Disease progression and health care resource consumption in patients affected by hepatitis C virus in real practice setting

Abstract

IntroductionHepatitis C virus (HCV) infection represents serious health problems worldwide and is a major contributor to end-stage liver disease including cirrhosis and hepatocellular carcinoma (HCC). In Italy, ~2% of subjects are infected with HCV. The objective of this study was to describe treatment patterns, disease progression, and resource use in HCV.MethodsAn observational retrospective cohort analysis based on four Local Health Units administrative and laboratory databases was conducted. HCV-positive patients between January 1, 2009 and December 31, 2010 were included and followed-up for 1 year. To explore which covariates were associated to disease progression (cirrhosis, HCC, death for any cause), Cox proportional hazards models were performed.ResultsA total of 9,514 patients were analyzed of which 55.6% were male, aged 58.1±16.1, and prevalence 0.4%; 5.8% were positive to human immunodeficiency virus (HIV) infection, 3.0% to hepatitis B virus (HBV), and 1.6% to HCV+HBV+HIV; 26.1% had cirrhosis and 4.3% HCC. The majority of patients (76%) did not receive an antiviral treatment; the main factors affecting this decision were age, 44.1% of untreated patients being aged >65 years; 31% were affected by cirrhosis, 6.6% had ongoing substance or alcohol abuse, and 5.5% were affected by HCC. Disease progression in the observed timeframe was less frequent among treated patients (incidence rate per 100 patients/year: cirrhosis 2.1±0.7 vs 13.0±1.0, HCC 0.5±0.3 vs 3.6±0.5, death 0.5±0.3 vs 6.4±0.7). The annual expenditure for HCV management (drugs, hospitalizations, outpatient services) was €4,700 per patient.ConclusionThis observational, real-life study shows that only a small proportion of patients received antiviral therapy in the territorial services investigated; among patients who were not treated, this is reflected in a disease progression and cost of management higher than treated patients. These results suggest the importance of better defining the categories of patients who can really postpone treatment, and those who require immediate antiviral therapy.

Epidemiology, patient profile, and health care resource use for hepatitis C in Italy

“…10 Our findings are in line with a recently published nationwide study, which used the same methods of analysis as ours in a real-world clinical setting. The study conducted by Perrone et al, 12 from 2009 to 2010, showed that the prevalence of HCV among ~2.5 million health-assisted individuals was 0.4%. The recent study conducted by Lapi et al, analyzing all outpatients aged at least 15 years registered in the Italian Health Search IMS Health Longitudinal Patient Database from January 1, 2002 to June 30, 2013 reported that the prevalence rate of HCV in the 11-year study period was in the range from 0.24% to 0.50%.…”

“…At any rate, our findings are consistent with those of other Italian studies under real-world circumstances, in the literature so far. 12 , 31 Stroffolini et al showed that only 33% of evaluated HCV-infected patients were treated with current standard of care for hepatitis C. 31 A recent retrospective Italian study revealed that 12 patients who have not received HCV treatments showed a higher rate of progression of disease than patients who underwent therapy; in addition, these results also showed that patients receiving no treatment led to an increase in health care resources, especially in terms of hospitalizations. Providing early appropriate therapeutic interventions that can prevent liver disease progression related to HCV can potentially further reduce the economic burden associated with chronic hepatitis infection.…”

“…At present, few data are available on the epidemiology of HCV infections considering the Italian general population. 6 – 12 In addition, the few Italian studies available were obtained in limited geographic areas and were not representative of the whole Italian population. 11 The limited evidence shows that prevalence of HCV seropositivity was higher in Southern (7.3%) and Insular areas than in Central (6.1%) and Northern regions (about 1.6%).…”

Healthcare resource consumption and cost of care among patients with polycystic kidney disease in Italy

“…The structure of these DBs, which are routinely updated for administrative and reimbursement purposes, has been described in detail elsewhere. 12 The following DBs were used in this study: the beneficiaries DB, which contains patient demographic data; the medication prescription DB, which comprises information, including the Anatomical-Therapeutic-Chemical code, number of packages ordered, number of units per package, dosages, unit cost per package, and prescription date for each drug purchased for the patient; the hospital discharge DB, which contains data regarding all hospitalizations and includes the discharge diagnosis codes (classified according to the International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]) and diagnosis-related group (DRG) reimbursement rate; and the ambulatory care specialist DB, which includes records for all outpatient specialist services provided to the patient. The DBs were linked via anonymized patient codes.…”

A Real-Life Study of New Antiviral Therapies in a High Prevalence Geographical Area for Hepatitis C Virus Infection

“…Italy, Romania, Spain, Germany, France, United King-dom, Poland, Greece, and Bulgaria are the countries in which there are more than 80% of the patients affected by HCV in Europe (2). Currently, a small number of data sets are available on the epidemiology of HCV infection in Italy (3)(4)(5)(6). However, the known data demonstrate a prevalence of seropositivity for HCV that is higher in the Southern areas (7.3%), Central island (6.1%), and Northern ones (about 1.6%) (4).…”