Comparación de la calidad de vida en personas que viven con infección por VIH en seguimiento mediante atención farmacéutica según metodología capacidad motivación-oportunidad vs. seguimiento convencional. Proyecto MAS-VIH / Comparison of quality of life in patients living with HIV infection through pharmaceutical care according to CMO methodology vs. conventional follow-up. MAS-VIH project

Objetivo. Comparar la calidad de vida en personas que viven con infección por el Virus de la Inmunodeficiencia Humana según el modelo de Atención Farmacéutica que reciben en los Servicios de Farmacia Hospitalaria: CMO (capacidad, motivación y oportunidad), versus seguimiento convencional. Método. Estudio longitudinal, prospectivo, multicéntrico, realizado entre octubre-2019 y noviembre-2021 en 14 Servicios de Farmacia Hospitalaria de España. Se incluyeron pacientes mayores de 18 años, que recibían tratamiento antirretroviral y acudían a las consultas de Atención Farmacéutica durante ≥1 año. Se excluyeron aquellos pacientes sin autonomía para completar los cuestionarios previstos. Los centros fueron aleatorizados a seguir utilizando la misma sistemática de trabajo (seguimiento tradicional) o implementar el modelo CMO, utilizando la estratificación, establecimiento de objetivos farmacoterapéuticos, uso de entrevista motivacional, así como el seguimientolongitudinal con nuevas tecnologías. La variable principal fue la diferencia en el número de dimensiones afectadas negativamente, en cada rama, a las 24 semanas, según cuestionario MOS-HIV. En el brazo CMO se registraron las intervenciones más frecuentemente realizadas.Resultados. Se incluyeron 151 pacientes. La mediana de edad fue de 51,3 años. Se encontró mejora significativa de la calidad de vida al final del seguimiento en el grupo CMO, reduciéndose el número de pacientes con dimensiones afectadas negativamente (2/11 vs 8/11). Las intervenciones más frecuentes llevadas a cabo, según la taxonomía, fueron: Motivación (51,7%) y Revisión y validación del TAR (49,4%). Conclusiones. La calidad de vida de los pacientes es superior en aquellos centros que desarrollan Atención Farmacéutica basada en metodología CMO en comparación con el seguimiento tradicional. (AU)

Objective. To compare quality of life, in patients livingwith HIV infection with pharmaceutical care according to the CMO methodology: capacity, motivation and opportunity versus conventional follow-up. Method. Longitudinal, prospective, multicenter, health intervention study, conducted between October 2019 and November 2021 in 14 centers throughout Spain. Patients over 18 years of age, receiving antiretroviral treatment and attending the consultations of the participating Pharmacy Services for 1 year were included. Patients who did not have the autonomy to complete the planned questionnaires were excluded. At baseline, participating centers were randomized to continue using the same systematics of work (traditional follow-up) or to implement the CMO model using patient stratification models, goal setting in relation to pharmacotherapy, use of motivational interviewing, as well as longitudinal follow-up enabled by new technologies. The main variable was the difference in the number of dimensions positively affected in each follow-up arm at 24 weeks of follow-up according to the MOS-HIV questionnaire. In the CMO group, the interventions performed the most frequently were recorded. Results. 151 patients were included. The median age was 51.35 years. A significant improvement in quality of life was found at the end of follow-up in the CMO group, reducing the number of patients with negatively affected dimensions (2/11 vs 8/11). The most frequent interventions carried out in the CMO group, according to the taxonomy, were Motivation (51,7%) and review and validation (49,4%) Conclusions. The quality of life of patients is higher in those centers that develop Pharmaceutical Care based on the CMO methodology compared to traditional follow-up. (AU)

Patient Experience Evaluation of the CMO-Based Pharmaceutical Care Model vs Usual Care in People Living with HIV.

Objective: To compare patient experience in a real-life population of people living with HIV (PLWH) who received pharmaceutical care (PC) based on the Capacity-Motivation-Opportunity (CMO) model versus the traditional model. Methods: Prospective cohort study in PLWH receiving either CMO-based PC or traditional PC in Spain between October 2019 and June 2021 (24 weeks), performed by the pharmacy department of 14 Spanish hospitals. Participants were adult patients with a clinical diagnosis of HIV treated with antiretrovirals who had been monitored in the participating hospital pharmacies for >1 year. Patient experience (IEXPAC questionnaire), clinical outcomes (cholesterol, triglycerides, HDL, glycated haemoglobin, and blood pressure), adherence to treatment, virologic control and patient satisfaction were determined. Results: Patient experience in the CMO group at week 24 was significantly better (7.6 vs 6.9) than in the traditional group, with a higher mean improvement. Adherence was better in the CMO group, particularly with regard to concomitant medications (53.2% to 91.7%, p<0.001); no changes were observed in the traditional group. Patient satisfaction improved in the CMO group vs the traditional group (48 vs 44, p<0.001). Conclusion: To our knowledge, this is the first study to compare CMO vs traditional methodology. The CMO model showed an overall improvement in real-life patient experience, satisfaction, and adherence to treatment compared to the traditional methodology.

Anaemia predictors in patients with chronic hepatitis C treated with ribavirin and direct-acting antiviral agents.

OBJECTIVES: Anaemia is the most common side effect associated with ribavirin (RBV). This study intended to assess its incidence and determine its predictive factors in patients with hepatitis C virus on RBV plus direct-acting antiviral agents (DAAs). METHODS: A retrospective study of patients receiving RBV+DAA was conducted. Serum haemoglobin (Hb) was determined at baseline and monitored 4 weekly. Anaemia was defined as a single occurrence of Hb <10 g/dL. Bivariate and multivariate logistic regression analyses were conducted to assess the relationship between the occurrence of anaemia and the following factors: age, gender, FibroScan score, viral load, cirrhotic status (yes/no), RBV dose, glomerular filtration rate (GFR), alanine amino transferase, albumin, treatment duration (12 vs ≥12 weeks), baseline Hb, and Hb% drop (weeks 0-2). RESULTS: 152 patients were included, of which 15.1% experienced anaemia. The analysis revealed that estimated GFR (eGFR), baseline Hb, 12-week treatment duration and Hb% drop (weeks 0-2) were significantly associated with the likelihood of developing anaemia (p<0.05). Two mathematical models were subsequently developed to predict patients at risk of anaemia: a pretreatment model (positive predictive value 86.6%) which included eGFR, baseline Hb and 12-week treatment duration and an intratreatment model (positive predictive value of 90.48%) which in addition included the Hb% drop (weeks 0-2). CONCLUSION: Anaemia was found to be less significant in this cohort compared with studies on RBV plus pegylated interferon, telaprevir or boceprevir combinations, but higher than those on newer DAAs. Baseline Hb, eGFR, 12-week treatment duration and Hb% drop (weeks 0-2) significantly predicted the risk of anaemia and were used to construct two predictive models.

Role of high-dose levetiracetam as add-on therapy for intractable epilepsy: case report and brief review of the literature.

CASE: We discuss the case of a 5-year-old long-standing epileptic woman, who received oxcarbazepine 2.1 g/day, and levetiracetam 3 g/day (started in 2005 and up-titrated according to response). In October/2008, due to poor seizure control, patient consent was obtained and levetiracetam up-titrated to 6 g/day, remaining invariable for 72 months; zonisamide was added in July/2009 and up-titrated to 500 mg/day. This combination achieved seizure frequency reduction ≥50 %, however, the patient ultimately necessitated temporal lobectomy for complete remission. Occasional agitation and moderate depression were the main side effects. CONCLUSION: Three anti-epileptic drugs (including levetiracetam 6 g/day) achieved statistically-significant seizure frequency reduction ≥50 % compared with lower doses, but not seizure freedom. Low-dose risperidone was initiated due to transient dose-dependent agitation, although it did not lead to discontinuation. This report provides insightful information on the use of high-dose levetiracetam in focal refractory epilepsy. The concomitance of anti-epileptics may have contributed to both efficacy and toxicity. Therefore, the risk/benefit ratio must be individually weighed until larger studies are available.

Granulocyte/monocyte apheresis as immunotherapic tool: cellular adsorption and immune modulation.

Cellular apheresis is now established as a rational therapeutic procedure in certain inflammatory and autoimmune diseases, particularly in inflammatory bowel diseases, but the efficacy of this procedure can not be fully explained solely on the basis of removal of granulocytes and monocytes. It is suggested that a selective modulator increase of regulatory T cells contributes to beneficial effect of adsorptive leukocytapheresis in patients with these pathologies. Though currently applied as second-line medication, it could be considered in the future as an effective alternative to the use of immune suppressive regimens or biological agents and taken into account to establish a tailor's patient therapy in inflammatory and autoimmune conditions.

Regulatory T cells in patients with inflammatory bowel diseases treated with adacolumn granulocytapheresis.

AIM: To investigate if the clinical efficacy of granulocytes and monocytes by adsorption (GMA) is associated with an increased frequency of peripheral regulatory T cells (Tregs), as these cells have proven to be successful in suppressing inflammatory bowel disease (IBD) in animal models. METHODS: We report four cases of corticosteroid-dependent ulcerative colitis (UC) and two Crohn's disease (CD) cases with severe cutaneous lesions who received GMA therapy. The frequency of CD4+ CD25(high) (Tregs) in peripheral blood was analyzed by flow cytometry and the expression of FoxP3 and TGF beta in purified CD4+ T cells was determined by real time PCR prior to and one month after the last apheresis session, and at the time of endoscopic and clinical assessing. RESULTS: Increased expression of Fox P3 mRNA was found in all five patients who responded to cytapheresis with remission of clinical symptoms, mucosal inflammation and cutaneous lesions, and an increased frequency of circulating Tregs was found in four patients. These changes were not observed in the patient with UC who did no respond to GMA. Variations in TGF-beta (mRNA) did not parallel that of FoxP3 mRNA. CONCLUSION: The clinical efficacy of GMA on IBD and related extra intestinal manifestations was associated with an expansion of circulating CD4+ CD25+ Tregs and higher expression of FoxP3 in CD4+ T cells. Accordingly, an elevated CD4+ CD25+ FoxP3 may be a valuable index of remission in patients with IBD and other chronic relapsing-remitting inflammatory conditions during treatment with GMA.

The impaired response of NK cells from HIV-infected progressor patients to A-class CpG oligodeoxynucleotides is largely dependent of a decreased production of IL-12.

We have reported that NK cells from HIV-infected progressors showed a markedly lower IFN-gamma production in response to an A-class CpG oligodeoxynucleotide as compared to LTNP subjects and healthy HIV-negative individuals. This functional defect was not related to the number of circulating plasmacytoid dendritic cells, nor to the alpha-interferon secreted. In contrast, defective response correlated negatively with the frequency of myeloid dendritic cells. Furthermore, peripheral blood mononuclear cells from LTNPs as well as those from some healthy HIV-negative donors secreted large amounts of IL-12 in unstimulated cultures and in response to the CpG-ODN whereas, HIV-progressor cells showed impaired responses and low level of spontaneous secretion. The addition of a monoclonal anti-IL-12 reduced the response to the CpG-ODN in a dose-dependent manner. These results suggest that the impaired response of NK cells to the CpG-ODN in HIV-progressors is largely dependent on a decreased production of IL-12.

HIV-infected progressors and long-term non-progressors differ in their capacity to respond to an A-class CpG oligodeoxynucleotide.

We used an A-class CpG oligodeoxynucleotide to explore innate immunity in HIV infection and observed that natural killer cells from progressors showed a markedly lower IFN-gamma production in response to the oligonuclotide as compared with long-term non-progressing subjects and healthy HIV-negative individuals. This functional defect was found in patients who showed a long immunological reduction and in those who had had a recent reduction in their CD4 cell counts.