Concordance between two models of stratification for patients living with HIV infection to providing pharmaceutical care.

OBJECTIVE: To determine the degree of agreement of 2 differents stratification models for pharmaceutical care to people living with HIV. METHODS: This was a single-center observational prospective cohort study of patients with regular follow-up in pharmaceutical care consultations according to the Capacity-Motivation-Opportunity methodology, conducted between January 1 and March 31, 2023. Patients received the pharmacotherapeutic interventions applied routinely to ambulatory care patients according to this model. As part of the usual clinical practice, the presence or absence of the variables that apply to both stratification models were collected. The scores obtained and the corresponding stratification level were collected for each patient according to both stratification models published (ST-2017 and ST-2022). To analyze the reliability between the measurements of 2 numerical score models of the stratification level with both tools, their degree of concordance was calculated using the intraclass correlation coefficient. Likewise, reliability was also evaluated from a qualitative perspective by means of Cohen's Kappa coefficient. Additionally, the existence of correlation between the scores of the 2 models was assessed by calculating Pearson's correlation coefficient. RESULTS: Of the total of 758 patients being followed in the cohort, finally, 233 patients were enrolled. The distribution of patients for each stratification model was: ST-2017: 59.7% level-3, 25.3% level-2, and 15.0% level-1, while for ST-2022: 60.9% level-3, 26.6% level-2, and 12.4% level-1. It was observed that the reclassification was symmetrical (P=.317). The qualitative analysis of the agreement between the models showed a good Cohen's kappa value, (K=0.66). A value of 0.563 was found as the intraclass correlation coefficient. Finally, the correlation analysis between the quantitative scores of the 2 models yielded a Pearson correlation coefficient of 0.86. CONCLUSIONS: The concordance between the 2 models was good, which confirms that the multidimensional adaptation and simplification of the model were correct and that its use can be extended in routine clinical practice.

Early versus late switch: How long should we extend the anti-vascular endothelial growth factor therapy in unresponsive diabetic macular edema patients?

PURPOSE: To compare the results of early versus late switch to the dexamethasone intravitreal implant Ozurdex® in patients with diabetic macular edema who had a poor response to vascular endothelial growth factor inhibitors. METHODS: Retrospective and single-center study conducted, in a real setting, on consecutive diabetic macular edema patients who were switch to an intravitreal dexamethasone implant after a poor response to anti-vascular endothelial growth factor treatment. Study sample was divided into two groups: (1) early-switch group, included those eyes who received three anti-vascular endothelial growth factor injections before switch and (2) late-switch group, included those eyes that received six or more anti-vascular endothelial growth factor injections before switch. The primary end-point was the difference in mean change in best-corrected visual acuity and in central subfoveal thickness. RESULTS: A total of 69 (31 early-switch group and 38 late-switch group) eyes were included. In the early-switch group, median (25-75 quartile range) best-corrected visual acuity significantly increase from 0.2 (0.2-0.5) at baseline to 0.4 (0.3 -0.7) at month 24 (p = 0.0043). Whereas, in the late-switch group, best-corrected visual acuity did not increase (p = 0.8602). Central subfoveal thickness was significantly reduced in both early- and late-switch groups, p = 0.0002 and 0.0038, respectively. The proportion of eyes obtaining a central subfoveal thickness reduction ⩾ 10% was significantly greater in the early-switch group than in the late-switch group (71.0% vs 47.4%, respectively, p = 0.0498). Three (9.7%) and 10 (26.3%) eyes have developed ocular hypertension during the study in the early- and late-switch groups, respectively, p = 0.0816. CONCLUSION: Early switch to Ozurdex in patients who did not adequately respond to anti-vascular endothelial growth factor therapy provided better functional and anatomical outcomes.

Iris-claw intraocular lens implantation: Efficiency and safety according to technique.

PURPOSE: To evaluate the safety, refractive and visual results of an iris-claw intraocular lens for aphakia (Artisan) according to the technique used. SETTING: Ophthalmology Department, Valme University Hospital and Oftalvist Clinic, Seville, Spain. DESIGN: Retrospective case series. METHODS: This study evaluated the outcomes of iris-claw IOL implantations performed by the same surgeon between 2011 and 2017. The results were analyzed by the incision type (corneal versus scleral tunnel) and lens position (prepupillary versus retropupillary). RESULTS: Seventy-six eyes (75 patients) were included. The postoperative uncorrected (UDVA) and corrected (CDVA) distance visual acuities were significantly better than the preoperative acuities (P < .001). The UDVA was 20/40 or better in 41.7% of patients, and had the CDVA was 20/40 or better in 68.1% of patients. The mean UDVA was significantly better in the scleral tunnel incision group (0.29 logarithm of the minimum angle of resolution [logMAR] ± 0.41 [SD]) than in the corneal incision group (0.66 ± 0.45 logMAR) (P < .001). The mean surgically induced astigmatism in the scleral tunnel incision group (0.73 ± 0.62 diopter [D]) was significantly lower than in the corneal incision group (2.49 ± 1.36 D) (P < .001). Although endothelial cell loss was lower in the retropupillary position, the difference was not significant (P = .07.) CONCLUSION: Implantation of the iris-claw IOL in the retropupillary position and through a scleral tunnel incision was an effective and safe alternative to aphakia without capsule support, providing better refractive results compared with other techniques.

Effect of a Structured Pharmaceutical Care Intervention Versus Usual Care on Cardiovascular Risk in HIV Patients on Antiretroviral Therapy: INFAMERICA Study.

BACKGROUND: HIV+ patients have increased their life expectancy with a parallel increase in age-associated comorbidities. OBJECTIVE: To determine the effectiveness of an intensive pharmaceutical care follow-up program in comparison to a traditional model among HIV-infected patients with moderate/high cardiovascular risk. METHOD: This was a multicenter, prospective, randomized study of a structured health intervention conducted between January-2014 and June-2015 with 12 months of follow-up at outpatient pharmacy services. The selected patients were randomized to a control group (usual care) or intervention group (intensive pharmaceutical care). The interventional program included follow-up of all medication taken by the patient to detect and work toward the achievement of pharmacotherapeutic objectives related to cardiovascular risk and making recommendations for improving diet, exercising, and smoking cessation. Individual motivational interview and periodic contact by text messages about health promotion were used. The primary end point was the percentage of patients who had reduced the cardiovascular risk index, according to the Framingham-score. RESULTS: A total of 53 patients were included. As regards the main variable, 20.7% of patients reduced their Framingham-score from high/very high to moderate/low cardiovascular risk versus 12.5% in the control group ( P=0.016). In the intervention group, the number of patients with controlled blood pressure increased by 32.1% ( P=0.012); 37.9% of patients overall stopped smoking ( P=0.001), and concomitant medication adherence increased by 39.4% at the 48-week follow-up ( P=0.002). Conclusion and Relevance: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies might lead to improved health outcomes in HIV+ patients at greater cardiovascular risk.

Identification of the Medication Regimen Complexity Index as an Associated Factor of Nonadherence to Antiretroviral Treatment in HIV Positive Patients.

BACKGROUND: Multiple studies have identified a relationship between the complexity of a medication regimen and non-adherence. However, most studies in people who live with HIV (PLWH) have focused on antiretroviral use and have failed to consider the impact of other medications. OBJECTIVE: The aim of our study is to identify the Medication Regimen Complexity Index (MRCI) as an associated factor for nonadherence to antiretroviral treatment (ART). The secondary aim is to analyze the relationship between clinical and pharmacotherapeutical variables and adherence to antiretroviral treatment and to generate an adherence model. METHODS: A transversal, observational study. Patients included were PLWH over 18 years of age on active antiretroviral therapy. Patients who participated in clinical trials or who did not meet the inclusion criteria were excluded. We had studied HIV transmission mode, viral load, treatment status, number of comorbidities and complexity index as factors associated with adherence to ART. RESULTS: We included 619 patients in the study. Number of comorbidities ( p = 0.021; OR = 1.038-1.570); viral load ( p = 0.023; OR = 1.108-4.505) and MRCI ( p < 0.001; OR = 1.138-1.262) (ART and concomitant treatment) were the independent associated factors to ART nonadherence. The value of the Hosmer and Lemeshow test confirmed the validity of this model (P = 0.333). CONCLUSION: A higher MRCI was associated with non-adherence. Therefore, the regimen complexity calculation may be appropriate in daily practice for identifying patients at a higher risk of becoming non-adherent.

Relationship between pharmacotherapy complexity and patient satisfaction with treatment for hepatitis C.

OBJECTIVE: To establish the relationship between the complexity of treatment for hepatitis C and patient satisfaction. Method: An observational, prospective, single-center study, which included HCV patients treated between October 2014 and February 2016. The primary endpoint was the assessment of satisfaction with treatment, measured by the HCV-ESTAR questionnaire, structured into two dimensions: clinical and lifestyle satisfaction, on a 0-60 score. A reliability analysis was performed. The data collected were: treatment prescribed for HCV, concomitant medication, and Sustained Viral Response. The complexity index of the complete pharmacotherapy was calculated by the computer application MRCI. T-Student was used to identify the complexity of treatment as a marker of dissatisfaction. RESULTS: The study included 171 patients (83.0% male). The mean satisfaction score was 47.9±7.5. The reliability of the complete questionnaire was high (Cronbach alpha, 0.864; intraclass coefficient, 0.843). There was correlation between the Complexity Index and satisfaction (P<0.05). A reduction of 5 points in the Complexity Index increased fourfold the value of satisfaction with treatment (p<0.0001). Similarly, a reduction in 12 points in the Concomitant Medication Index doubled the satisfaction (p=0.028). Regarding the overall complexity, 10 points less doubled the satisfaction (p<0.05). Finally, patients with higher values of satisfaction presented a higher response rate (p=0.029). CONCLUSIONS: An increase in pharmacotherapeutical complexity has an impact on satisfaction, and at the same time, on achieving Sustained Viral Response.

Objetivos: Establecer la relación entre complejidad del tratamiento frente a la hepatitis C y la satisfacción con el mismo.Método: Estudio observacional, prospectivo, unicéntrico. Se incluyeron pacientes con VHC, tratados entre octubre-2014 y febrero-2016. La variable principal fue la valoración de satisfacción con el tratamiento, medida según el cuestionario ESTAR-VHC, estructurado en dos dimensiones: satisfacción clínica y con el estilo de vida, puntuándose de 0-60. Se realizó un análisis de fiabilidad. Se recogió el tratamiento frente al VHC prescrito, la medicación concomitante y la respuesta viral sostenida. El índice de complejidad de la farmacoterapia completa se calculó a través de la aplicación informática MRCI. Para identificar la complejidad del tratamiento como marcador de insatisfacción se utilizó la t-Student.Resultados: Se incluyeron 171 pacientes (83,0% hombres). La media de puntuación sobre satisfacción fue 47,9±7,5. La fiabilidad del cuestionario completo fue elevada (alfa Cronbach=0,864, coeficiente intraclase= 0,843). Existió correlación entre IC y la satisfacción (P<0,05). Una disminución de 5 puntos en el índice de complejidad multiplicó por cuatro el valor de la satisfacción con el tratamiento (p<0,0001). Análogamente, 12 puntos menos del índice de medicación concomitante duplicó la satisfacción (p=0,028). Respecto a la complejidad global, 10 puntos menos dobló la satisfacción (p<0,05). Por último, los pacientes con mayores valores de satisfacción presentaron mayor porcentaje de respuestas (p=0,029).Conclusiones: El incremento en la complejidad farmacoterapéutica influye en la satisfacción y, paralelamente, en la obtención de respuesta viral sostenida.

Persistence to single-tablet regimen versus less-drug regimen in treatment experienced HIV-infected patients on antiretroviral therapy.

BACKGROUND: Decreased antiretroviral therapy persistence is associated with increased rates of virologic failure, development of antiretroviral resistance, and increased morbidity and mortality. Different therapeutic strategies, such as single-tablet regimens (STR) and less-drug regimens (LDR), have been developed in order to simplify antiretroviral therapy (ART) and increase persistence. OBJECTIVES: The primary objective was to compare antiretroviral persistence among patients receiving STRs and patients receiving LDRs. A secondary objective was to identify factors associated with non-persistence. METHODS: This was a retrospective study that included treatment- experienced HIV-infected patients who received ART based on STR or LDR. Baseline patient characteristics collected included demographic information, HIV risk transmission, substance abuse during the therapy, presence of psychiatric disorder and hepatitis B or C virus infection. Kaplan-Meier analysis and Log rank was utilized to compare persistence to STR and LDR. To identify independent predictors of non-persistence we developed a multivariate Cox regression analysis. RESULTS: A total of 244 patients were included, 176 with STR and 68 with LDR. 60 (34.1%) patients discontinued in the STR group and 13 (19.1%) in the LDR group. The Cox regression model showed that the only variable associated with higher risk of non-persistence was the substance abuse (HR = 2.59; p = 0.005). Adverse events were the main reason for ART discontinuation in the STR group and virologic failure in the LDR group. CONCLUSIONS: Persistence to STR and LDR seems to be similar in pretreated HIV-infected patients. Drug abuse was the only factor identified with a higher risk of non-persistence.

Objetivos: Analizar y comparar la persistencia entre las estrategias basadas en Single-Tablet Regimen (STR) y Less Drug Regimen (LDR) en pacientes VIH+. El objetivo secundario del estudio fue determinar factores predictores de persistencia. Material y métodos: Estudio observacional retrospectivo que incluyo los siguientes criterios: pacientes VIH+ con tratamiento antirretroviral (TAR) con un regimen basado en STR o LDR. Se recogieron variables demograficas, factores de riesgo de adquisicion, consumo de drogas, presencia de algun trastorno psiquiatrico y coinfeccion por el virus de la hepatitis B o C. Para comparar la persistencia entre ambas estrategias se realizo un analisis de supervivencia de Kaplan-Meir y se aplico el metodo de log-rank. Se realizo un analisis de regresion de Cox para identificar los factores predictores de persistencia. Resultados: Se incluyeron 244 pacientes, 176 con STR y 68 con LDR. El 34,1% (n = 60) de los pacientes que recibieron un regimen STR abandonaron y en el LDR el 19,1% (n = 13). Los efectos adversos fueron la principal causa de abandono del tratamiento en los pacientes que recibieron STR y el fallo virologico en el regimen LDR. La persistencia de las estrategias STR y LDR fue similar, no encontrandose diferencias estadisticamente significativas entre ambas. El consumo de drogas fue el unico factor predictivo asociado con una menor persistencia (HR = 2,59; p = 0,005). Conclusiones: La persistencia entre los regimenes STR y LDR fue similar, no detectandose diferencias significativas entre ambos. El consumo de drogas fue el unico factor independiente asociado con una menor persistencia del tratamiento antirretroviral.

[Patients'adherence-related beliefs about medicines prescribed for long-term conditions in HIV patients]. / Influencia de las creencias hacia los medicamentos en la adherencia al tratamiento concomitante en pacientes VIH+

PURPOSE: To assess adherence and beliefs about long-term medicines for other chronic conditions among HIV-infected patients as well as to evaluate their relationship. METHOD: A cross-sectional study was conducted from may to july 2014 in HIV-infected patients treated with antiretroviral treatment (ART) and ≥1 long-term medicines for other chronic diseases. The variables analysed in the study were demographics: sex, age, education, employment status, living situation; clinical: mode of transmission, HIV plasma viral load, T-CD4+, CDC classification; and pharmacotherapeutics: type of ART, adherence to long-term medicines for other chronic conditions using the 4-item Morisky Medication Adherence (MMAS) Scale. MMAS scores were dichotomised into adherent/non-adherent. The Beliefs about Medicines Questionnaires (BMQ) was used to assess patients' beliefs about the long-term medicines. The BMQ-Specific has two scales (necessity and concern) with five questions each that uses a 5-point Likert scale. Internal consistency within BMQ scales was measured with Cronbach's α and their association with adherence was assessed with t-Student tests, using SPSS 20.0. RESULTS: We included 126 patients (80.4% male, mean age 49.0 ± 8.3). The mean of long-term medicines was 2.9 ± 2.0. The percentage of non-adherent patients was 54.0%. 63.5% of patients had AIDS, that showed statistically significant relationship with non-adherence. Concerns were negatively related to self-reported adherence (14.6 ± 5.7 vs. 12.1 ± 6.1; p=0.019). No relationship between adherence and necessity was found (17.3 ± 5.6 vs. 18.8 ± 4.4; p=0.188). Internal consistency for BMQ-Specific was high (Cronbach's α=0.724). CONCLUSION: Higher concerns are associated with higher self-reported adherence to long-term medicines in HIV infected-patients.

Objetivo: Determinar a adherencia y las creencias hacia la medicacion para patologias cronicas concomitantemente prescrita al TAR en pacientes infectados por el VIH, asi como determinar si existen diferencias significativas en las creencias entre los pacientes adherentes y no adherentes al los tratamientos concomitantes al TAR. Método: Estudio transversal llevado a cabo durante mayo y julio 2014 en pacientes VIH+ con tratamiento antirretroviral y uno o mas medicamentos para patologias cronicas. Se recogieron variables sociodemograficas: edad, sexo, educacion, situacion laboral, si vivia solo; clinicas: modo de transmision de la infeccion, carga viral plasmatica, T-CD4, estadio; y farmacoterapeuticas: tipo de tratamiento antirretroviral, comedicacion y adherencia a esta mediante el cuestionario Morisky. Se midieron las creencias hacia dicha comedicacion mediante el Beliefs about Medicines Questionnare (BMQ), que incluye dos escalas, necesidad y preocupacion. Los datos se analizaron con SPSSR 20.0. Se aplico la prueba t de Student. La fiabilidad del cuestionario se estimo mediante el alfa de Cronbach. Resultados: Se incluyeron 126 pacientes (80.4% hombres, 49}8.3 anos). El numero de medicamentos concomitantes fue 2.9}2.0. Se clasifico como no adherente al 54.0%. El 63.5% tenia sida, que se identifico como una variable independiente predictora de no adherencia. Las diferencias en la escala de preocupacion entre los pacientes no adherentes y adherentes fue estadisticamente significativa (14.6}5.7 vs. 12.1}6.1; p=0.019), mientras que en aquellas relativas a la necesidad no hubo diferencias (17.3}5.6 vs. 18.8}4.4; p=0.188). La fiabilidad del BMQ-especifico, asi como de las escalas de necesidad y preocupacion, fue buena (0.724, 0.794, 0.785, respectivamente). Conclusiones: Los pacientes VIH positivos con otras patologias cronicas no adherentes presentan creencias negativas relacionadas con la preocupacion en cuanto a la comedicacion.

Influence of treatment complexity on adherence and incidence of blips in HIV/HCV coinfected patients.

BACKGROUND: The addition of antihepatitis C therapy to highly active antiretroviral treatment (HAART) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfected patients leads to an increase in the treatment complexity that may result in decreased adherence. Blips, defined as intermittent episodes of detectable low-level HIV viremia, may be an indication of poor adherence to HAART. OBJECTIVES: To (a) determine the influence of adding anti-HCV therapy to HAART on complexity index, adherence, and incidence of blips and (b) determine complexity index and adherence in patient subgroups based on anti-HCV therapy. METHODS: We conducted a prospective 2-center observational study. HIV/HCV coinfected patients under antiretroviral treatment who started anti-HCV bi-therapy or triple therapy between January 2011 and December 2013 were included. Patients were excluded if they were virologically uncontrolled (HIV viral load greater than 50 copies RNA/mL) or if they had changed antiretroviral treatment in the 6 months prior to the introduction of anti-HCV therapy. Data were collected before and after the addition of anti-HCV therapy to HAART. The main variables were complexity index, incidence of blips, and adherence. The complexity index was based on a score that utilized the number of pills per day, dosing schedule, dosage form, and any specific instructions linked to use of the drug. Blips were defined as a detectable HIV-RNA level ( greater than 50 copies/mL but no more than 1,000 copies/mL) occurring between 2 negative assays. Medication adherence was assessed using electronic pharmacy refill records. The threshold for optimal adherence was defined at 95% and above. Differences in the variables collected were assessed before and after the addition of anti-HCV therapy to HAART.R ESULTS: A total of 66 patients were included in the study. Based on the complexity index, the median value before and after the addition of anti-HCV therapy to HAART was 4.2 (interquartile range [IQR] = 3.5-5.5) and 11.5 (IQR = 10.4-13.4), respectively. The median difference between both complexity indices was 6.9 (95% CI = 6.9-7, P less than 0.001). After introducing the anti-HCV therapy into HAART, the number of adherent patients decreased from 50 (75.8%) to 45 (68.2%, P greater than 0.05), and 12 (18.2%) patients presented blips (P less than 0.001). Subgroup analysis based on anti-HCV therapy showed that patients on boceprevir or telaprevir therapy had a higher complexity index, 16.8 (IQR = 6.0-18.4), compared with patients on bi-therapy anti-HCV, 11.3 (IQR = 10.3-12). The median difference was 6.0 (95% CI = 5.0-7.2, P less than 0.001). The number of adherent patients decreased only in patients on bi-therapy from 42 (79.2%) to 37 (69.8%, P greater than 0.05). CONCLUSIONS: Adding anti-HCV therapy to antiretroviral treatment significantly increases treatment complexity and the incidence of blips. The introduction of anti-HCV therapy is also associated with a decrease in the number of adherent patients. The regimen complexity calculation may be useful for identifying patients who need more care from health care professionals or are at risk for failure to comply with treatment regimens.