usuarios de PrEP seguidos en el Hospital Clínic de Barcelona hasta octubre de 2020, el 89% refirió utilizar drogas y el 63% en contexto de chemsex, iniciando el consumo el 64% durante el último año. El 21% refería policonsumo, siendo GHB/GBL, nitritos, sildenafilo y metanfetamina la combinación más prevalente. El 8% reportó slamming. El 41% describió haber tenido experiencias negativas y el 8% no recordaba la última vez que tuvo sexo sobrio. Metanfetamina, mefedrona, GHB/GBL y haber tenido relaciones abiertas, sexo en grupo, doble penetración y fisting fueron significativamente más frecuentes. El 49% refirió estar preocupado por la práctica de chemsex y el 18% necesitar ayuda. Un abordaje integral e interdisciplinar mejoraría el acompañamiento global de la sexualidad en estas personas.

Impact of coronavirus disease 2019 epidemics on prevention and care for HIV and other sexually transmitted infections.

OBJECTIVE: To assess the impact of coronavirus disease 2019 (COVID-19) epidemics on the prevention and care for HIV and other sexually transmitted infections at a major reference centre providing preventive and clinical services in Catalonia, Spain. DESIGN: We retrospectively compared anonymized clinical and laboratory data from March to December 2020 vs. 2019. METHODS: Monthly clinical data on HIV preexposure and postexposure prophylaxis users and on adults with HIV infection were retrieved from the administrative hospital database. Monthly tests for HIV, hepatitis B and C, Treponema pallidum, Neisseria gonorrhoeae,and Chlamydia trachomatis, and plasma lipids and glucose were recovered from the laboratory database. RESULTS: There were less (↓28%, P  = 0.003) but more advanced (mean CD4+ cells/µl 305 vs. 370, P  < 0.001) HIV infections and more gonorrhoea (↑39%, P  < 0.001) and chlamydia (↑37%, P  < 0.001) infections in 2020 vs. 2019. In people with HIV, rates of HIV RNA less than 50 copies/ml remained stable (11 vs. 11%, P  = 0.147) despite less scheduled visits (↓25%, P  < 0.001). However, they had less antiretroviral prescription changes (↓10%, P  = 0.018), worse plasma lipids [mean total cholesterol 190 vs. 185 mg/dl, P  < 0.001;mean low-density lipoprotein (LDL) cholesterol 114 vs. 110 mg/dl, P  < 0.001; mean triglycerides 136 vs. 125 mg/dl, P  < 0.001; mean high-density lipoprotein (HDL) cholesterol 47 vs. 48 mg/dl, P  = 006], and an excess of mortality (↑264%, P  = 0.006) due in great part not only to COVID-19 but also to other causes. CONCLUSION: In our setting, COVID-19 epidemics was associated with an increase in some prevalent sexually transmitted infections, with less but more advanced HIV infections, and with worse nonvirologic healthcare outcomes and higher mortality in people living with HIV.

Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre.

BACKGROUND: The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is mainly based on robust, pivotal clinical trials. OBJECTIVES: To provide data on clinical use of BIC/FTC/TAF in real life. PATIENTS AND METHODS: This was an observational, retrospective and single-centre study. We included all adult, treatment-naive (TN) and treatment-experienced (TE) people living with HIV (PLWH) starting BIC/FTC/TAF from 8 June 2018. We evaluated effectiveness [on treatment (OT), modified intention-to-treat (mITT) and intention-to-treat (ITT)], tolerability and safety in those patients who reached 6 months of follow-up (M6). RESULTS: We included 1584 PLWH [213 TN (13%) and 1371 TE (87%)]. The median (IQR) follow-up was 16 (7-21) months, with 81% and 53% of PLWH reaching M6 and M12, respectively. By OT, mITT and ITT, HIV-RNA <50 copies/mL was 77%, 70% and 62% at M6 and 92%, 77% and 63% at M12 for TN PLWH and 94%, 89% and 83% at M6 and 93%, 85% and 78% at M12 for TE PLWH, respectively. In PLWH carrying an M184V/I substitution, OT RNA <50 copies/mL was 89.5% at M6. The median CD4 cell count increased from 329 to 511/µL in TN PLWH and from 630 to 683/µL in TE PLWH at M6. Of the total, 1148 (88%) PLWH continued on BIC/FTC/TAF at M6. The most frequent known reason for discontinuation was toxicity [42 (69%) cases]; only 7 cases were considered virological failures (0.6% of the total OT cohort at M6), with no emerging resistance substitutions. CONCLUSIONS: In real life, BIC/FTC/TAF showed high rates of virological suppression and also in PLWH carrying lamivudine/emtricitabine resistance substitutions. The tolerability and safety of BIC/FTC/TAF were good, with high persistence observed for patients on this regimen at M6.

Long-term evolution in liver fibrosis and immune profile after direct-acting antivirals therapy in hepatitis C virus-human immunodeficiency virus co-infected patients.

OBJECTIVE: Hepatitis C virus (HCV) therapy with direct-acting antivirals (DAA) achieves high rates of sustained virological response in people living with human immunodeficiency virus (HIV) (PLWH). Information on its long-term clinical impact is scarce. The aim of this study was to analyse liver fibrosis and immune response evolution after DAA treatment. METHODS: Retrospective, single centre cohort study of HIV-HCV co-infected patients treated with DAA between June 2013 and June 2018. We analysed the changes during follow up in liver fibrosis (assessed by transient elastography (TE), aspartate aminotransferase to platelet ratio index (APRI) and FIB-4 scores) and immunity (CD4 and CD8 cells counts and CD4/CD8 ratio). RESULTS: We included 410 patients; 75% (308/407) men with a mean age of 50 years (SD 8); 78% (318/410) had long chronic HCV infection (median 21 years, interquartile range (IQR) 6-27 years) and 27% (107/393) had liver cirrhosis. Liver fibrosis improvement based on the decrease in TE value compared with the baseline occurred in 43% (131/302) of patients and 31% of patients based on biological scores (APRI: 124/398; FIB-4: 104/398) (p < 0.0001), being more frequent in those with advanced baseline fibrosis (83/144). The higher decrease was observed at 6 months after DAA therapy (-0.23; 95% CI -0.29 to -0.18), but a continuum in fibrosis regression of at least 30% from baseline value of TE was observed along the follow up (32% of patients at month 6, 51% at month 24 and 55% at month 48). Regarding the immunological profile, there was a significant decrease in CD8 counts at month 48 (-62.38; 95% CI -106.77 to -17.99; p 0.0001) and a progressive rise in the CD4/CD8 ratio after 24 months of follow up reaching an increment of +0.07 (95% CI 0.03-0.10, p 0.0001) at month 48. CONCLUSIONS: HCV treatment with DAA in PLWH is associated with significant progressive improvement in liver fibrosis and recovery of the immune system with an increase in the CD4/CD8 ratio in long-term follow up.

Factors associated with the use and composition of two-drug regimens in a large single-centre HIV cohort.

OBJECTIVES: We aimed to assess the clinical characteristics associated with the use of two-drug regimens (2DRs) and the factors associated with specific antiretrovirals in 2DRs in a large single-centre HIV cohort. METHODS: Retrospective analysis of demographics, HIV characteristics and AIDS events, antiretroviral prescription, virological failure and genotypic resistance testing, and laboratory results from all adult people with HIV (PWH) prospectively followed at the Hospital Clinic of Barcelona who were receiving a 3DR or a 2DR in January 2020. We assessed factors associated with the probability of receiving 2DRs relative to three-drug regimens (3DRs) using a logistic regression model, controlling for age, sex and year of HIV diagnosis. The same methodology was applied to identify factors associated with the prescription of integrase inhibitor-based regimens or PI-based regimens among PWH receiving 2DRs. RESULTS: There were 3432 (88%) PWH receiving 3DRs and 463 (12%) receiving 2DRs. In the final adjusted model, ≥2 previous virological failures, previous resistance mutations, previous AIDS diagnosis, longer time on current regimen, higher total cholesterol or triglycerides and lower baseline haemoglobin were independent factors associated with 2DRs. The majority of 2DRs included an integrase inhibitor or/and a PI. We identified independent factors associated with the inclusion of integrase inhibitors (lower HDL cholesterol) or PIs (prior AIDS, prior genotypic resistance mutations and lower CD4/CD8 ratio) in the 2DR. CONCLUSIONS: In this large single-centre HIV cohort, a worse cardiometabolic status or more archived resistance were key factors associated with inclusion of integrase inhibitors or PIs, respectively, in 2DRs.

PrEP program experience in a hospital HIV unit. Description of baseline user profile and identification of opportunities for improvement. / Experiencia de un programa de profilaxis preexposición en una unidad de virus de la inmunodeficiencia humana hospitalaria. Descripción del perfil basal del usuario e identificación de oportunidades de mejora.

INTRODUCTION: Pre-Exposure Prophylaxis (PrEP) is a biomedical intervention to prevent HIV infection in seronegative people at high risk of becoming infected. This strategy was endorsed in October 2019 by the Spanish Ministry of Health. OBJECTIVE: To present the PrEP initial experience in the HIV Unit of the Hospital Clínic of Barcelona, paying special attention to the analysis of the vulnerability factors in the cohort. MATERIALS AND METHODS: Retrospective, descriptive study. The epidemiological, sociodemographic, and clinical characteristics of the users included in the program during the first year are analyzed, paying particular attention to Infections, risky practices, and substance use. RESULTS: 190 individuals were included, 177 men and 12 trans women with a mean age of 35 years (8 SD). 70% had higher education, and half had Spanish nationality. An average of 10 couples per trimester and 60% reported unprotected anal sex. 31% had at least one positive PCR for STIs, with N. gonorrhoeae being the most prevalent microorganism (51%) and the rectal sample the most affected (21%). 63% reported chemsex use, 19% polydrug use, and 8% "slamming". Half expressed concern about consumption and/or sexual practices and 25% the need for help. CONCLUSIONS: The PrEP user profile attended in our Hospital Unit justifies the creation of multidisciplinary teams that allow us to provide holistic attention to the sexual life of these people.

High rates of long-term progression in HIV-1-positive elite controllers.

INTRODUCTION: Elite controllers (EC) are a rare group of HIV-1-positive individuals who suppress viral loads (VL) to undetectable levels with elevated CD4 T-cell counts in the absence of ART. While rates of short- and mid-term progression have been described in these patients, few studies have focused on their long-term outcome This study aims to describe the virological and immunological behaviour in a cohort of elite controllers followed up for a median of 17 years in the University Hospital, and to identify factors that may be related to disease progression. METHODS: We conducted a descriptive, prospective and single-centre study of all HIV-positive adults recorded in the University Hospital database who met the definition criteria for EC. EC were defined as patients having two consecutive undetectable VL without ART for at least one year. Patients were followed from baseline up to December 2019, to the development of a progression event (loss of VL control, CD4+ T cell decline, AIDS or death) or to the censoring date (lost to follow-up or initiation of ART). Predictive models of progression were calculated. RESULTS: Fifty-nine EC were identified with a median follow-up of 17 years contributing 1033 PYFU. The median (95% CI) time duration from HIV-1 diagnosis to disease progression was four (1.7 to 6.3) years. Forty-nine (83%) presented progression to the composite end-point, 44 (74.6%) lost viral control, 39 (66.1%) lost immunological control, two developed AIDS and two died. Only 10 patients (16.9%) did not show progression of any kind. Independent predictors of virological progression were sexual risk of HIV-1 acquisition and VL blips during the first year of follow-up (baseline). The only independent predictor detected for progression to a composite end-point was VL blips during the first year of follow-up (baseline). CONCLUSIONS: The rate of long-term progression in EC was very high. Only a minority of patients did not show clinical progression after a median of 17 years of follow-up. These results should be taken in account when considering EC as a model of HIV-1 remission.

A Classifier to Predict Viral Control After Antiretroviral Treatment Interruption in Chronic HIV-1-Infected Patients.

OBJECTIVES: To construct a classifier that predicts the probability of viral control after analytical treatment interruptions (ATI) in HIV research trials. METHODS: Participants of a dendritic cell-based therapeutic vaccine trial (DCV2) constituted the derivation cohort. One of the primary endpoints of DCV2 was the drop of viral load (VL) set point after 12 weeks of ATI (delta VL12). We classified cases as "controllers" (delta VL12 > 1 log10 copies/mL, n = 12) or "noncontrollers" (delta VL12 < 0.5 log10 copies/mL, n = 10) and compared 190 variables (clinical data, lymphocyte subsets, inflammatory markers, viral reservoir, ELISPOT, and lymphoproliferative responses) between the 2 groups. Naive Bayes classifiers were built from combinations of significant variables. The best model was subsequently validated on an independent cohort. RESULTS: Controllers had significantly higher pre-antiretroviral treatment VL [110,250 (IQR 71,968-275,750) vs. 28,600 (IQR 18737-39365) copies/mL, P = 0.003] and significantly lower proportion of some T-lymphocyte subsets than noncontrollers: prevaccination CD4CD45RA+RO+ (1.72% vs. 7.47%, P = 0.036), CD8CD45RA+RO+ (7.92% vs. 15.69%, P = 0.017), CD4+CCR5+ (4.25% vs. 7.40%, P = 0.011), and CD8+CCR5+ (14.53% vs. 27.30%, P = 0.043), and postvaccination CD4+CXCR4+ (12.44% vs. 22.80%, P = 0.021). The classifier based on pre-antiretroviral treatment VL and prevaccine CD8CD45RA+RO+ T cells was the best predictive model (overall accuracy: 91%). In an independent validation cohort of 107 ATI episodes, the model correctly identified nonresponders (negative predictive value = 94%), while it failed to identify responders (positive predictive value = 20%). CONCLUSIONS: Our simple classifier could correctly classify those patients with low probability of control of VL after ATI. These data could be helpful for HIV research trial design.