Analysing Early Diagnosis Strategies for HIV Infection: A Retrospective Study of Missed Diagnostic Opportunities.

Early diagnosis of a Human Immunodeficiency Virus (HIV)-infected person represents a cornerstone of HIV prevention, treatment, and care. Numerous publications have developed recommendations where HIV serology is indicated to reduce missed diagnostic opportunities (MDOs). This retrospective study analyses new HIV infection diagnoses and the relationship between late diagnosis (LD)/advanced HIV disease (AHD), baseline characteristics, and MDOs. Sociodemographic data and data related to contact with the health system in the 5 years before diagnosis were collected. Most of the 273 diagnoses were made in primary care (48.5%). Approximately 50.5% and 34.4% had LD and AHD criteria, respectively. Female sex was associated with a higher incidence of LD. Persons infected through the heterosexual route and those at an older age had a higher risk for LD and AHD. People with previous HIV serology presented a lower percentage of LD and AHD. In total, 10% of the health contact instances were classified as MDOs, mostly occurring in primary care. A significant increase in the median of MDOs was observed in patients with LD/AHD. Female sex and hepatitis C virus co-infection were associated with an increase in the number of MDOs. The high percentage of LD and AHD and the significant number of MDOs show that the current screening system should be improved.

Lipid profile changes associated with antiretroviral therapies in a real-world cohort. / [Artículo traducido] Cambios en el perfil lipídico asociados con las terapias antirretrovirales en una cohorte de vida real.

OBJECTIVE: To compare lipid profile changes and cardiovascular events among HIV naïve and experienced patients from a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. METHOD: A retrospective cohort study in HIV naïve and experienced people at a reference hospital in Spain was done. During the follow-up (March 2015-June 2019), patients were treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Epidemiological, clinical and immunovirological variables were recorded. A statistical analysis of the lipid profile at baseline, 48 and 120 weeks after initiating the study therapy, cardiovascular events (myocardial infarction, heart failure, cerebrovascular accident, deep venous thrombosis, myocardiopathy, non-ST- segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction) and cardiovascular risks factors was performed. Data were analysed in naïve and experienced patients from each of the study treatments. The data was obtained from the medical history. The statistical analysis was performed with SPSS v.24 software. RESULTS: A total of 266 and 191 patients receiving treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine were included in the study, respectively. After 120 weeks of treatment, a worsening of the lipid profile was found in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group, both in naïve and experienced patients, whereas not so conspicuously observed in the dolutegravir/abacavir/lamivudine group. Statistically significant differences between both groups were found in experienced patients favoring dolutegravir/abacavir/lamivudine; in total cholesterol (204.1 ± 38.2 vs. 187.3 ± 29.4, p < 0.001) and LDL-C (126.1 ± 31.9 vs. 113.5 ± 28.5, p = 0.001) at week 48, and in total cholesterol (201.1 ± 33.4 vs. 188.7 ± 33.9, p = 0.013) and HDL-C (54.2 ± 15.6 vs. 48.3 ± 14.3, p = 0.01) at week 120. No significant differences in cardiovascular events were found, neither in naïve nor in experienced patients. CONCLUSIONS: The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in naïve and experienced patients, not so remarkable in the dolutegravir/abacavir/lamivudine group. Both regimens were well tolerated, with similar rates of cardiovascular events.

Cambios del perfil lipídico asociados con las terapias antirretrovirales en una cohorte de vida real / Lipid profile changes associated with antiretroviral therapies in a real-world cohort

Objective To compare lipid profile changes and cardiovascular events among HIV naïve and experienced patients from a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Method A retrospective cohort study in HIV naïve and experienced people at a reference hospital in Spain was done. During the follow-up (March 2015–June 2019), patients were treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Epidemiological, clinical, and immunovirological variables were recorded. A statistical analysis of the lipid profile at baseline, 48, and 120 weeks after initiating the study therapy, cardiovascular events (myocardial infarction, heart failure, cerebrovascular accident, deep venous thrombosis, myocardiopathy, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction), and cardiovascular risks factors was performed. Data were analysed in naïve and experienced patients from each of the study treatments. The data were obtained from the medical history. The statistical analysis was performed with SPSS v. 24 software. Results A total of 266 and 191 patients receiving treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine were included in the study, respectively. After 120 weeks of treatment, a worsening of the lipid profile was found in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group, both in naïve and experienced patients, whereas not so conspicuously observed in the dolutegravir/abacavir/lamivudine group... (AU)

Objetivo Comparar los cambios en el perfil lipídico y los eventos cardiovasculares en vida real en una cohorte de pacientes VIH naive y pretratados que han recibido elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida fumarato o dolutegravir/abacavir/lamivudina. Método Se realizó un estudio de cohortes retrospectivo en personas VIH naive y pretratadas que durante el periodo de seguimiento (marzo 2015 - junio 2019) recibieron elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida fumarato o dolutegravir/abacavir/lamivudina en un hospital de referencia en España. Se registraron variables epidemiológicas, clínicas e inmunovirológicas. Se consideraron datos del perfil lipídico al inicio del estudio, a las 48 y 120 semanas después de iniciar la terapia del estudio, de los eventos cardiovasculares (infarto de miocardio, insuficiencia cardíaca, accidente cerebrovascular, trombosis venosa profunda, miocardiopatía, síndrome coronario agudo sin elevación del segmento ST e infarto de miocardio con elevación del segmento ST) y factores de riesgo cardiovascular. Los datos se obtuvieron de la historia clínica. Se realizó un análisis estadístico utilizando el software SPSS v.24. Resultados Se incluyeron en el estudio un total de 266 pacientes en tratamiento con elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida fumarato y 191 con dolutegravir/abacavir/lamivudina. Después de 120 semanas de tratamiento, se observó un empeoramiento del perfil lipídico basal en el grupo elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida fumarato, tanto en pacientes naive como pretratados, no siendo tan pronunciado en el grupo de pacientes que recibieron dolutegravir/abacavir/lamivudina... (AU)

Lipid profile changes associated with antiretroviral therapies in a real-world cohort.

OBJECTIVE: To compare lipid profile changes and cardiovascular events among HIV naïve and experienced patients from a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. METHOD: A retrospective cohort study in HIV naïve and experienced people at a reference hospital in Spain was done. During the follow-up (March 2015-June 2019), patients were treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Epidemiological, clinical, and immunovirological variables were recorded. A statistical analysis of the lipid profile at baseline, 48, and 120 weeks after initiating the study therapy, cardiovascular events (myocardial infarction, heart failure, cerebrovascular accident, deep venous thrombosis, myocardiopathy, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction), and cardiovascular risks factors was performed. Data were analysed in naïve and experienced patients from each of the study treatments. The data were obtained from the medical history. The statistical analysis was performed with SPSS v. 24 software. RESULTS: A total of 266 and 191 patients receiving treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine were included in the study, respectively. After 120 weeks of treatment, a worsening of the lipid profile was found in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group, both in naïve and experienced patients, whereas not so conspicuously observed in the dolutegravir/abacavir/lamivudine group. Statistically significant differences between both groups were found in experienced patients favouring dolutegravir/abacavir/lamivudine; in total cholesterol (204.1±38.2 vs. 187.3±29.4, P < .001) and LDL-C (126.1±31.9 vs. 113.5±28.5, P = .001) at week 48, and in total cholesterol (201.1±33.4 vs. 188.7±33.9, P = .013) and HDL-C (54.2±15.6 vs. 48.3±14.3, P = .01) at week 120. No significant differences in cardiovascular events were found, neither in naïve nor in experienced patients. CONCLUSIONS: The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in naïve and experienced patients, not so remarkable in the dolutegravir/abacavir/lamivudine group. Both regimens were well tolerated, with similar rates of cardiovascular events.

Conciliación de la medicación en el alta desde la unidad de cuidados intensivos a la planta de hospitalización / Medication reconciliation for patients after their discharge from intensive care unit to the hospital ward

Objetivos : el objetivo de este estudio fue determinar si la transición del alta de la unidad de cuidados intensivos a la planta de hospitalización conlleva un alto riesgo de errores de conciliación. Se definió como objetivo principal del estudio describir y cuantificar las discrepancias y los errores de conciliación. Los objetivos secundarios incluyeron clasificar los errores de conciliación por tipo, grupo terapéutico de los medicamentos implicados y la gravedad potencial. Métodos: se llevó a cabo un estudio observacional retrospectivo de los pacientes dados de alta de la unidad de cuidados intensivos a la planta de hospitalización. Antes de que un paciente fuese dado de alta desde la unidad de cuidados intensivos, sus últimas prescripciones fueron comparadas con el listado de medicación propuesto en la planta de hospitalización. Las discrepancias entre ambos listados fueron clasificadas como discrepancias justificadas o errores de conciliación. Los errores de conciliación fueron clasificados por tipo de error, por gravedad potencial y por grupo terapéutico. Resultados: fueron conciliados 452 pacientes. Se encontró al menos una discrepancia en un 34,29% (155/452), y presentaba al menos un error de conciliación 18,14% (82/452). Los errores de conciliación más frecuentes fueron diferente dosis o vía de administración (31,79% [48/151]) y errores de omisión (31,79% [48/151]). Un 19,20% (29/151) involucraba a medicamentos de alto riesgo. Conclusiones: el alta desde la unidad de cuidados intensivos a la planta de hospitalización convencional es una transición asistencial que presenta alto riesgo de errores de conciliación. Los errores de conciliación ocurren con frecuencia, en ocasiones involucran a medicamentos de alto riesgo, su potencial gravedad puede requerir una monitorización adicional o producir daño temporal, y en algunos casos, más de un error de conciliación puede tener lugar. ... (AU)

Objectives: The aim of this study was to determine whether the transition of care from the intensive care unit to the ward would pose a high risk for reconciliation errors. The primary outcome of this study was to describe and quantify the discrepancies and reconciliation errors. Secondary outcomes included classification of the reconciliation errors by type of medication error, therapeutic group of the drugs involved and grade of potential severity. Methods: We conducted a retrospective observational study of reconciliated adult patients discharged from the Intensive Care Unit to the ward. Before a patient was discharged from the intensive care unit, their last intensive care unit’s prescriptions were compared with their proposed medication list in the ward. The discrepancies between these were classified as justified discrepancies or reconciliation errors. Reconciliation errors were classified by type of error, potential severity, and therapeutic group. Results: We found that 452 patients were reconciliated. At least one discrepancy was detected in 34.29% (155/452), and 18.14% (82/452) had at least one reconciliation errors. The most found error types were a different dose or administration route (31.79% [48/151]) and omission errors (31.79% [48/151]). High alert medication was involved in 19.20% of reconciliation errors (29/151). Conclusions: Our study shows that intensive care unit to non-intensive care unit transitions are high-risk processes for reconciliation error. They frequently occur and occasionally involve high alert medication, and their severity could require additional monitoring or cause temporary harm. Medication reconciliation can reduce reconciliation errors. (AU)

Medication reconciliation for patients after their discharge from intensive care unit to the hospital ward. / [Artículo traducido] Conciliación de la medicación en el alta desde la unidad de cuidados intensivos a la planta de hospitalización.

OBJECTIVES: The aim of this study was to determine whether the transition of care from the intensive care unit to the ward would pose a high risk for reconciliation errors. The primary outcome of this study was to describe and quantify the discrepancies and reconciliation errors. Secondary outcomes included classification of the reconciliation errors by type of medication error, therapeutic group of the drugs involved and grade of potential severity. METHODS: We conducted a retrospective observational study of reconciliated adult patients discharged from the Intensive Care Unit to the ward. Before a patient was discharged from the intensive care unit, their last intensive care unit's prescriptions were compared with their proposed medication list in the ward. The discrepancies between these were classified as justified discrepancies or reconciliation errors. Reconciliation errors were classified by type of error, potential severity, and therapeutic group. RESULTS: We found that 452 patients were reconciliated. At least one discrepancy was detected in 34.29% (155/452), and 18.14% (82/452) had at least one reconciliation errors. The most found error types were a different dose or administration route (31.79% [48/151]) and omission errors (31.79% [48/151]). High alert medication was involved in 19.20% of reconciliation errors (29/151). CONCLUSIONS: Our study shows that intensive care unit to non-intensive care unit transitions are high-risk processes for reconciliation error. They frequently occur and occasionally involve high alert medication, and their severity could require additional monitoring or cause temporary harm. Medication reconciliation can reduce reconciliation errors.

Renal profile of patients treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine: 120-week results from a real-world cohort.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) and dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) are currently available for HIV patients. OBJECTIVES: This study evaluated modifications in the renal safety profile in a large real-world cohort of patients who had received EVG/c/FTC/TAF or DTG/ABC/3TC. METHODS: A retrospective observational study of HIV-infected patients who received EVG/c/FTC/TAF or DTG/ABC/3TC between March 2015 and June 2019 at a reference hospital in north-western Spain was conducted. Epidemiological, clinical, immunovirological data and information regarding antiretroviral therapy were recorded. The statistical differences between treatments were calculated. RESULTS: A total of 457 patients were evaluated, 266 using EVG/c/FTC/TAF and 191 using DTG/ABC/3TC. Up to week 120, serum creatinine improved in both study groups among experienced patients (EVG/c/FTC/TAF 1.01±0.24 vs 0.91±0.19, p<0.001; DTG/ABC/3TC 1.08±0.24 vs 1.02±0.31, p<0.001), while in naïve patients serum creatinine remained stable compared with baseline. Statistically significant differences were found in serum creatinine when comparing both treatments at week 48 in experienced (0.94±0.21 vs 1.09±0.28, p<0.001) and naïve patients (0.89±0.16 vs 1.06±0.20, p=0.001), and among experienced patients at week 120 (0.91±0.19 vs 1.02±0.31, p=0.015) for the EVG/c/FTC/TAF and DTG/ABC/3TC groups, respectively. During the follow-up, 39 patients in EVG/c/FTC/TAF and 33 in DTG/ABC/3TC (p=0.449) discontinued treatment. The main reason for stopping treatment was adverse events, which were similar in both groups. CONCLUSIONS: During the follow-up, patients experienced changes that were not clinically relevant in both treatment groups. Differences in renal events were not found.

Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study.

OBJECTIVES: Despite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients. METHODS: A retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. RESULTS: A total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p<0.001) and the main AEs in both groups, NPAEs (8.2% vs 25.0%, p<0.001). Female gender (OR 2.610 (95% CI 1.327 to 5.133), p=0.005) was associated with discontinuations due to AEs. Patients with documented psychiatric disorders were at higher risk of discontinuation due to NPAEs (OR 4.782 (95% CI 1.190 to 19.220), p=0.027). The multivariate analysis showed a 61.2% risk reduction in benzodiazepine prescriptions in patients treated with DTG. In both groups, patients needed consultation and follow-up in the psychiatry unit (16.9% in the EFV group and 8.9% in the DTG group, p=0.021). CONCLUSIONS: We found a high rate of discontinuations due to AEs and NPAEs, prescription of benzodiazepines and a requirement for consultation in a psychiatric unit in both treatment groups, especially with EFV.

Influence of drug-drug interactions on effectiveness and safety of direct-acting antivirals against hepatitis C virus.

OBJECTIVES: Direct-acting antivirals are the recommended treatment for hepatitis C-infected patients. Drug-drug interactions with concomitant treatments can cause lack of effectiveness and/or safety. The objective of this study is to characterise drug-drug interactions of direct-acting antivirals and to analyse their influence both on the effectiveness of antiviral treatment and on the overall safety of pharmacological treatment in hepatitis C-infected patients. METHODS: Observational and prospective cohort study for 3 years in the pharmaceutical care outpatient consultation of a general hospital, undertaking detection, evaluation and management of drug-drug interactions by clinical pharmacists and physicians. The main outcome measures were sustained virologic response at week 12 for effectiveness and serious drug-related adverse events for safety. Multivariate statistical analysis applied to: (a) patient basal characteristics related to presence of drug-drug interactions; (b) previous antiviral treatments, viral genotype, cirrhosis, decompensations and presence of drug-drug interactions related to the effectiveness of direct-acting antivirals. RESULTS: Of a total of 1092 patients, the majority of them were men, around 60 years old and HCV-genotype 1 mono-infected, with a high basal viral load, naive to antiviral treatment, treated with ledipasvir/sofosbuvir and without cirrhosis. 24.5% had drug-drug interactions. Proton pump inhibitors were the concomitant drugs that caused the most drug-drug interactions. Age ≥65 years and direct-acting antivirals based on protease inhibitors were independently related to the presence of drug-drug interactions (p≤0.012). All (100%) of the therapeutic recommendations based on detected drug-drug interactions were implemented; 97.7% of patients with interactions versus 99.0% without them reached sustained virologic failure (p=0.109). The serious adverse events rates were 1.5% and 1.3% in patients with and without drug-drug interactions, respectively (p=0.841). CONCLUSIONS: Drug-drug interactions are frequent among hepatitis C-infected patients receiving treatment with direct-acting antivirals. However, the collaboration between physicians and clinical pharmacists makes it possible to detect, evaluate, avoid or clinically manage these drug-drug interactions, in order to maintain whole treatment therapeutic safety and the effectiveness of direct-acting antivirals.

Hipotermia grave tras administración de paliperidona depot: a propósito de un caso / No disponible

No disponible

Effectiveness and safety of sofosbuvir/velpatasvir ± ribavirin vs glecaprevir/pibrentasvir in genotype 3 hepatitis C virus infected patients.

Objectives: Sofosbuvir/velpatasvir±ribavirin (SOF/VEL±RBV) and glecaprevir/pibrentasvir (GLE/PIB) are the drug combinations of choice for treating individuals with genotype 3 hepatitis C virus (G3-HCV) infection. The objective of this study was to evaluate the effectiveness and safety of SOF/VEL±RBV compared with GLE/PIB for treating G3-HCV infection under routine clinical practice conditions. Methods: We conducted a prospective observational cohort study of individuals with G3-HCV infection who initiated treatment with SOF/VEL +/-RBV or GLE/PIB between April 2017 and July 2018. Prisoners and children were excluded. The outcome variable of effectiveness was sustained virological response 12 weeks after completing treatment (SVR12). The safety variable was withdrawal secondary to severe adverse events (SAEs). Covariates included sex, age, HIV co-infection, previous liver transplant, cirrhosis, hepatic fibrosis and previous antiviral treatment. Statistical significance was calculated using Fisher's exact test or the Mann-Whitney U-test. Results: A total of 76 patients were included in the analysis, of whom 46 were treated with SOF/VEL±RBV and 30 were treated with GLE/PIB. No baseline differences were observed between treatment groups with respect to age, sex, HIV co-infection, fibrosis stage, cirrhosis and previous antiviral treatment. Of the patients treated with SOF/VEL±RBV and GLE/PIB, 95.7% and 96.7% reached SVR12, respectively (P=0.7). Of patients with and without cirrhosis, 83.3% and 98.4% reached SVR12, respectively (P=0.09). Of the patients with low-grade hepatic fibrosis (F0-2) and advanced fibrosis (F3-4), 100% and 85.7% reached SVR12, respectively (P=0.03). In treatment-naïve and treatment-experienced patients, 95.7% and 100% reached SVR12, respectively (P=0.57), without significant differences independent of the treatment group (P=0.28 for SOF/VEL±RBV; P=0.18 for GLE/PIB). The incidence of AEs was 21.1% (95% CI 11.3% to 30.9%). None of the patients developed an SAE or required antiviral treatment withdrawal. Conclusions: SOF/VEL±RBV or GLE/PIB are safe and effective for treating G3-HCV-infections, with a lower effectiveness in patients with advanced fibrosis F3-4.

Effectiveness and safety of direct-acting antivirals in hepatitis C infected patients with mental disorders: Results in real clinical practice.

The aim of this study is to analyze the effectiveness and safety of direct-acting antivirals (DAAs) in psychiatric patients with chronic hepatitis C (CHC). Secondary objectives included adherence and drug-drug interaction (DDIs) evaluations. Prospective observational comparative study carried out during 3 years. Psychiatric patients were included and mental illness classified by a psychiatric team based on clinical records. Main effectiveness and safety variables were sustained virologic response (SVR) at posttreatment week 12 (SVR12) and rate of on-treatment serious drug-related adverse events (AEs), respectively. A total of 242 psychiatric and 900 nonpsychiatric patients were included. SVR12 by intention-to-treat (ITT) analysis of psychiatric vs nonpsychiatric patients was 92.6% (95% confidence interval [CI], 89.1-96.1) vs 96.2% (95% CI, 94.9-97.5) (P = .02). SVR12 by modified-ITT analysis was 97.8% (95% CI, 95.0-99.3) vs 98.4% (95% CI, 97.5-99.3) (P = .74). 92.2% of psychiatric patients with mental disorders secondary to multiple drug use (MDSDU) and 93.0% of psychiatric patients without MDSDU vs 96.2% of nonpsychiatric patients reached SVR12 (P = .05 and P = .20, respectively). The percentage of adherent patients to DAAs did not show differences between cohorts (P = .08). 30.2% of psychiatric patients and 27.6% of nonpsychiatric patients presented clinically relevant DDIs (P = .47). 1.7% vs 0.8% of psychiatric vs nonpsychiatric patients developed serious AEs (P = .39); no serious psychiatric AEs were present. DAAs have shown a slightly lower effectiveness in psychiatric patients with CHC, as a result of loss of follow up, which justifies the need for integrated and multidisciplinary health care teams. DAAs safety, adherence, and DDIs, however, are similar to that of nonpsychiatric patients.

Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice / Efectividad y seguridad de daclatasvir/sofosbuvir con o sin ribavirina en pacientes infectados por el genotipo 3 del virus de la hepatitis C. Resultados en práctica clínica real

Objectives: 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. Patients and 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

Objetivos: Los antivirales de acción directa han demostrado una alta eficacia en todos los genotipos del virus de la hepatitis C (VHC), pero los tratamientos para el genotipo 3 (G3) siguen siendo un desafío, principalmente en pacientes cirróticos. El objetivo de este estudio es analizar la efectividad y la seguridad del daclatasvir asociado con sofosbuvir con o sin ribavirina en pacientes infectados por G3-VHC en la práctica clínica real. Pacientes y métodos: Estudio observacional, prospectivo, de cohorte de más de 2,5 años, en pacientes adultos infectados con G3-VHC, en todos los estadios de fibrosis, incluidos los pacientes con cirrosis descompensada. El tratamiento fue una combinación de sofosbuvir 400 mg / día + daclatasvir 60 mg / día, con o sin una dosis de ribavirina ajustada por peso durante 12 o 24 semanas. El criterio de valoración principal de eficacia fue la tasa de respuesta virológica sostenida 12 semanas después del tratamiento (RVS12). La variable principal de seguridad fue la tasa de suspensiones de tratamiento secundaria a eventos adversos graves. Resultados: Se incluyeron 111 pacientes, 32.4% cirróticos y 29.9% con experiencia previa de tratamiento antiviral. La tasa global de RVS12 fue del 94,6%, mientras que la tasa de RVS12 en pacientes con estadio de fibrosis F3-4 fue del 90,8% frente al 100% en pacientes con fibrosis F0-2 (p = 0,03). En pacientes cirróticos, la RVS12 fue del 100% en comparación con el 40%, dependiendo de si se agregó o no ribavirina a daclatasvir / sofosbuvir (p = 0,001). Ninguna otra variable basal del paciente o del tratamiento influyó en la efectividad del tratamiento. No se observó ninguna suspensión del tratamiento secundario a eventos adversos graves. Conclusiones: Daclatasvir / sofosbuvir ± ribavirina es altamente efectivo en pacientes infectados por G3-VHC. Los grados avanzados de fibrosis disminuyen significativamente la efectividad de este tratamiento, lo que motiva la necesidad de la adición de ribavirina en pacientes cirróticos. El régimen fue seguro y bien tolerado

Late HIV Diagnosis but Earlier Antiretroviral Treatment Initiation in Northwest Spain: Impact of Current Treatment Guidelines.

BACKGROUND: Current HIV treatment guidelines recommend antiretroviral treatment (ART) initiation for all HIV-infected individuals regardless of CD4 count. This study evaluates the immunological and virological status and the clinical characteristics of patients who have started ART in the last 8 years in the Northwest of Spain. METHODS: All HIV-infected patients who have started ART between January 2009 and December 2016 at a reference hospital in the Northwest of Spain were included in this retrospective observational study. Epidemiological, clinical, and immunovirological features and antiretroviral drugs used for initiation were recorded. A statistical analysis was performed using SPSS version 19 software. Categorical and continuous variables were compared by the specific statistical tests, and a logistic regression model was used to identify time associated with Center for Disease Control and Prevention (CDC) categories change. RESULTS: A high proportion of HIV-infected patients (66.7%) had initiated ART with CD4 counts <350 cells/mm3 in the last 8 years. From these, most of them (68.3%) had <350 CD4 counts at first contact with HIV specialist medical team, 12.2% had no indications for ART initiation in the last clinic visit before ART initiation according to the national guidelines at that moment, 11.0% were lost to follow-up because of lack of compliance with scheduled visits and 8.5% of patients refused treatment. A logistic regression model showed that a delay of one month since the first contact with HIV specialist medical team to ART initiation involves a risk of worsening in the CDC clinical category (odds ratio: 1.02 [95% confidence interval: 1.012-1.029]; P < .001). A trend towards an earlier start of ART was observed during 2015 and 2016, likely influenced by the last treatment guidelines recommendations. CONCLUSION: High proportion of HIV-infected patients (66.7%) had initiated ART with CD4 counts <350 cells/mm3 in the last 8 years. The main reasons for this problem were analyzed and an important rate of late diagnosis was identified. However, a trend towards an earlier start of ART was observed during 2015 and 2016, likely influenced by the last treatment guidelines recommendations. These findings highlight the need to promote and facilitate HIV testing to reduce the late diagnosis as well as counseling on HIV prevention, treatment, and linkage care.

Teleconsultation for the Pharmaceutical Care of HIV Outpatients in Receipt of Home Antiretrovirals Delivery: Clinical, Economic, and Patient-Perceived Quality Analysis.

Background/Introduction:Pharmacist teleconsultations, combined with home drug delivery or mail-order pharmacy (MOP), can help hospital outpatients with difficulties accessing treatment. The objectives of this study are to describe a teleconsultation protocol and to evaluate clinical, economic, and patient-perceived quality results.Materials and Methods:A cohort observational study was carried out for 3 years on HIV outpatients. Clinical variables were adherence, plasma HIV-RNA, and CD4+ levels. A pharmacoeconomic analysis was carried out through a cost-minimization study. Patient-perceived quality was assessed through a satisfaction survey. Simple random sampling was performed for 95% safety, accuracy ±1%, and losses ±20%.Results:The 38 participants (sample size) consisted of 82% male patients, aged 44.7 ± 8.4 years. There were 854 teleconsultations and 100% treatment adherence. All HIV outpatients kept virally suppressed (p = 1.00) and maintained a controlled immunological level (p = 0.87). The economic evaluation revealed 137 ± 23 € patient/year costs-saved and 18.5 ± 7.2 h/patient/year working time gained. Patient-perceived quality average score was >9.4 out of 10 in all items; the most valued factors were the saving of direct costs and reconciliation with work commitments (45%) and the least valued attributes were making the payment for the shipment and having to adjust to a telephone appointment (41%).Discussion/Conclusions:A teleconsultation protocol associated with home antiretrovirals delivery or MOP obtains a high degree of satisfaction from the HIV hospital outpatients receiving treatment, without repercussions on the therapeutic objectives and with the saving of important direct costs for the patient and indirect costs in relation to labor productivity.

Treatment with tenofovir alafenamide fumarate worsens the lipid profile of HIV-infected patients versus treatment with tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine.

Two elvitegravir/cobicistat-based therapies combined with emtricitabine/tenofovir disoproxil fumarate (EVG/c/FTC/TDF) or emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) are currently available for HIV patients. This study evaluated the modifications in the lipid profile of patients who received these treatments in the last three years at our institution. A retrospective observational study in HIV-infected patients who received EVG/c/FTC/TDF or EVG/c/FTC/TAF from January 2015 to January 2018 at a reference hospital in northwestern Spain was carried out. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed using SPSS software. A total of 384 EVG/c-based therapies were initiated during the study period, 151 EVG/c/FTC/TDF and 233 EVG/c/FTC/TAF. A significantly negative influence in all the lipid profile parameters in experienced patients and total cholesterol (TC), and LDL-C in naïve patients were observed after 48 weeks of treatment with EVG/c/FTC/TAF, while these parameters remained stable in the EVG/c/FTC/TDF group. During follow-up, a greater proportion of patients had lipid levels above the normal range (63.1% TC, 56.2% LDL-C) and new lipid-modifying drugs were prescribed (11.9%) in the EVG/c/FTC/TAF group. The number of cardiovascular risk factors (OR 1.66 [95% CI 1.01-2.72]; P = 0.043) was recognised as an independent predictor of lipid-lowering prescription for patients treated with both EVG/c/FTC/TDF and EVG/c/FTC/TAF. For patients treated with EVG/c/FTC/TAF, the mean total cholesterol to HDL ratio in the first 48 weeks of the study treatment was associated with a higher likelihood of lipid-lowering prescription in multivariate analysis (OR 1.6 [95% CI 1.12-2.52]; P = 0.011). Significant changes in lipid profile have been observed in patients who have received EVG/c/FTC/TAF. It was necessary to prescribe almost twice the number of lipid-lowering drugs to patients who received EVG/c/FTC/TAF (11.9%) vs EVG/c/FTC/TDF (4.7%).

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.

Initial treatment response among HIV subtype F infected patients who started antiretroviral therapy based on integrase inhibitors.

: HIV-1 subtype B (54.4%) and subtype F (27.2%) are the most prevalent variants in patients who started antiretroviral therapy including an integrase inhibitor in the last 2 years in Northwest Spain. Virological response rates to antiretroviral therapy based on integrase inhibitor were significantly lower among F subtypes compared with B subtypes at weeks 12 (25.0% vs. 75.0%) and 24 (59.1% vs. 95.0%). Subtype F was independently associated with virological response at 24 weeks [odds ratio 11.8 (95% confidence interval 1.1-119.9); P = 0.037].

Implantación de consultas externas monográficas de atención farmacéutica en un servicio de farmacia hospitalaria / Implementation of specialized pharmaceutical care hospital outpatient clinics in a hospital pharmacy department

Objetivo: Describir la organización asistencial de Consultas Externas Monográficas de Atención Farmacéutica de un Servicio de Farmacia Hospitalaria, evaluar su calidad asistencial y la calidad percibida por los pacientes externos. Método: Estudio observacional retrospectivo en un servicio de farmacia de un hospital de nivel terciario durante tres períodos (años 2010, 2013 y 2016); descripción de la organización asistencial a nivel de estructura, recursos humanos, recursos materiales y procedimientos de trabajo; evaluación de la calidad asistencial mediante el análisis de tres variables de procedimiento: cumplimiento cita previa, tiempo de espera y documentación de la atención farmacéutica; evaluación de la calidad percibida por los pacientes externos mediante encuestas de satisfacción; análisis estadístico comparativo de medias (t Student) y proporciones (chi cuadrado Pearson). Resultados: 15 consultas monográficas abiertas atendidas por 18 farmacéuticos; entre el período inicial y el período final del estudio (2010 vs. 2016) el cumplimiento de cita previa fue del 61,3% vs. 88,8% (p< 0001), el tiempo de espera fue 27,6±12,1 vs. 12,1±5,4 minutos (p< 0,0001), la documentación de la atención farmacéutica en la historia clínica del 2,3% vs. 9,81% (p< 0,0001) y la satisfacción global percibida por los pacientes del 6,63±2,36 vs. 9,16±1,27 (p< 0,01). Conclusiones: El modelo de Consulta Externa Monográfica de Atención Farmacéutica expuesto, centrado en el paciente y con continuidad asistencial, ha mejorado la calidad asistencial y la calidad percibida por los pacientes y se encuentra en condiciones óptimas para investigar su aportación a los resultados en salud del paciente y al sistema sanitario a través de una mejor calidad, seguridad y eficiencia de la farmacoterapia (AU)

Objective: To describe the organization of patient care into Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department, to evaluate their healthcare quality, and the quality perceived by outpatients. Method: A retrospective observational study in a High-Level Hospital Pharmacy Department during three periods (years 2010, 2013 and 2016); description of the organization at the levels of structure, human resources, material resources and working procedures; evaluation of healthcare quality through the analysis of three variables in terms of procedure: prior appointment compliance, waiting time and documentation of pharmaceutical care; evaluation of quality perceived by outpatients through a satisfaction survey; comparative statistical analysis of means (Student's t) and proportions (Pearson's chi square). Results: Fifteen (15) specialized outpatient clinics were opened and managed by 18 pharmacists; between the initial and final periods of the study (2010 vs. 2016), the compliance with previous appointments was of 61.3% vs. 88.8% (p < 0001), waiting time was 27.6±12.1 vs. 12.1±5.4 minutes (p < 0.0001), documentation of pharmaceutical care in the clinical record was of 2.3% vs. 9.81% (p < 0.0001), and the overall satisfaction perceived by the patients was 6.63±2.36 vs. 9.16±1.27 (p< 0.01). Conclusions: The model of Specialized Pharmaceutical Care Hospital Outpatient Clinics exposed, focused on the patient and with continuity of care, has improved the quality of care and the quality perceived by the patients and it´s in optimal conditions to investigate its contribution on health outcomes and on the health system through a better quality, safety and efficiency of pharmacotherapy (AU)