Effectiveness, safety and discontinuation rates of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in people with HIV using real-world data: a systematic review and meta-analysis.

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) < 50 copies/mL at 48 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 48 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 48 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.

Rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy in HIV infection. A prospective study.

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.

Stillbirth of a mandrill (Mandrillus sphinx) in the wild: perinatal behaviors and delivery sequences.

Birth is a fundamental event in the life of animals, including our own species. More reports of wild non-human primate births and stillbirths are thus needed to better understand the evolutionary pressures shaping parturition behaviors in our lineage. In diurnal non-human primates, births generally occur at night, when individuals are resting. Consequently, they are difficult to observe in the wild and most of the current knowledge regarding perinatal behaviors comes from rare daytime births. Information about stillbirths is even rarer and their proximate causes are generally unknown. Here, we present detailed observations of a daytime birth of a stillborn wild mandrill (Mandrillus sphinx). During this event, which lasted an entire day, we recorded the behaviors of the parturient female ad libitum, using video recordings and photos. The 5-year-old female was primiparous and of low dominance rank. The length of her pregnancy was shorter than usual and the partum phase was extremely long compared to other birth reports in non-human primates. The female disappeared shortly after this event and was assumed to have died. We discuss the possible causes of this stillbirth including the infant's presentation at birth and maternal inexperience.

An early-life challenge: becoming an older sibling in wild mandrills.

In monotocous mammals, most individuals experience the birth of a younger sibling. This period may induce losses in maternal care and can be physiologically, energetically and emotionally challenging for the older sibling, yet has rarely been studied in wild primates. We used behavioural data collected from a natural population of mandrills to investigate changes in maternal care and mother-juvenile relationship throughout the transition to siblinghood (TTS), by comparing juveniles who recently experienced the birth of a younger sibling, to juveniles who did not. We found that the TTS was associated with an abrupt cessation of the weaning process for the juvenile, and to a decrease in maternal affiliation. Juveniles' reactions were sex-specific, as males associated less with their mother, while females tended to groom their mother more often after the birth of their sibling. Despite the substantial loss of maternal care, juveniles did not show an increase in conflict or anxiety-related behaviours. This study contributes to explain why short interbirth intervals often pose a risk to juveniles' survival in monotocous primates. Our results contrast existing studies and further highlight the importance of examining the TTS in species and populations with various life histories and ecologies.

Toxic-Induced Encephalopathy Following Chemsex in a Young HIV-Positive Male: A Complex Case of Acute Cognitive Impairment with Anterograde Amnesia and Behavioral Alterations.

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.

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

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)

Efficacy of Elbasvir/Grazoprevir in Early Chronic G1/G4 Hepatitis C infection in HIV/HCV co-infected patients with mild fibrosis / Eficacia de elbasvir/grazoprevir en la infección por hepatitis C crónica reciente G1/G4 en pacientes coinfectados por el VIH/VHC con fibrosis leve

Background: Acute hepatitis C virus (AHC) infection is increasingly common among HIV+ men who have sex with men (MSM). Until 2017, the guidelines recommended therapy with pegylated-interferon plus ribavirin with a mild sustained virological response (SVR). This prompted many patients to reject that treatment, at that time, waiting to be treated with better and safer options with new Direct-Acting-Antivirals (DAA). Objectives: Assess the efficacy and safety of Elbasvir/Grazoprevir to treat recent chronic hepatitis C infection, genotype 1 or 4, in HIV+ MSM patients. Methods: Prospective, open-labeled, two center, pilot study. SVR is analyzed for treatment with Elbasvir/Grazoprevir (8 weeks in GT1b or 12 in GT1a or GT4) in patients with a recent chronic HCV infection, defined as HCV infection lasting less than 4 years and mild liver fibrosis (liver stiffness <8kPa). Results: Forty-eight patients were included (May 2017–March 2018): 2 GT1b, 24 GT1a and 22 GT4. HCV-RNA>800000UI in 63% and medium liver stiffness 4.9kPa. The SVR was 98%, one patient failed due to poor adherence. 67% of patients had adverse effects, but only 16% treatment related. The most frequent side effects were gastrointestinal (19%), related with the central nervous system (18%), respiratory (16%) and systemic symptoms (15%).During one year of follow-up post-therapy, 4 AHC and 18 patients with sexually transmitted diseases (STD) were diagnosed. Conclusions: Treatment with Elbasvir/Grazoprevir in this scenario is highly effective and safe. Patients with risky sexual practices must remain linked to the medical care system to detect new STD and HCV reinfection.(AU)

Antecedentes: La infección aguda por el virus de la hepatitis C (HCA) es cada vez más frecuente entre los hombres VIH+ que mantienen relaciones sexuales con hombres (HSH). Hasta 2017, las directrices recomendaban el tratamiento con interferón pegilado más ribavirina con una respuesta virológica sostenida (RVS) leve. Esto llevó a muchos pacientes a rechazar dicho tratamiento en ese momento, a la espera de recibir tratamiento con opciones mejores y más seguras con los nuevos antivirales de acción directa (AAD). Objetivos: Evaluar la eficacia y la seguridad de elbasvir/grazoprevir para tratar la infección por hepatitis C crónica reciente, genotipo 1 o 4, en pacientes HSH VIH+. Métodos: Estudio preliminar, prospectivo, abierto y realizado en 2 centros. Se evalúa la RVS para el tratamiento con elbasvir/grazoprevir (8 semanas en GT1b o 12 en GT1a o GT4) en pacientes con una infección por VHC crónica reciente, definida como una infección por VHC que dura menos de 4 años y fibrosis hepática leve (rigidez hepática <8kPa). Resultados: Se incluyeron 48 pacientes (mayo de 2017-marzo de 2018): 2 en GT1b, 24 en GT1a y 22 en GT4. ARN-VHC>800.000UI en el 63% y rigidez hepática media de 4,9Kpa. La RVS fue del 98%; un paciente fracasó debido a un cumplimiento terapéutico deficiente. El 67% de los pacientes presentó efectos adversos, pero solo el 16% estuvo relacionado con el tratamiento. Los efectos secundarios más frecuentes fueron síntomas gastrointestinales (19%), relacionados con el sistema nervioso central (18%), respiratorios (16%) y sistémicos (15%). Durante un año de seguimiento postratamiento se diagnosticaron 4 HCA y 18 pacientes con enfermedades de transmisión sexual (ETS). Conclusiones: El tratamiento con elbasvir/grazoprevir en este contexto es muy eficaz y seguro. Los pacientes con prácticas sexuales de riesgo deben permanecer vinculados al sistema de asistencia médica para detectar nuevas ETS y reinfecciones por VHC.(AU)

Evaluation of stress academic levels of medical students of the south university center: case: Ciudad Guzman / Evaluación de niveles de estrés de estudiantes de medicina de la universidad del sur: caso: Ciudad Guzmán

OBJECTIVE: Identify the Factors associated to the academic stress of the student Population of the Medical School University Center in Mexico. METHOD: A descriptive correlational analysis was taken place starting with the implementation of the daily stress questionnaire (CED-44). The acquired results were the stress levels as much as gen eral as the different social environments of the participants. In the study were included demographic factors and study levels. The mea sures were compared through the T tests for independent samples to determine the significant relation between the changeable and the stress levels. RESULTS: The relation between the stress levels and the gender shows a major grade of influence of the stressful ones about the feminine gender. Likewise factors like the academic overload and the few time of recreation emphasize like the major stressful of the students population. DISCUSSION AND CONCLUSSIONS: Prior to the latent psychosocial risk between University young students, it is suggested, the implementation of an initiative at stressors that at the time serves as motivational factor.

OBJETIVO: Identificar los factores asociados al estrés académico de la Población de estudiantes de la Escuela de Medicina del Centro Universitario en México. MÉTODO: Se realizó un análisis correlacional descriptivo comenzando con la implementación del cuestionario de estrés diario (CED-44). Los resultados obtenidos mostraron niveles de estrés tan generales como los diferentes ambientes sociales de los participantes. En el estudio fueron incluidos factores demográficos y niveles de estudio. Las mediciones fueron comparadas por medio de pruebas T para muestras independientes para determinar la relación significante entre las variables y los niveles de estrés. RESULTADOS: La relación entre los niveles de estrés y el género muestra un mayor grado de influencia de los estresados en el género femenino. Asimismo, factores como la sobrecarga académica y el poco tiempo de recreación enfatiza como la mayoría de la población estudiantil estresada. DISCUSIÓN Y CONCLUSIONES: Antes del latente riesgo sicológico entre estudiantes universitarios jóvenes, se sugiere, la implementación de una iniciativa en los factores de estrés que al momento sirva de factor motivacional.

Brote epidémico de hepatitis aguda C en pacientes infectados por el virus de la inmunodeficiencia humana / Acute outbreak of hepatitis C in human immunodeficiency virus-infected patients

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

Esclerosis múltiple como efecto adverso de los agentes antifactor de necrosis tumoral alfa: una complicación infrecuente pero relevante de infliximab en la enfermedad de Crohn / No disponible

Los agentes antifactor de necrosis tumoral alfa (TNF- ) son efectivos en el tratamiento de la enfermedad inflamatoria intestinal. Su perfil de efectos adversos es bien conocido y son seguros, adecuadamente utilizados. En la práctica su riesgo más importante son las infecciones. Otras reacciones adversas son también posibles, pero mucho menos frecuentes. Sin embargo, la generalización del uso de estos agentes hace que sus efectos adversos menos frecuentes también puedan aparecer en la práctica clínica. Presentamos el caso de uno de ellos, la esclerosis múltiple, infrecuente pero muy relevante por sus consecuencias. Ante la (..) (AU)

Anti-tumor necrosis factor alpha (TNF- ) agents have been a great advantage in the treatment of inflammatory bowel disease. The safety profile of these agents is well-known and they canbeconsideredsafewhenproperlyused.Inclinicalpractice,themostimportant adverse events are infections. Other adverse effects are also possible but are much less frequent. However, because of the widespread use of these drugs, these uncommon adverse effects may also (..) (AU)