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BACKGROUND: Women with HIV are globally underrepresented in clinical research. Existing studies often focus on reproductive outcomes, seldom focus on older women, and are often underpowered to assess sex/gender differences. We describe CD4, HIV viral load (VL), clinical characteristics, comorbidity burden, and use of antiretroviral therapy (ART) among women with HIV in the RESPOND study and compare them with those of the men in RESPOND. METHODS: RESPOND is a prospective, multi-cohort collaboration including over 34 000 people with HIV from across Europe and Australia. Demographic and clinical characteristics, including CD4/VL, comorbidity burden, and ART are presented at baseline, defined as the latter of 1 January 2012 or enrolment into the local cohort, stratified by age and sex/gender. We further stratify men by reported mode of HIV acquisition, men who have sex with men (MSM) and non-MSM. RESULTS: Women account for 26.0% (n = 9019) of the cohort, with a median age of 42.2 years (interquartile range [IQR] 34.7-49.1). The majority (59.3%) of women were white, followed by 30.3% Black. Most women (75.8%) had acquired HIV heterosexually and 15.9% via injecting drug use. Nearly half (44.8%) were receiving a boosted protease inhibitor, 31.4% a non-nucleoside reverse transcriptase inhibitor, and 7.8% an integrase strand transfer inhibitor. The baseline year was 2012 for 73.2% of women and >2019 for 4.2%. Median CD4 was 523 (IQR 350-722) cells/µl, and 73.6% of women had a VL <200 copies/mL. Among the ART-naïve population, women were more likely than MSM but less likely than non-MSM (p < 0.001) to have CD4 <200 cells/µL and less likely than both MSM and non-MSM (p < 0.001) to have VL ≥100 000 copies/mL. Women were also more likely to be free of comorbidity than were both MSM and non-MSM (p < 0.0001). CONCLUSION: RESPOND women are diverse in age, ethnicity/race, CD4/VL, and comorbidity burden, with important differences relative to men. This work highlights the importance of stratification by sex/gender for future research that may help improve screening and management guidelines specifically for women with HIV.
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OBJECTIVE: Fractures of the proximal humerus (PHF) are commonly treated conservatively. Evidence suggests that a period of immobilization of one week or less may lead to some advantages compared to a traditional 3-4 weeks of immobilization. The purpose of this systematic review was to assess the clinical and radiological results in the case of early rehabilitation vs. delayed rehabilitation after PHF. MATERIALS AND METHODS: In July 2023, a literature search was carried out on the PubMed, MEDLINE, and Embase databases to identify all the randomized trials comparing early rehabilitation vs. delayed rehabilitation after PHF. The following data were extracted from each included study: patients' demographics, study design and level of evidence, follow-up times, treatment groups, evaluation scores adopted, and overall clinical and radiological findings. The quality of the trials was assessed using the Cochrane Risk of Bias Assessment. RESULTS: A total of 5 studies, including 378 patients and dealing with early vs. delayed rehabilitation in case of conservative treatment of PHF, were included in this study. Early rehabilitation was started within 1 week and consisted mainly of pendulum exercise and progressive passive mobilization. Early rehabilitation was associated with better pain and functional scores within the first 3 months in 3 studies. No difference in pain or function was reported at 6 months or longer follow-up, and no differences in complications rate were observed between early vs. delayed rehabilitation groups. CONCLUSIONS: This systematic review suggests that early mobilization within one week in case of conservative treatment of PHF leads to improved function recovery and reduced pain, especially in the first months of rehabilitation, without differences at longer follow-up and without increasing complications rate. Reducing immobilization time could accelerate function recovery and regaining independence in daily life activities.
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Inmovilización , Fracturas del Hombro , Humanos , Fracturas del Hombro/rehabilitación , Fracturas del Hombro/terapia , Tratamiento Conservador , Factores de TiempoRESUMEN
BACKGROUND: Inverted-bearing reverse shoulder arthroplasty (IB-RSA) is characterized by a polyethylene glenosphere and a metallic humeral liner to minimize PE wear and debris secondary to impingement between the humerus and glenoid neck. IB-RSA long-term survivorship, complication and revision rates, as well as clinical and radiographic outcomes have not been reported yet. METHODS: This is a monocentric retrospective study on a consecutive series of 151 patients who underwent primary IB-RSA from January 2009 to September 2015 and were evaluated clinically and radiologically at minimum 8 years follow-up. All complications and reoperations were recorded. Survivorship analysis with any revision surgery as endpoint was done using Kaplan-Meier survival curves. RESULTS: Seventy-eight patients (follow-up rate 51.7%) were reviewed at a mean follow-up of 10.1 ± 1.9 years. At 10 years the revision-free survival was 98.7% (95% CI: 94.8-99.7). Sixteen complications (10.6%) were observed: 2 axillary nerve injuries, 2 infections, 2 glenoid loosenings (which stabilized within one year), 2 cases of otherwise unexplained painful stiffness, 4 acromial fractures, 1 post-traumatic scapular pillar fracture and 3 post-traumatic humeral periprosthetic fractures. Two patients were revised due to infection. No cases of late glenoid loosening and humeral loosening were observed. The revision rate was 1.3%. All the clinical scores and range of motion significantly improved at the last follow-up compared with preoperative status: final Constant score was 66.1 ± 17.4, SSV 79.1 ± 20.9, ASES 82.2 ± 17.7. Scapular notching was observed in 51.4% of patients: only 1 case of grade 3 notching was observed in an early glenoid subsidence case. CONCLUSIONS: Primary IB-RSA appears to be a safe and effective procedure and does not present specific implant-associated complications at long-term follow-up. Radiographic analysis showed that inverting the biomaterials leads to a distinct kind of notching with mainly mechanical features.
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The first description of polymyalgia rheumatica (PMR) is generally attributed to Dr. Bruce. In an 1888 article entitled Senile rheumatic gout, he described five male patients aged from 60 to 74 years whom he had visited at the Strathpeffer spa in Scotland. In 1945, Dr. Holst and Dr. Johansen reported on five female patients examined over several months at the Medical Department of Roskilde County Hospital in Denmark. These patients suffered from hip, upper arms, and neck pain associated with elevated ESR and constitutional manifestations such as low-grade fever or loss of weight. In the same year, Meulengracht, another Danish physician, reported on two patients with shoulder pain and stiffness associated with fever, weight loss, and an increased erythrocyte sedimentation rate. As in the five patients reported by Dr. Holst and Dr. Johansen, a prolonged recovery time was recorded. On reading and comparing these three accounts, we question whether it is correct to attribute the first description of PMR to Dr. Bruce and put forward shifting this accolade to the three Danish physicians.
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Arteritis de Células Gigantes , Polimialgia Reumática , Humanos , Masculino , Femenino , Polimialgia Reumática/complicaciones , Polimialgia Reumática/diagnóstico , Brazo , Escocia , Fiebre , Dinamarca/epidemiologíaRESUMEN
BACKGROUND: Randomized clinical trials in non-critically ill COVID-19 patients showed that therapeutic-dose heparin increased survival with reduced organ support as compared with usual-care thromboprophylaxis, albeit with increased bleeding risk. The purpose of the study is to assess the safety of intermediate dose enoxaparin in hospitalized patients with moderate to severe COVID-19. METHODS: A phase II single-arm interventional prospective study including patients receiving intermediate dose enoxaparin once daily according to body weight: 60 mg for 45-60 kg, 80 mg for 61-100 kg or 100 mg for > 100 kg for 14 days, with dose adjustment according to anti-factor Xa activity (target range: 0.4-0.6 UI/ml); an observational cohort (OC) included patients receiving enoxaparin 40 mg day for comparison. Follow-up was 90 days. Primary outcome was major bleeding within 30 and 90 days after treatment onset. Secondary outcome was the composite of all-cause 30 and 90-day mortality rates, disease severity at the end of treatment, intensive care unit (ICU) admission and length of ICU stay, length of hospitalization. All outcomes were adjudicated by an independent committee and analyzed before and after propensity score matching (PSm). RESULTS: Major bleeding was similar in IC (1/98 1.02%) and in the OC (none), with only one event observed in a patient receiving concomitantly anti-platelet therapy. The composite outcome was observed in 53/98 patients (54%) in the IC and 132/203 (65%) patients in the OC (p = 0.07) before PSm, while it was observed in 50/90 patients (55.6%) in the IC and in 56/90 patients (62.2%) in the OC after PSm (p = 0.45). Length of hospitalization was lower in the IC than in OC [median 13 (IQR 8-16) vs 14 (11-21) days, p = 0.001], however it lost statistical significance after PSm (p = 0.08). At 30 days, two patients had venous thrombosis and two pulmonary embolism in the OC. Time to first negative RT-PCR were similar in the two groups. CONCLUSIONS: Weight adjusted intermediate dose heparin with anti-FXa monitoring is safe with potential positive impact on clinical course in COVID-19 non-critically ill patients. TRIAL REGISTRATION: The study INHIXACOVID19 was registred on ClinicalTrials.gov with the trial registration number (TRN) NCT04427098 on 11/06/2020.
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COVID-19 , Tromboembolia Venosa , Humanos , Anticoagulantes/efectos adversos , COVID-19/complicaciones , Enoxaparina/efectos adversos , Hemorragia/tratamiento farmacológico , Heparina/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & controlRESUMEN
About 30 percent of patients diagnosed with myelodysplastic syndromes (MDS) progress to acute myeloid leukemia (AML). The senescence of bone marrow?derived mesenchymal stem cells (BMSCs) seems to be one of the determining factors in inducing this drift. Research is continuously looking for new methodologies and technologies that can use bioelectric signals to act on senescence and cell differentiation towards the phenotype of interest. The Radio Electric Asymmetric Conveyer (REAC) technology, aimed at reorganizing the endogenous bioelectric activity, has already shown to be able to determine direct cell reprogramming effects and counteract the senescence mechanisms in stem cells. Aim of the present study was to prove if the anti-senescence results previously obtained in different kind of stem cells with the REAC Tissue optimization - regenerative (TO-RGN) treatment, could also be observed in BMSCs, evaluating cell viability, telomerase activity, p19ARF, P21, P53, and hTERT gene expression. The results show that the REAC TO-RGN treatment may be a useful tool to counteract the BMSCs senescence which can be the basis of AML drift. Nevertheless, further clinical studies on humans are needed to confirm this hypothesis.
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Leucemia Mieloide Aguda , Síndromes Mielodisplásicos , Telomerasa , Diferenciación Celular , Humanos , Síndromes Mielodisplásicos/genética , Síndromes Mielodisplásicos/metabolismo , Síndromes Mielodisplásicos/terapia , Telomerasa/metabolismo , Proteína p53 Supresora de Tumor/metabolismoRESUMEN
OBJECTIVE: To analyze the available evidence comparing the clinical and functional outcomes of physiotherapy vs. surgical repair in the management of degenerative rotator cuff tears (RCTs), and to perform a meta-analysis to clarify the possible superiority of one approach vs. the other. MATERIALS AND METHODS: A literature search was carried out on the PubMed, Scopus and Web of Science databases on May 30th, 2020, to identify all the randomized trials comparing surgery to conservative management of degenerative rotator cuff tears. The following data were extracted from each included study: patients' demographics, study design and level of evidence, follow-up times, treatment groups, evaluation scores adopted, overall clinical findings. The quality of the trials was assessed using the Cochrane Risk of Bias Assessment. RESULTS: A total of 7 studies, including 326 patients and dealing with conservative treatment vs. surgical repair for rotator cuff tears, were included in this study. Although surgery provided superior results both in terms of VAS (p=0.017) and Constant score (p<0.0001) compared to conservative management at 1 year follow-up, this superiority did not reach the "minimal clinical important difference". Otherwise, a few data are available about long-term outcomes, thus there is insufficient evidence about the role of surgery to prevent the progression of tendon wear. CONCLUSIONS: A proper rehabilitation program is able to provide similar results compared to surgery at a short term follow-up in degenerative RCTs. Further long term data are necessary to understand if tendon repair might have a protective role towards worsening of degeneration thus providing better clinical outcome than conservative management.
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Tratamiento Conservador , Lesiones del Manguito de los Rotadores/cirugía , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Lesiones del Manguito de los Rotadores/metabolismoRESUMEN
In cancer, myeloid cells have tumor-supporting roles. We reported that the protein GPNMB (glycoprotein nonmetastatic B) was profoundly upregulated in macrophages interacting with tumor cells. Here, using mouse tumor models, we show that macrophage-derived soluble GPNMB increases tumor growth and metastasis in Gpnmb-mutant mice (DBA/2J). GPNMB triggers in the cancer cells the formation of self-renewing spheroids, which are characterized by the expression of cancer stem cell markers, prolonged cell survival and increased tumor-forming ability. Through the CD44 receptor, GPNMB mechanistically activates tumor cells to express the cytokine IL-33 and its receptor IL-1R1L. We also determined that recombinant IL-33 binding to IL-1R1L is sufficient to induce tumor spheroid formation with features of cancer stem cells. Overall, our results reveal a new paracrine axis, GPNMB and IL-33, which is activated during the cross talk of macrophages with tumor cells and eventually promotes cancer cell survival, the expansion of cancer stem cells and the acquisition of a metastatic phenotype.
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Fibrosarcoma/patología , Receptores de Hialuranos/metabolismo , Interleucina-33/metabolismo , Neoplasias Pulmonares/patología , Macrófagos/inmunología , Glicoproteínas de Membrana/metabolismo , Células Madre Neoplásicas/patología , Animales , Apoptosis , Proliferación Celular , Fibrosarcoma/etiología , Fibrosarcoma/metabolismo , Regulación Neoplásica de la Expresión Génica , Humanos , Receptores de Hialuranos/genética , Interleucina-33/genética , Neoplasias Pulmonares/etiología , Neoplasias Pulmonares/metabolismo , Masculino , Glicoproteínas de Membrana/genética , Ratones , Ratones Endogámicos DBA , Células Madre Neoplásicas/inmunología , Células Madre Neoplásicas/metabolismo , Sarcoma Experimental/etiología , Sarcoma Experimental/metabolismo , Sarcoma Experimental/patología , Células Tumorales Cultivadas , Ensayos Antitumor por Modelo de XenoinjertoRESUMEN
PURPOSE: The optimal (SBJI) surgical treatment for acute acromioclavicular (AC) joint disruption remains controversial. What is being presented is the long-term functional outcomes of a double cross-looped coracoclavicular (CC) suture technique with the intention of restoring both anteroposterior and superior displacement of the clavicle. METHODS: Between 2007 and 2016, 81 patients underwent surgical reconstruction for acute acromioclavicular joint (AC) disruption in two orthopaedic centers. Two patients died for reasons unrelated to the treatment, and seven missed the final follow-up appointment, leaving 72 patients (67 males; 5 females; age 37 ± 12.4; range 15-64 years) for clinical and radiological assessments. All cases were classified according to the Rockwood classification as type III (n = 34), IV (n = 14) or V (n = 24). The dislocation was repaired with double cross-looped CC fixation using four Ethibond sutures passing underneath the coracoid and through a 4.5 mm drill hole in the clavicle in opposing directions to control both anteroposterior and vertical displacement. Radiological investigation preoperatively and at the last follow-up included anteroposterior and/or Zanca views, axillary or Alexander views, and comparative stress radiography of both AC joints. Patients were evaluated clinically with the Constant-Murley score (CMS) and Acromio Clavicular Joint Instability Score (ACJIS). Loss of reduction, subluxation, CC ligament ossification, post-traumatic arthritis, and peri-implant fractures were also recorded. RESULTS: Seventy-two patients were available for the last clinical and radiological evaluations. At a median follow-up period of 6.3 ± 2.1 years (range 3-12 years), the CMS and ACJIS were 92.1 ± 7.2 (range 60-100 points) and 90.4 ± 8.6 (range 45-100 points), respectively. Complications included 9 (12.5%) patients with slight loss of reduction, 2 (1.7%) with dislocation recurrence, 1 (1.3%) with superficial infection, 1 (1.3%) with a fracture of the lateral end of the clavicle, and 2 (1.7%) with persistent tenderness in the AC joint. The incidence of periarticular ossification was 22.4% and did not affect the final outcome. CONCLUSIONS: This technique represents an effective and low-cost treatment for acute AC joint separations. LEVEL OF EVIDENCE: IV.
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Clavícula/lesiones , Clavícula/cirugía , Apófisis Coracoides/lesiones , Apófisis Coracoides/cirugía , Luxaciones Articulares/cirugía , Procedimientos Ortopédicos/métodos , Técnicas de Sutura , Adolescente , Adulto , Traumatismos en Atletas/diagnóstico por imagen , Traumatismos en Atletas/cirugía , Clavícula/diagnóstico por imagen , Apófisis Coracoides/diagnóstico por imagen , Femenino , Humanos , Luxaciones Articulares/diagnóstico por imagen , Inestabilidad de la Articulación/diagnóstico por imagen , Inestabilidad de la Articulación/cirugía , Ligamentos Articulares/cirugía , Masculino , Persona de Mediana Edad , Procedimientos Ortopédicos/efectos adversos , Complicaciones Posoperatorias , Radiografía , Resultado del Tratamiento , Adulto JovenRESUMEN
The aim of our study was to define if Arthroscopic Transosseous Rotator Cuff Techniques should have comparable results to those of the suture-anchors technique in a single row configuration. We reported the preliminary results of a consecutive population of 22 patients who underwent a rotator cuff treatment on the left and right sides for average medium-sized thickness tears with minimal fatty infiltration with the two different techniques: transosseous rotator cuff repair technique on one side and single row with suture-anchors on the other side, in different times. Subjective evaluation with DASH questionnaires, Constant Scores and Numerical Rating Scale (NRS) for pain evaluation, have been submitted pre and postoperatively after both operations. A statistical analysis was performed to assess the superiority of one technique and to compare pre and postoperative ROM data and clinical outcomes. A transosseous rotator cuff repair was performed in 7 patients on the dominant arm, while the other 15 patients had dominant arm cuff tear lesions repaired by using suture-anchors technique. At last follow-up a significant improvement, in shoulder pain and function, was referred at both sides. Also, DASH, Constant Scores and NRS for pain evaluation improved with both techniques, but no statistical difference was found between them. Arthroscopic transosseous rotator cuff repair technique shows comparable results to those of the suture-anchors technique in a single row configuration.
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Lesiones del Manguito de los Rotadores , Manguito de los Rotadores , Artroscopía , Humanos , Manguito de los Rotadores/cirugía , Lesiones del Manguito de los Rotadores/cirugía , Anclas para Sutura , Técnicas de Sutura , Resultado del TratamientoRESUMEN
The purpose of this study is to evaluate at a mid-term follow up, the radiological survival of an uncemented humeral stem in shoulder arthroplasty. One hundred and twenty-six replacements including hemi (HA), total (TSA) and reverse (RSA) implanted from 1999 to 2008 were reviewed at a mean follow up of 7.2 years (48-144 months). The same uncemented triconical stem (SMR, Lima Corporate) was implanted. There were: 23 HSA, 43 TSA, 60 RSA. An independent observer evaluated all the patients with Constant Score. A radiologic analysis by an expert radiologist and an orthopaedic surgeon was performed: humeral component-bone interface was divided in seven zones. They judged a mobilisation if a migration or tilt of the humeral implant or if≥ 2 mm radiolucent line in at least three zones was present. Chi-squared test, Fisher test and analysis of variance were performed and a p<0.05 was considered statistically significant. No major radiological signs of loosening and no tilt or migration of the humeral component were found. Only 23 (18.2%) patients had no RL around the humeral implant. In the remaining 103 (81.7%) implants: 96 (76.1%) presented RL less than 2 mm, particularly 75 (59.5%) in less than 3 zones and 21 (16.6%) in more than 3 zones. Of the remaining 7 (5.5%) implants the presence of RL of 2 mm or greater in only one zone was seen. Apart from sepsis no revision was performed for humeral component loosening. Although a high rate of RL, uncemented humeral stem has an excellent survivorship at a mid-term follow up. Relationship between presence, position and depth of RL and internal stress shielding is commonly observed but does not appear to compromise quality of fixation or clinical outcomes in shoulder arthroplasty.
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Artroplastía de Reemplazo de Hombro , Articulación del Hombro , Estudios de Seguimiento , Humanos , Húmero/diagnóstico por imagen , Húmero/cirugía , Prótesis e Implantes , Rango del Movimiento Articular , Estudios Retrospectivos , Articulación del Hombro/diagnóstico por imagen , Articulación del Hombro/cirugía , Resultado del TratamientoRESUMEN
The aim of this study was to evaluate the impact of early treatment with corticosteroids on SARS-CoV-2 clearance in hospitalized COVID-19 patients. Retrospective analysis on patients admitted to the San Raffaele Hospital (Milan, Italy) with moderate/severe COVID-19 and availability of at least two nasopharyngeal swabs. The primary outcome was the time to nasopharyngeal swab negativization. A multivariable Cox model was fitted to determine factors associated with nasopharyngeal swab negativization. Of 280 patients included, 59 (21.1%) patients were treated with steroids. Differences observed between steroid users and non-users included the proportion of patients with a baseline PaO2/FiO2 ≤ 200 mmHg (45.8% vs 34.4% in steroids and non-steroids users, respectively; p = 0.023) or ≤ 100 mmHg (16.9% vs 12.7%; p = 0.027), and length of hospitalization (20 vs 14 days; p < 0.001). Time to negativization of nasopharyngeal swabs was similar in steroid and non-steroid users (p = 0.985). According to multivariate analysis, SARS-CoV-2 clearance was associated with age ≤ 70 years, a shorter duration of symptoms at admission, a baseline PaO2/FiO2 > 200 mmHg, and a lymphocyte count at admission > 1.0 × 109/L. SARS-CoV-2 clearance was not associated with corticosteroid use. Our study shows that delayed SARS-CoV-2 clearance in moderate/severe COVID-19 is associated with older age and a more severe disease, but not with an early use of corticosteroids.
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Corticoesteroides/uso terapéutico , Tratamiento Farmacológico de COVID-19 , Carga Viral/efectos de los fármacos , Factores de Edad , Anciano , COVID-19/epidemiología , Femenino , Hospitalización , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Pandemias , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoAsunto(s)
Infecciones por VIH , VIH-1 , Recuento de Linfocito CD4 , Infecciones por VIH/genética , VIH-1/genética , HumanosRESUMEN
OBJECTIVES: Although outcomes of antiretroviral therapy (ART) have been evaluated in randomized controlled trials, experiences from subpopulations defined by age, CD4 count or viral load (VL) in heterogeneous real-world settings are limited. METHODS: The study design was an international multicohort collaboration. Logistic regression was used to compare virological and immunological outcomes at 12 ± 3 months after starting ART with an integrase strand transfer inhibitor (INSTI), contemporary nonnucleoside reverse transcriptase inhibitor (NNRTI) or boosted protease inhibitor (PI/b) with two nucleos(t)ides after 1 January 2012. The composite treatment outcome (cTO) defined success as VL < 200 HIV-1 RNA copies/mL with no regimen change and no AIDS/death events. Immunological success was defined as a CD4 count > 750 cells/µL or a 33% increase where the baseline CD4 count was ≥ 500 cells/µL. Poisson regression compared clinical failures (AIDS/death ≥ 14 days after starting ART). Interactions between ART class and age, CD4 count, and VL were determined for each endpoint. RESULTS: Of 5198 ART-naïve persons in the International Cohort Consortium of Infectious Diseases (RESPOND), 45.4% started INSTIs, 26.0% PI/b and 28.7% NNRTIs; 880 (17.4%) were aged > 50 years, 2539 (49.4%) had CD4 counts < 350 cells/µL and 1891 (36.8%) had VL > 100 000 copies/mL. Differences in virological and immunological success and clinical failure among ART classes were similar across age groups (≤ 40, 40-50 and > 50 years), CD4 count categories (≤ 350 vs. > 350 cells/µL) and VL categories at ART initiation (≤ 100 000 vs. > 100 000 copies/mL), with all investigated interactions being nonsignificant (P > 0.05). CONCLUSIONS: Differences among ART classes in virological, immunological and clinical outcomes in ART-naïve participants were consistent irrespective of age, immune suppression or VL at ART initiation. While confounding by indication cannot be excluded, this provides reassuring evidence that such subpopulations will equally benefit from contemporary ART.
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Infecciones por VIH/tratamiento farmacológico , Inhibidores de Integrasa VIH/uso terapéutico , VIH-1/genética , Inhibidores de Proteasas/uso terapéutico , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Adulto , Recuento de Linfocito CD4 , Estudios de Cohortes , Femenino , Infecciones por VIH/inmunología , Infecciones por VIH/virología , Inhibidores de Integrasa VIH/farmacología , VIH-1/efectos de los fármacos , Humanos , Cooperación Internacional , Modelos Logísticos , Masculino , Persona de Mediana Edad , Inhibidores de Proteasas/farmacología , ARN Viral/efectos de los fármacos , Inhibidores de la Transcriptasa Inversa/farmacología , Resultado del Tratamiento , Carga ViralRESUMEN
BACKGROUND: We explored the combination of rilpivirine plus cobicistat-boosted darunavir [a two-drug regimen (2DR)] when switching from standard triple combined ART. METHODS: In this randomized, open-label, non-inferiority trial, participants had an HIV-RNA <50â copies/mL on a stable (>6â months) three-drug regimen. The primary endpoint was proportion with HIV-RNA <50â copies/mL at Week 24 (snapshot algorithm), with a -12% non-inferiority margin. ClinicalTrials.gov: NCT04064632. RESULTS: One hundred and sixty patients were allocated (1:1) to 2DR or to continue current ART (CAR). At Week 24, 72 (90.0%) of participants with 2DR and 75 (93.8%) with CAR maintained HIV-RNA <50â copies/mL [difference -3.75% (95% CI = -11.63 to 5.63)], confirming non-inferiority. Non-inferiority was confirmed considering an HIV-RNA >50â copies/mL (0% for 2DR; 3.7% for CAR; 95% CI = -0.4 to 7.9). Four patients reported adverse events not leading to treatment discontinuation (one patient in the 2DR group and three patients in the CAR group); eight subjects discontinued therapy in the 2DR group and three in the CAR group. With 2DR, lipid serum concentrations increased, but differences were statistically significant only for tenofovir disoproxil fumarate-containing CAR and in 2DR patients receiving a pre-switch regimen including tenofovir disoproxil fumarate. Median bone stiffness decreased in the CAR group from 86.1â g/cm2 (IQR = 74-98) to 83.2â g/cm2 (IQR = 74-97) and increased in the 2DR group from 84.9â g/cm2 (IQR = 74-103) to 85.5â g/cm2 (IQR = 74-101). The reduction within the CAR group was significant (P = 0.043). CONCLUSIONS: Once-daily rilpivirine plus cobicistat-boosted darunavir is an effective 2DR that combines a high virological efficacy with a potential to avoid major NRTI toxicities.
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Fármacos Anti-VIH , Infecciones por VIH , VIH-1 , Preparaciones Farmacéuticas , Adenina/uso terapéutico , Fármacos Anti-VIH/efectos adversos , Cobicistat/uso terapéutico , Darunavir/efectos adversos , Emtricitabina/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Humanos , Rilpivirina/uso terapéutico , Resultado del Tratamiento , Carga ViralRESUMEN
Recent studies have reported equivalent outcomes of arthroscopic and open shoulder stabilization. However, surgical strategy for shoulder instability is a challenging and controversial problem for surgeons that have to treat collision sport athletes. In fact, only few studies support the arthroscopic surgery for this group of patients. The aim of this study is to evaluate the outcome of arthroscopic stabilization in a homogenous population of professional young athletes practicing in high-level collision sport. We treated 22 consecutive professional rugby players, with a mean age of 23.6 years, affected by traumatic anterior shoulder instability. All patients underwent arthroscopic Bankart repair with bone suture-anchors. Exclusion criteria were: failed previous shoulder surgery, atraumatic, multidirectional or posterior instability, bone defects greater than 20% of the anterior-inferior glenoid, engaging Hill-Sachs, rotator cuff tears, capsular-ligament avulsion on the humeral side (HAGL). Patients were evaluated according to Constant score, Rowe score and Visual Analogue Scale (VAS) for discomfort and handicap. The mean follow-up was 40.7 months (range, 6 to 87 months). All patients except one were able to return at the same previous sports level at 5 to 6 months postoperatively. Re-dislocation occurred in 3 players for high impact trauma during competition or training. Our results confirm that, also in the collision sport patients, anatomic arthroscopic Bankart repair is a good option for the treatment of traumatic anterior instability without associated lesions. .
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Artroscopía , Lesiones de Bankart/cirugía , Fútbol Americano/lesiones , Inestabilidad de la Articulación/cirugía , Articulación del Hombro/cirugía , Humanos , Resultado del Tratamiento , Adulto JovenRESUMEN
Initiating antiretroviral therapy (ART) as early as the day of HIV diagnosis is a strategy of increasing global interest to control the HIV epidemic and optimize the health of people living with HIV (PLWH). No detrimental effects of rapid-start ART have been identified in randomized controlled trials undertaken in low- or middle-income countries, or in cohort studies performed in high-income countries. Rapid-start ART may be a key approach in reaching the 2020 Joint United Nations Programme on HIV/AIDS goal of 90% of all PLWH knowing their status, 90% of those diagnosed receiving sustained ART, and 90% of those receiving ART achieving viral suppression; it may also be important for achieving the suggested fourth "90%" goal: improving health-related quality-of-life in PLWH. Presently there is insufficient broad evidence for guidelines to recommend universal test-and-treat strategies for all people, in all settings, at HIV diagnosis; consequently, there is a pressing need to conduct high-quality studies that investigate immediate ART initiation. This article evaluates global evidence regarding rapid-start ART, including same-day start, with particular focus on the implementation of this strategy in high-income countries.
Asunto(s)
Antirretrovirales/uso terapéutico , Terapia Antirretroviral Altamente Activa/métodos , Manejo de la Enfermedad , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Prevención Secundaria/métodos , Antirretrovirales/efectos adversos , Terapia Antirretroviral Altamente Activa/efectos adversos , Ensayos Clínicos como Asunto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Salud Global , Humanos , Resultado del TratamientoRESUMEN
OBJECTIVES: The management of HIV disease is complicated by the incidence of a new spectrum of comorbid noncommunicable diseases (NCDs). It is important to document changes in the prevalence of NCDs over time. The aim of the study was to describe the impact of ageing on HIV markers and on the prevalence of NCDs in people living with HIV (PLWHIV) in the Italian Cohort of Individuals, Naïve for Antiretrovirals (ICONA) seen for care in 2004-2014. METHODS: Analyses were conducted separately for a closed cohort (same people seen at both times) and an open cohort (all people under follow-up). We used the χ2 test for categorical factors and the Wilcoxon test for quantitative factors to compare profiles over time. RESULTS: The closed cohort included 1517 participants and the open cohort 3668 under follow-up in 2004 and 6679 in 2014. The median age of the open cohort was 41 [interquartile range (IQR) 37-46] years in 2004 and 44 (IQR 36-52) years in 2014. Analysis of the closed cohort showed an increase in the prevalence of some NCDs [the prevalence of dyslipidaemia increased from 75% in 2004 to 91% in 2014, that of hypertension from 67 to 84%, and that of cardiovascular disease (CVD) from 18 to 32%] and a decrease in renal function (5% with eGFR < 60 mL/min per 1.73 m2 in 2004 versus 30% in 2014); the percentage of people in the high-risk group for the Framingham CHD score more than tripled (from 13 to 45%). Results in the open cohort were similar. CONCLUSIONS: The burden of NCDs in our PLWHIV population markedly worsened over a 10-year time-span, which is likely to be a result of the effects of both ageing and HIV infection as well as their interaction. Special attention must be given to the management and prevention of NCDs.