Manuel Vélez-Díaz-Pallarés

Objectives: To describe the impact of immune checkpoint inhibitors (ICPi) in infection control in people living with HIV (PLWHIV) and to explore their safety compared with a matched cohort of people living without HIV (PLWOHIV). Secondary, to report inclusion and exclusion criteria for PLWHIV in clinical trials (CT) with ICPi. Methods: Observational, retrospective, single-center study. PLWHIV initiating ICPi from January 2018 until June 2023 were included. Biomarkers of HIV infection control were collected at baseline and after ICPi initiation. Safety data were compared with a 1:2 matched cohort of PLWOHIV. CT with ICPi starting recruitment between January 2018 and December 2022 were analyzed. Results: Twenty-eight PLWHIV were included, most male (22; 78.6%), median age 57 years (IQI 55.0–60.0). Follow-up data on infection control were available in 19 (67.9%) patients. In 17 (89.5%) the viral load was <200 copies/ml throughout the complete follow-up, in 13 (68.4%) CD4 + remained above 200 cells/µl and in 13 (68.4%) the CD4/CD8 ratio persisted ≥0.4. In 11 (57.9%) all three conditions were met. Forty-eight PLWOHIV were identified for the matched cohort. Adverse events rates were similar between groups. A total of 126 CT with ICPi were identified: 91 (72.2%) explicitly excluded PLWHIV, 24 (19.0%) did not mention HIV infection, and 11 (8.7%) allowed their inclusion under certain conditions. Conclusions: ICPi in PLWHIV appeared to have a safety profile similar to that observed in PLWOHIV without evident negative effects on viral control. However, PLWHIV remain frequently excluded from ICPi CT.

Background: People living with HIV (PLWH) are increasingly affected by ageing-related issues, including multimorbidity and polypharmacy, which heighten the risk of drug-related problems. The 3-HIT phenomenon— defined as the simultaneous presence of high pharmacotherapeutic complexity, clinically relevant drug–drug interactions, and poor adherence to concomitant medication—represents a significant challenge in the care of older PLWH. Objective: To evaluate the impact of a Capacity-Motivation-Opportunity (CMO) pharmaceutical care model on reducing the prevalence of the 3-HIT criteria in PLWH aged ≥ 50 years and to assess pharmacotherapeutic goal achievement according to patient stratification. Methods: A prospective, multicentre intervention study was conducted in nine Spanish hospitals (March 2023–March 2024), including PLWH aged ≥ 50 on antiretroviral and concomitant therapy. Participants were stratified into three levels of pharmaceutical care according to the CMO model (Capacity, Motivation, Opportunity). Clinical, virological, and pharmacotherapeutic data were collected at baseline and week 24. Interventions were tailored to individual needs and stratification level. Results: Among 154 participants (mean age 62.6 years (SD: 7.47); 75.3% male), the predominance of male participants was consistent with the demographic profile of ageing PLWH cohorts in Spain. Polypharmacy was highly prevalent (96.1%), and 17.5% of participants simultaneously met all three 3-HIT criteria at baseline. After 24 weeks, 3-HIT prevalence decreased significantly to 9.4% (p< 0.05), with marked improvements in adherence to concomitant medication (from 50% to 76.6%). The proportion of individuals achieving at least one pharmacotherapeutic goal increased from 58.4% at baseline to 73.8% at follow-up. The intervention was associated with sustained pharmaceutical actions, particularly regarding adherence support, treatment validation, and care coordination. Conclusion: Implementation of a structured, stratified pharmaceutical care model based on the CMO methodology significantly reduces 3-HIT prevalence in older PLWH, primarily through improved adherence to concomitant medication, while maintaining virological control. These findings support the inclusion of CMO-based approaches in clinical practice to optimise pharmacotherapy and improve outcomes in ageing HIV populations.

Objectives: This study aimed to determine the prevalence of potentially inappropriate prescriptions (PIPs) and potential prescription omissions (PPOs) in a Spanish cohort of people living with HIV (PLWH) aged ≥65 years and to identify risk factors for the presence of PIPs and PPOs.Methods: This retrospective cross‐sectional study was conducted across 10 public hospitals in the Autonomous Community of Madrid, Spain. Clinical and demographic data were cross‐checked against hospital and community pharmacy dispensation registries. PIPs and PPOs were assessed using the American Geriatrics Society (AGS)/Beers and Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert Doctors to Right Treatment (START) criteria. Risk factors for PIPs and PPOs and agreement between AGS/Beers and STOPP/START criteria were statistically analysed.Results: This study included 313 PLWH (median age 72 years), of whom 80.5% were men. PIP prevalence rates were 29.4% and 44.4% based on the AGS/Beers and STOPP criteria, respectively. The concordance between AGS/Beers and STOPP criteria was moderate. Benzodiazepines and proton pump inhibitors were the chronic comedications most commonly involved in PIPs. PPOs were observed in 61.4% of the patients. The leading omissions were insufficient influenza and pneumococcal vaccine coverage and inadequate bone health‐related treatments. The number of chronic comedications, female sex, neuropsychiatric disorders, and cancer diagnosis were risk factors for PIPs, whereas osteopenia and osteoporosis were risk factors for PPOs.Conclusions: A high prevalence of PIPs and PPOs was observed in our cohort of older PLWH. These findings emphasize the importance of comprehensive medication reviews in this population to reduce inappropriate medication use and address their specific and underserved therapeutic needs.

Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.

The COVID-19 pandemic and associated lockdown measures have been associated with substantial disruptions to health care services, including screening for human immunodeficiency virus (HIV) and management of people living with HIV (PLWH). Data from 3265 patients were examined in a retrospective cohort study. We compared outpatient follow-up for PLWH, the number of new patients, treatment adherence, hospitalizations, and deaths during the “pandemic period” (March 2020 to February 2021), the “pre-pandemic period” (the equivalent time frame in 2019), and the “post-pandemic period” (March to September 2021). During the pandemic period, the number of new patients seen at the HIV clinic (116) as well as the requested viral load tests (2414) decreased significantly compared to the pre-pandemic (204 and 2831, respectively) and post-pandemic periods (146 and 2640, respectively) (p < 0.01 for all the comparisons). However, across the three study periods, the number of drug refills (1385, 1330, and 1411, respectively), the number of patients with undetectable viral loads (85%, 90%, and 93%, respectively), and the number of hospital admissions among PLWH remained constant. Despite the COVID-19 pandemic’s impact, our findings show stability in the retention of clinical care, adherence to treatment, and viral suppression of PLWH, with no significant impact on hospitalization rates or all-cause mortality.

Introducción. La satisfacción y el conocimiento del cambio de tenofovir por tenofovir-alafenamida en pacientes con HIV no se han estudiado aún. Estos dos parámetros se relacionan con mejores resultados en salud y, por lo tanto, es importante medirlos durante la práctica clínica habitual.Objetivo. Evaluar el grado de conocimiento y satisfacción de los pacientes positivos para HIV ante el cambio de tratamiento antirretroviral con rilpivirina, emtricitabina y tenofovir (RPV-FTC-TDF) por rilpivirina, emtricitabina y tenofovir-alafenamida (RPV-FTC-TAF).Materiales y métodos. Se llevó a cabo un estudio prospectivo en un hospital de tercer nivel entre los meses de septiembre y noviembre de 2018. Se incluyeron pacientes previamente tratados con RPV-FTC-TDF que acudían por segunda vez a consulta para recibir el tratamiento con RPV-FTC-TAF. La satisfacción y el grado de conocimiento se analizaron mediante nueve preguntas, usando una escala de tipo Likert de 5 puntos para evaluar el grado de acuerdo.Resultados. Se incluyeron 116 pacientes en el estudio. El 75 % de ellos se mostró satisfecho con el cambio y se consideró que el 64 % conocía lo que implicaba. Los pacientes jóvenes se mostraron menos satisfechos con el modo en que se les explicó el cambio (p=0,0487). Los pacientes estaban mejor informados sobre las ventajas renales (85 % de conocimiento) y óseas (82 %) de la nueva medicación, que sobre sus inconvenientes para el perfil lipídico (40 %).Conclusiones. En general, los pacientes se mostraron satisfechos con el cambio de medicación y conocían la posología del medicamento y las ventajas de la tenofovir-alafenamida frente al tenofovir, pero no sus posibles efectos adversos.