[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]. / 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.

OBJECTIVE: To compare quality of life, in patients living with HIV infection with pharmaceutical care according to the CMO methodology: capacity, motivation and opportunity versus conventional follow-up. METHODS: 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.

Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.

OBJECTIVE: Direct-acting antivirals have shown high efficacy in all hepatitis C virus (HCV) genotypes, but genotype 3 (G3) treatments continue to be a challenge, mainly in cirrhotic patients. The aim of this study is to analyse effectiveness and safety of daclatasvir associated with sofosbuvir with or without ribavirin in G3-HCV infected patients in real clinical practice. METHODS: An observational, prospective, cohort study over 2.5 years, in G3-HCV infected adult patients, in all fibrosis stages including patients with decompensated cirrhosis. Treatment was a combination of sofosbuvir 400 mg/day + daclatasvir 60 mg/day, with or without a weight-adjusted dosing of ribavirin for 12 or 24 weeks. The primary efficacy endpoint was sustained virologic response rates 12 weeks after therapy (SVR12). The primary safety endpoint was treatment withdrawal rates secondary to severe adverse events. RESULTS: A total of 111 patients were enrolled, 32.4% cirrhotics and 29.9% treatment-experienced. The global SVR12 rate was 94.6%, while the SVR12 rate in F3-4 fibrosis stage patients was 90.8% versus 100% in patients with F0-2 fibrosis (p=0.03). In cirrhotic patients, SVR12 was 100% versus 40% depending on whether ribavirin was added or not to daclatasvir/sofosbuvir (p=0.001). No other patient or treatment basal variables influenced the treatment effectiveness. No patient treatment withdrawal secondary to severe adverse events was observed. CONCLUSIONS: Daclatasvir/sofosbuvir ± ribavirin is highly effective in G3-HCV infected patients. Advanced degrees of fibrosis significantly decrease the effectiveness of this treatment, which motivates the need for the addition of ribavirin in cirrhotic patients. The regimen was safe and well tolerated.

[Status of the structure, process and outcoms of pharmaceutical care to HIV patient in Spain. Origen study]. / Situación actual de la estructura, procesos y resultados de la Atención Farmacéutica al paciente VIH en España. Proyecto ORIGEN.

OBJECTIVES: To describe the structure, process and outcomes with which hospital pharmacist performs health care activity, teaching and research about Pharmaceutical Care (PC) in HIV patients in Spain. METHODS: Observational, cross-sectional and multicenter study carried out between November 2011-February 2012 in spanish hospitals. The inclusion criteria were: hospitals pharmacy services that dispensed antiretroviral medication to HIV patients. The questionnaire had 41 questions structured in 9 groups: hospital type and person conducting the survey, structure and resources, health care activities, interventions, communication with the rest of the multidisciplinary team, adherence, and quality records, management and pharmacoeconomy and teaching and research. Descriptive analysis was performed. To analyze the existence of statistically significant relationships, we applied fisher test, chi-square or logistic regression. RESULTS: 86 hospitals completed the survey. In 93%, PC consultation was not classified by pathologies. 27.9% provided continuing PC to all patients. Adherence was determined regularly or when pharmacist suspected poor adherence (57.5 %). 20% of hospital s teaching had a program that allowed a high level of training in PC to HIV patient. 52,3% of participating centers had published scientific articles related to HIV. CONCLUSIONS: Pharmaceutical care to HIV patients in Spain need to adapt to a new situation. For this, hospital pharmacists have to consider several issues such as chronicity, comorbidity, incorporation of new technologies and the stratification of patients in order to make it more efficient.

Objetivos: Describir la estructura, proceso y resultados con la que se lleva a cabo la actividad asistencial, docente e investigadora en torno a la Atención Farmacéutica (AF) al paciente VIH en los hospitales españoles. Material y métodos: Estudio observacional, transversal, pragmático y multicéntrico realizado entre Noviembre 2011-Febrero 2012. Participaron servicios de farmacia de hospitales españoles que dispensaran medicación antirretroviral para pacientes VIH. El cuestionario presentaba 41 preguntas estructuradas en 9 bloques: tipo de hospital y persona que realiza la encuesta, estructura y recursos disponibles, actividad asistencial, intervenciones, comunicación con el resto del equipo multidisciplinar, adherencia, registros y calidad, gestión y farmacoeconomía y docencia e investigación. Se realizó un análisis descriptivo y se aplicó la prueba de fisher, Chi cuadrado o regresión logística para analizar la existencia de relaciones estadísticamente significativas. Resultados: 86 hospitales cumplimentaron la encuesta. En el 93%, la consulta de AF era compartida con el resto de patologías. El 27,9% proporcionaba AF continuada a todos los pacientes. El 57,5% determinaban la adherencia periódicamente o en casos de sospecha de mala adhesión. El 20% de los hospitales docentes tenían un programa que permitía un alto nivel de formación en AF al paciente VIH. El 52,3% de los hospitales no habían publicado artículos científicos relacionados con el VIH. Conclusiones: La AF al paciente VIH+ en España debe adaptarse a un nuevo escenario donde se han de considerar aspectos como la cronicidad, la pluripatología, la incorporación de nuevas tecnologías y la necesidad de estratificación de los pacientes para hacerla más eficiente.

[The prophylaxis and treatment of c virus liver disease in the liver transplantation setting. Narrative review]. / Profilaxis y tratamiento de la hepatopatía por virus C en el entorno del trasplante hepático. Revisión narrativa.

OBJECTIVE: To review the use of antiviral therapy as prophylaxis or treatment of virus C liver disease in the liver transplantation setting. METHOD: A search was made of the literature in PubMed with the strategy liver transplantation AND hepatitis C AND (interferon OR peginterferon OR ribavirin) from 1966 to June 2007 and a manual search of the journals Gastroenterología y Hepatología, Journal of Hepatology and Hepatology between 2001 and June 2007, to identify publications and communications to congresses relating to the subject. The studies identified were selected and evaluated. RESULTS: A total of 48 articles were chosen for review. Hepatitis C virus is one of the main indications for liver transplantation. Post-transplant re-infection is immediate and almost universal, and results, in many cases, in a recurrent liver disease that reduces the patients survival. Four basic therapeutic strategies have been studied: pre-transplant anti-viral treatment, prophylaxis, early or preventative treatment and treatment of acute or chronic recurrent hepatitis C. CONCLUSIONS: Currently, the hepatitis C treatment in the liver transplantation setting is based on the use of peginterferon associated with ribavirin as pre-transplant treatment in selected patients or as treatment of recurrent post-transplant hepatitis C, achieving sustained virological responses of around 20% and 35% respectively. The main limitation of these treatments is the high frequency of the adverse effects and interruptions to treatment, meaning it is important to carry out strict follow-up of the treatment safety.

Profilaxis y tratamiento de la hepatopatía por virus C en el entorno del trasplante hepático. Revisión narrativa / The prophylaxis and treatment of C virus liver disease in the liver transplantation setting. Narrative review

Objetivo: Revisar la utilización de terapia antiviral como profilaxis otratamiento de la hepatopatía por virus C en el entorno del trasplantehepático.Método: Se realizó una búsqueda bibliográfica en PubMed con laestrategia “liver transplantation” AND “hepatitis C” AND (“interferon”OR “peginterferon” OR “ribavirin”) desde 1966 hasta junio2007 y una búsqueda manual en las revistas Gastroenterología yHepatología, Journal of Hepatology y Hepatology desde 2001 hastajunio 2007, para identificar publicaciones y comunicaciones a congresosrelacionadas con el tema. Se seleccionaron y evaluaron losestudios identificados.Resultados: Se seleccionaron 84 trabajos para realizar la revisión.La hepatopatía por virus C es una de las principales indicaciones detrasplante hepático. La re-infección post-trasplante es inmediata ycasi universal, y deriva, en muchos casos, en una hepatopatía recurrenteque disminuye la supervivencia del paciente. Se han estudiadocuatro estrategias terapéuticas básicas: tratamiento antiviral pretrasplante,profiláctico, anticipado o preventivo y tratamiento de lahepatitis C aguda y crónica recurrente.Conclusiones: Actualmente el tratamiento de la hepatitis C en elentorno del trasplante hepático se basa en la utilización de peginterferónasociado a ribavirina como tratamiento pre-trasplante enpacientes seleccionados o como tratamiento de la hepatitis C recurrentepost-trasplante, alcanzándose respuestas virológicas sostenidasen torno al 20% y 35% respectivamente. La principallimitación de estos tratamientos es la alta frecuencia de efectosadversos y suspensiones de tratamiento, por lo que es muy importanterealizar un seguimiento estricto de la seguridad del tratamiento

Objective: To review the use of antiviral therapy as prophylaxis ortreatment of virus C liver disease in the liver transplantation setting.Method: A search was made of the literature in PubMed with thestrategy “liver transplantation” AND “hepatitis C” AND (“interferon”OR “peginterferon” OR “ribavirin”) from 1966 to June 2007 and amanual search of the journals Gastroenterología y Hepatología,Journal of Hepatology and Hepatology between 2001 and June2007, to identify publications and communications to congressesrelating to the subject. The studies identified were selected and evaluated.Results: A total of 48 articles were chosen for review. Hepatitis C virusis one of the main indications for liver transplantation. Post-transplantre-infection is immediate and almost universal, and results, inmany cases, in a recurrent liver disease that reduces the patient’s survival.Four basic therapeutic strategies have been studied: pre-transplantanti-viral treatment, prophylaxis, early or preventative treatmentand treatment of acute or chronic recurrent hepatitis C.Conclusions: Currently, the hepatitis C treatment in the liver transplantationsetting is based on the use of peginterferon associatedwith ribavirin as pre-transplant treatment in selected patients or astreatment of recurrent post-transplant hepatitis C, achieving sustainedvirological responses of around 20% and 35% respectively. Themain limitation of these treatments is the high frequency of the adverseeffects and interruptions to treatment, meaning it is importantto carry out strict follow-up of the treatment safety

[The influence of antiretroviral-resistance tests on treatment effectiveness in patients with HIV and virological failure]. / Influencia de las pruebas de resistencias a antirretrovirales sobre la efectividad del tratamiento en pacientes con infección por VIH y fracaso virológico.

OBJECTIVE: The objective of this study is to determine the influence of antiretroviral-resistance tests on the suppression of HIV (< 400 copies/mL) in patients with virological failure who require an alternative antiretroviral treatment. METHOD: A retrospective observational study on cohorts of adult patients. Two groups were defined: cases in which the prescription of antiretrovirals was based on resistance tests (group A), and controls in which no such test was performed (group B). Each group was divided into two sub-groups according to the number of changes in treatment: first treatment change (A1 and B1); a subsequent change (A2 and B2). The main variable was defined as the proportion of patients with negative viral load (< 400 copies/mL) at the third month of treatment; secondary variables were the proportion of patients with negative viral load at the sixth month and an average variation in the CD4 level at the third and sixth months after this change. RESULTS: A total of 152 patients were included in this study, 59 in group A and 93 in group B (control). No differences were found in the stage of the disease at the time of administering an alternative treatment. 59.3% of the patients in group A and 47.3% of the patients in group B had suppressed the HIV viral load at the third month, although this difference was not statistically significant (p = 0.149). No statistically significant differences were found in the secondary variables. CONCLUSIONS: The use of antiretroviral-resistance tests increased effectiveness in the response to the selected antiretroviral treatment in the study group, although we did not obtain significant differences for the group of patients in which these tests were not performed.

[Analysis of initial antiretroviral therapy in HIV-infected patients]. / Análisis del tratamiento antirretroviral inicial en pacientes VIH.

INTRODUCTION: The timing of highly active antiretroviral therapy (HAART) initiation and regimen combination treatment for HIV-infected patients are parameters requiring assessment, since they decisively influence results. The aim of the study was to evaluate initial HAART in HIV-infected patients in our hospital. MATERIALS AND METHODS: Retrospective study of the first 6 months after initiation of HAART in all treatment-naive adult patients so treated from January 2001 to June 2002. Baseline plasma viral load (PVL) and CD4+ count and HAART combination regimens were analyzed as well as therapy effectiveness and safety at 12 and 24 weeks after initiation of treatment. RESULTS: HAART was initiated in 85 patients, 45 of which met the inclusion criteria. Eighty seven percent (87%) of the patients had a baseline CD4+ count < 350 cells/microl. Fifty-nine percent of treatments consisted of regimens based on non-nucleoside analogs, 34% were based on protease inhibitors, and 7% on nucleosides. The CD4+ count increased in 78 and 73% of patients at the 12th and 24th week respectively, and the percentage of patients with no detectable PVL was 67 and 71%, respectively. No significant differences in effectiveness were seen between the different combination regimens. CONCLUSIONS: In most cases HAART may recover immune status and control PVL in treatment-naive HIV-infected patients. No differences were seen between combination regimens at the initiation of therapy.

[Change of antiretroviral therapy in HIV-infected patients]. / Cambio del tratamiento antirretroviral en el paciente VIH.

INTRODUCTION: Antiretroviral therapy adherence plays a vital role in treatment onset and in the durability of antiviral response. In addition, clinical status, plasma viral load, and CD4+ cell count are essential in making therapeutic change decisions in various clinical situations. The aim of our study was to assess the reasons for therapy change in both treatment-naive and treatment-experienced patients, and to know the casuistry of antiretroviral therapy change. PATIENTS AND METHODS: A retrospective study of 100% of patients who underwent at least one antiretroviral treatment change from January to December 2002. The type of antiretroviral therapy before and after change was analyzed, as were the causes leading to treatment change. RESULTS: During year 2002, 131 patients (20.15%) had their antiretroviral therapy modified, and the total number of treatment changes in these patients was 151. An analysis of treatment changes revealed that 69 modifications resulted from intolerance/toxicity (45%), 51 from therapeutic failure (34%), 14 from lack of adherence (9%), 10 from therapy simplification (7%), 1 from therapy enhancement (1%), and 6 from other causes (4%). CONCLUSIONS: Adverse events such as (resulting from) intolerance, renal colic, lipodystrophy, pancreatitis, etc., are responsible for a high incidence of therapy changes, mostly in treatment-naive patients. Therapeutic failure and lack of adherence are further causes of medically-relevant therapy modifications.

Trombosis venosa cerebral del posparto / Postpartum cerebral venous thrombosis

La tromboflebitis cerebral es una complicación poco frecuente de la gestación y del puerperio. Aportamos el caso de una paciente de 22 años que ha presentado una tromboflebitis cerebral del posparto secundaria a un déficit adquirido en antitrombina III. La sintomatología clínica de las tromboflebitis cerebrales es a veces engañosa. La angiografía y la resonancia magnética permiten realizar un diagnóstico rápido y acertado. El tratamiento está basado en la heparinoterapia a dosis anticoagulantes. Este tratamiento deberá adaptarse en caso de déficit en factores de la coagulación que deben ser investigados ante todo accidente tromboembólico de localización inhabitual (AU)