RESUMEN
[This corrects the article DOI: 10.1371/journal.pone.0215783.].
RESUMEN
BACKGROUND AND OBJECTIVES: The pangenotypic single tablet regimen of NS5B inhibitor sofobuvir (SOF) and NS5A inhibitor velpatasvir (VEL) is advised for 12 weeks in HCV-infected patients including those with compensated cirrhosis. Addition of ribavirin (RBV) may be considered in genotype 3 (GT3) with compensated and is recommended in decompensated cirrhosis. Real-life results with SOF/VEL are limited. To evaluate efficacy and safety in a large real-world-cohort including patients with different GTs and various fibrosis stages. DESIGN: In total, 1429 patients were treated with SOF/VEL 400/100 mg for 12 weeks in the Puglia registry between June 2017 and May 2018. 1319 (92.3%) reached week 12 post-treatment (SVR12) at the moment. Only 41 received RBV. Diagnosis of cirrhosis was based on transient elastography and/or APRI or FIB-4 scores. Sensitivity analysis in the population including all patients except non virological failure was conducted. Primary efficacy endpoint was the percentage of patients with SVR12. RESULTS: Patients' mean age was 63.8 years, 42.3% had GT1. The majority were naïve and 735 (55.5%) F0/F2. Of the remaining 587, 282 had cirrhosis. SVR12 was 98.5%, 98.0% in GT1, 99.4% in GT2, 97.1% in GT3, 100% in GT4. Overall, SVR12 by sensitivity analysis was 99.4%; 99.7% among F0-F1. Among 218 PWID, SVR12 was 94.5%. Discontinuation rates were 3.7% among PWID and 0.7% among non-PWID (p = 0.004). CONCLUSIONS: SOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID.
Asunto(s)
Carbamatos/uso terapéutico , Hepatitis C/complicaciones , Hepatitis C/tratamiento farmacológico , Compuestos Heterocíclicos de 4 o más Anillos/uso terapéutico , Cirrosis Hepática/complicaciones , Sofosbuvir/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Carbamatos/efectos adversos , Interacciones Farmacológicas , Femenino , Compuestos Heterocíclicos de 4 o más Anillos/efectos adversos , Humanos , Cirrosis Hepática/patología , Masculino , Persona de Mediana Edad , Seguridad , Sofosbuvir/efectos adversos , Resultado del Tratamiento , Adulto JovenAsunto(s)
Enfermedades Cardiovasculares/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Índice de Masa Corporal , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/prevención & control , Complicaciones de la Diabetes/epidemiología , Femenino , Humanos , Hipercolesterolemia/complicaciones , Hipertensión/complicaciones , Italia/epidemiología , Masculino , Tamizaje Masivo/tendencias , Síndrome Metabólico/complicaciones , Persona de Mediana Edad , Obesidad/complicaciones , Sobrepeso/complicaciones , Estudios Retrospectivos , Factores de Riesgo , Sicilia/epidemiología , Fumar/efectos adversosRESUMEN
BACKGROUND: The Italian National Prevention plan includes 10-year cardiovascular risk (CR) assessment of the Italian general population aged 35-69 years using the CUORE Project risk score. A national training program for general practitioners (GPs) was launched by the Ministry of Health in 2003. GPs were encouraged to collect data on risk factors and risk assessment and to contribute to the CUORE Project Cardiovascular Risk Observatory (CRO). The aim of this analysis is to demonstrate the feasibility and effectiveness of risk assessment in primary care. METHODS: The cuore.exe software, free of charge for GPs and easily downloadable from the CUORE Project web site (www.cuore.iss.it), is the frame for the GP data collection. The CRO provides a platform to analyze data collected on risk assessment and risk factors, and compare results at regional and national level in order to support health policy makers in their decision process. RESULTS: From January 2007 to April 2009, 2858 GPs have downloaded the cuore.exe software; 102,113 risk assessments were sent to the CRO based on risk factors profile of 87,556 persons (3617 persons had more than 1 risk assessment). Mean level of CR was 3.1% in women and 8.4% in men; 30% of men and 65% of women were at low risk (CR < 3%), 9% of men and 0.4% of women were found at high risk (CR > or = 20%). Among those with at least 2 risk assessments, 8% shifted to a lower class of risk after 1 year. Mean level of systolic and diastolic blood pressure decreased by about 1% in 1 year; total cholesterol more than 2%, and prevalence of smokers decreased by about 3% in the second risk assessment. CONCLUSIONS: These data demonstrate that risk assessment can be included as a first step of prevention in primary care. The CUORE Project individual score is expected to become an important tool for GPs to assess their patients' CR, to promote primary prevention, and to focus attention to healthy lifestyle adoption.