Background: Treatment of Opioid Use Disorder (OUD) in prisons is challenging, mainly because of the risks of abuse, diversion and suboptimal treatment adherence. New weekly/monthly long-acting injectable formulations of buprenorphine could represent a paradigm shift in OUD treatment, limiting the risks of daily-dose therapies and ensuring a better quality of life for inmates with OUD. In light of this new pharmacological technology, actions and areas for improvement in the management and recovery of detained people with OUD were highlighted. Methods: During four workshops, improvement areas for treating patients with OUD were identified. Based on the outputs, two modified group consensus techniques (Nominal Group and Delphi) were used consecutively, involving a growing number of experts in the field. The overall results led to a manifesto focused on improving the management and recovery of inmates with OUD. Results: Significant needs of inmates with OUD are reduction of stigma and equity in access to treatment options. Regarding operators, dissemination of best practices, application of scientific evidence and adequate educational training are required. Concerning treatments, new long-acting buprenorphine formulations could reduce the risks of abuse and diversion linked to current daily therapies. These innovative treatments find one of their ideal contexts in prisons and therapeutic communities. Conclusions: Inmates with OUD have the right to access innovative treatments like other citizens. Long-acting buprenorphine formulations are of particular interest because of their efficacy and tolerability and their potential to improve the quality of life of detained people with OUD.
The infectious diseases are an important comorbidity in drugs users and a health warming.Today only a few percentages of drug users are subjected to screening for hepatitis and human immunodeficiency virus (HIV).In the recent years an effort has been made in drug users for the elimination of hepatitis C virus (HCV).Unfortunately, several barriers are now limiting the achievement of the goal of HCV elimination, as suggested by WHO.Drug users are people highly at risk to contract HBV and HDV infections. Only a few percentages of drug users receive HBV/HDV treatments, although they are effective and safe. The lack of treatment for drug users may be due to several factors. The main is that only a few percentages of drug users are tested for HBV and linked to treatment.The principal aim of this work is to defi ne a therapeutic diagnostic pathway (Percorso Diagnostico Terapeutico Assistenziale – PDTA) able to favorite HBV/HDV screening and linkage to care in drug users.
Italy has had the highest prevalence of hepatitis C virus (HCV) infection and mortality from HCV-related liver cancer in Europe. Although direct-acting antivirals (DAA) were initially restricted to persons with advanced fibrosis, their use has since been extended to all infected individuals; more than 244 000 persons have been treated to date. HCV liver-related mortality is expected to decline by 75% by 2030, achieving the World Health Organization target for mortality. However, Italy risks failing to meet the overall goal of eliminating HCV infection by 2030. In this light, €71.5 million have been allocated for screening initially specific target populations (persons who inject drugs, prison inmates, and the 1969-1989 birth cohort). Herein, we outline the challenges and recommendations for how to move Italy toward HCV elimination, including expanding screening programs in other populations, increasing awareness through strategic communication, sustaining DAA access, and tailoring care models to meet the needs of key populations.
Purpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic directantiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment with DAAs, resource consumptions for the National Patients and Methods: During 01/2011-06/2020, administrative databases of Italian healthcare entities, covering 3,900,000 individuals, were browsed to identify PWUDs with or without HCV infection. Among HCV+ patients, a further stratification was made into treated and untreated with DAAs. The date of PWUD or HCV first diagnosis or DAA first prescription was considered as index-date. Patients were then followed-up for one year. Alcohol-dependency was also investigated.Results: Total 3690 PWUDs were included, of whom 1141 (30.9%) PWUD-HCV+ and 2549 (69.1%) PWUD-HCV-. HCV-positive were significantly older (43.6 vs 38.5 years, p < 0.001), had a worse comorbidity profile (Charlson-index: 0.8 vs 0.4, p < 0.001), and high rates of psychiatric, respiratory, dermatological, musculoskeletal diseases and genitourinary (sexually transmitted) infections. Moreover, they received more drug prescriptions (other than DAAs, like anti-acids, antiepileptics, psycholeptics) and had undergone more frequent hospitalization, predominantly for hepatobiliary, respiratory system and mental disorders. DDA-untreated had significantly higher Charlson-index than DAA-treated (0.9 vs 0.6, p = 0.003). Alcoholism was found in 436 (11.8%) cases.Conclusion: This Italian real-world analysis suggests that PWUDs with HCV infection, especially those untreated with DAAs, show an elevated drug consumption due to their complex clinical profile. These findings could help to ameliorate the healthcare interventions on PWUDs with HCV infection.
The infectious diseases are the most prevalent illnesses in prisoners, and they have a relevant burden for the society. Several studies have shown that the screening and the treatment of the infectious diseases inside prisons may be effective in reducing their burden in the general community. The main aim of the study was to determine between 2019-2021 the incidence and the prevalence of HIV, HBV, HCV, TB and syphilis in the people inside Padua prisons. The study has demonstrated that the screening of the infectious diseases in detainees was very high, raising in 2021 in the entrant people the 100%. The research also has shown that during 2021 the most prevalent incidence of infectious diseases was for TB (16.3%), followed by HCV (11.3%), HBV (7.9%) and HIV (1.6%). Interestingly, our data has indicated how during 2021 versus the previous years the prevalence of the infectious diseases increased for HBV (41.5%), HCV (18.8%), and TB (48.1%). These data indicate as different conditions such as the geographic origin of the prisoners people or several environmental factors such as the overcrowding may influence the prevalence of the infectious disease inside prisons. The study suggests how the prisons may represent a place where may be easier the treatment of the patients affected by infectious diseases and how universal and periodic screening campaigns and facilitated treatment programs as the point of care may increase the access to care and to control the spread of infectious also in the general community.
Hepatitis D virus (HDV) is a public health concern for its severe medical consequences. The aim of this pilot study was to evaluate the prevalence of the main infectious disease between the detainees of the Veneto Region. The study consisted of a survey carried between the heads of the prison healthcare staff. The data showed that on 2,119 detainees the prevalence of hepatitis B (HBV) is the 6% and that the most relevant prevalence of HBV was revealed in the East Europe detainees (Ex USSR countries, Albania, Bosnia, Kosovo, Macedonia), being the 39% of all HBcAb positive subjects. The survey also revealed as the population less protected by HVB vaccination was that comes from East Europe. Moreover, the study indicates that hepatitis D diagnosis is not well known by clinician working inside prisons and that it should be improved through specific diagnostic and therapeutic procedures. Our data indicate that the prison setting may play an important and crucial role in term of public health both in intercepting patients that need of treatment and in preventing actions able to minimize the risk of infection. In prison settings screening, linkage to care and harm reduction measures should be improved in order to protect the general population from the impact of the emerging infectious diseases, including HDV.
Italy has two different public healthcare services taking in care patients with dual diagnosis: (1) the mental health services (Centri di Salute Mentale - CSM) and (2) and the drug abuse services (Servizi per le Dipendenze - Ser.D.). We collected and analyzed data regarding the frequency of the co-morbidities in Veneto Region during 2019. Our study shows that only the 1% of the patients in treatment in the mental health services and the 8.7% of those in drug abuse services are recognized as dual diagnosed subjects. In drug abuse services the most frequent substance use disorders (SUD) correlated with a psychiatric disease were the alcohol and opioids use disorders, while the most prevalent psychiatric disorders associated with a SUD were the personality disorders and the schizophrenia, schizotypal and delusional disorders. Our data indicate that the diagnosis of co-morbidity should be improved in both services and that integrated programs between the above services should be developed to improve the best practices.
Abstract Background It has been estimated that the incidence of chronic hepatitis C virus (HCV) will not decline over the next 10 years despite the improved efficacy of antiviral therapy because most patients remain undiagnosed and/or untreated. This study aimed to investigate the opinion of relevant target populations on the practicability, effectiveness and best modalities of the test-and-treat approach in the fight against HCV in Italy. Methods A survey was delivered to patients with HCV from the general population, patients from drug addiction services, hospital physicians and healthcare providers for drug addiction services. Results For both hospital clinicians and SerD HCPs, tolerability is shown as the most important feature of a suitable treatment. Time to treatment (the time from first contact to initiation of treatment) is deemed important to the success of the strategy by all actors. While a tolerable treatment was the main characteristic in a preferred care pathway for general patients, subjects from drug addiction services indicated that a complete Meet–Test–Treat pathway is delivered within the habitual care center as a main preference. This is also important for SerD HCPs who are a strong reference for their patients; hospital clinicians were less aware of the importance of the patient-HCP relationship in this process. Conclusion The health system is bound to implement suitable pathways to facilitate HCV eradication. A Meet–Test–Treat program within the drug addiction services may provide good compliance from subjects mainly concerned with virus transmission.
Although Italy has been on track for Hepatitis C Virus (HCV) elimination since 2019, it fell off track due to the decrease in the number of treated patients. HCV elimination in Italy will be possible if immediate action is taken. A health policy was implemented beginning in 2021, consisting of screening among key populations and birth cohorts (1969-1989), estimated to have a high prevalence of undiagnosed individuals. The active screening requires regional governance that manages the processes' complexity integrating a well-organized network between territory assistance and hospital to achieve an effective HCV care cascade. This document aims to support the regional decision-making process by defining paths for screening and linkage-to-care. Implementing active screening strategies beyond a risk-based approach is required as a General Practitioners' task. Simplified paths must be drawn for the key populations screening. The infrastructure built for COVID-19 vaccination could be used also for HCV screening. According to a multidisciplinary care delivery, screening should be supplemented with rapid linkage-to-care and treatment of newly diagnosed patients. The realization of the proactive screening during the first two years is vital because it will define the tracks for the whole HCV cost-effective screening of 1948-1988 birth cohorts in Italy.
Proposal for the enhancement of alcohology (prevention, treatment and rehabilitation of alcohol problems): the position of Società Italiana di Alcologia (SIA), Federazione Italiana degli Operatori dei Dipartimenti e dei Servizi delle Dipendenze (FeDerSerD) and Società Italiana Tossicodipendenze (SITD)
Background Hepatitis C is a disease correlated with severe systemic consequences having elevated social and health costs. The HCV elimination is a public health concern that may be solved reaching DAAs treatment for drug users. The principal aim of this work is to evaluate the cost-benefit of a point of care for HCV treatment of drug users inside Drug abuse services (Ser.D.). Methods The study consists in a cost-benefit analysis able to evaluate the "return of health" induced by a point of care for a HCV treatment. Results The work shows that the point of care is cost-benefit in comparison with the "traditional" treatment being cost saving for the public health system. The data suggest that the cost of the point of care is corresponding to euros 593,40 while the cost of not treatment of euros 8.679,60 (due to the direct and indirect costs of the disease). Conclusions The study demonstrate the point of care is an effective model of care able to reduce the barriers of treatment and to induce a "health return" in term of cost saving for the public health systems. Indeed, the work shows how the point of care may make the elimination HCV plans sustainable for the public health agencies.
Significant steps must be taken to reduce the global incidence and prevalence of hepatitis C virus (HCV) and mortality from HCV infection to achieve the WHO goal of eliminating viral hepatitis as a public health threat by 2030. Proper epidemiological surveillance of the full continuum of care is essential for monitoring progress and identifying gaps that need to be addressed. The tools required for elimination have largely been established, and the issue at hand is more how they should best be implemented in different settings around the world. Documenting good practices allows for knowledge exchange to prevent transmission and improve health outcomes for people with HCV. This review found 13 well documented HCV good practices that have become the standard of care or that should become the standard of care as soon as possible. In 2013, highly effective direct-acting antiviral therapy became available, which has cure rates of over 95%. Together with this new therapy, evidence-based good practices can help countries eliminate viral hepatitis C.
The Covid-19 emergency in prisons is a public health warming due to overcrowding, poor structural conditions,and life promiscuities.Worldwide a lot of prisoners were Sars-CoV-2 positive and in Italy several outbreaks occurred in many prisons.This paper examines, using a clinical audit, a Covid-19 outbreak occurred in an Italian prison during the spring2021.The study showed that the best measures to mitigate the outbreak negative consequences both in prisoners andin the staff are the preventive actions, the hygiene and disinfection of the common detention areas; the reductionof overcrowding; the stop of the working activities during the quarantine period.Only an improvement of living conditions inside the prisons may reduce the risk of infection among inmates.
Introduction: Sodium oxybate (SMO) has been approved in Italy and in Austria for the treatment of alcohol use disorder (AUD). This study describes the cumulative postmarketing and clinical safety experience with SMO in AUD. Areas covered: Safety data for SMO at approved posology in AUD were identified from: (i) the clinical trial registries of the US National Institutes of Health (NIH) and the European Medicines Agency (EMA), (ii) reports from the biomedical literature and (iii) available pharmacovigilance safety information from the EMA. Expert opinion: Safety data from 3 recent large randomized clinical studies (520 participants) and 43 earlier clinical studies (2547 participants) showed that SMO has a good safety profile in AUD patients. The safety profile was confirmed by pharmacovigilance data resulting from 299 013 patients exposed to SMO in Austria and Italy. Main adverse events were transitory dizziness and vertigo. Serious adverse events were rare. No death attributable to SMO has been reported. Risks of abuse or dependence are low in patients without psychiatric comorbidities or poly-drug use. The adverse events of SMO are transitory and do not require discontinuation of treatment. SMO abuse or dependence are extremely rare in patients without psychiatric comorbidities or poly-drug use.
The epidemiological data suggests that people who use drugs (PWUDs) are the most important "reservoir" for the spread of HCV infection. For this reason PWUDs should be included in all HCV elimination plan as priority target for treatment.We performed an observational study in 5 Italian Drug Abuse Services (SerDs) with the main aims to determine: 1) the prevalence of HCV infection in PWUDs; 2) the most important barriers to HCV treatment.Of the about 4,000 drug users included in the study only about the 36% was tested and of them the 20% were anti HCV positive; only about the 60% of the HCV RNA positive patients were treated.The study showed several important barriers to the screening, especially when cannot used rapid tests and/or if test is not proposed periodically, and to the linkage to care, in particular when the HCV treatment cannot be given inside the SerDs.The study has also revealed as the harm reduction measures as suggested by WHO are not offered to all PWUDs. In conclusion the study suggests how inside the SerDs the barriers for HCV treatment that can be overcome with a simpler model of treatment as represented by the point of care.