Anti SARS-CoV-2 antibodies monitoring in a group of residents in a long term care facility during COVID-19 pandemic peak.

Objectives Clinical laboratories plays a key role in screening, diagnosis and containment of the Coronavirus 2019 infection epidemic. The etiological diagnosis presupposes the isolation of virus genetic material in the patient's biological sample but laboratory diagnostics also make use of searching possibility for immunoglobulin (Ig)G, IgM classes antibodies. The characteristics of the antibody response are not yet completely clear. Methods This study describes a serological monitoring of subjects, elderly nursing care residence guests, interested by a very large infection outbreak. After first nasopharyngeal swab, all the positive subjects (43) were monitored for the persistence of the virus infection through nasopharyngeal swab after 20 days (16-24), 32 days (28-36) and after 49 days (47-50). At the same time, during the second (day 32) and third (day 49) follow up, all the guests were investigated for IgM and IgG anti SARS-CoV-2 antibodies, by using a quantitative chemiluminescence method. Results Thirty two days after performing the first diagnostic swab, 39 of 43 patients (90%) had IgG higher than the cut off value. After 49 days the four patients with negative IgG were still negative. The comparison of the levels of IgG-Ab between the controls shows a significant decrease in concentrations (-10%). Conclusions Our study confirms that in most patients affected by COVID-19 there is a typical antibody response with IgG-Ab present in 90% of nursing care COVID-19 positive residence guests. For IgM-Ab only 23% of tested subjects were positive on the 32nd and 49th day of illness, always in parallel with the IgG-Ab positivity.

Cost-Effectiveness of Tele-Video-Consultation for the Neuro-Surgical Emergency Management at the General Hospitals in Italy.

Background: Neuro-surgical emergencies are serious (long-term disability and high mortality) and costly to the national health services. Tele-medicine intervention can facilitate to reduce this gap. Our study aims to evaluate the cost-effectiveness of tele-video-consultation intervention for the management of neuro-surgical emergencies in the general hospitals. Methods: We retrieved health service data from the tele-consultation service, online tele-medicine database portal and hospital patient registry, between January 2009 and December 2012 and evaluated cost-effectiveness of the tele-video-consultation intervention from an Italian National Health Service perspective. Results: Seventy-five percent of the tele-consultations were completed within 15 min and 90% within 30 min. The average costs were €2,326 in the intervention group and €4,173 in the care as usual group. The intervention avoided 73% potential transfer (saving of 139,916 km travel distance during a 4-years period). The incremental cost-saving per transfer avoided from the tele-medicine intervention was €365. Conclusions: Tele-medicine intervention could be worth investing from the Italian National Health Service perspective.

Therapy of chronic hepatitis C with PEG-IFN α-2b plus ribavirin in patients with genotype 2 or 3: 16 versus 24 weeks, clinical outcome and direct cost analyses.

INTRODUCTION: Short antiviral therapy has been proposed for patients with chronic hepatitis C, easy genotypes, low fibrosis score, low viral load at baseline, and rapid virological response (RVR). However, this approach is not completely accepted. OBJECTIVES: The aims of this study were (a) to evaluate the sustained virological response (SVR) in noncirrhotic patients with genotype 2 or 3, achieving an RVR, randomized to receive pegylated-interferon (IFN) α-2b plus ribavirin for either 16 or 24 weeks and (b) to carry out direct cost analysis comparing patients treated for 16 versus 24 weeks. RESULTS: Of the 142 initially evaluated patients, 130 were enrolled according to the selection criteria, but independent of the viral load. According to the intention-to-treat analysis, SVR was achieved in 104 patients (80%). Logistic regression analysis showed that RVR (P<0.001) and genotype 2 (P<0.03) were the most important factors independently associated with SVR. Among patients with RVR, SVR was comparable between patients treated for 16 weeks and those treated for 24 weeks (86.2 vs. 89.7%, P=NS). The mean direct costs were €4003.7 for patients treated for 16 weeks and €5676.7 for those treated for 24 weeks, with a 30% difference between the two arms. CONCLUSION: In patients achieving an RVR, a 16-week treatment with pegylated-interferon plus ribavirin was comparable to a 24-week treatment. Short treatment in patients with RVR allows us to save 30% of the direct costs, independent of the viral load at baseline.

Taking decisions on expenditure for high-cost drugs at the regional level: a model for evaluating the overall impact of Trastuzumab in the Veneto Region of Italy.

INTRODUCTION: Cost-effectiveness analysis provides a ratio that indicates the value created per unit of money by a given therapy but says nothing about the total expected costs or net health and social impact of this therapy in a particular population of interest. OBJECTIVE: The main objective of this study is to define a methodology to calculate the effects of interventions from a local perspective. This will help determine parameters that provide information about resource planning and management to local decision makers. METHODS: The described methodology calculates four indicators using local demographic and epidemiological data and a Markovian decision tree approach. RESULTS: The method was applied to evaluate the economic, health and social impact of introducing a new cancer drug, Trastuzumab, for the early treatment of breast cancer in the Veneto Region of Italy. DISCUSSION: The indicators described in this study allow public policy makers to clearly understand the benefits and costs of a particular health intervention in a local population and to compare it with other strategies.

The impact of disease stage on direct medical costs of HIV management: a review of the international literature.

The global prevalence of HIV infection continues to grow, as a result of increasing incidence in some countries and improved survival where highly active antiretroviral therapy (HAART) is available. Growing healthcare expenditure and shifts in the types of medical resources used have created a greater need for accurate information on the costs of treatment. The objectives of this review were to compare published estimates of direct medical costs for treating HIV and to determine the impact of disease stage on such costs, based on CD4 cell count and plasma viral load. A literature review was conducted to identify studies meeting prespecified criteria for information content, including an original estimate of the direct medical costs of treating an HIV-infected individual, stratified based on markers of disease progression. Three unpublished cost-of-care studies were also included, which were applied in the economic analyses published in this supplement. A two-step procedure was used to convert costs into a common price year (2004) using country-specific health expenditure inflators and, to account for differences in currency, using health-specific purchasing power parities to express all cost estimates in US dollars. In all nine studies meeting the eligibility criteria, infected individuals were followed longitudinally and a 'bottom-up' approach was used to estimate costs. The same patterns were observed in all studies: the lowest CD4 categories had the highest cost; there was a sharp decrease in costs as CD4 cell counts rose towards 100 cells/mm³; and there was a more gradual decline in costs as CD4 cell counts rose above 100 cells/mm³. In the single study reporting cost according to viral load, it was shown that higher plasma viral load level (> 100,000 HIV-RNA copies/mL) was associated with higher costs of care. The results demonstrate that the cost of treating HIV disease increases with disease progression, particularly at CD4 cell counts below 100 cells/mm³. The suggestion that costs increase as the plasma viral load rises needs independent verification. This review of the literature further suggests that publicly available information on the cost of HAART by disease stage is inadequate. To address the information gap, multiple stakeholders (governments, pharmaceutical industry, private insurers and non-governmental organizations) have begun to establish and support an independent, high quality and standardized multicountry data collection for evaluating the cost of HIV management. An accurate, representative and relevant cost-estimate data resource would provide a valuable asset to healthcare planners that may lead to improved policy and decision-making in managing the HIV epidemic.

Changing epidemiology of HCV and HBV infections in Northern Italy: a survey in the general population.

AIM: To evaluate the hepatitis B virus (HBV) and the hepatitis C virus (HCV) epidemiology in the general population of Northern Italy, a cohort of 965 subjects, all residents (including 47 immigrants), were anonymously tested for HBV and HCV infections. MATERIAL AND METHODS: Serum samples were assayed for anti-HCV and anti-HBV markers by enzyme-linked immunosorbent assay and for HCV-RNA by polymerase chain reaction, and the positive cases were genotyped. HBsAg-positive cases were assayed for HBeAg/anti-HBe, whereas HBsAg negatives were tested for both anti-HBc and anti-HBs. RESULTS: The overall prevalence of anti-HCV was 2.6%, with a bimodal distribution characterized by the highest prevalence (12%) in subjects over 75 years old. None of the subjects under 25 years old was anti-HCV positive. Anti-HCV positivity was similar in males and females (2.4% vs. 2.7%). HCV-RNA was positive in 40% of cases and genotype 1 was the most common. The HBsAg prevalence was 1%, with a significant difference according to country of origin (0.8% in Italian subjects vs. 6.4% in immigrants, P=0.01). HBsAg positivity increased significantly with age (R2=0.57, P<0.02). The overall percentages for the prevalence of isolated anti-HBs, anti-HBs+/anti-HBc+, and isolated anti-HBc were 23.8%, 8.4%, and 4.2%, respectively. CONCLUSIONS: Our study provides a new picture of HCV and HBV epidemiology in Northern Italy, with these features: (1) a cohort effect showing a reduction of HCV infection in the elderly, possible due to age-related mortality; (2) an unchanged overall prevalence of HBV infection, despite continuing immigration of subjects from endemic countries.

Cost-effectiveness of tipranavir versus comparator protease inhibitor regimens in HIV infected patients previously exposed to antiretroviral therapy in the Netherlands.

BACKGROUND: This study compares the costs and effects of a regimen with ritonavir-boosted tipranavir (TPV/r) to a physician-selected genotypically-defined standard-of-care comparator protease inhibitor regimen boosted with ritonavir (CPI/r) in HIV infected patients that were previously exposed to antiretroviral therapy in the Netherlands. METHODS: We compared the projected lifetime costs and effects of two theoretical groups of 1000 patients, one receiving a standard of care regimen with TPV/r as a component and the other receiving a standard of care regimen with CPI/r. A 3-stage Markov model was formulated to represent three different consecutive HAART regimens. The model uses 12 health states based on viral load and CD4+ count to simulate disease progression. The transition probabilities for the Markov model were derived from a United States cohort of treatment experienced HIV patients. Furthermore, the study design was based on 48-week data from the RESIST-2 clinical trial and local Dutch costing data. Cost and health effects were discounted at 4% and 1.5% respectively according to the Dutch guideline. The analysis was conducted from the Dutch healthcare perspective using 2006 unit cost prices. RESULTS: Our model projects an accumulated discounted cost to the Dutch healthcare system per patient receiving the TPV/r regimen of euro167,200 compared to euro145,400 for the CPI/r regimen. This results in an incremental cost of euro21,800 per patient. The accumulated discounted effect is 7.43 life years or 6.31 quality adjusted life years (QALYs) per patient receiving TPV/r, compared to 6.91 life years or 5.80 QALYs per patient receiving CPI/r. This translates into an incremental effect of TPV/r over CPI/r of 0.52 life years gained (LYG) or 0.51 QALYs gained. The corresponding incremental cost effectiveness ratios (iCERs) are euro41,600 per LYG and euro42,500 per QALY. CONCLUSION: We estimated the iCER for TPV/r compared to CPI/r at approximately euro40,000 in treatment experienced HIV-1 infected patients in the Netherlands. This ratio may well be in range of what is acceptable and warrants reimbursement for new drug treatments in the Netherlands, in particular in therapeutic areas as end-stage oncology and HIV and other last-resort health-care interventions.

Prospective study of amphotericin B formulations in immunocompromised patients in 4 European countries.

BACKGROUND: Amphotericin B is a widely used broad-spectrum antifungal agent, despite being associated with significant adverse events, including nephrotoxicity. METHODS: The present prospective study collected data on outcomes for 418 adult patients treated consecutively with polyenes in hematology and oncology wards in 20 hospitals in Europe. RESULTS: Patients initially received amphotericin B deoxycholate (62% of patients), liposomal amphotericin B (27%), or other lipid formulations of amphotericin B (11%). Of the patients initially treated with amphotericin B deoxycholate, 36% had therapy switched to lipid formulations of amphotericin B, primarily because of increased serum creatinine levels (in 45.7% of patients) or other amphotericin B-attributable adverse events (in 41.3% of patients). Nephrotoxicity, which was defined as a > or = 50% increase in the serum creatinine level, developed in 57% of patients with normal kidney function at baseline. Predictors of nephrotoxicity included formulation type and duration of treatment. Compared with patients without nephrotoxicity, patients with nephrotoxicity had a higher mortality rate (24%), and their mean length of stay in the hospital was prolonged by 8.6 days. Slight increases in the serum creatinine level (i.e., > or = 50%) were associated with a significantly longer stay in the hospital. Severe nephrotoxicity (i.e., a > or = 200% increase in the serum creatinine level) was a significant predictor of death, as were severe underlying medical conditions and documented fungal infection. CONCLUSION: This prospective study confirmed that, in European hospitals, amphotericin B formulations have a major influence on the length of stay in the hospital and nephrotoxicity-associated mortality.

Economic evaluation of HIV treatments: the I.CO.N.A. cohort study.

OBJECTIVE: To describe the changes in costs of care for HIV-positive patients in Italy after the spread of antiretroviral combination therapies (HAART). METHODS: Five thousand four hundred and twenty-two patients from the I.CO.N.A. (Italian Cohort Naive Antiretrovirals) study were followed between 1997 and 2002. Costs included antiretroviral therapies (ART), hospital admissions, prophylaxis, and main laboratory examinations. The perspective was that of the National Health Service. RESULTS: Admission costs per person-year decreased from 2148 euro in 1997 to 256 in 2002, while the average annual costs of ART increased from 2145 to 3149 euro (1997 prices). From 1997 to 1999, ART costs increased from 42.3 to 85.9% of the total, while admission costs decreased from 42.3 to 7.0% and prophylaxis from 7.3 to 1.7%. The breakdown of ART costs shows how dual therapies decreased over time in favor of HAART, falling from 26.8% in 1997 to 5.9% in 2002. Patients with fewer than five treatment switches had the lowest costs distributions over the entire observation period. CONCLUSIONS: From 1997 to 2002 inpatient costs progressively decreased in favor of antiretroviral therapy. Annual average costs per patient decreased, while total direct costs increased over time: health resources, initially concentrated on hospitalized patients were then distributed over a growing number of subjects.

Alcohol is an important co-factor for both steatosis and fibrosis in Northern Italian patients with chronic hepatitis C.

BACKGROUND/AIMS: Steatosis in patients with chronic hepatitis C (CHC) may be the result of both viral and host factors. To evaluate: (1) the relationship between steatosis and either host or viral factors; (2) the correlation between steatosis and fibrosis in patients with CHC. METHODS: A consecutive series of 349 patients were evaluated for steatosis. At liver biopsy, patients were tested for virological, and laboratory analysis and questioned for alcohol consumption. RESULTS: Logistic regression analysis demonstrated that steatosis was independently associated with genotype 3a (odds ratio, OR 3.5), alcohol intake at the time of biopsy (OR 2.6) and age >35 years (OR 2.7). In multivariate analysis the presence of fibrosis was associated with past alcohol abuse (OR 3.7), and age older than 44 years (OR 2.2). Overall, a weak correlation was found between grade of steatosis and fibrosis score (r=0.861, P=0.05), which disappeared excluding patients without past or current alcohol intake. A direct correlation emerged between grade of steatosis and both 'grading' and 'staging' only in patients with genotypes other than 3a. CONCLUSIONS: Genotype 3a is the main risk factor for steatosis in patients with CHC. The grade of steatosis correlated with both grading and staging only in patients with genotypes other than 3a and this relationship is strictly linked to alcohol consumption.

Association between diarrhea and quality of life in HIV-infected patients receiving highly active antiretroviral therapy.

Diarrhea is a common symptom that many HIV patients experience either as a consequence of HIV infection or of highly active antiretroviral therapy (HAART). A multicenter, prospective observational study was conducted in 11 AIDS clinics in Italy to determine the effect of diarrhea on health-related quality of life among patients receiving HAART. The study enrolled 100 consecutive HIV positive patients who had diarrhea while on HAART. For each enrolled patient a control patient with matching disease stage who did not have diarrhea was identified using existing data from another prospective observational study conducted in 34 AIDS clinics (including the 11 in current study). Quality of life was measured by MOS-HIV Health Survey (MOS-HIV). Paired t-test and multiple regression analysis were used to compare the quality of life among patients with and without diarrhea. Mean patient age was 40 +/- 7 years; 69% were male. Mean CD4 cell count was 342 +/- 239 cells/mm3; 59% had AIDS. Of the cases, 49 patients had severe diarrhea (> 5 bowel movements or > 3 watery per day) and 46 patients had moderate diarrhea (3-5 bowel movements). Compared to matched control patients, cases experiencing diarrhea while on HAART had significantly lower MOS-HIV scores in all domains. The significant adverse effect of diarrhea on quality of life should be considered when choosing the appropriate antiretroviral drugs regimen.

A multicentre study of patient survival, disability, quality of life and cost of care: among patients with AIDS in northern Italy.

OBJECTIVE: To describe the epidemiological, clinical and economic changes that occurred in the HIV epidemic in Italy prior to and after the introduction of highly active antiretroviral therapy (HAART). DESIGN: A prospective, observational, multicentre case-control study was conducted comparing data, collected over 6 months, from an AIDS cohort in 1998 with that of a cohort in 1994. Out of 77 patients with AIDS in the 1998 cohort, 74 survived. These 74 patients were matched for severity of illness with 74 patient survivors from the 1994 cohort to enable valid comparisons of mortality, disability-dependency (DD), health-related QOL (HR-QOL), and direct costs. RESULTS: Overall, a considerable difference was observed in mortality (33.8% in 1994 vs 3.9% in 1998) between unmatched patients of the two cohorts. As for matched patients, the number of hospital admissions was 1.7 in 1994 and 0.8 in 1998; the average length of stay was 28.1 days in 1994 and 12.6 days in 1998. The direct cost per patient per year was euro15 390 and euro11 465 for the 1994 and 1998 cohorts, respectively (1999 values). The 1998 patient cohort had significantly better HR-QOL at 6 months in two domains of the instrument used (emotional reaction and energy) and the percentage of totally dependent patients was significantly lower compared with the 1994 cohort (1.4% vs 6.8%). CONCLUSIONS: This is the first study to present a comprehensive comparison of direct costs, DD and HR-QOL of patients with AIDS between two time periods. The use of a case-control design has enabled changes in costs and outcomes to be linked to the introduction of HAART in Italy in 1997.

Modifications of health resource-use in Italy after the introduction of highly active antiretroviral therapy (HAART) for human immunodeficiency virus (HIV) infection. Pharmaco-economic implications in a population-based setting.

OBJECTIVE: To assess the impact of highly active antiretroviral therapy (HAART) on health resource utilisation (HRU) and to estimate associated direct costs in a population based setting. DESIGN: Retrospective study of all patients in the Institute of Infectious and Tropical Diseases (Brescia, Northern Italy) during a 4 years period related to the prescription of HAART has been performed: from 1997 (before HAART) to 2000 (after substantial period of HAART prescription). MAIN OUTCOME MEASURES AND RESULTS: HIV inpatient admissions (IA's) decreased from 506.8/1000 patients (pts) in 1997 to 246.3/1000 pts in the year 2000. Day care admissions (DCA's) also decreased from 1658.3/1000 pts to 942/1000 pts, while outpatient consultations (OC's) increased from 2046.9/1000 pts to 2590.6/1000 pts in the same years, respectively. By contrast, a relative increase of IA's and DCA's of patients whose serostatus was HIV-negative or unknown has been found. Cost of antiretroviral therapy increased by 2582 Euro (2272 US Dollars), while cost of HIV care (IA+DCA+OC) decreased by 1546 Euro (1360.4 US Dollars) per patient, resulting in a saving in direct cost equal to 60% of the increase in the expenditure for antiretroviral drugs. CONCLUSIONS: Our results demonstrate the shift of HIV care from inpatient to outpatient services that occurred after HAART had been introduced into clinical practice. Despite persisting clinical benefits, an increase in total direct cost for HIV pts has been seen for the first time during the HAART era in the year 2000, probably due to an over-prescription of HAART, according to actual Guideline for antiretroviral therapy use, to pts who were not at risk of clinical progression in the short term. Pharmacoeconomical surveillance of HAART is necessary while a favourable impact on the saving in cost is expected from the new treatment guidelines that suggest a relative delay in starting HAART.