Implementation of long-acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations.

INTRODUCTION: Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long-acting (LA) regimen recommended for maintaining HIV-1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation-effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months. METHODS: Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm-S) or enhanced arm (Arm-E). Arm-S included video injection training and provider/patient toolkits. Additionally, Arm-E included skilled wrap-around team meetings, face-to-face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi-structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1-5 Likert scale ranging from 1 = "completely disagree" to 5 = "completely agree"). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed. RESULTS: Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation- and intervention-based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (n = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections. CONCLUSIONS: CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible. GOV NUMBER: NCT04399551.

Potentially inappropriate prescriptions and therapeutic complexity in older HIV patients with comorbidities.

BACKGROUND: The prolonged current survival of human immunodeficiency virus (HIV) patients exposes them to new problems arising from the comorbidities they face. OBJECTIVES: To describe the situation of comorbidities, polypharmacy, therapeutic complexity and adherence in people living with HIV over 65 years of age and to assess the presence of potentially inappropriate prescriptions (PIP) by applying deprescription criteria. METHODS: Observational study including HIV people (> 65 years) from a university tertiary level hospital. Demographic, clinical and pharmacotherapeutic characteristics of the patients and their treatments were studied. The prevalence of polypharmacy (> 5 medications) and the pharmacotherapy complexity, quantified by the Medication Regimen Complexity Index (MRCI), were calculated. Therapeutic adherence was assessed by the Simplified Medication Adherence Questionnaire (SMAQ) and the medication possession ratio, according to prescription dispensing records. The Screening Tool of Older People's Prescriptions (STOPP) and List of Evidence-baSed depreScribing for CHRONic patients (LESS-CHRON) criteria were applied to identify PIP. MAIN OUTCOME MEASURE: PIP in elderly people living with HIV. RESULTS: Thirty patients were included, 73% of whom were men, with a median age of 71 years (IQR 67 - 76) and a median duration of infection of 17 years (IQR, 9 - 21). Seventy percent of the patients suffered from dyslipemia, 66.7% from hypertension, 43.3% from diabetes and 26.7% from mental health disorders. Seventy percent of the patients took more than 5 medications and 30% more than 10. The MRCI of concomitant medications was higher (18.3 points) than the MRCI of antiretroviral therapy (5.1 points), 66.7% of the studied population was classified as adherent. Finally, 70% of the patients present some PIP according to the STOPP or LESS-CHRON criteria. The polypharmacy was significantly associated (p = 0.008) with meeting deprescription criteria. CONCLUSION: The elderly people living with HIV present numerous comorbidities and met the criteria for polypharmacy. Their pharmacotherapy complexity is mainly determined by the concomitant treatments. There is a high prevalence of meeting deprescription criteria in people living with HIV over the age of 65 and a clear relationship between polypharmacy and deprescription. The optimization of pharmacotherapy is necessary in this population.

Cribado neurocognitivo en población con virus de inmunodeficiencia adquirida / Neurocognitive screening in a population with acquired immunodeficiency virus

INTRODUCCIÓN: El trastorno neurocognitivo asociado al virus de la inmunodeficiencia humana (VIH) es un problema emergente a pesar del tratamiento antirretroviral. Los test de cribado que mejor se adaptan a la población española son la Brief Neurocognitive Scale (BNCS) y el Neu Screening. Desconocemos la magnitud del trastorno neurocognitivo en la población con VIH. OBJETIVOS: Comprobar si existe asociación entre la infección por el VIH y el trastorno neurocognitivo, y conocer su prevalencia. SUJETOS Y MÉTODOS: Estudio observacional, descriptivo y transversal que compara a 24 pacientes con VIH y a 21 controles sanos, pareados por sexo, edad y nivel de estudios. Se utilizó la Hospital Anxiety and Depression Scale, el Neu Screening y la BNCS para el cribado neuropsicológico. Se consideró positivo un cribado con una alteración en uno o más test. RESULTADOS: Un 33,3% de los pacientes con VIH y un 33,3% de los controles sanos tuvieron un cribado positivo, sin diferencias significativas entre ambos grupos. El cribado positivo presentó una relación significativa con ansiedad y depresión. Existe una correlación lineal positiva entre niveles nadir de CD4 y resultados del Digit Symbol, y entre nadir de CD4 y fluencia verbal. No hubo relación significativa entre VIH positivo y cribado positivo. CONCLUSIONES: Los pacientes con VIH con buen control clínico presentan un perfil neurocognitivo sin diferencias significativas frente a la población control. Los niveles de CD4 son posiblemente una variable predictora para el desarrollo de trastorno neurocognitivo. La BNCS y el Neu Screening son buenas alternativas, pero resulta necesario un abordaje neuropsiquiátrico concomitante. Se precisan estudios con muestras mayores para confirmar la hipótesis alternativa

INTRODUCTION: Neurocognitive impairment associated to human immunodeficiency virus (HIV) is a current problem despite the effectiveness of antiretroviral treatment. The screening tests which best suit to Spanish population are Brief Neuro¬cognitive Scale (BNCS) and Neu Screening. We are unaware of our HIV populations neurocognitive impairment magnitude. AIMS. To verify if association between HIV and neurocognitive impairment does exist and to know its prevalence. SUBJECTS AND METHODS: An observational, descriptive and transversal study comparing 24 HIV-outpatients and 21 non-HIV-healthy control matched by age, gender and educational level. Hospital Anxiety and Depression Scale, Neu Screening and BNCS were used as neurocognitive impairment screening. Positive screening was considered with one or more abnormal test. RESULTS: 33.3% of VIH+ and 33.3% of healthy controls had positive screening without significant difference between both populations. Positive screening was significantly associated with anxiety-punctuation and depression-punctuation. A lineal correlation between CD4-nadir-levels and Digit Symbol and between CD4-nadir-levels and verbal fluency results were found. There was no significant relationship between HIV serology and screening result. CONCLUSIONS: HIV-patients clinically controlled had no significantly different neurocognitive profile compared to control population. CD4-nadir levels may be a predictor variable in terms of neurocognitive impairment development. BNCS and Neu Screening are reasonable alternatives for neurocognitive impairment screening. A concomitant psychiatric and neuro¬psychological assessment is necessary. Further studies with bigger samples are necessary in order to confirm the alternative hypothesis

Diferencias en supervivencia según el tipo de cáncer y el grado de inmunodeficiencia en pacientes con infección VIH / Differences in survival according to malignancy type and degree of immunodeficiency in HIV-infected patients

ANTECEDENTES Y OBJETIVO: Tras la introducción del tratamiento antirretroviral se objetiva una disminución de los tumores definitorios de sida (TDS), mientras que los tumores no definitorios de sida (TNDS) han aumentado en pacientes infectados por VIH (PIV). Disponemos de poca información sobre el pronóstico y factores de riesgo asociados. Hemos estudiado la supervivencia y su relación con la inmunodeficiencia tras el diagnóstico de TDS o TNDS. MATERIALES Y MÉTODOS: Estudio observacional, retrospectivo, sobre 788 PIV de los que 133 desarrollaron una neoplasia maligna entre 2000-2016. Las neoplasias se dividieron en TDS o TNDS y el grado de inmunodeficiencia según el recuento de linfocitos T CD4 >o

BACKGROUND AND OBJECTIVE: After the introduction of antiretroviral therapy, a decrease in AIDS defining cancers (ADCs) is observed, while non-AIDS-defining cancers (NADCs) have increased in HIV-infected patients (HIP). We have little information about the prognosis and associated risk factors. We studied survival and its relationship with immunodeficiency after the diagnosis of ADC or NADC. MATERIAL AND METHODS: Observational, retrospective study of 788 HIP of whom 133 developed a malignancy between 2000-2016. Malignancies were divided into ADCs or NADCs and degree of immunodeficiency according to the CD4 T lymphocyte count> or

Differences in survival according to malignancy type and degree of immunodeficiency in HIV-infected patients. / Diferencias en supervivencia según el tipo de cáncer y el grado de inmunodeficiencia en pacientes con infección VIH.

BACKGROUND AND OBJECTIVE: After the introduction of antiretroviral therapy, a decrease in AIDS defining cancers (ADCs) is observed, while non-AIDS-defining cancers (NADCs) have increased in HIV-infected patients (HIP). We have little information about the prognosis and associated risk factors. We studied survival and its relationship with immunodeficiency after the diagnosis of ADC or NADC. MATERIAL AND METHODS: Observational, retrospective study of 788 HIP of whom 133 developed a malignancy between 2000-2016. Malignancies were divided into ADCs or NADCs and degree of immunodeficiency according to the CD4 T lymphocyte count> or

Polypharmacy in older adults with human immunodeficiency virus infection compared with the general population.

BACKGROUND: The percentage of older HIV-positive patients is growing, with an increase in age-related comorbidities and concomitant medication. OBJECTIVES: To quantify polypharmacy and profile types of non-antiretroviral drugs collected at community pharmacies in 2014 by HIV-positive individuals on antiretroviral therapy and to compare these findings with those of the general population. METHODS: HIV-positive patients (n=199) were compared with a group of patients from the general population (n=8,172), aged between 50 and 64 years. The factors compared were prevalence of polypharmacy (≥5 comedications with cumulative defined daily dose [DDD] per drug over 180), percentage of patients who collected each therapeutic class of drug, and median duration for each drug class (based on DDD). Results were stratified by sex. RESULTS: Polypharmacy was more common in HIV-positive males than in the male general population (8.9% vs 4.4%, P=0.010). Polypharmacy was also higher in HIV-positive females than in the female general population (11.3% vs 3.4%, P=0.002). Percentage of HIV-positive patients receiving analgesics, anti-infectives, gastrointestinal drugs, central nervous system (CNS) agents, and respiratory drugs was higher than in the general population, with significant differences between male populations. No differences were observed in proportion of patients receiving cardiovascular drugs. The estimated number of treatment days (median DDDs) were higher in HIV-positive males than in males from the general population for anti-infectives (32.2 vs 20.0, P<0.001) and CNS agents (238.7 vs 120.0, P=0.002). A higher percentage of HIV-positive males than males from the general population received sulfonamides (17.1% vs 1.5%, P<0.001), macrolides (37.1% vs 24.9%, P=0.020), and quinolones (34.3% vs 21.2%, P=0.009). CONCLUSION: Polypharmacy is more common in HIV-positive older males and females than in similarly aged members of the general population. HIV-positive patients received more CNS drugs and anti-infectives, specifically sulfonamides, macrolides, and quinolones, but there were no differences in the percentage of patients receiving cardiovascular drugs. It is essential to investigate nonantiretroviral therapy medication use in the HIV-positive population to ensure these patients receive appropriate management.

Prevalence of concomitant medications in older HIV+ patients and comparison with general population.

OBJECTIVE: The increasing population of human immunodeficiency virus (HIV)-infected elderly patients results in a higher number of comorbidities and greater incidence of polypharmacy in addition to antiretroviral therapy (ART). The aim of this study is to describe the use of concomitant medication in older HIV-infected patients and to compare it with older general population. METHODS: The study included HIV-positive outpatients (>49 years) who received ART in 2011. Co-medication dispensed by pharmacies in that year was collected. Defined daily dose (DDD) for each drug was calculated by patient. A comparison was made between the use of co-medication among men between 50 and 64 years old in general population against the HIV-infected population. RESULTS: The study was based on 118 patients (77% men), of which 82% took at least one co-medication and 58% at least five. The commonest co-medications used by HIV-positive patients were antibiotics (44%); analgesics (44%); anti-inflammatories (39%); antacids (38%); and psycholeptics (38%). The medicines used for the greatest number of days per HIV-positive patient were those related to the renin-angiotensin system; anti-diabetics; lipid modifying agents; antithrombotics; and calcium channel blockers. In comparison with the general male population, a higher proportion of HIV-infected patients used antibiotics (42 vs 30%, P = 0.018), antiepileptics (16 vs 5%, P = 0.000), psycholeptics (35 vs 17%, P = 0.000) and COPD medications (14 vs 7%, P = 0.008). The duration of antibiotics and psycholeptic use in HIV-infected patients was longer compared to the general population (P < 0.05). CONCLUSIONS: Older HIV-positive patients frequently take a higher number of co-medication, which increases the risk of adverse events, interactions with other medication, and may lead to poorer treatment adherence.

Clinical characteristics and antiretroviral treatment of older HIV-infected patients.

BACKGROUND: The number of Human Immunodeficiency Virus (HIV) patients aged 50 years or over is growing year on year, due to both late diagnoses and the chronicity of the illness. This increase is a new phenomenon. OBJECTIVE: To describe the clinical and epidemiological characteristics of the older HIV infected population and determine if there are differences in antiretroviral treatment between younger and older patients. SETTING: This study was conducted in the outpatient hospital pharmacy service of a University Hospital in Spain. METHOD: A descriptive study involving HIV infected patients aged 50 years or older who received ambulatory antiretroviral therapy between January and December 2011. Variables related to HIV and to antiretroviral therapy were collected. A comparison of antiretroviral drugs used was made with the populations older and younger than 50 years. MAIN OUTCOME MEASURE: Antiretroviral therapy differences between older and younger HIV-patients. RESULTS: 130 patients (20% of the antiretroviral treated patients) were 50 or over and 77% of these was aged between 50 and 59. At the time of diagnosis, 50% suffered an advanced state of disease. At the end of the study period, 58% had CD4 lymphocyte levels of over 500 cells/mm(3) and 90% had an undetectable viral load. The antiretroviral therapy of the older group that was based on protease inhibitors was used in the 51.5% of the patients compared with 54.4% in the younger group. The figures for nonnucleoside reverse transcriptase inhibitors based therapy were 43.8 and 39.8%, respectively. The older population used treatments that included tenofovir (56.9 vs. 64.8%, p = 0.105) less frequently and used more treatments that included abacavir (26.9 vs. 19.1%, p = 0.054) than the under 50's. CONCLUSION: Half the older HIV-infected patients were diagnosed with an advanced disease and the majority showed a positive response to antiretroviral therapy. There are no statistically significant differences between the frequency of antiretroviral therapy use in older and younger HIV-patients, although older HIV-patients has less often used treatments with tenofovir and more often used treatments with abacavir.