Prevalence of Viral Hepatitis in Unselected, Consecutively Enrolled Patients Hospitalised for SARS-CoV-2

Diagnosing people living with chronic viral hepatitis is challenging due to the absence of symptoms as long as liver decompensated cirrhosis come out. The aim of this retrospective study was to evaluate the prevalence of HBV and/or HCV infections in a non-selected population, hospitalised for SARS-CoV-2 infection in a tertiary care hospital in Northern Italy. During the study period 1,429 patients were admitted to hospital for SARS-CoV-2 infection, serologic tests for HBV and/or HCV were available for 382 (27%) patients and 3 were excluded due to their previous known serologic status. Among 379 patients, 235 (62%) were male, median age was 70 years (range 21-103), 360 (95%) were Caucasian. Among them, 372/379 (98%) were screened for HBsAg, 320/379 (84%) for HBcAb. HBsAg was positive in 2/372 (0.5%, 95% CI 0.0006-0.02) patients (only in one HBV-DNA was performed that was negative), while HBcAb was found positive in 55/320 (17%, 95% CI 0.13-0.22). Among 370/379 (98%) patients screened for HCV, 11/370 (3%, 95% CI 0.02-0.05) had positive HCV-Ab. Five out of 11 (45%) were tested for HCV-RNA that resulted positive in two patients (0.5%, 95% CI 0.0006-0.02). Considering this data, even though the screening was performed in only 27% of study population, a tailored screening in people with known risk factors for hepatitis might be preferable to universal screening in low prevalence areas. Also a prompt diagnostic workout should begin in case of clinical or laboratory suspicion of hepatitis and in those starting immunosuppressive treatments

Clinical significance of inflammatory markers of bacterial infection in critically ill patients with COVID-19 after treatment with anti-inflammatory and immunomodulatory drugs: a complex new scenario.

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Budget impact analysis of sofosbuvir-based regimens for the treatment of HIV/HCV-coinfected patients in northern Italy: A multicenter regional simulation

Objectives: Chronic hepatitis C virus (HCV) is a leading cause of hospitalization and death in populations coinfected with human immunodeficiency virus (HIV). Sofosbuvir (SOF) is a pan-genotypic drug that should be combined with other agents as an oral treatment for HCV. We performed a 5-year horizon budget impact analysis of SOF-based regimens for the management of HIV/HCV-coinfected patients. Methods: A multicenter, prospective evaluation was conducted, involving four Italian Infectious Diseases Departments (Galliera, San Martino, Sanremo, and La Spezia). All 1,005 genotype-coinfected patients (30% cirrhotics) under observation were considered (patients in all disease-stages were considered: chronic hepatitis C, cirrhosis, transplant, hepatocellular carcinoma). Disease stage costs per patient were collected; the expected disease progression in the absence of treatment and sustained virological response (SVR) success rate for SOF-based regimens were calculated based on the literature and expert opinion. Drug prices were based on what the National Health Service paid for them. The comparison of \u201cno treatment\u201d disease progression costs versus the economic impact of SOF-based regimens was investigated. Results: Over the following 5 years, the disease progression scenario resulted in direct costs of approximately \u20ac54 million. Assuming an SVR success rate of 90%, average SOF-based regimens cost up to \u20ac50,000 per person, resulting in a final cost of more than \u20ac56 million, so this option is not economically viable. At the average price of \u20ac12,000, SOF-based regimens, expense was \u20ac17 million, saving 68%. At this price level, the economic resources invested in treating mild to moderate fibrosis stage patients would be equal to the amount of direct costs of disease management in this stage, resulting in a valid return of investment in the short-term. Conclusion: Given the high rates of SVR, in the Italian Healthcare System, SOF-based regimens, price is a determinant and a predictor of the overall cost for the Hepatitis C patient\u2019s management. At the average price per therapy of \u20ac12,000 over the next 5 years, SOF-based regimens are becoming highly sustainable

Cost per care of the first year of direct antiviral agents in the liguria region: A multicenter analysis

Aims: Despite the remarkable efficacy shown in clinical practice, concerns have been raised about the costs associated with direct antiviral agent (DAA) therapy. This article presents the real-life costs for DAA treatment sustained by the Italian National Health Service in the Liguria Region (Northern Italy). Methods: A retrospective analysis of the cost per care sustained for DAA treatment, relating to the period from January 1 to December 31, 2015 in five centers in Liguria was performed. All patients undergoing DAA-based treatments for hepatitis C virus (HCV) infection were enrolled. On-treatment costs included: HCV treatment, laboratory test, outpatient services, attended visits, drugs used for the management of adverse events (erythropoietin, albumin or red blood cell packs) and inpatient service admissions. Results: In total, 327 patients were enrolled. No difference in terms of sustained virologic response (SVR) rate among different treatments was reported. The majority (85.0%) of patients did not report any side effects and only 15 (4.6%) required hospital admission. Forty-two patients (12.8%) required high-cost drugs for the management of adverse events. The overall cost sustained was \u20ac14,744,433. DAA\ub1ribavirin (RBV) accounted for the wide majority of this cost (98.9%; \u20ac14,585,123). Genotype (GT) 1, the most commonly treated GT, was associated with an average cost of \u20ac43,445 per patient. Detailed analysis of the costs for GT 1 showed the treatment based on ritonavir boosted paritaprevir/ombitasvir + dasabuvir\ub1RBV with an average cost of \u20ac24,978 (RBV+) and \u20ac25,448 (RBV 12) per patient was the most cost-effective. The average cost per SVR was \u20ac48,184. Once again, the ritonavir boosted paritaprevir/ ombitasvir + dasabuvir regimen was associated with the lowest cost/SVR (\u20ac25,448/SVR [GT 1b] and similar results for other GTs). Conclusion: Antiviral regimen is the major contributor to costs in the treatment of HCV infection. Appropriate regimen selection could result in a major cost saving, which can be reinvested to allow more patients to be treated

Inflammatory effects of atazanavir/ritonavir versus darunavir/ritonavir in treatment naïve, HIV-1-infected patients

Background: Limited studies have compared the impact of different antiretroviral regimens on soluble markers of inflammation with discordant results. Methods: In this prospective study, treatment naïve HIV-1-infected patients were included if they started their current regimen with atazanavir/ritonavir (ATV/r) (N = 73, Group 1) or darunavir/ritonavir (DRV/r) (N = 85, Group 2) plus tenofovir/emtricitabine. The analysis of IL-6, MCP-1, sCD163, VCAM-1, ox-LDL, and adiponectine was performed on two stored plasma samples, the first prior to antiretroviral therapy initiation and the second one year after initiation. Results: The results of our analysis show a difference in ox-LDL between the two groups with higher mean (SD) values in ATV/r based group 608.5 ± 137.4 versus 519.1 ± 119.6 in DRV/r group, after controlling for baseline levels of ox-LDL as well as other potential confounding factors controlled by means of matching design or linear regression modelling. Conclusions: Our analysis provides further data examining the association between the modulation of vascular inflammatory and of activation markers with specific protease inhibitors-based treatments over one year of exposure to these drugs. The data show little evidence for an association, supporting the notion that antiretroviral regimens has generally poor efficiency in downregulating these soluble markers

High–temporal resolution profiling reveals distinct immune trajectories following the first and second doses of COVID-19 mRNA vaccines

Knowledge of the mechanisms underpinning the development of protective immunity conferred by mRNA vaccines is fragmentary. Here, we investigated responses to coronavirus disease 2019 (COVID-19) mRNA vaccination via high–temporal resolution blood transcriptome profiling. The first vaccine dose elicited modest interferon and adaptive immune responses, which peaked on days 2 and 5, respectively. The second vaccine dose, in contrast, elicited sharp day 1 interferon, inflammation, and erythroid cell responses, followed by a day 5 plasmablast response. Both post-first and post-second dose interferon signatures were associated with the subsequent development of antibody responses. Yet, we observed distinct interferon response patterns after each of the doses that may reflect quantitative or qualitative differences in interferon induction. Distinct interferon response phenotypes were also observed in patients with COVID-19 and were associated with severity and differences in duration of intensive care. Together, this study also highlights the benefits of adopting high-frequency sampling protocols in profiling vaccine-elicited immune responses

Una rete multicentrica standardizzata per gestire e analizzare le co-morbidit\ue0 e gli effetti collaterali legati a terapie HAART in pazienti con infezione da HIV

Abstract: Nel contesto sanitario, l\u2019utilizzo dell\u2019Information and Communication Technology (ICT) \ue8 diventato uno strumento fondamentale. A tale proposito, anche la Commissione Europea si \ue8 espressa in tale senso (\u201ceHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century\u201d, Brussels, 6.12.2012) evidenziando l\u2019importanza strategica dell\u2019ICT per ottenere una sanit\ue0 migliore a costi ridotti. In particolare, la gestione del paziente con infezione da HIV \ue8 diventata sempre pi\uf9 complessa nel corso degli anni, potrebbe trarre enormi vantaggi dall\u2019ICT. Infatti, con l\u2019avvento della HAART l\u2019infezione da HIV \ue8 diventata una malattia cronica da monitorare e gestire nel tempo. Tali terapie, spesso causa di effetti collaterali, e la presenza di comorbidit\ue0, collegate allo stato d\u2019immunodeficienza e di immunoattivazione, hanno generato la necessit\ue0 di una visione clinica complessiva del paziente infetto con l\u2019esigenza di accedere a una grande mole d\u2019informazioni. Inoltre, i pazienti sieropositivi sono spesso coinvolti in studi clinici all\u2019interno dei quali tali informazioni provengono da strutture e fonti diverse. La soluzione che proponiamo \ue8 una rete multicentrica basata su web e database relazionale che permettono di gestire il paziente sieropositivo nella sua completezza e il rapido accesso alle informazioni, con particolare accento sugli effetti collaterali legati alla HAART e alle comorbidit\ue0. Inoltre, attraverso tale piattaforma web \ue8 possibile supportare Studi Clinici Multicentrici nell\u2019ambito dell\u2019HIV. La struttura del database \ue8 stata sviluppata in modo da renderla facilmente scalabile. In primo luogo \ue8 stata attuata una forte strutturazione dell\u2019informazione facendo largo uso di Ontologie Biomediche (i.e. LOINC, SNOMED e ICD) e Standard Internazionali (i.e. HL7) . Inoltre, altro aspetto fondamentale \ue8 l\u2019archiviazione delle informazioni relative alle metodologie di lavoro usate da ciascun centro che partecipa al progetto (unit\ue0 di misura e intervalli di normalit\ue0). Tali metodologie permettono non solo un rapido accesso alle informazioni ma anche la possibilit\ue0 di un\u2019efficiente condivisione e confronto anche da un punto di vista semantico. Secondariamente, l\u2019utilizzo del web permette una larga fruibilit\ue0 a costi relativamente bassi. Attualmente, dopo un anno e mezzo, \u201cLa rete ligure dell\u2019HIV\u201d \ue8 utilizzata da 11 centri di Malattie Infettive in Liguria e Piemonte. Attualmente, la coorte \ue8 costituita da circa 350 pazienti, i cui dati clinici sono facilmente accessibili e utilizzabili sia durante la pratica clinica sia per scopi di ricerca, nel totale rispetto della privacy del paziente. Obiettivo futuro sar\ue0 l\u2019importazione delle informazioni attraverso un\u2019interfaccia standard (HL7) direttamente dai sistemi informativi ospedalieri aumentando cos\uec sia la quantit\ue0 che la qualit\ue0 dei dati archiviati