Economic consequences of investing in anti-HCV antiviral treatment from the Italian NHS perspective : a real-world-based analysis of PITER data

OBJECTIVE: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. METHODS: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. RESULTS: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. CONCLUSIONS: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV

Il dolore dipinto: l'espressione della sofferenza nell'arte figurativa

Our study examines several autobiographical works that express life lived, a privileged access key to understand suffering people and the afflicted, and which reveal the ethico-anthropological dimension of medicine

Impact of HBV genotypes A and D genetic variability on infection evolution

HBV is characterized by a high genetic variability, which is the basis of its classification into eight genotypes (A-H). HBV infection is associated with different outcomes, from self-limiting acute hepatitis to active chronic hepatitis, asymptomatic carriage, and occult infection.The aim of this study was to analyze the genetic variability of HBV genotypes A and D isolates from 79 cases of self-limiting acute hepatitis and chronic hepatitis, in order to identify HBV variants associated with resolution or chronicity of acute HBV infection. The entire preS-S sequence and a fragment of 346. bp of the preC-C region, containing Enhancer II and Basal Core Promoter sequences, were analyzed. A phylogenetic analysis of preS/S region showed that the 45.45% (15/33) of isolates from acute hepatitis cases were genotype A compared to 8.69% (4/46) of chronic hepatitis cases. (p=0.0002). Mutations associated with immune-escape (T131N, D144A/E, G145K), amino acid polymorphisms in ". a determinant" domain of S protein and mutations/deletions in preC/C region were found in isolates from acute and chronic hepatitis B cases. In this study mutations/deletions in preS-S and preC-C regions, usually associated with fulminant acute hepatitis, advanced forms of liver disease and increased risk for HCC, were identified in HBV strains of genotype A and D obtained both from patients with self-limiting acute HBV infection and from persistent infected patients. This founding probably is due to the natural viral evolution under host immune response and to the circulation of a wide variety of HBV strains in our geographic area because of the ancient introduction of genotype D and the migrant fluxes from North Africa. Moreover, the analysis of circulation of new HBV antigenic variants is fundamental for the epidemiological surveys and for the evaluation of the impact of viral evolution on vaccine prophylaxis strategies

Pre-treatment factors predicting sustained virological response in treatment-naive HCV genotype I patients participating in a large, practice-based nationwide observational study

none7noneALBERTI A.; ASCIONE A; COLOMBO M; CRAXI A; PICCININO E; RIZZETTO M; SARRACINO MAlberti, Alfredo; Ascione, A; Colombo, M; Craxi, A; Piccinino, E; Rizzetto, M; Sarracino, M

Characteristics of hepatocellular carcinoma in Italy

This study aimed to assess the main features of hepatocellular carcinoma at the time of diagnosis in Italy, particularly in relation to the presence or absence of underlying cirrhosis, hepatitis virus marker patterns, age of the subjects and alpha-foetoprotein values.METHODS:A total of 1148 patients with hepatocellular carcinoma seen at 14 Italian hospitals in the 1-year period from May 1996 to May 1997 were the subjects of this prevalence study. Both newly diagnosed cases (incident cases) and cases diagnosed before May 1996 but still attending the hospitals during the study period (prevalent cases) were included.RESULTS:We found that 71.1% of cases were positive for hepatitis C virus antibodies but negative for HBsAg; in contrast, 11.5% were negative for anti-HCV but positive for HBsAg; 5.3% were positive for both markers; and 12.1% were negative for both viruses. The mean age of detection was over 60 years, with a younger mean age in HBsAg-positive compared to anti-HCV-positive patients (59.3 years vs. 65.6 years, p20 ng/ml) in 57.9% of patients; only 18% of cases presented diagnostic (>400 ng/ml) values. Anti-HCV positivity (O.R. 2.0; CI 95%=1.3-3.1) but not HBsAg positivity (O.R. 1.0; CI 95%=0.6-1.8) was shown to be an independent predictor of the likelihood of altered alpha-foetoprotein values by multivariate analysis.CONCLUSIONS:These findings point to differences in the characteristics of the populations infected by hepatitis B and hepatitis C. Factors other than the hepatitis viruses are important in non-cirrhotic patients. A change in the relative prevalence of hepatitis virus markers among hepatocellular carcinoma cases was demonstrated, reflecting a significant change in the rate of HBV endemicity in the Italian population. Finally, the increased trend in the mortality rate from liver cancer in Italy from 4.8 per 100,000 in 1969 to 10.9 in 1994 may reflect the large cohort of subjects infected with HCV via the iatrogenic route during 1950s and 1960s when glass syringes were commonly used for medical treatmen

Hepatitis C Virus Infection Is Associated With Increased\ua0Cardiovascular Mortality: A Meta-Analysis of Observational Studies

There have been many studies of the effects of hepatitis C virus (HCV) infection on cardiovascular risk, but these have produced ambiguous results. We performed a meta-analysis of these studies to systematically assess the risk of HCV infection on cardiovascular disease (CVD)-related morbidity and mortality