Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial.

OBJECTIVE: Multiple strategies have been utilized to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system retention obtained with rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve patients. METHODS: This phase IV, multicenter, open-label, single-arm, 48-week clinical trial enrolled patients between January 2020 and June 2022. Adherence to treatment was evaluated with the SMAQ questionnaire and patient satisfaction with the EQ-5D. RESULTS: 208 participants were enrolled with mean age of 35.6 years; 87.6% were males; mean CD4 count was 393.5 cells/uL (<200 cells/uL in 22.1%); viral load log was 5.6 (VL>100,000 cop/mL in 43.3%); 22.6% had AIDS, and 4.3% were coinfected with HBV. BIC/FTC/TAF was initiated on the day of their first visit to the HIV specialist in 98.6% of participants, and 9.6% were lost to follow-up. The efficacy at week 48 was 84.1 % by intention-to- treat (ITT), 94.6% by modified ITT, and 98.3% by per protocol analysis. The regimen was discontinued in two subjects (0.9%) during week 1 for grade 3 adverse events. Treatment adherence [weeks 4 (90%, IQR: 80-99%) vs. 48 (90%, IQR: 80-95%; p=0.49)] and patient satisfaction [weeks 4 (90%, IQR: 80-99%) vs. 48 (90%, IQR: 80-95 p=0.49) rates were very high over the 48- week study period. CONCLUSIONS: BIC/FTC/TAF is an appropriate option for rapid ART initiation in naïve HIV patients, offering high efficacy, safety, durability, treatment adherence, retention in the healthcare system, and patient satisfaction. Number Clinical Trial registration: NCT06177574.

Long or complicated mpox in patients with uncontrolled HIV infection.

To date, former research about the impact of HIV infection on mpox poor outcomes is still limited and controversial. Therefore, the aim of this study was to assess the impact of HIV on the clinical course of mpox, in a large population of patients from Spain. Nationwide case-series study. Patients from 18 Spanish hospitals, with PCR-confirmed mpox from April 27, 2022 to June 30, 2023 were included in this study. The main outcome was the development of long or complicated (LC) mpox, defined as: (i) duration of the clinical course ≥ 28 days, or; (ii) disseminated disease, or: (iii) emergence of severe complications. One thousand eight hundred twenty-three individuals were included. Seven hundred eighty-six (43%) were people living with HIV (PLWH), of whom 11 (1%) had a CD4 cell count < 200 cells/mm3 and 33 (3%) <350 cells/mm3 . HIV viral load ≥ 1000 cp/mL was found in 27 (3%) PLWH, none of them were on effective ART. Fifteen (60%) PLWH with HIV-RNA ≥ 1000 cp/mL showed LC versus 182 (29%) PLWH with plasma HIV-RNA load < 1000 copies/mL and 192 (24%) individuals without HIV infection (p < 0.001). In multivariate analysis, adjusted by age, sex, CD4 cell counts and HIV viral load at the time of mpox, only plasma HIV-RNA ≥ 1000 cp/mL was associated with a greater risk of developing LC mpox [adjusted OR = 4.06 (95% confidence interval 1.57-10.51), p = 0.004]. PLWH with uncontrolled HIV infection, due to lack of ART, are at a greater risk of developing LC mpox. Efforts should be made to ensure HIV testing is carried out in patients with mpox and to start ART without delay in those tested positive.

Listeriosis no gestacional: cambios en frecuencia, formas clínicas y factores pronósticos / Non-perinatal listeriosis: changes in frequency, clinical spectrum and prognostic factors

Introducción: La infección por Listeria monocytogenes es una enfermedad grave que afecta mayoritariamente a personas de edad avanzada e inmunodeprimidos y cuya incidencia está aumentando. En este estudio se analizan los casos de listeriosis en dos hospitales con el fin de estudiar cambios en su incidencia, formas de presentación clínica y posibles factores asociados a mortalidad. Material y métodos: Estudio retrospectivo multicéntrico de pacientes con listeriosis diagnosticada por aislamiento microbiológico entre 1977 y 2021 en dos hospitales universitarios de Madrid. Se recogen variables epidemiológicas, clínicas, estado de inmunodepresión, pruebas complementarias y tratamiento. Se analizan factores asociados a mortalidad. Resultados: Se analizaron 194 casos de listeriosis. La incidencia de listeriosis por ingresos aumentó a lo largo del estudio, con una importante caída del número de casos en 2020. La bacteriemia aislada (37,1%) y la afectación del sistema nervioso central (SNC) (36,6%) fueron las presentaciones más frecuentes. El 21% de los casos tuvo síntomas de gastroenteritis. El 16,5% presentó otras infecciones focales, siendo las más frecuentes peritonitis bacteriana espontánea (8,2%), colecistitis (2,1%), infección respiratoria (1,5%) e infección de prótesis vascular (1,5%). La mortalidad intrahospitalaria fue del 24,7%. Fueron factores independientes asociados a mortalidad al ingreso la edad (odds ratio [OR] 1.027, intervalo de confianza [IC] 95% 1.003-1.056) y la presencia de tumor sólido (OR 3.525, IC 95% 1.652-7.524). Conclusiones: En este estudio se constata un aumento de la incidencia de listeriosis en nuestro medio. Las presentaciones más frecuentes fueron la bacteriemia aislada y la afectación del SNC. La mortalidad intrahospitalaria se asoció a la edad y al diagnóstico de tumor sólido.(AU)

Introduction: Listeria monocytogenes infection is a severe disease affecting mainly aged people and patients with immune depression. The incidence of listeriosis seems to be increasing. In the present study cases of listeriosis from two hospitals are analyzed with the aims of studying changes in its incidence, clinical forms of presentation and possible factors associated with mortality. Methods: Retrospective multicentric study of patients with culture-proven listeriosis in two university hospitals in Madrid between 1977 and 2021. Epidemiological and clinical variables, as well as factors for immune depression, complementary studies and treatments were registered. Factors associated with mortality were analyzed. Results: A total of 194 cases of listeriosis were analyzed. The incidence of listeriosis among in-patients increased through the study period, with a significant drop in the number of cases in 2020. The most common clinical presentations were isolated bacteriemia (37.1%) and central nervous system involvement (CNS) (36.6%). Symptoms of gastroenteritis occurred in 21% of cases. Other focal infections were present in 16.5% of patients, the most frequent were spontaneous bacterial peritonitis (8.2%), cholecystitis (2.1%), respiratory infection (1.5%) and vascular prothesis infection (1.5%). In-hospital mortality was 24.7%. Independent factors associated with mortality at admission were age (odds ratio [OR] 1.027, 95% confidence interval [95% CI]1.003–1.056) and a diagnosis of a solid tumor (OR 3.525, 95% CI1.652–7.524). Conclusions: This study confirms an increasing incidence of listeriosis in our millieu. The most common clinical presentations were isolated bacteriemia and central nervous system involvement. In-hospital mortality was associated with age and the diagnosis of a solid tumor.(AU)

Lilian Harrison y la travesía del Río de la Plata (1923): repercusión en la prensa uruguaya / Lilian Harrison e a travessia do Rio da Prata (1923): repercussão na imprensa uruguaia / Lilian Harrison and the crossing of the River Plate (1923): repercussion in the Uruguayan press

RESUMEN Lilian Harrison fue la primera persona en completar la travesía del Río de la Plata a nado, entre Colonia (Uruguay) y Punta Lara (Argentina) en 1923. La prensa argentina de la época coronó la victoria como un logro de toda la nación, a despecho de las apelaciones sexistas de los reportajes. Este artículo pretende analizar los discursos de la prensa uruguaya sobre la hazaña de la nadadora, utilizando las principales publicaciones periódicas de la época. El análisis de los reportajes permite concluir que, además de los artículos sexistas, que disminuían los logros de la atleta en comparación con sus compañeros masculinos, había cierto nivel de contrariedad en los reportajes, lo que indicaba el desagrado de la prensa hacia los propios nadadores del país.

ABSTRACT Lilian Harrison was the first person to complete the crossing of the River Plate by swimming between Colonia (Uruguay) and Punta Lara (Argentina) in 1923. The Argentine press of the time crowned the victory as an achievement of the whole nation, despite the sexist appeals of the reports. This article aims to analyse the discourses of the Uruguayan press about the swimmer's achievement, using the main periodicals published at the time. An analysis of the reports allows us to conclude that, in addition to the sexist articles, which also diminished the athlete's achievements compared to her male companions, there was some level of contrariness in the reports, signalling the displeasure of the press towards the country's swimmers.

RESUMO Lilian Harrison foi a primeira pessoa a completar a Travessia do Rio da Prata à nado, entre Colônia (Uruguay) e Punta Lara (Argentina) no ano de 1923. A imprensa argentina da época coroou a vitória como uma conquista de toda a nação, em que pesem os apelos sexistas das reportagens. Esse artigo tem como objetivo analisar os discursos da imprensa Uruguaya sobre o feito da nadadora, utilizando os principais periódicos publicados na época. Uma análise das reportagens permite concluir que, para além das matérias sexistas, que também diminuíram os feitos da atleta frente aos companheiros do gênero masculino, houve algum nível de contrariedade nas reportagens, sinalizando o desagrado da imprensa em relação aos próprios nadadores do país.

Kinetics of emergence of liver complications in hepatitis C virus infected patients and advanced fibrosis, with and without HIV-coinfection, after sustained virological response.

OBJECTIVE: There is scarce available evidence on the distribution over time of liver complications emergence in hepatitis C virus (HCV)-infected patients who achieve sustained virological response (SVR) with direct-acting antiviral (DAA)-based therapy. Therefore, we aimed at describing the kinetics of liver-related events appearance in this setting. DESIGN: A multicentric prospective cohort study. METHODS: HCV-monoinfected and HIV/HCV-coinfected patients from GEHEP-011 cohort, whose inclusion criteria were had achieved SVR with DAA-based therapy; liver stiffness prior to starting treatment at least 9.5 kPa; and available liver stiffness measurement at SVR. SVR was considered as the baseline time-point. RESULTS: One thousand and thirty-five patients were included, 664 (64%) coinfected with HIV. Before DAA-based therapy, 63 (6.1%) individuals showed decompensated cirrhosis. After SVR, 51 (4.9%) patients developed liver complications. Median (Q1-Q3) time to the emergence of hepatic events was hepatic encephalopathy 11 (7-24) months, ascites 14 (6-29) months, hepatocellular carcinoma (HCC) 17 (11-42) months and portal hypertension gastrointestinal bleeding (PHGB) 28 (22-38) months (P = 0.152). We define two profiles of liver complications: those emerging earlier (encephalopathy and ascites) and, those occurring continuously during the follow-up (HCC, PHGB) [median (Q1-Q3) time to emergence 12.7 (6.6-28.2) months vs. 25.4 (12.5-41.53) months, respectively (P = 0.026)]. CONCLUSION: The vast majority of HCV-infected patients who develop liver complications after reaching SVR with DAA do it within 3 years after SVR time-point. Specifically, hepatic encephalopathy and ascites do not usually emerge after this period. Conversely, HCC and PHGB may occur in longer term. It is critical to identify patients at risk of developing hepatic events to continue performing surveillance for them.

Human Immunodeficiency Virus (HIV) Infection Is Associated With Lower Risk of Hepatocellular Carcinoma After Sustained Virological Response to Direct-acting Antivirals in Hepatitis C Infected Patients With Advanced Fibrosis.

BACKGROUND: The aim of this study was to assess the impact of human immunodeficiency virus (HIV) infection on the risk of developing hepatocellular carcinoma (HCC) in patients infected with hepatitis C virus (HCV) who achieve sustained virological response (SVR) with direct-acting antiviral (DAA). METHODS: Multisite prospective cohort study, where HCV-monoinfected patients and HIV/HCV-coinfected individuals were included if they met: (1) SVR with DAA-based combination; (2) liver stiffness (LS) ≥9.5 kPa previous to treatment; (3) LS measurement at the SVR time-point. The main endpoint was the occurrence of HCC. Propensity score (PS) was calculated to address potential confounders due to unbalanced distribution of baseline characteristics of HIV/HCV-coinfected and HCV-monoinfected patients. RESULTS: In total, 1035 HCV-infected patients were included, 667 (64%) coinfected with HIV. After a median (Q1-Q3) follow-up time of 43 (31-49) months, 19 (1.8%) patients developed HCC (11 [3.0%]; HCV-monoinfected, 8[1.2%]; HIV/HCV-coinfected individuals; P = .013). In the multivariable analysis, HIV coinfection was associated with a lower adjusted risk of developing HCC (subhazard ratio [sHR] = 0.27, 95% confidence interval [CI]: .08-.90; P = .034). Predictors of HCC emergence were: HCV genotype 3 (sHR = 7.9, 95% CI: 2.5-24.9; P < .001), MELD score at SVR >10 (sHR = 1.37, 95% CI: 1.01-1.86; P = .043) and LS value at SVR (sHR = 1.03, 95% CI: 1.01-1.06, for 1 kPa increase; P = .011). Using inverse probability weighting method on the PS, HIV-infected patients had a lower risk of HCC (powered HR = 0.33, 95% CI: .11-.85). CONCLUSIONS: Among HCV-infected patients with advanced fibrosis, who achieve SVR with DAA, HIV coinfection seems to be associated with a lower risk of HCC occurrence. The underlying causes for this finding need to be investigated.

Impact of HIV on the survival of hepatocellular carcinoma in hepatitis C virus-infected patients.

BACKGROUND: Previous studies have suggested that hepatocellular carcinoma (HCC) has an aggressive presentation and a shorter survival in people with HIV (PWH). This could be due to later diagnosis or lower rates of HCC treatment, and not to HIV infection itself. AIM: :: To assess the impact of HIV on HCC survival in hepatitis C virus (HCV)-infected patients. METHODS: Multicenter cohort study (1999-2018) of 342 and 135 HCC cases diagnosed in HIV/HCV-infected and HCV-monoinfected patients. Survival after HCC diagnosis and its predictors were assessed. RESULTS: HCC was at Barcelona-Clinic Liver-Cancer (BCLC) stage 0/A in 114 (33%) HIV/HCV-coinfected and in 76 (56%) HCV-monoinfected individuals (P < 0.001). Of them, 97 (85%) and 50 (68%) underwent curative therapies (P = 0.001). After a median (Q1-Q3) follow-up of 11 (3-31) months, 334 (70%) patients died. Overall 1 and 3-year survival was 50 and 31% in PWH and 69 and 34% in those without HIV (P = 0.16). Among those diagnosed at BCLC stage 0/A, 1 and 3-year survival was 94 and 66% in PWH whereas it was 90 and 54% in HIV-negative patients (P = 0.006). Independent predictors of mortality were age, BCLC stage and α-fetoprotein levels. HIV infection was not independently associated with mortality [adjusted hazard ratio (AHR) 1.57; 95% confidence interval: 0.88-2.78; P = 0.12]. CONCLUSION: HIV coinfection has no impact on the survival after the diagnosis of HCC in HCV-infected patients. Although overall mortality is higher in HIV/HCV-coinfected patients, this seem to be related with lower rates of early diagnosis HCC in HIV-infected patients and not with HIV infection itself or a lower access to HCC therapy.

HCV-coinfection is related to an increased HIV-1 reservoir size in cART-treated HIV patients: a cross-sectional study.

In HIV-1/HCV-coinfected patients, chronic HCV infection leads to an increased T-lymphocyte immune activation compared to HIV-monoinfected patients, thereby likely contributing to increase HIV-1 reservoir that is the major barrier for its eradication. Our objective was to evaluate the influence of HCV coinfection in HIV-1 viral reservoir size in resting (r) CD4+ T-cells (CD25-CD69-HLADR-). Multicenter cross-sectional study of 97 cART-treated HIV-1 patients, including 36 patients with HIV and HCV-chronic co-infection without anti-HCV treatment, 32 HIV patients with HCV spontaneous clearance and 29 HIV-monoinfected patients. rCD4+ T-cells were isolated and total DNA was extracted. HIV viral reservoir was measured by Alu-LTR qPCR. Differences between groups were calculated with a generalized linear model. Overall, 63.9% were men, median age of 41 years and Caucasian. Median CD4+ and CD8+ T-lymphocytes were 725 and 858 cells/mm3, respectively. CD4+ T nadir cells was 305 cells/mm3. Proviral HIV-1 DNA size was significantly increased in chronic HIV/HCV-coinfected compared to HIV-monoinfected patients (206.21 ± 47.38 vs. 87.34 ± 22.46, respectively; P = 0.009), as well as in spontaneously clarified HCV co-infected patients when compared to HIV-monoinfected individuals (136.20 ± 33.20; P = 0.009). HIV-1/HCV co-infected patients showed a larger HIV-1 reservoir size in comparison to HIV-monoinfected individuals. This increase could lead to a greater complexity in the elimination of HIV-1 reservoir in HIV-1/HCV-coinfected individuals, which should be considered in the current strategies for the elimination of HIV-1 reservoir.

HIV infection in immigrants in Spain: Epidemiological characteristics and clinical presentation in the CoRIS Cohort (2004–2006)

Introducción En España, la proporción de inmigrantes en los servicios clínicos de infección por virus de la inmunodeficiencia humana (VIH) es creciente. El objetivo del presente artículo es describir las características sociodemográficas, epidemiológicas y clínicas de una cohorte de personas con infección por VIH de la Red de Investigación en Sida (CoRIS) según su lugar de origen. Métodos CoRIS es una cohorte abierta, prospectiva y multicéntrica de adultos con infección por VIH sin tratamiento antirretrovírico previo, que se atendieron en 19 hospitales de 9 Comunidades Autónomas españolas entre enero de 2004 y octubre de 2006. Se describen las características por región de origen y se comparan con los casos españoles Resultados Se incluyeron 2.507 pacientes: el 76,3% fueron varones, con una mediana de edad de 36 años. Por el lugar de origen, el 71,5% fueron españoles; el 16,0% fueron latinoamericanos; el 5,8% fueron de África Subsahariana; el 3,7% fueron de Europa occidental; el 1,7% fueron de Europa del este, y el 1,4% fueron de África del norte. En comparación con los españoles, hubo diferencias significativas en sexo, edad y categoría de transmisión. La mediana de linfocitos CD4 al ingreso a la cohorte fue de 352×106/l, sin que hubiera diferencias según el origen. La mediana de carga vírica fue de 48,962 copias/ml, significativamente menor en el grupo de África subsahariana. Tras 11,4 meses de seguimiento, el 57,9% había iniciado tratamiento, sin que hubiera diferencias por origen. La prevalencia de coinfección con hepatitis C fue del 29,9% en españoles, del 7,3% en latinoamericanos, del 11,7% en los sujetos de África subsahariana y del 45,7% en los sujetos de Europa del este (p-60;0,05). El 13,4% tuvo prueba de tuberculina positiva; el 28,6% en los sujetos del África subsahariana y el 30,8% en los sujetos de África del norte. La tuberculosis fue más frecuente entre los sujetos de Europa del este (9,5%) y del África subsahariana (8,3%) que en españoles (4,8%) (p-60;0,05). Conclusiones Casi un tercio de las personas con infección por VIH que se atendieron recientemente en España fueron extranjeros. Sus características sociodemográficas, epidemiológicas y clínicas reflejan la epidemia en sus lugares de origen. Sin embargo, su situación inmunológica cuando acceden al hospital y en el inicio del tratamiento no difiere de la de los pacientes españoles (AU)

Introduction A growing number of immigrants are using the public health services for HIV in Spain. We describe the sociodemographic, epidemiological, and clinical characteristics of a cohort of naïve HIV-infected subjects (CoRIS cohort) according to their place of origin. Methods CoRIS is an open, hospital-based cohort of naïve, HIV-infected persons attended in 19 hospitals from 9 of the 19 autonomous regions in Spain. We describe the characteristics of the cohort members by place of origin, and compare them with the Spanish cases identified from January 2004 to October 2006, using the chi-square and Fisher exact tests. Results Of 2507 patients, 76.3% were men and median age was 36 years. By origin, 71.5% were Spanish, 16.0% Latin Americans (LA), 5.8% sub-Saharan Africans (SSA), 3.7% Western Europeans (WE), 1.7% Eastern Europeans (EE) and 1.4% North Africans (NA). Compared to Spaniards, there were significant differences by origin in sex, age, and transmission category. Median CD4 count at cohort entry was 352 cell/μL, with no differences according to origin. Median viral load was 48 962 copies/mL and was significantly lower for SSA. Over 11.4 months of follow-up, 57.9% initiated HAART with no differences by origin. Hepatitis C prevalence was 29.9% in Spaniards, 7.3% in Latin Americans, 11.7% in SSA, and 45.7% in EE (P-60;0.05). Overall, 13.4% were Mantoux-positive (28.6% in SSA and 30.8% in NA). Tuberculosis was more common among cases from EE (9.5%) and SSA (8.3%) compared to Spaniards (4.8%) (P-60;0.05).ConclusionsAlmost one third of naïve HIV-infected patients in CoRIS are foreign-born. Their sociodemographic, epidemiological and clinical characteristics reflect the epidemic in their places of origin. However, their immunological status at cohort entry and initiation of HAART is no different from that of Spaniards(AU)