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BACKGROUND: The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is based on the results of robust clinical trials. OBJECTIVES: To assess the effectiveness and safety of BIC/FTC/TAF in treatment-naïve (TN) and treatment-experienced (TE) people with HIV using available real-world cohort studies. METHODS: Systematic review and meta-analysis of publications and communications identified via Boolean search in Medline, PubMed and Embase, and conference abstracts reporting retrospective real-world use of BIC/FTC/TAF, published until 31 January 2024. The primary endpoint was the proportion of TN and TE people with HIV with viral load (VL)â<â50â copies/mL at 48â weeks while on treatment. RESULTS: Of the 38 identified publications and conference abstracts, for the present analysis we included 12 publications (comprising 792 TN and 6732 TE individuals). For the three publications including 507 TN participants reporting the primary outcome, VL suppression was 97% [95% confidence intervals (CI): 89-100]. For the nine publications including 4946 TE participants reporting the primary outcome, VL suppression was 95% (95% CI: 94-96), with suppression >93% in all studies. Total discontinuations at 48â weeks in TE individuals were 3% (95% CI: 2-5), 1% (95% CI: 0-2) due to side effects. A total of four publications with 151 TE individuals with previous presence of M184V substitution were identified, reporting a suppression rate at 48â weeks of 95% (95% CI: 88-100). CONCLUSIONS: Real-world studies demonstrate low discontinuation rates and high rates of virologic suppression in individuals treated with BIC/FTC/TAF, both TN and TE with and without previous detection of M184V substitution.
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Alanina , Fármacos Anti-HIV , Emtricitabina , Infecções por HIV , Compostos Heterocíclicos com 3 Anéis , Compostos Heterocíclicos de 4 ou mais Anéis , Tenofovir , Carga Viral , Humanos , Infecções por HIV/tratamento farmacológico , Tenofovir/uso terapêutico , Tenofovir/administração & dosagem , Tenofovir/análogos & derivados , Fármacos Anti-HIV/uso terapêutico , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Emtricitabina/uso terapêutico , Emtricitabina/administração & dosagem , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Compostos Heterocíclicos de 4 ou mais Anéis/administração & dosagem , Compostos Heterocíclicos de 4 ou mais Anéis/efeitos adversos , Alanina/uso terapêutico , Carga Viral/efeitos dos fármacos , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Compostos Heterocíclicos com 3 Anéis/efeitos adversos , Compostos Heterocíclicos com 3 Anéis/administração & dosagem , Combinação de Medicamentos , Amidas/uso terapêutico , Piperazinas , Piridonas , Adenina/análogos & derivados , Adenina/uso terapêutico , Adenina/efeitos adversos , Adenina/administração & dosagem , Resultado do Tratamento , HIV-1/efeitos dos fármacos , HIV-1/genética , Estudos RetrospectivosRESUMO
INTRODUCTION: Rapid initiation of ART after HIV diagnosis is recommended for individual and public health benefits. However, certain clinical and ART-related considerations hinder immediate initiation of therapy. METHODS: An open-label, single-arm, single-centre 48-week prospective clinical trial involving ART-naïve HIV-diagnosed adults who started bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) within a week from the first hospital visit, before the availability of baseline laboratory and genotype results. The primary aim was to determine the proportion of people with at least one condition that would hinder immediate initiation of any recommended ART regimen other than BIC/FTC/TAF. Clinicaltrials.gov: NCT04416906. RESULTS: We included 100 participants: 79% men, 64% from Latin America, median age 32 years. According to European AIDS Clinical Society (EACS) and US Department of Health and Human Services 2023 guidelines, 11% (95%CI 6; 19) of participants had at least one condition that made any ART different from BIC/FTC/TAF less appropriate for a rapid ART strategy. Seventy-nine percent of the people started BIC/FTC/TAF within the first 48 hours of their first hospital visit. There were 16 early discontinuations (11 lost to follow-up). By week 48, 92% (95%CI 86; 98) of the participants of the ITT population with observed data achieved viral suppression. Eight grade 3-4 adverse events (AEs), five serious AEs and six ART-related AEs were identified. Adherence remained high. CONCLUSIONS: BIC/FTC/TAF is an optimal treatment for rapid initiation of ART. However, additional strategies to improve retention in care must be implemented.
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BACKGROUND: A broadened clinical spectrum of concomitant complications emerges among the escalating incidence of substance use, particularly within the 'chemsex' context. This case exemplifies the profound neurotoxic repercussions and neurological risk of chemsex in a young HIV-positive male and addresses the multifaceted challenges of such evolving paradigms in substance utilization. CLINICAL FINDING: After consuming cannabis, poppers, methamphetamine, and cocaine, a 28-year-old HIV-positive male exhibited significant neurological and cognitive impairment. The initial presentation included dysarthria and profound anterograde amnesia. Laboratory findings showed leukocytosis with a PCR of 3 mg/dl - elevated cerebrospinal fluid protein levels with no cells. Urine toxicology returned positive for cannabis and amphetamines. A brain CT scan revealed bilateral and symmetrical hippocampi and pale globes hypodensity, indicative of toxic-metabolic encephalopathy. MRI further identified lesions in the globus pallidus, cerebellum, and hippocampi. Following the detection of toxic encephalopathy, Initial neuropsychological was performed screening using the Montreal Cognitive Assessment (MoCA), which highlighted immediate memory deficits. An in-depth neuropsychological assessment conducted 3 weeks later included the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV), the Rey Auditory Verbal Learning Test (RAVLT), and tests for visuospatial skills, motor functions, and memory recall. The evaluations revealed pronounced anterograde amnesia, persistent long-term memory inconsistencies, and notable executive function challenges, detailed in Table 1. CONCLUSIONS: The detailed analysis of this case underpins the severe neurological consequences that can manifest from heavy substance use. Comprehensive diagnostic evaluations, including neuroimaging and neuropsychological assessments, are crucial in elucidating the full spectrum of substance-induced cognitive impairments. There is an urgent need for enhanced public awareness and preventative measures, especially in the context of chemsex, to bring forth multifaceted health, social, and government implications that modern society must adeptly navigate.
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Introducción: La profilaxis preexposición (PrEP) es una intervención biomédica dirigida a prevenir la infección por el VIH en personas seronegativas con alto riesgo de contraer la infección. Esta estrategia fue aprobada por el Ministerio de Salud de España en octubre de 2019. Objetivo: Presentar la experiencia inicial de la PrEP en la Unidad de VIH del Hospital Clínic de Barcelona, poniendo especial atención en el análisis de los factores de vulnerabilidad de la cohorte. Materiales y métodos: Estudio retrospectivo, descriptivo. Se analizan las características epidemiológicas, sociodemográficas y clínicas basales de los usuarios incluidos en el programa durante el primer año de funcionamiento, prestando particular atención a las infecciones, las prácticas de riesgo y el consumo de sustancias. Resultados: Se incluyeron 190 individuos, 177 hombres y 12 mujeres transexuales con una edad media de 35 años (8DE). El 70% tenía estudios superiores y la mitad nacionalidad española. Informaron de tener 10 parejas de media al trimestre y el 60% de practicar sexo anal desprotegido. El 31% presentó al menos una PCR positiva para ITS, siendo la N. gonorrhoeae el germen más prevalente (51%) y la muestra rectal la más afectada (21%). El 63% reportó el uso de chemsex, el 19% policonsumo y el 8% slamming. La mitad expresó su preocupación por el consumo y/o prácticas sexuales y un 25% la necesidad de ayuda. Conclusiones: El perfil del usuario de PrEP visitado en nuestra unidad hospitalaria justifica la creación de equipos multidisciplinares que permitan prestar una atención holística de la vida sexual de estas personas.(AU)
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.(AU)
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Humanos , Masculino , Feminino , Adulto , HIV , Profilaxia Pré-Exposição , Infecções Sexualmente Transmissíveis , Doenças Transmissíveis , EspanhaRESUMO
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Humanos , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , ConsensoRESUMO
INTRODUCCIÓN: Estudios recientes confirman un aumento de la incidencia de infección aguda por el virus de la hepatitis C (HAC) en hombres que tienen sexo con hombres (HSH) infectados o no por el VIH. El tratamiento temprano con interferón-alfa, solo o asociado a ribavirina, reduce significativamente el riesgo de evolución a la cronicidad. MÉTODOS: Estudio retrospectivo que incluye todos los pacientes VIH diagnosticados de HAC en nuestro centro desde junio del 2003 a marzo del 2013, definida la HAC por la seroconversión de anticuerpos contra el VHC y la detección de ARN-VHC sérico. RESULTADOS: Se diagnosticaron 93 episodios de HAC en 89 pacientes. Excepto en 3 casos todos eran HSH con antecedentes de prácticas sexuales de riesgo. Treinta y 7 (40%) pacientes presentaban otra enfermedad de transmisión sexual asociada. El 29% (27) presentaron algún síntoma sugestivo de HAC. El genotipo 4 del VHC fue el más frecuente (41%), seguido del genotipo 1. En 70 casos se inició tratamiento con interferón-alfa y ribavirina ajustada a peso. En la actualidad 46 han finalizado el tratamiento y el seguimiento, alcanzando 26 de ellos (56,5%) una respuesta viral sostenida. CONCLUSIONES: La incidencia de HAC en los pacientes VIH HSH de nuestro centro ha aumentado de forma exponencial en los últimos años, siendo la transmisión sexual la vía principal de infección. El tratamiento precoz con interferón-alfa y ribavirina consigue una respuesta moderada en estos pacientes
BACKGROUND: Recent studies suggest an increased incidence of acute infection with hepatitis C virus (AHC) in men who have sex with men (MSM) co-infected with HIV. Early treatment with interferon-alpha, alone or in combination with ribavirin, significantly reduces the risk of chronic evolution. METHODS: This retrospective study includes all HIV patients with AHC in our centre from 2003 to March 2013. AHC was defined by seroconversion of HCV antibodies and detection of serum HCV RNA.RESULTS: 93 episodes of AHC were diagnosed in 89 patients. All but three were MSM with a history of unprotected sex. Thirty-seven (40%) patients had other associated sexually transmitted disease. The 29% (27) had any symptoms suggestive of AHC. HCV genotype 4 was the most common (41%), followed by genotype 1. Seventy patients started treatment with interferon-alfa and weight-adjusted ribavirin. Currently 46 have completed treatment and follow-up, reaching 26 of them (56.5%) sustained viral response. CONCLUSIONS: The incidence of AHC in HIV MSM patients from our centre has increased exponentially in recent years; sexual transmission remains the main route of infection. Early treatment with interferon-alpha and ribavirin achieved a moderate response in these patients
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Humanos , Masculino , Coinfecção/epidemiologia , Infecções por HIV/epidemiologia , Hepatite C/epidemiologia , Falência Hepática Aguda/epidemiologia , Homossexualidade Masculina/estatística & dados numéricos , Fatores de Risco , Comportamento Sexual , Infecções Sexualmente Transmissíveis/epidemiologia , Surtos de Doenças/estatística & dados numéricos , Estudos Retrospectivos , Ribavirina/uso terapêutico , Interferons/uso terapêuticoRESUMO
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Humanos , Masculino , Pessoa de Meia-Idade , Infecções por HIV/tratamento farmacológico , Hepacivirus , Hepatite C/complicações , Homossexualidade Masculina , Sexo sem Proteção , Doença Aguda , Coinfecção/virologia , Infecções por HIV/complicações , Infecções por HIV/virologia , Hepatite C/tratamento farmacológico , Recidiva , Fatores de RiscoRESUMO
Introduction: In the interferon era, the treatment of hepatitis C virus (HCV) infection in patients on haemodialysis (HD) was limited due to the significant number of treatment-related adverse events (AEs). Direct-acting antivirals (DAAs) have demonstrated their efficacy and safety in the treatment of HCV in patients with advanced chronic kidney disease on haemodialysis. The objective of the study was to evaluate the success in eliminating HCV infection from our dialysis unit using DAAs, and to assess the impact of HCV elimination on clinical and analytical outcomes. Patients and methods: This is a prospective, interventional, single-center study at Hospital Clínic de Barcelona. All HCV-RNA positive patients who received antiviral therapy with DAAs within a 3-year period (2014-2017) were analyzed (n=20). Data on virologic response, adverse events, and biochemical and hematological parameters during and after DAA therapy were analyzed. Results: All patients achieved sustained virologic response (SVR) and only 40% of patients presented with mild AEs. None of the patients presented with HCV reinfection after a 1-year follow-up period, and thus HCV was eliminated from our HD unit. SVR was associated with a significant increase in hemoglobin and hematocrit, and a tendency toward the need for lower doses of iron supplementation with no changes in darbepoetin dose. Conclusion: HCV infection can be safely eliminated from HD units with the use of DAAs, preventing new infections in patients and healthcare staff. In the short term, the achievement of SVR is associated with an improvement in the control of anemia
Introducción: En la época del interferón, el tratamiento del virus de la hepatitis C (VHC) en pacientes en hemodiálisis (HD) se veía limitado por la presencia de efectos adversos relacionados con el tratamiento. Los agentes antivirales directos (AAD) han demostrado ser seguros y eficaces en el tratamiento del VHC en pacientes con insuficiencia renal crónica en hemodiálisis. El objetivo del estudio fue evaluar el éxito en eliminar la infección por VHC de nuestra unidad de diálisis con el uso de AAD, y determinar el impacto clínico y analítico de la curación de la infección. Pacientes y métodos: Para ello se realizó un estudio prospectivo de intervención en el Hospital Clinic de Barcelona y su centro de diálisis. Se incluyeron todos los pacientes (n=20) con ARN-VHC positivo que recibieron tratamiento antiviral con AAD durante un periodo de 3 años (2014-2017). Se analizaron los datos de respuesta virológica, efectos adversos y parámetros hematológicos y bioquímicos durante y después del tratamiento. Resultados: Todos los pacientes alcanzaron una respuesta viral sostenida (RVS) y solo una 40% presentaron efectos adversos leves. Ningún paciente presentó reinfección por el VHC y por ello tras un año de seguimiento se consideró la eliminación del VHC de nuestra unidad de diálisis. La RVS se asoció con aumento significativo de la hemoglobina y el hematocrito, y una tendencia a la necesidad de una dosis más baja de suplemento de hierro sin cambios en la dosis de darbepoetina. Conclusión: Con la utilización de AAD, la infección por el VHC puede ser eliminada de forma segura de las unidades de diálisis, previniendo la transmisión de la infección a pacientes y personal sanitario. A corto plazo, la RVS se asoció con una mejoría en el control de la anemia
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Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Hepatite C/terapia , Anemia/terapia , Antivirais/administração & dosagem , Resposta Viral Sustentada , Resultado do Tratamento , Anemia/prevenção & controle , Unidades Hospitalares de Hemodiálise , Estudos Prospectivos , Antivirais/efeitos adversosRESUMO
Actualmente la enfermedad hepática es una de las causas más importantes de morbilidad y mortalidad en los pacientes con infección por VIH. La supervivencia de los pacientes con enfermedad hepática terminal es más corta comparada con la de las personas no infectadas. La infección por VIH ha dejado de ser una contraindicación para el trasplante de órganos sólidos...
Currently, liver disease is one of the most important cause of morbidity and mortality in HIV-1 infected patients. Survival of HIV-coinfected patients with end-stage liver disease (ESLD) is poor and shorter than that of the non-HIV-infected population. HIV infections is no longer a contraindication to solid organ transplantation...
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Humanos , Terapia Antirretroviral de Alta Atividade , Cirrose Hepática/mortalidade , Hepacivirus , Vírus da Hepatite B , HIV-1 , Infecções por HIV/complicações , Imunoglobulinas/uso terapêutico , Transplante de Fígado/patologiaRESUMO
La hepatitis aguda C (HAC) representa un problema sanitario en auge. A pesar del descenso de la transmisión del VHC por vía hematológica gracias a los programas de detección de donantes y el menor consumo de drogas por vía intravenosa, actualmente existe un aumento de su incidencia debido al contagio por vía sexual, sobretodo en pacientes homosexuales infectados por el VIH. La presentación de forma paucisintomática es frecuente, lo cual dificulta su diagnóstico. La eliminación espontánea del virus ocurre en el 25% de los casos y, habitualmente, durante los primeros tres meses tras el inicio de la clínica y en pacientes sintomáticos. Si el ARN del VHC persiste detectable pasado este tiempo debe iniciarse sin demora tratamiento antiviral, ya que en la fase aguda el porcentaje de respuesta viral sostenida es mayor al que se obtiene después en la hepatopatía crónica. La pauta de tratamiento óptima (interferón sólo o asociado a ribavirina), así como la duración de la misma no están claramente establecidas en el momento actual (AU)
Acute hepatitis C (AHC) is an increasing health issue. Despite the decline of blood-to-blood transmissionof hepatitis C virus (HCV) through donor screening programs and a decline in intravenous drug use, theincidence of sexual transmission has now increased, particularly in HIV-infected homosexual patients.The presentation is almost always asymptomatic, which complicates diagnosis. Spontaneous clearanceof the virus occurs in 25% of cases and usually, within the first three months after onset of symptomsand in symptomatic patients. If serum HCV-RNA remains detectable after this period, antiviral treatmentshould be started without delay, since sustained viral response rate in the acute phase is higher than thatachieved with chronic liver disease. The optimal treatment regimen (interferon alone or combined withribavirin) and its duration are not clearly established at the present time (AU)
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Humanos , Masculino , Feminino , Hepatite C/epidemiologia , Hepatite C/diagnóstico , Hepatite C/tratamento farmacológico , Fatores de Risco , Espanha/epidemiologiaRESUMO
El trasplante de órgano sólido puede ser la única alternativa terapéutica en ciertos pacientes infectados por el virus de la inmunodeficiencia humana (VIH). La experiencia acumulada en América del Norte y Europa en los últimos 5 años indica que la supervivencia a los 3 años del trasplante de órgano sólido es similar a la de los pacientes no infectados por el VIH. Los criterios consensuados para seleccionar a los pacientes infectados por el VIH con indicación de trasplante son: no haber tenido infecciones oportunistas (a excepción de la tuberculosis, candidiasis esofágica o neumonía por Pneumocystis jiroveci antes carinii), tener una cifra de linfocitos CD4 > 200 cél./μl (100 cél./μl en el caso del trasplante hepático) y una carga viral del VIH indetectable o suprimible con tratamiento antirretroviral. También se exige una abstinencia a la heroína y cocaína de 2 años de duración, pudiendo estar el paciente en programa de metadona. Los principales problemas del período postrasplante son las interacciones farmacocinéticas y farmacodinámicas entre los antirretrovirales y los inmunosupresores, el rechazo y la posibilidad de que la recidiva de la infección por el virus de la hepatitis C (VHC), que es una de las principales causas de mortalidad postrasplante hepático, siga una evolución peor. La experiencia del tratamiento con interferón pegilado y ribavirina es escasa en esta población hasta el momento actual (AU)
Solid organ transplantation may be the only therapeutic option for some human inmunodeficience virus (HIV)-infected patients. Experience in North America and Europe over the last five years has shown that three-year survival of these patients following organ transplantation is similar to that of HIV-negative patients. The consensus criteria for the selection of HIV patients for transplantation include the following: no opportunistic infections (except tuberculosis, esophageal candidiasis or Pneumocystis jiroveci previously carinii pneumonia), CD4 lymphocyte count above 200 cells/μl (100 cells/μl in the case of liver transplantation) and HIV viral load that is undetectable or suppressible with antiretroviral therapy. Also required is a two-year abstinence from heroin and cocaine, although the patient may be in a methadone program. The main problems in the post-transplantation period in these patients are pharmacokinetic and pharmacodynamic interactions between antiretorivirals and immunosuppressors, rejection, and the fact that the risk of relapsed HCV infection is exacerbated, and this is one of the main causes of post-liver transplantation (..) (AU)
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Adulto , Humanos , Seleção de Pacientes/ética , Infecções por HIV/complicações , Infecções por HIV/imunologia , Sobrevivência de Enxerto/fisiologia , Transplante de Órgãos/ética , Transplante de Órgãos/normas , Carga Viral , Antirretrovirais/uso terapêutico , Espanha/epidemiologiaRESUMO
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