ABSTRACT
OBJECTIVE: To assess the use of resources and the costs associated with following up patients infected with the human immunodeficiency virus after discontinuation of an antiretroviral treatment and initiation of a new one due to a lack of effectiveness or unacceptable toxicity, as compared to the costs involved in the routine follow-up of patients on antiretroviral treatment, from the Spanish National Health System perspective. Method: The use of resources (clinical tests, medical visits, and hospital pharmacy visits) associated with following three profiles of patients infected with the human immunodeficiency virus (stable ones, those discontinuing an existing antiretroviral treatment and being switched to a new one due to a lack of effectiveness, and those discontinuing an existing antiretroviral treatment and being switched to a new one due to unacceptable toxicity) was identified, based on clinical practice guidelines and the findings of a multidisciplinary expert panel (n = 5). The experts agreed on the main adverse events leading to discontinuation, classifying them into gastrointestinal, renal, osseous, musculoskeletal, dermatological, hepatic, lipid profile-related, neuropsychiatric and sexual alterations. Unit costs were identified from official healthcare costs databases. The cost (, 2020) of following up each patient profile was estimated, excluding the cost of the antiretroviral treatment itself, with a time horizon of two years. RESULTS: The per-patient cost of following up stable patients over two years was estimated at 4,148 (tests: 2,293; visits: 1,855). Patient follow-up after discontinuation of an existing antiretroviral treatment and initiation of a different one due to a lack of effectiveness was estimated at 5,434 (tests: 2,777; visits: 2,657). The cost of follow-up after discontinuation of an existing regimen and initiation of a new one due to unacceptable toxicity varied according to the adverse event prompting the switch, ranging from 4,690 for lipid profile dysregulation, to 5,304, for musculoskeletal alterations. In this patient profile, the cost of tests ranged from 2,403 to 3,017, and that of visits from 2,287 to 2,842. CONCLUSIONS: The cost associated with following up of patients infected with the human immunodeficiency virus after discontinuation of an existing antiretroviral regimen and initiation of a new one is higher than that of routine follow-up, without taking the cost of drugs into account. The treatment discontinuation rate is a relevant factor when selecting the most appropriate therapy for each patient.
OBJETIVO: Estimar el uso de recursos y costes asociados al seguimiento de pacientes con infección por el virus de la inmunodeficiencia humana tras discontinuación del tratamiento antirretroviral actual debido a falta de efectividad o toxicidad inaceptable y cambio a un nuevo tratamiento antirretroviral, comparado con el seguimiento habitual de los pacientes con tratamiento antirretroviral, desde la perspectiva del Sistema Nacional de Salud español.Método: Se identificó el uso de recursos (pruebas clínicas, visitas médicas, visitas a la farmacia hospitalaria) asociado al seguimiento de pacientes con infección por el virus de la inmunodeficiencia humana en tres perfiles de pacientes (estable, discontinuación y cambio por falta de efectividad, discontinuación y cambio por toxicidad inaceptable), a partir de las guías de práctica clínica y un panel de expertos multidisciplinar (n = 5). Los expertos consensuaron los principales eventos adversos que conducían a la discontinuación, agrupándolos en: alteraciones gastrointestinales, renales, óseas, musculoesqueléticas, dermatológicas, hepáticas y del perfil lipídico, trastornos neuropsiquiátricos y sexuales. Los costes unitarios se identificaron a partir de bases de datos oficiales assode costes sanitarios y de la literatura. Se estimó el coste (, 2020) del seguimiento en cada perfil de paciente, sin incluir el coste derivado del tratamiento antirretroviral, en un horizonte temporal de dos años. RESULTADOS: El coste por paciente a dos años se estimó en 4.148 (pruebas: 2.293 ; visitas: 1.855 ) para el seguimiento del paciente estable. El seguimiento del paciente tras discontinuación por falta de efectividad y cambio de tratamiento antirretroviral se estimó en 5.434 (pruebas: 2.777 ; visitas: 2.657 ). El coste del seguimiento tras la discontinuación por toxicidad inaceptable y cambio de tratamiento antirretroviral varió en función del evento adverso que motivó el cambio, oscilando entre 4.690 para las alteraciones del perfil lipídico, y 5.304 para las alteraciones musculoesqueléticas. En este perfil de pacientes, las pruebas variaron entre 2.403 y 3.017 y las visitas entre 2.287 y 2.842 . CONCLUSIONES: El coste asociado al seguimiento del paciente con infección por el virus de la inmunodeficiencia humana tras discontinuación y cambio a un nuevo tratamiento antirretroviral es mayor comparado con el seguimiento habitual, sin tener en cuenta el coste farmacológico. La tasa de discontinuación del tratamiento antirretroviral es un factor relevante a la hora de seleccionar la terapia más adecuada para cada paciente.
Subject(s)
HIV Infections , Humans , HIV , Spain , Follow-Up Studies , Cost-Benefit Analysis , Anti-Retroviral Agents/adverse effects , Health Care Costs , Lipids/therapeutic useABSTRACT
Objetivo: Estimar el uso de recursos y costes asociados al seguimientode pacientes con infección por el virus de la inmunodeficiencia humanatras discontinuación del tratamiento antirretroviral actual debido a faltade efectividad o toxicidad inaceptable y cambio a un nuevo tratamientoantirretroviral, comparado con el seguimiento habitual de los pacientescon tratamiento antirretroviral, desde la perspectiva del Sistema Nacionalde Salud español.Método: Se identificó el uso de recursos (pruebas clínicas, visitasmédicas, visitas a la farmacia hospitalaria) asociado al seguimiento depacientes con infección por el virus de la inmunodeficiencia humana entres perfiles de pacientes (estable, discontinuación y cambio por faltade efectividad, discontinuación y cambio por toxicidad inaceptable), apartir de las guías de práctica clínica y un panel de expertos multidisciplinar (n = 5). Los expertos consensuaron los principales eventos adversos que conducían a la discontinuación, agrupándolos en: alteracionesgastrointestinales, renales, óseas, musculoesqueléticas, dermatológicas,hepáticas y del perfil lipídico, trastornos neuropsiquiátricos y sexuales.Los costes unitarios se identificaron a partir de bases de datos oficiales de costes sanitarios y de la literatura. Se estimó el coste (, 2020) delseguimiento en cada perfil de paciente, sin incluir el coste derivado deltratamiento antirretroviral, en un horizonte temporal de dos años.Resultados: El coste por paciente a dos años se estimó en 4.148 (pruebas: 2.293 ; visitas: 1.855 ) para el seguimiento del pacienteestable. (AU)
Objective: To assess the use of resources and the costs associatedwith following up patients infected with the human immunodeficiency virusafter discontinuation of an antiretroviral treatment and initiation of a newone due to a lack of effectiveness or unacceptable toxicity, as comparedto the costs involved in the routine follow-up of patients on antiretroviraltreatment, from the Spanish National Health System perspective.Method: The use of resources (clinical tests, medical visits, and hospitalpharmacy visits) associated with following three profiles of patients infected with the human immunodeficiency virus (stable ones, those discontinuing an existing antiretroviral treatment and being switched to a newone due to a lack of effectiveness, and those discontinuing an existingantiretroviral treatment and being switched to a new one due to unacceptable toxicity) was identified, based on clinical practice guidelinesand the findings of a multidisciplinary expert panel (n = 5). The expertsagreed on the main adverse events leading to discontinuation, classifyingthem into gastrointestinal, renal, osseous, musculoskeletal, dermatological,hepatic, lipid profile-related, neuropsychiatric and sexual alterations. Unitcosts were identified from official healthcare costs databases. The cost (, 2020) of following up each patient profile was estimated, excludingthe cost of the antiretroviral treatment itself, with a time horizon of twoyears.Results: The per-patient cost of following up stable patients over twoyears was estimated at 4,148 (tests: 2,293; visits: 1,855). Patientfollow-up after discontinuation of an existing antiretroviral treatment andinitiation of a different one due to a lack of effectiveness was estimatedat 5,434 (tests: 2,777; visits: 2,657). (AU)
Subject(s)
Humans , Pharmacy , Aftercare , Pharmacy Service, Hospital , Toxicity , Health Care Costs , Cost Control , Therapeutics , SpainABSTRACT
OBJECTIVE: To evaluate the safety and the serological response after two doses of mRNA-based SARS-CoV-2 vaccination in people with HIV (PWH). METHODS: Participants were evaluated 4 weeks after the second dose of mRNA-1273 or BNT162b2 vaccine. Tolerability was evaluated with a specific adverse event questionnaire. Patient's sera were analysed using LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin). RESULTS: One-hundred PWH were included, 75% of them men, with a mean age of 44â±â11âyears old, all receiving antiretroviral treatment and mostly with controlled viral loads (98% with HIV RNA <50âcopies/ml) and 96% had >200âCD4+/µl. All patients seroconverted after vaccination (antibody concentration ≥33.8âbinding antibody units [BAU]/ml). Only 3% of the patients had a low antibody concentration (<520âBAU/ml), whereas 67% of them had concentrations above the assay's detection range (>2080âBAU/ml). Fifty-six patients had local or systemic symptoms, with mild arthromyalgia being the most common systemic symptom. No severe adverse events were reported. CONCLUSIONS: Vaccination with two doses of mRNA-1273 or BNT162b2 is well tolerated in PWH under effective antiretroviral treatment and it leads to a successful antibody response.
Subject(s)
COVID-19 , HIV Infections , Adult , Antibodies, Viral , BNT162 Vaccine/adverse effects , BNT162 Vaccine/therapeutic use , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/therapeutic use , Female , HIV Infections/drug therapy , Humans , Immunogenicity, Vaccine , Male , Middle Aged , SARS-CoV-2ABSTRACT
INTRODUCTION: Many elderly patients with COVID-19 are at risk of malnutrition. The aim of our study was to evaluate the risk of malnutrition and sarcopenia in elderly COVID-19 patients with the R-MAPP (Remote-Malnutrition APP). MATERIALS AND METHODS: A cross-sectional study of 337 consecutive outpatients ≥65 years who attended the Central Emergency COVID-19 Hospital of Castilla y Leon was conducted. In all patients, the protocol of R-MAPP (Malnutrition Universal Screening Tool [MUST] and Simple Questionnaire to Rapidly Diagnose Sarcopenia [SARC-F]) was realized. RESULTS: The mean age was 86.1 ± 8.7 years, with a sex distribution of 167 males (49.5%) and 170 females (51.5%). According to the MUST test, patients with 0 points have a low nutritional risk (n = 50, 14.8%), 1 point a medium nutritional risk (n = 19, 5.6%), and 2 or more points a high nutritional risk (n = 268, 79.6%). The SARC-F questionnaire generates patients with 4 or more points as predictive of sarcopenia (n = 304, 80.2%) and <4 points without prediction of sarcopenia (n = 33, 9.8%). Global mortality was 24.03% (n = 81). The mortality rate was related to the pathological SARC-F score ≥4 (27.1% vs. 3.1%; p = 0.01) and MUST score ≥2 (26.7% vs. 16.4%; p = 0.04). In the logistic regression analysis, only the SARC-F score ≥4 remained as an independent variable related to mortality; odds ratio was 8.34 (95% CI: 1.1-63.8; p = 0.04), adjusted for age, sex, albumin levels, and MUST test. CONCLUSIONS: During COVID-19 infection, hospitalized patients at risk of sarcopenia have a high risk of mortality and have a poor nutritional status.
Subject(s)
COVID-19 , Malnutrition/epidemiology , Sarcopenia/diagnosis , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Hospitals , Humans , Male , Malnutrition/diagnosis , Mortality , Prevalence , SARS-CoV-2 , Sarcopenia/epidemiology , Surveys and QuestionnairesABSTRACT
Cardiovascular disease is an important cause of morbidity and mortality in people living with HIV (PLWH), who commonly experience lipid disturbances. The aim of this study was to determine whether the plasma lipidomic profile differs between PLWH receiving a darunavir-based ART and those receiving integrase inhibitor-based ART. This was a cross-sectional study of unselected patients for whom metabolomic analysis was performed using ultra-high-performance liquid chromatography coupled to mass spectrometry. Data for the two subgroups were compared by calculating the log2 of the fold change for each metabolite and then grouping these into the main lipid families. Sixty-two PLWH aged 49.3 ± 8.6 years (82% men) were included: 12 patients (19.4%) had hypertension, 8 (12.9%) had type 2 diabetes, 25 (41.0%) had dyslipidaemia and 9 (14.5%) were taking statins, without significant differences in all these variables between the two groups. Twenty-five (40.3%) received darunavir-based ART and 37 (59.7%) integrase inhibitor-based ART. Although the differences were not statistically significant, patients treated with darunavir-based ART had higher concentrations of total cholesterol (211 mg/dL vs 194 mg/dL), LDL-cholesterol (132 mg/dL vs 117 mg/dL) and triglycerides (155 mg/dL vs 122 mg/dL), and lower HDL-cholesterol concentration (50 mg/dL vs 52 mg/dL). The main lipid families and metabolites differed slightly between groups (log2-fold change; P-value): ceramides (-0.07; 0.49), phosphatidylinositols (-0.05; 0.63), diacylglycerols (0.10; 0.64), phosphatidylethanolamines (0.03; 0.78), triacylglycerols (0.27; 0.18) and lysophosphatidylethanolamines (0.03; 0.83). In the integrase inhibitor-based group, the use of tenofovir alafenamide fumarate significantly increases the majority of lipid fractions, when compared with tenofovir disoproxil fumarate. The lipidomic profile did not differ between PLWH treated with darunavir-based or integrase inhibitor-based ART. This was especially true for ceramides, which are involved in cardiovascular disease. Further studies are needed to study the impact of ART in lipidomic profile.
Subject(s)
Darunavir/therapeutic use , HIV Infections/blood , HIV Integrase Inhibitors/therapeutic use , HIV Protease Inhibitors/therapeutic use , HIV/drug effects , Lipids/blood , Cross-Sectional Studies , Female , HIV Infections/drug therapy , HIV Infections/virology , HIV Integrase/chemistry , Humans , Lipidomics , Male , Middle Aged , Viral LoadABSTRACT
BACKGROUND: Most of the circulating Vitamin D (VitD) is transported bound to vitamin D-binding protein (DBP), and several DBP single nucleotide polymorphisms (SNPs) have been related to circulating VitD concentration and disease. In this study, we evaluated the association among DBP SNPs and AIDS progression in antiretroviral treatment (ART)-naïve-HIV-infected patients. METHODS: We performed a retrospective study in 667 patients who were classified according to their pattern of AIDS progression (183 long-term non-progressors (LTNPs), 334 moderate progressors (MPs), and 150 rapid progressors (RPs)) and 113 healthy blood donors (HIV, HCV, and HBV negative subjects). We genotyped seven DBP SNPs (rs16846876, rs12512631, rs2070741, rs2282679, rs7041, rs1155563, rs2298849) using Agena Bioscience's MassARRAY platform. The genetic association was evaluated by Generalized Linear Models adjusted by age at the moment of HIV diagnosis, gender, risk group, and VDR rs2228570 SNP. Multiple testing correction was performed by the false discovery rate (Benjamini and Hochberg procedure; q-value). RESULTS: All SNPs were in HWE (p > 0.05) and had similar genotypic frequencies for DBP SNPs in healthy-controls and HIV-infected patients. In unadjusted GLMs, we only found significant association with AIDS progression in rs16846876 and rs12512631 SNPs. In adjusted GLMs, DBP rs16846876 SNP showed significant association under the recessive inheritance model [LTNPs vs. RPs (adjusted odds ratio (aOR) = 3.53; q-value = 0.044) and LTNPs vs. MPs (aOR = 3.28; q-value = 0.030)] and codominant [LTNPs vs. RPs (aOR = 4.92; q-value = 0.030) and LTNPs vs. MPs (aOR = 3.15; q-value = 0.030)]. Also, we found DBP rs12512631 SNP showed significant association in the inheritance model dominant [LTNPs vs. RPs (aOR = 0.49; q-value = 0.031) and LTNPs vs. MPs (aOR = 0.6; q-value = 0.047)], additive [LTNPs vs. RPs (aOR = 0.61; q-value = 0.031)], overdominant [LTNPs vs. MPs (aOR = 0.55; q-value = 0.032)], and codominant [LTNPs vs. RPs (aOR = 0.52; q-value = 0.036) and LTNPs vs. MPs (aOR = 0.55; q-value = 0.032)]. Additionally, we found a significant association between DBP haplotypes (composed by rs16846876 and rs12512631) and AIDS progression (LTNPs vs RPs): DBP haplotype AC (aOR = 0.63; q-value = 0.028) and the DBP haplotype TT (aOR = 1.64; q-value = 0.028). CONCLUSIONS: DBP rs16846876 and rs12512631 SNPs are related to the patterns of clinical AIDS progression (LTNP, MP, and RP) in ART-naïve HIV-infected patients. Our findings provide new knowledge about AIDS progression that may be relevant to understanding the pathogenesis of HIV infection.
Subject(s)
Acquired Immunodeficiency Syndrome/genetics , Anti-Retroviral Agents/therapeutic use , DNA-Binding Proteins/genetics , Disease Progression , HIV/physiology , Polymorphism, Single Nucleotide , Transcription Factors/genetics , Acquired Immunodeficiency Syndrome/virology , Adult , Cohort Studies , DNA-Binding Proteins/metabolism , Female , Humans , Male , Middle Aged , Retrospective Studies , Spain , Transcription Factors/metabolismABSTRACT
BACKGROUND AND AIMS: Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015. MATERIAL AND METHODS: Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records. RESULTS: Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision. CONCLUSIONS: These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials.
Subject(s)
Antiviral Agents/therapeutic use , Coinfection/drug therapy , HIV Infections/complications , HIV Infections/drug therapy , HIV-1 , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/therapy , 2-Naphthylamine , Aged , Anilides/therapeutic use , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Carbamates/therapeutic use , Cyclopropanes , Drug Therapy, Combination , Female , Genotype , Hepacivirus/classification , Hepacivirus/genetics , Hepatitis C, Chronic/virology , Humans , Lactams, Macrocyclic , Macrocyclic Compounds/therapeutic use , Male , Middle Aged , Proline/analogs & derivatives , Renal Dialysis , Retrospective Studies , Ribavirin/therapeutic use , Ritonavir/therapeutic use , Spain , Sulfonamides/therapeutic use , Sustained Virologic Response , Treatment Outcome , Uracil/analogs & derivatives , Uracil/therapeutic use , ValineABSTRACT
BACKGROUND: Direct-acting antivirals (DAAs) are effective in patients aged ≥65 years. However, little is known about the effects of DAAs on survival, liver decompensation and development of hepatocellular carcinoma (HCC). OBJECTIVE: To compare the incidence of liver-related events and mortality between patients aged ≥65 and <65 years. METHODS: Prospective study comparing patients aged ≥65 and <65 years treated with DAAs. The incidence of liver-related events and mortality, and HCC was compared between age groups. RESULTS: Five hundred patients (120 aged ≥65 and 380 aged <65 years) were included. The incidence of liver-related events was 2.62 per 100 patient-years (py) in older and 1.41/100 py in younger patients. All-cause mortality was 3.89 and 1.27/100 py in older and younger patients, respectively. The respective liver-related mortality rates were 1.12 and 0.31/100 py. In patients with cirrhosis (stage F4), all-cause mortality (P = 0.283) and liver-related mortality (P = 0.254) did not differ between groups. All five liver-related deaths were related to multifocal HCC. The incidence of HCC was 1.91 and 1.43 per 100 py in the older and younger groups, respectively (P = 0.747). The diagnosis of HCC was 8 months after the end of treatment. CONCLUSIONS: The incidence of liver-related events and liver-related mortality was low in older people treated with DAAs and was similar to that in younger patients. The extra mortality in people aged ≥65 years treated with DAAs seems to be secondary to non-liver-related causes. These results support the utilization of DAAs in patients aged ≥65 years.
Subject(s)
Antiviral Agents/pharmacology , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/mortality , Liver/drug effects , Aged , Antiviral Agents/therapeutic use , Carcinogenesis , Carcinoma, Hepatocellular/complications , Carcinoma, Hepatocellular/pathology , Female , Hepatitis C, Chronic/complications , Humans , Liver/pathology , Liver Neoplasms/complications , Liver Neoplasms/pathology , Male , Middle AgedABSTRACT
BACKGROUND: Little is known about the influence of ongoing barriers to care in the persistence of hepatitis C virus (HCV) viremia after treatment with direct-acting antivirals (DAAs) among people living with human immunodeficiency virus (PLWH). METHODS: We conducted a retrospective cohort analysis of PLWH treated through the standard of care in 3 Western countries, to investigate the predictors of HCV treatment failure (clinical or virologic), defined as having a detectable serum HCV ribonucleic acid within 12 weeks after DAA discontinuation. In addition to HCV and liver-related predictors, we collected data on ongoing illicit drug use, alcohol abuse, mental illness, and unstable housing. Logistic regression analyses were used to identify predictors of HCV treatment failure. RESULTS: Between January 2014 and December 2017, 784 PLWH were treated with DAA, 7% (n = 55) of whom failed HCV therapy: 50.9% (n = 28) had a clinical failure (discontinued DAA therapy prematurely, died, or were lost to follow-up), 47.3% (n = 26) had an HCV virologic failure, and 1 (1.8%) was reinfected with HCV. Ongoing drug use (odds ratio [OR] = 2.60) and mental illness (OR = 2.85) were independent predictors of any HCV treatment failure. Having both present explained 20% of the risk of any HCV treatment failure due to their interaction (OR = 7.47; P < .0001). Predictors of HCV virologic failure were ongoing illicit drug use (OR = 2.75) and advanced liver fibrosis (OR = 2.29). CONCLUSIONS: People living with human immunodeficiency virus with ongoing illicit drug use, mental illness, and advanced liver fibrosis might benefit from enhanced DAA treatment strategies to reduce the risk of HCV treatment failure.
ABSTRACT
OBJECTIVE: the purpose of this investigation was to investigate the associations between nutritional status by Mini Nutritional Assessment (MNA) test and dysphagia by EAT-10 in elderly individuals requiring nutritional oral care in an acute hospital. PATIENTS: this was a cross-sectional survey covering a sample of 560 elderly individuals. As anthropometric parameters, weight and body mass index (BMI) have been included. Glucose, creatinine, sodium, potassium, albumin, prealbumin and transferrin serum levels were measured. The EAT-10 and MNA tests were carried out. The days of hospital stay and mortality were recorded. RESULTS: the mean EAT-10 was 11.2 ± 0.89, the median was 10 and the interquartile range, 6-15. A total of 465 (83.1%) elderly patients had EAT-10 scores between 3 and 40, indicating the presence of dysphagia. The mean MNA test was 15.2 ± 1.1, median was 15 and interquartile rage, 11-18.5. According to their MNA score, a total of 340 (60.7%) elderly patients had MNA scores under 17 (malnutrition) and 177 subjects (31.6%) had a MNA score of 17-23.5 (risk of malnutrition). The MNA score and EAT-10 score were independently associated with hospital stance Beta -0.111 (CI 95%: -0.031- -0.78) and Beta 0.122 (CI 95%: 0.038-0.43), respectively. MNA score was associated with EAT-10 score Beta -0.236 (CI 95%: -0.213-0.09). The MNA score and EAT-10 score were independently associated with mortality odds ratio 0.91 (CI 95%: 0.84-0.96) and 1.040 (CI 95%: 1.008-1.074), respectively. CONCLUSION: dysphagia assessed by the EAT-10 is associated with nutritional status in elderly subjects requiring acute hospitalization. Subsequently, malnutrition and dysphagia were associated with poor outcome such as hospital stay and mortality.
Subject(s)
Acute Disease , Hospital Mortality , Length of Stay/statistics & numerical data , Nutrition Assessment , Nutritional Status , Aged , Aged, 80 and over , Cross-Sectional Studies , Deglutition Disorders/diagnosis , Female , Geriatric Assessment , Hospitalization , Humans , Male , Malnutrition/diagnosis , Malnutrition/etiologyABSTRACT
Objective: the purpose of this investigation was to investigate the associations between nutritional status by Mini Nutritional Assessment (MNA) test and dysphagia by EAT-10 in elderly individuals requiring nutritional oral care in an acute hospital. Patients: this was a cross-sectional survey covering a sample of 560 elderly individuals. As anthropometric parameters, weight and body mass index (BMI) have been included. Glucose, creatinine, sodium, potassium, albumin, prealbumin and transferrin serum levels were measured. The EAT-10 and MNA tests were carried out. The days of hospital stay and mortality were recorded. Results: the mean EAT-10 was 11.2 ± 0.89, the median was 10 and the interquartile range, 6-15. A total of 465 (83.1%) elderly patients had EAT-10 scores between 3 and 40, indicating the presence of dysphagia. The mean MNA test was 15.2 ± 1.1, median was 15 and interquartile rage, 11-18.5. According to their MNA score, a total of 340 (60.7%) elderly patients had MNA scores under 17 (malnutrition) and 177 subjects (31.6%) had a MNA score of 17-23.5 (risk of malnutrition). The MNA score and EAT-10 score were independently associated with hospital stance Beta -0.111 (CI 95%: -0.031- -0.78) and Beta 0.122 (CI 95%: 0.038-0.43), respectively. MNA score was associated with EAT-10 score Beta -0.236 (CI 95%: -0.213-0.09). The MNA score and EAT-10 score were independently associated with mortality odds ratio 0.91 (CI 95%: 0.84-0.96) and 1.040 (CI 95%: 1.008-1.074), respectively. Conclusion: dysphagia assessed by the EAT-10 is associated with nutritional status in elderly subjects requiring acute hospitalization. Subsequently, malnutrition and dysphagia were associated with poor outcome such as hospital stay and mortality
Objetivo: el objetivo de este estudio fue investigar la relación entre el estado nutricional mediante el test Mini Nutritional Assessment (MNA) y la presencia de disfagia por EAT-10 en personas ancianas que requieren ingreso en un hospital de agudos. Pacientes: el trabajo evaluó una muestra de 560 ancianos. Como parámetros antropométricos, hemos incluido el peso y el índice de masa corporal (IMC). Se midieron los niveles séricos de glucosa, creatinina, sodio, potasio, albúmina, prealbúmina y transferrina. Las pruebas EAT-10 y MNA se realizaron a todos los pacientes. Se registraron los días de estancia hospitalaria y la mortalidad Resultados: la media de EAT-10 fue de 11,2 ± 0,89 puntos, mediana de 10 y rango intercuartílico de 6-15. Un total de 465 (83,1%) pacientes de edad avanzada tenían puntuaciones EAT-10 entre 3 y 40, lo que indica presencia de disfagia. La puntuación promedio de MNA fue 15,2 ± 1,1 puntos, mediana de 15 y rango intercuartílico de 11-18,5. Según la puntuación MNA, un total de 340 (60,7%) pacientes de edad avanzada tenían MNA menores de 17 (desnutrición) y 177 sujetos (31,6%) presentaron una puntuación MNA de 17-23,5 (riesgo de desnutrición). Las puntuaciones de MNA y EAT-10 se asociaron independientemente con la estancia en el hospital Beta -0,111 (IC 95%: -0,031- -0,78) y Beta 0,122 (IC 95%: 0,038-0,43), respectivamente. El MNA se asoció con el EAT-10 Beta -0,236 (IC 95%: -0,213-0,09). Las puntuaciones MNA y EAT-10 se asociaron independientemente con la razón de probabilidad de mortalidad 0,91 (IC 95%: 0,84-0,96) y 1,040 (IC 95%: 1,008-1,074), respectivamente. Conclusión: la disfagia evaluada por el EAT-10 se asocia con el estado nutricional en sujetos ancianos que requieren hospitalización aguda. La malnutrición y la disfagia se asociaron con la estancia hospitalaria y la mortalidad
Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Acute Disease , Hospital Mortality , Length of Stay/statistics & numerical data , Nutrition Assessment , Nutritional Status , Cross-Sectional Studies , Deglutition Disorders/diagnosis , Geriatric Assessment , Hospitalization , Malnutrition/diagnosis , Malnutrition/etiologyABSTRACT
OBJECTIVES: Darunavir/ritonavir (DRV/r) in mono or dual therapy has proven efficacy in selected patients. The aim of this study was to evaluate the efficacy of switching from DRV/r to DRV/cobicistat (DRV/c) in patients under mono or dual therapy. METHODS: This was a prospective multicenter cohort study of patients using DRV/r under mono or dual therapy plus lamivudine who changed to DRV/c maintaining the previous regimen. All patients had a controlled HIV viral load (<50 copies/ml) when switched and were examined every 12 weeks. The primary end-point was the percentage of participants without virological failure (VF) at week 48 in the intent-to-treat analysis. The CD4 cell count and concentrations of cholesterol, triglyceride, and creatinine were measured from baseline to week 48. RESULTS: A total of 162 patients were included: 68.5% were men, and their mean age was 46 ± 12 years. Seventy (43.2%) patients were treated with DRV/r monotherapy, and 92 (56.8%) were treated with DRV/r plus lamivudine. The efficacy at week 48 was 95.1% (95% CI: 90.6%-97.5%) in the intent-to-treat analysis and 98.7% (95.5-99.6%) in the on-treatment analysis. Two VFs were documented but without development of resistance mutations. No significant changes were found in the lipid profile. Creatinine concentration increased significantly by 0.07 mg/dl (0.04-0.10, P < 0.001). CONCLUSIONS: Switching from DRV/r to DRV/c in patients under mono or dual therapy is safe and effective.
Subject(s)
Cobicistat/therapeutic use , Darunavir/therapeutic use , HIV Infections/drug therapy , Ritonavir/therapeutic use , Adult , Cobicistat/administration & dosage , Cohort Studies , Darunavir/administration & dosage , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Prospective Studies , Ritonavir/administration & dosage , Viral LoadABSTRACT
No disponible
Subject(s)
Humans , Lung Neoplasms/diagnosis , Tomography, Spiral Computed/methods , Mass Screening/methods , Early Detection of Cancer/methods , Radiography, ThoracicABSTRACT
BACKGROUND: New direct-acting antivirals agents (DAAs) are very safe and well tolerated. OBJECTIVES: The purpose of this study is to analyse the efficacy and safety of DAAs in elderly patients, who have co-morbidities and are on chronic medications. STUDY DESIGN: All HCV-infected patients over 65 years old in clinical follow-up at two Hospitals in Spain who initiated anti-HCV therapy were included (August 2012-October 2015). RESULTS: A total of 120 HCV mono-infected patients were recorded. Mean age of patients was 72.6±7.4years. There were 53.3% women and GT1b was the most frequent (83.3%); 64.2% had cirrhosis and 42.5% were treatment experienced. Ombitasvir+Paritaprevir/r±Dasabuvir±Ribavirin (RBV) and sofosbuvir/ledipasvir±RBV were the most frequently used regimens. Weight-adjusted dosing of RBV was included in 61.7% and 43.6% of them required a dose reduction. Most of the patients (86.7%) had concomitant chronic medication and in 35.8% adjustment was necessary. Adverse events (AE) were seen in 65% of the patients; more frequent when a protease inhibitor (PI) was being used. The sustained virological response (SVR12) per ITT was 88.3%. Only 3 patients discontinued treatment and 2 patients died. CONCLUSIONS: High rates of SVR12 (88.3%) were observed among elderly patients with DAAs-based regimens. The presence of AE was frequent (65%). The majority of these patients (86.7%) had concomitant medication that required adjustment in 1/3 of them. These findings highlight the high rates of response to DAAs in the elderly HCV-population. However, special caution must be taken when using RBV and a PI.
Subject(s)
Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Aged , Aged, 80 and over , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Prospective Studies , Spain , Treatment OutcomeABSTRACT
BACKGROUND: Cases of renal tubular dysfunction have been reported in patients with hepatitis B and in patients with human immunodeficiency virus who are undergoing tenofovir treatment. However, little is known about the impact on tubular function in patients with chronic hepatitis B (CHB) under long-term use of entecavir (ETV) and tenofovir disoproxil fumarate (TDF). We evaluated markers of renal tubular function and bone turnover in patients with CHB treated with ETV or TDF. PATIENTS AND METHODS: A multicenter, cross-sectional study was performed on markers of renal tubular function and bone turnover in hepatitis B virus-monoinfected patients on long-term treatment with Entecavir or Tenofovir (the MENTE study). The analyzed parameters were: retinol-binding protein/creatinine, neutrophil gelatinase-associated lipocalin/creatinine, excretion of phosphates, uric acid excretion, glomerular filtrate, protein/creatinine, albumin/creatinine, serum creatinine, phosphate, CTX, P1NP, vitamin D, and parathormone. RESULTS: A total of 280 patients (ETV: 89, TDF: 69, control: 122) were included in this study. The TDF group was associated with altered levels of retinol-binding protein (RBP)/creatinine (TDF 25% vs. 7% ETV and control; P<0.001). Protein/creatinine, uric acid excretion, P1NP1, and parathormone were higher in the TDF group. The proportion of patients with serum phosphate <2.5 mg/dL was higher in both the ETV and the TDF groups compared with the control. The multivariate analysis showed that the use of TDF was independently associated with a higher risk of altered excretion of RBP/creatinine (4.4; interquartile range: 1.4 to 14; P=0.013). CONCLUSIONS: We found an independent association between TDF use and altered RBP excretion. This finding indicates subclinical tubular damage. Because tubular dysfunction can precede the decline of renal function, close monitoring of RBP levels in patients with CHB on nucleos(t)ide analog treatment must be performed for early detection of TDF-related renal toxicity. In this study, these differences in tubular function were not associated with concomitant changes in markers of bone turnover.
Subject(s)
Antiviral Agents/therapeutic use , Hepatitis B, Chronic/drug therapy , Kidney Tubules, Proximal/physiopathology , Tenofovir/therapeutic use , Adolescent , Adult , Aged , Antiviral Agents/administration & dosage , Creatinine/urine , Cross-Sectional Studies , Disease Progression , Female , Glomerular Filtration Rate , Guanine/adverse effects , Guanine/analogs & derivatives , Guanine/therapeutic use , Hepatitis B, Chronic/urine , Humans , Male , Middle Aged , Nucleosides/adverse effects , Nucleosides/therapeutic use , Nucleotides/adverse effects , Nucleotides/therapeutic use , Retinol-Binding Proteins/urine , Retrospective Studies , Spain , Tenofovir/adverse effects , Young AdultSubject(s)
HIV Infections/complications , Lung Neoplasms/epidemiology , Lung Neoplasms/mortality , Female , Humans , MaleABSTRACT
INTRODUCTION: Etravirine has become an alternative in HIV/HCV coinfected patients because of safety and lack of interactions with anti-HCV drugs. The aim of this study was to establish the risk of liver toxicity in HIV/HCV coinfected patients receiving etravirine in the clinical setting, according to the degree of liver fibrosis and different accompanying drugs. MATERIAL AND METHODS: Cohort study of 211 patients initiating etravirine as part of their antiretroviral regimen. HCV coinfection was defined as a positive RNA-HCV, whereas baseline liver fibrosis was assessed by transient elastography at baseline. Hepatotoxicity was defined as an increased AST/ALT, 5-fold higher over upper, normal limits for patients with normal baseline values, or 3.5-fold if altered at baseline. RESULTS: HCV coinfection was observed in 145 patients (69%) with a longer time of HIV infection and time on HAART than mono-infected patients, and a lower nadir (182 vs 227 cells/mL; p=0.02) and baseline CD4+ count (446 vs 552 cells/mL; p=0.02). Etravirine was used with two nucleoside analogues in 62%, with boosted darunavir in 17%, with raltegravir in 10%, and with darunavir plus raltegravir or maraviroc in 10% of patients without differences according to HCV serostatus. Transient elastography in 117 patients performed at etravirine initiation (median, 33 days) showed fibrosis 1 and fibrosis 4 in 37% and 24% of cases, and median stiffness value was 8.25 kPa (3.5-69). During an accumulated follow-up of 449.3 patient-years (median, 611 days), only one coinfected patient with fibrosis 4 (stiffness value, 50.1 kPa), receiving a rescue regimen including darunavir/r plus maraviroc plus two nucleoside analogues, developed a grade 3-4 of liver toxicity (0.5%). There were no other episodes of liver toxicity, as defined, and only 6 (3%) and 9 patients (4%) had a grade 1 and 2 of toxicity, respectively, in most cases related to HCV coinfection (6 and 6 cases). Moreover, HCV coinfection or advanced fibrosis was not associated to a higher risk of etravirine discontinuation (26% vs 21%; p=0.27, log-rank test) or virologic failure (9% vs 11%, p=0.56). CD4+ cell count increase was lower in HCV patients (+23 vs +86 at 6 month; p=0.02). CONCLUSIONS: Etravirine is safe in HIV/HCV coinfected patients, even in presence of moderate and advanced liver fibrosis and as part of different antiretroviral regimens.
ABSTRACT
BACKGROUND AND AIM: There are few data of fibrosis development in chronic hepatitis B (CHB) patients classified as inactive carriers. The aim of this study is to determinate the prevalence of significant fibrosis and probable cirrhosis measured by FibroScan in real inactive CHB carriers and investigate the relationship with virological, epidemiological, and metabolic factors. METHODS: Cross-sectional cohort study including CHB inactive carriers. Liver stiffness measurement was performed with transient elastography (FibroScan). Significant fibrosis (≥ F2) was defined as stiffness > 7.5 kPa, and probable cirrhosis as > 11.8 kPa. Factors associated with significant fibrosis were explored with univariate and multivariate adjusted logistic regression analyses. RESULTS: Ninety-six CHB inactive carriers were analyzed. Of them, 24 (25%) had significant fibrosis and 7 (7%) probable cirrhosis; mean stiffness was 6.2 ± 2.3 kPa. Of them, 24% had metabolic syndrome, with higher FibroScan value than those without (8.4 kPaâ vs 5.5 kPa, P < 0.001). Factors associated with significant fibrosis were (odds ratio, 95% confidence interval, P value): central obesity (7.1, 1.8-27.9, 0.005), elevated fasting glucose (4.3, 1.3-27.9, 0.036), reduced high-density lipoprotein cholesterol (5.2, 1.2-23.6, 0.032) and elevated triglycerides (6.2, 1.4-28.3, 0.019). Factors as age, sex, transaminases, hepatitis B virus DNA or genotype were not related with liver fibrosis. The presence of metabolic syndrome has a 69% of positive predictive value and 89% of negative predictive value for significant fibrosis. CONCLUSION: Different components of metabolic syndrome are associated with fibrosis development in CHB inactive carriers. In the absence of metabolic syndrome, significant fibrosis is uncommon in this population.
Subject(s)
Carrier State , Hepatitis B, Chronic/complications , Liver Cirrhosis/etiology , Metabolic Syndrome/complications , Adult , Aged , Cross-Sectional Studies , Elasticity Imaging Techniques , Female , Humans , Liver Cirrhosis/diagnostic imaging , Male , Middle Aged , Regression Analysis , Retrospective Studies , Virus ActivationABSTRACT
INTRODUCTION: The development of malignancies is a problem associated with HIV infection. The incidence and spectrum of malignancies has been modified with the addition of highly active antiretroviral therapy (HAART). AIM: To describe the clinical and epidemiological characteristics and prognosis of HIV patients who have developed a malignancy. METHODS: Retrospective observational study was conducted in HIV + patients who developed a malignancy between 1993-2010 in a referral hospital. AIDS-defining malignancies (ADN) and non-AIDS-defining malignancies (NADN) were compared. RESULTS: 125 patients were identified with at least one malignancy. The most frequent malignancies were: non-Hodgkin lymphoma (n; 39; 30.2%), Kaposi's sarcoma (n: 20; 15.5%), Hodgkin's disease (n: 11; 8.8%), lung cancer (n: 20; 15.5%) and hepatocellular carcinoma (n: 9; 6.9 %). The mean age was 42 ± 11 years, 84% male, 55.8% were coinfected with HBV and or HCV. The risk behaviors were: 45.6% intravenous drug users, 16.8% men who have sex with men and 20% heterosexuals). There were 67 (52%) NADN and 62 (48%) ADN; NADN patients had a longer story of HIV infection and longer exposure to HAART, better level of immunodeficiency and better virological control than ADN patients. Four patients developed a second malignancy. Overall survival was 34.7%. CONCLUSIONS: We found an increased incidence of NADN, appearing in patients with better virological and immunological control than ADN group. Mortality of patients with HIV infection and malignancy is still very high.
Subject(s)
HIV Infections/complications , Neoplasms/etiology , Adult , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Male , Middle Aged , Neoplasms/epidemiology , Prognosis , Retrospective Studies , Spain/epidemiology , Survival AnalysisABSTRACT
Introduction: The development of malignancies is a problem associated with HIV infection. The incidence and spectrum of malignancies has been modified with the addition of highly active antiretroviral therapy (HAART). Aim: To describe the clinical and epidemiological characteristics and prognosis of HIV patients who have developed a malignancy. Methods: Retrospective observational study was conducted in HIV + patients who developed a malignancy between 1993-2010 in a referral hospital. AIDS-defining malignancies (ADN) and non-AIDS-defining malignancies (NADN) were compared. Results: 125 patients were identified with at least one malignancy. The most frequent malignancies were: non-Hodgkin lymphoma (n; 39; 30.2%), Kaposi's sarcoma (n: 20; 15.5%), Hodgkin's disease (n: 11; 8.8%), lung cancer (n: 20; 15.5%) and hepatocellular carcinoma (n: 9; 6.9 %). The mean age was 42 ± 11 years, 84% male, 55.8% were coinfected with HBV and or HCV. The risk behaviors were: 45.6% intravenous drug users, 16.8% men who have sex with men and 20% heterosexuals). There were 67 (52%) NADN and 62 (48%) ADN; NADN patients had a longer story of HIV infection and longer exposure to HAART, better level of immunodeficiency and better virological control than ADN patients. Four patients developed a second malignancy. Overall survival was 34.7%. Conclusions: We found an increased incidence of NADN, appearing in patients with better virological and immunological control than ADN group. Mortality of patients with HIV infection and malignancy is still very high.
Introducción: Uno de los problemas asociados a la infección por VIH es el desarrollo de neoplasias. La incidencia y espectro de los distintos cánceres se ha visto modificada con la incorporación del tratamiento anti-retroviral de gran actividad (TARGA). El objetivo del presente estudio es describir las características clínicas y epidemiológicas y el pronóstico de pacientes infectados con VIH que han desarrollado una neoplasia. Material y Métodos: Estudio observacional retrospectivo de una cohorte de pacientes con infección por VIH que desarrollaron algún cáncer en el periodo comprendido entre 1993-2010 en un hospital de referencia. Se compararon las variables entre los casos de neoplasias definitorias de SIDA (NDS) y no definitorios de SIDA (NNDS). Resultados: Se identificaron 125 pacientes con al menos una neoplasia. Los cánceres más frecuentes fueron: linfoma no Hodgkin (n: 39; 30,2%), sarcoma de Kaposi (n: 20; 15,5%), enfermedad de Hodgkin (n: 11; 8,8%), neoplasia pulmón (n: 20; 16%) y hepatocarcinoma (n: 9; 6,9 %). La edad media fue 42 ± 11 años, 84% varones, 55,8% estaban co-infectados por VHB y/o VHC. Las conductas de riesgo fueron: 45,6% usuarios de drogas vía parenteral, 16,8% hombres con relaciones sexuales con hombres y 20% heterosexuales. Se encontraron 67 NNDS (52%) y 62 (48%) NDS; los pacientes con NNDS presentaron mayor tiempo de evolución de la infección por VIH y de exposición a TARGA, mayor recuento de CD4 y mejor control virológico que los del grupo de NDS. Desarrollaron un segundo tumor cuatro pacientes. La supervivencia global fue de 34,7%. Conclusiones: Se constata un aumento en la incidencia de NNDS, que se presentan en pacientes con mejor control virológico e in-munológico que los NDS. La mortalidad de los pacientes con infección por VIH y enfermedad tumoral continúa siendo muy elevada.
