Identifying risk factors for anal cancer in people with HIV in Spain: a multicentre retrospective cohort study nested in the PISCIS cohort.

BACKGROUND: People with HIV have a substantially higher risk of anal cancer than the general population. We aimed to identify risk factors associated with the development of anal cancer among people with HIV to implement more effective and targeted screening strategies. METHODS: We conducted a multicentre retrospective cohort study in 16 hospitals across Catalonia and the Balearic Islands, Spain, between Jan 1, 1998, and Dec 31, 2022. Treatment-naive people with HIV nested in the PISCIS cohort aged 16 years and older with biopsy-proven squamous cell carcinoma of the anus or anal canal were eligible for inclusion. Data were retrieved from every hospital registry and were centrally validated in the PISCIS cohort and the Public Data Analysis for Health Research and Innovation Program. The primary outcome was the incidence rate (IR) of histologically confirmed anal cancer. We used Poisson regression to examine the association between the following risk factors and incidence of anal cancer: age, mode of HIV transmission, nadir CD4 cell count, and time period of HIV diagnosis. FINDINGS: Among 14 238 people with HIV, 107 (0·8%) developed anal cancer, with an overall IR of 72·5 cases per 100 000 person-years (95% CI 59·4-87·6) and median follow-up of 9·5 years (IQR 4·4-15·7). Of these patients with anal cancer, 37 (34·6%) died, of which 24 (64·9%) deaths were related to anal cancer. Incidence was highest among people with HIV with historical nadir CD4 counts of less than 200 cells per µL (IR 105·0 person-years, 95% CI 82·0-132·5) and lowest among those with counts of more than 350 cells per µL (2·9 person-years, 0·1-16·0). Among men who have sex with men (MSM), the IR was 211·5 person-years (95% CI 151·1-211·7) among those with a CD4 count of less than 200 cells per µL, 37·6 person-years (16·2-74·1) among those with a count of 200-350 cells per µL, and 4·8 person-years (0·1-26·9) among those with a count of more than 350 cells per µL. Among people with HIV younger than 30 years, there were no cases of anal cancer among women or men who do not have sex with men, and one case among MSM with a nadir CD4 count of more than 350 cells per µL (IR 4·8 person-years, 95% CI 0·1-26·9). In the multivariable analysis, people with HIV with nadir CD4 counts of more than 350 cells per µL had the lowest risk of developing anal cancer, compared with people with HIV with counts of less than 200 cells per µL (adjusted IR ratio 0·03, 95% CI 0·00-0·25; p=0·0010) or 200-350 cells per µL (0·30, 0·17-0·55; p<0·0001). Compared with people with HIV younger than 30 years, people with HIV aged 60 years and older had an adjusted IR ratio of 27·6 (3·7-206·9; p=0·0010) and people with HIV aged 45-59 years of 21·6 (3·0-156·4; p=0·0020). Compared with individuals diagnosed after 2015, a diagnosis of HIV before 1998 had an adjusted IR ratio of 33·0 (7·9-137·5; p<0·0001). INTERPRETATION: A nadir CD4 count threshold below 350 cells per µL, particularly less than 200 cells per µL, has the potential to identify people with HIV at heightened risk of developing anal cancer. Customised screening strategies that prioritise screening for individuals at high risk with this surrogate marker could maximise available resources. External validation of these data with other cohorts is required before screening recommendations can be updated. FUNDING: Catalan Health Department, Generalitat de Catalunya.

Assessing the reduction of viral infectivity in HPV16/18-positive women after one, two, and three doses of Gardasil-9 (RIFT): Study protocol.

Human Papillomavirus (HPV) prophylactic vaccination has proven effective in preventing new infections, but it does not treat existing HPV infections or associated diseases. Hence, there is still an important reservoir of HPV in adults, as vaccination programs are mainly focused on young women. The primary objective of this non-randomized, open-label trial is to evaluate if a 3-dose regimen of Gardasil-9 in HPV16/18-positive women could reduce the infective capacity of their body fluids. We aim to assess if vaccine-induced antibodies could neutralize virions present in the mucosa, thus preventing the release of infective particles and HPV transmission to sexual partners. As our main endpoint, the E1^E4-HaCaT model will be used to assess the infectivity rate of cervical, anal and oral samples, obtained from women before and after vaccination. HPV DNA positivity, virion production, seroconversion, and the presence of antibodies in the exudates, will be evaluated to attribute infectivity reduction to vaccination. Our study will recruit two different cohorts (RIFT-HPV1 and RIFT-HPV2) of non-vaccinated adult women. RIFT-HPV1 will include subjects with an HPV16/18 positive cervical test and no apparent cervical lesions or cervical lesions eligible for conservative treatment. RIFT-HPV2 will include subjects with an HPV16/18 positive anal test and no apparent anal lesions or anal lesions eligible for conservative treatment, as well as women with an HPV16/18 positive cervical test and HPV-associated vulvar lesions. Subjects complying with inclusion criteria for both cohorts will be recruited to the main cohort, RIFT-HPV1. Three doses of Gardasil-9 will be administered intramuscularly at visit 1 (0 months), visit 2 (2 months) and visit 3 (6 months). Even though prophylactic HPV vaccines would not eliminate a pre-existing infection, our results will determine if HPV vaccination could be considered as a new complementary strategy to prevent HPV-associated diseases by reducing viral spread. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05334706.

Evolving AIDS- and non-AIDS Mortality and Predictors in the PISCIS Cohort of People Living With HIV in Catalonia and the Balearic Islands (Spain), 1998-2020.

Background: Effective antiretroviral therapy (ART) has substantially reduced acquired immunodeficiency syndrome (AIDS)-related deaths, shifting the focus to non-AIDS conditions in people living with human immunodeficiency virus (HIV) (PLWH). We examined mortality trends and predictors of AIDS- and non-AIDS mortality in the Population HIV Cohort from Catalonia and Balearic Islands (PISCIS) cohort of PLWH from 1998 to 2020. Methods: We used a modified Coding Causes of Death in HIV protocol, which has been widely adopted by various HIV cohorts to classify mortality causes. We applied standardized mortality rates (SMR) to compare with the general population and used competing risks models to determine AIDS-related and non-AIDS-related mortality predictors. Results: Among 30 394 PLWH (81.5% male, median age at death 47.3), crude mortality was 14.2 per 1000 person-years. All-cause standardized mortality rates dropped from 9.6 (95% confidence interval [CI], 8.45-10.90) in 1998 through 2003 to 3.33 (95% CI, 3.14-3.53) in 2015 through 2020, P for trend = .0001. Major causes were AIDS, non-AIDS cancers, cardiovascular disease, AIDS-defining cancers, viral hepatitis, and nonhepatitis liver disease. Predictors for AIDS-related mortality included being aged ≥40 years, not being a man who have sex with men, history of AIDS-defining illnesses, CD4 < 200 cells/µL, ≥2 comorbidities, and nonreceipt of ART. Non-AIDS mortality increased with age, injection drug use, heterosexual men, socioeconomic deprivation, CD4 200 to 349 cells/µL, nonreceipt of ART, and comorbidities, but migrants had lower risk (adjusted hazard risk, 0.69 [95% CI, .57-.83]). Conclusions: Mortality rates among PLWH have significantly decreased over the past 2 decades, with a notable shift toward non-AIDS-related causes. Continuous monitoring and effective management of these non-AIDS conditions are essential to enhance overall health outcomes.

Sífilis atípica extracutánea en pacientes con infección por VIH / Extracutaneous atypical syphilis in HIV-infected patients

Introducción y objetivo: Se describe una serie de casos de sífilis con presentaciones clínicas atípicas extracutáneas en pacientes con infección por VIH. Métodos: Estudio observacional retrospectivo. Se analizaron todos los casos de sífilis diagnosticados en pacientes VIH+ en el período de junio de 2013 a junio de 2016 en un hospital terciario del área metropolitana de Barcelona. Resultados: Se diagnosticaron 71 casos de sífilis, de los cuales 32 presentaron manifestaciones clínicas. De estos, 7 casos (un 9,8% del total y un 21,8% de los casos sintomáticos) tuvieron una presentación clínica atípica con afectación extracutánea, en forma de sífilis ocular (4), gástrica (uno), abscesos hepáticos múltiples (uno) y adenopatías generalizadas sin afectación cutánea (uno). Todos los pacientes fueron tratados con penicilina por vía intramuscular o intravenosa, con evolución clínica y serológica favorable. Conclusión: En el 21,8% de los casos de sífilis sintomática en pacientes VIH+ se observaron presentaciones clínicas extracutáneas atípicas siendo la más frecuente la afectación ocular (AU)

Introduction and objective: We describe a series of cases of syphilis with atypical extracutaneous clinical presentation diagnosed in HIV-infected patients. Methods: Retrospective observational study. All cases of syphilis diagnosed in HIV-infected patients during the period between June 2013 and June 2016 in a tertiary hospital of the Barcelona metropolitan area were analysed. Results: A total of 71 cases of syphilis were diagnosed, 32 of them presenting with clinical signs or symptoms. Seven of these cases (9.8% of the total and 21.8% of the symptomatic cases) had atypical presentations with extracutaneous involvement: ocular (4), gastric (1), multiple hepatic abscesses (1) and generalised adenopathies (1). Patients were treated with intramuscular or intravenous penicillin and the clinical and serological evolution was good in all of them. Conclusions: Extracutaneous atypical clinical presentations were observed in 21.8% of symptomatic cases of syphilis in HIV+ patients with ocular involvement being the most frequent (AU)

Visceral leishmaniasis with mediastinal lymphadenopathy diagnosed by endoscopic ultrasound-guided fine needle aspiration

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Cohorte RIS de pacientes con infección por VIH sin tratamiento antirretroviral previo (CoRIS): metodología y primeros resultados / Spanish cohort of naïve HIV-infected patients (CoRIS): Rationale, organization and initial results

Objetivo. Describir la metodología y los resultados basales de la cohorte de pacientes con infección por virus de la inmunodeficiencia humana (VIH) de la Red de Investigación de Sida (CoRIS). Métodos. Cohorte abierta, prospectiva, multicéntrica, de pacientes mayores de 13 años con diagnóstico de VIH sin tratamiento antirretroviral previo. La selección se realizó entre enero de 2004 y octubre de 2005 en 17 hospitales de 8 comunidades autónomas. Se recogieron variables sociodemográficas, epidemiológicas, clínicas y analíticas, junto con muestras biológicas iniciales y de seguimiento. Resultados. Se han incluido 1.591 pacientes, 24% mujeres, mediana de edad 36 años, el 74% diagnosticados de VIH en 2004 o 2005. El 27% provenían de otros lugares de origen, destacando Latinoamérica (16%) y África subsahariana (5%). El 32% tenían estudios secundarios y el 16% universitarios. La categoría de transmisión más frecuente fue la de hombres homosexuales (37%), seguida por la heterosexual (36%); y sólo el 21% tenían antecedente de consumo de drogas inyectadas. Al ingreso en la cohorte la mediana de CD4 era 317 células/µl, la de carga viral 52.300 copias/ml y el 18% tenían diagnóstico de sida. Las enfermedades diagnósticas de sida más frecuentes fueron: neumonía por Pneumocystis jiroveci (6,1%), candidiasis esofágica (3,3%) y tuberculosis extrapulmonar (3,0%) y pulmonar (2,7%). Se registraron 35 fallecimientos (2,2%). El 33% de los pacientes han aportado muestras basales al BioBanco. Conclusiones. CoRIS proporciona información relevante del perfil epidemiológico reciente de la infección por el VIH en nuestro medio, en el que predomina la transmisión sexual. Se demuestra la viabilidad de esta cohorte, recogiendo datos clínicos y epidemiológicos junto con muestras biológicas, lo que abre grandes posibilidades de investigación (AU)

Objective. To describe the methodology and baseline results of the Spanish cohort of naïve HIV-infected patients included in the Research Network on HIV/AIDS (CoRIS). Methods. CoRIS is a multicenter, hospital-based prospective cohort of HIV sero-prevalent, retroviral-naïve subjects, over 13 years old, and seen at 17 hospitals in 8 of the 17 Autonomous Regions in Spain from January 2004 to October 2005. The socio-demographic characteristics, as well as epidemiological, clinical, laboratory and treatment data were recorded, and biological samples were collected at baseline and during follow-up. Results. A total of 1,591 subjects have been included in CoRIS; 24% are women, median age at cohort entry is 36 years, and 74% were diagnosed during 2004 or 2005. Twenty-seven percent came from countries other than Spain, mainly Latin-America (16%) and sub-Saharan Africa (5%). Thirty-two percent had completed secondary education and 16% university studies. The most frequent categories of transmission were men having sex with men (37%) and heterosexual sex (36%); only 21% were injection drug users. At cohort entry, median CD4 count was 317 cells/mm 3 and median viral load was 52,300 copies/mL; 18% were diagnosed with AIDS. Main AIDS-defining illnesses were Pneumocystis jiroveci pneumonia (6.1%), esophageal candidiasis (3.3%) and tuberculosis (extrapulmonary, 3.0% and pulmonary 2.7%). There were 35 deaths (2.2%). Thirty-three percent of patients gave a baseline sample to the BioBank. Conclusions. CoRIS offers relevant information about the current epidemiological profile of HIV infection in Spain, where sexual transmission has become predominant. The type and amount of information obtained from clinical and epidemiological data collection together with biological samples demonstrate the viability of the project, which offers many possibilities for future research (AU)