All-oral direct-acting antiviral therapy against hepatitis C virus (HCV) in human immunodeficiency virus/HCV-coinfected subjects in real-world practice: Madrid coinfection registry findings.

We evaluated treatment outcomes in a prospective registry of human immunodeficiency virus/hepatitis C virus (HCV)-coinfected patients treated with interferon-free direct-acting antiviral agent-based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% did not have cirrhosis, 33.9% had compensated cirrhosis, and 6.6% had decompensated cirrhosis. The predominant HCV genotypes were 1a (40.9%), 4 (22.4%), 1b (15.1%), and 3 (15.0%). Treatment regimens included sofosbuvir (SOF)/ledipasvir (61.9%), SOF plus daclatasvir (14.6%), dasabuvir plus ombitasvir/paritaprevir/ritonavir (13.2%), and other regimens (10.3%). Ribavirin was used in 30.6% of patients. Less than 1% of patients discontinued therapy owing to adverse events. The frequency of sustained viral response by intention-to-treat analysis was 92.0% (95% confidence interval, 90.9%-93.1%) overall, 93.8% (92.4%-95.0%) for no cirrhosis, 91.0% (88.8%-92.9%) for compensated cirrhosis, and 80.8% (73.7%-86.6%) for decompensated cirrhosis. The factors associated with treatment failure were male sex (adjusted odds ratio, 1.75; 95% confidence interval, 1.14-2.69), Centers for Diseases Control and Prevention category C (adjusted odds ratio, 1.65; 95% confidence interval, 1.12-2.41), a baseline cluster of differentiation 4-positive (CD4+) T-cell count <200/mm3 (adjusted odds ratio, 2.30; 95% confidence interval, 1.35-3.92), an HCV RNA load ≥800,000 IU/mL (adjusted odds ratio, 1.63; 95% confidence interval, 1.14-2.36), compensated cirrhosis (adjusted odds ratio, 1.35; 95% confidence interval, 0.96-1.89), decompensated cirrhosis (adjusted odds ratio, 2.92; 95% confidence interval, 1.76-4.87), and the use of SOF plus simeprevir, SOF plus ribavirin, and simeprevir plus daclatasvir. CONCLUSION: In this large real-world study, direct-acting antiviral agent-based therapy was safe and highly effective in coinfected patients; predictors of failure included gender, human immunodeficiency virus-related immunosuppression, HCV RNA load, severity of liver disease, and the use of suboptimal direct-acting antiviral agent-based regimens. (Hepatology 2018;68:32-47).

Predictive model of short-term amputation during hospitalization of patients due to acute diabetic foot infections

Introduction Factors predicting short-term amputation during hospital treatment of patients admitted for acute diabetic foot infections are of interest for clinicians managing the acute episode. Methods A retrospective clinical records analysis of 78 consecutive patients hospitalized for acute diabetic foot infections was performed to identify predictive factors for short-term amputation by comparing the data of patients who ultimately required amputation and those who did not. Clinical/epidemiological, laboratory, imaging, and treatment variables were comparatively analyzed. A logistic regression model was performed, with amputation as the dependent variable and factors showing significant differences in the bivariate analysis as independent variables. A prediction score was calculated (and validated by ROC curve analysis) using beta coefficients for significant variables in the regression analysis to predict amputation. Results Of the 78 patients (70.5% with peripheral vasculopathy) included, 26 ultimately required amputation. In the bivariate analysis, white blood cell count, previous homolateral lesions, odor, lesion depth, sedimentation rate, Wagner ulcer grade, and arterial obstruction on Doppler study were significantly higher in patients ending in amputation. In the multivariate analysis, the risk of amputation was increased only by Wagner grade 4 or 5 (20-fold higher), obstruction (12.5-fold higher), and elevated sedimentation rate (6% higher per unit). Logistic regression predicted outcome in 76.9% of patients who underwent amputation and 92.3% of those who did not. Conclusion The score calculated using beta coefficients for significant variables in the regression model (Wagner grades 4 and 5, obstruction on Doppler, and elevated sedimentation rate for the clinical, imaging, and laboratory data, respectively) correctly predicted amputation during hospital management of acute diabetic foot infections (AU)

Introducción La identificación de factores que predigan amputación temprana durante la hospitalización de pacientes ingresados por infección aguda de pie diabético es de alto interés para el clínico que trata el episodio agudo. Métodos Se realizó un análisis retrospectivo de las historias clínicas de 78 pacientes consecutivos ingresados por infección aguda de pie diabético para identificar los factores que predicen amputación temprana mediante la comparación de los datos de los pacientes finalmente amputados con los de aquellos en los que finalmente no se realizó amputación. Se analizaron datos clínicos, epidemiológicos, analíticos, de imagen y de tratamiento. Se realizó un modelo de regresión logística utilizando como variable dependiente la amputación y como variables independientes aquellas que mostraron diferencias significativas en el análisis bivariado. Se calculó una escala de puntuaciones (validada por curvas de especificidad y sensibilidad) utilizando los coeficientes beta de las variables significativas en el modelo de regresión para predecir la amputación. Resultados De los 78 pacientes incluídos (70,5% con vasculopatía periférica), 26 fueron finalmente amputados. En el análisis bivariado, el recuento de leucocitos, las lesiones homolaterales previas, el olor, la extensión de la lesión, la velocidad de sedimentación, el grado en la escala de Wagner y la obstrucción arterial en el Doppler fueron significativamente mayores en los pacientes finalmente amputados. En el análisis multivariado el riesgo de amputación solo se incrementó por los grados 4–5 de la escala de Wagner (20 veces), obstrucción en el Doppler (12,5 veces) y la elevación en la velocidad de sedimentación (6% por unidad). La (..) (AU)

Predictive model of short-term amputation during hospitalization of patients due to acute diabetic foot infections.

INTRODUCTION: Factors predicting short-term amputation during hospital treatment of patients admitted for acute diabetic foot infections are of interest for clinicians managing the acute episode. METHODS: A retrospective clinical records analysis of 78 consecutive patients hospitalized for acute diabetic foot infections was performed to identify predictive factors for short-term amputation by comparing the data of patients who ultimately required amputation and those who did not. Clinical/epidemiological, laboratory, imaging, and treatment variables were comparatively analyzed. A logistic regression model was performed, with amputation as the dependent variable and factors showing significant differences in the bivariate analysis as independent variables. A prediction score was calculated (and validated by ROC curve analysis) using beta coefficients for significant variables in the regression analysis to predict amputation. RESULTS: Of the 78 patients (70.5% with peripheral vasculopathy) included, 26 ultimately required amputation. In the bivariate analysis, white blood cell count, previous homolateral lesions, odor, lesion depth, sedimentation rate, Wagner ulcer grade, and arterial obstruction on Doppler study were significantly higher in patients ending in amputation. In the multivariate analysis, the risk of amputation was increased only by Wagner grade 4 or 5 (20-fold higher), obstruction (12.5-fold higher), and elevated sedimentation rate (6% higher per unit). Logistic regression predicted outcome in 76.9% of patients who underwent amputation and 92.3% of those who did not. CONCLUSION: The score calculated using beta coefficients for significant variables in the regression model (Wagner grades 4 and 5, obstruction on Doppler, and elevated sedimentation rate for the clinical, imaging, and laboratory data, respectively) correctly predicted amputation during hospital management of acute diabetic foot infections.