HCV spread among female incarcerated population and treatment pathways to viral elimination in Italian prison settings: clinical perspectives and medico legal aspects.

BACKGROUND: Hepatitis C virus (HCV) infection is more frequent among incarcerated people than in general population. In the DAAs era, the short schedules and the low risk of adverse reactions, increased the number of HCV treatments. However, the most part of literature reports lack of incarcerated women inclusion in studies on field. Our aim is to assess the screening execution, HCV prevalence, and DAAs treatment among incarcerated women. A focused insight on quick vs standard diagnosis and staging approach will be also provided. METHODS: Incarcerated women from 4 Italian regions' penitentiary institutes were included. HCV screening was executed with HCV saliva test (QuickOral Test®) or phlebotomy. Stage of liver fibrosis was evaluated with FIB-4 value or fibroscan®, based on physicians' decision. Treatment prescription followed national protocols. RESULTS: We included 156 women, 89 (57%) were Italian, mean age was 41 ± 10 years, and 28 (17.9%) were people who inject drugs (PWIDs). Overall, the HCV seroprevalence was 20.5%. Being PWID and on opioid substitution therapy (OST) were significantly associated with serological status (p-value < 0.001). Of them, the 75.5% of patients had active infection, the most frequent genotype was 3a (50%). Among them, 4 (16.6%) and 6 (25%) had psychosis or alcohol abuse history. The 62.5%, 25% and 12.5% had low, intermediate, and advanced fibrosis, respectively. Out of the 24 HCV-RNA positive patients, the 75% underwent to DAAs treatment. The sustained virological response (SVR12) was achieved in 88.8% of cases. When evaluating the influence of quick diagnosis and staging methods vs standard phlebotomy and fibroscan® on SVR12, FIB-4 use showed higher performance for retainment in treatment during prison staying (p = 0.015), while the use of quick saliva test had no influence on the outcome (p = 0.22). CONCLUSION: HCV seroprevalence and active infections are very high among incarcerated women. More tailored interventions should be focused on HCV diagnosis and treatment in female prison population. The use of quick staging methods (FIB-4) is useful to increase SVR12 achievement without delays caused by the fibroscan® awaiting.

The role of teicoplanin in the treatment of SARS-CoV-2 infection: A retrospective study in critically ill COVID-19 patients (Tei-COVID study).

Teicoplanin has a potential antiviral activity expressed against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and was suggested as a complementary option to treat coronavirus disease 2019 (COVID-19) patients. In this multicentric, retrospective, observational research the aim was to evaluate the impact of teicoplanin on the course of COVID-19 in critically ill patients. Fifty-five patients with severe COVID-19, hospitalized in the intensive care units (ICUs) and treated with best available therapy were retrospectively analysed. Among them 34 patients were also treated with teicoplanin (Tei-COVID group), while 21 without teicoplanin (control group). Crude in-hospital Day-30 mortality was lower in Tei-COVID group (35.2%) than in control group (42.8%), however not reaching statistical significance (p = .654). No statistically significant differences in length of stay in the ICU were observed between Tei-COVID group and control group (p = .248). On Day 14 from the ICU hospitalization, viral clearance was achieved in 64.7% patients of Tei-COVID group and 57.1% of control group, without statistical difference. Serum C-reactive protein level was significantly reduced in Tei-COVID group compared to control group, but not other biochemical parameters. Finally, Gram-positive were the causative pathogens for 25% of BSIs in Tei-COVID group and for 70.6% in controls. No side effects related to teicoplanin use were observed. Despite several limitations require further research, in this study the use of teicoplanin is not associated with a significant improvement in outcomes analysed. The antiviral activity of teicoplanin against SARS-CoV-2, previously documented, is probably more effective at early clinical stages.

Feasibility and efficacy of 8 week Glecaprevir/Pibrentasvir to treat incarcerated viraemic HCV patients: A case-control study.

Inmates have higher HCV prevalence than general population, representing a fundamental step towards HCV eradication. Our aim was to compare 8-week glecaprevir/pibrentasvir treatment in a case-control study between incarcerated and free patients. Eleven Italian prisons and six outpatient clinics were involved. Patients were matched for sex, risk factors, METAVIR grade, HIV and HBV co-infections. About 131 incarcerated (Group A) and 131 free patients (Group B) were included. Mean age was 43.0 ± 9.6 years and 42.8 ± 9.9 in Group A and B, respectively (P = .74). SVR rates were 96.2% and 99.2% in Group A and Group B respectively (P = .21). Five drop-outs occurred in Group A, one in Group B. Incarceration, being PWIDs and OST were not associated with SVR reductions (CI 95%). In conclusion, imprisonment does not influence unplanned interruptions or SVR rates when receiving short-term therapies. Short schedules with pangenotypic regimens could be a good approach to hard-to-reach populations, such as incarcerated patients.

Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis: A real-life study.

INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

Women Living with HIV in Italian Prison Settings: Results from the Gender-Specific ROSE Network.

BACKGROUND: Incarcerated women are a minority in the Italian prison population. The lack of prevention and awareness of HIV infection and the lack of access to treatment make the treatment path difficult. METHODS: we conducted a multi-center study including incarcerated women living with HIV (WLWH). RESULTS: The study included 85 WLWH with a mean age of 41.7 ± 8.7 years, and 58.8% (50/85) of them were Italian. Principally, HIV transmission was related to sexual intercourse, 47% of all patients were PWIDs, and 62.5% of them were on opioid substitution therapy (OST). Overall, 56.4% of the included patients had a CD4+ cell count of >500 cells/mmc. Among the participants, 92.9% were on antiretroviral therapy, 87.3% had treatment before incarceration, and 83.5% were virologically suppressed. Among the 13 non-virally-suppressed patients, 53.8% were unaware of their serological status before incarceration and had started HAART but were still not virologically suppressed; 46.2% (6/13) had a lack of compliance or had suspended the treatment before incarceration and restarted it after admission. All patients with chronic hepatitis C underwent treatment with direct-acting antivirals and reached a sustained virological response. CONCLUSIONS: the detention of these women could represent an occasion for the patients' healthcare provision and use, and the creation of a gender-specific network can be an effective strategy for reaching this population.

High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients.

Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV.

Treatment with direct-acting antivirals in a multicenter cohort of HCV-infected inmates in Italy.

BACKGROUND: People who are incarcerated have a significantly higher prevalence of HCV infection than the general population. Given their high-risk behavior, they represent a reservoir of HCV infection for the whole community. METHODS: We evaluated all HCV-infected people who were incarcerated in 25 Italian prisons starting direct-acting antivirals (DAAs) treatment between May 2015 and October 2016. We collected information on demographic characteristics, liver disease, HCV-related aspects, anti-HCV treatment, HIV or HBV co-infection. RESULTS: We enrolled 142 incarcerated people treated with DAAs. They were mostly Italians (93.7%) and males (98.6%). Median age was 50 years and 108/142 (76.1%) were cirrhotic patients. Prevalent genotypes were 1a (35.9%) and 3 (35.9%). Two patients were HBV co-infected, twenty-one patients (14.8%) were HIV co-infected and almost all (95.2%) received antiretroviral therapy. 118/142 (83.1%) DAAs-based regimens included sofosbuvir. Treatment completion rate was 94.4%. There were eight (5.6%) discontinuations, one (0.7%) due to an adverse reaction, one due to death (0.7%) and six (5.6%) due to release from prison. SVR12 was achieved in 90.8%. Four patients relapsed but no breakthrough occurred. CONCLUSIONS: Our study shows that in Italian penitentiary settings DAAs treatment is feasible and effective. This intervention is crucial for reducing HCV circulation with possible benefits to the general population.

Hospital admissions for HIV-infected prisoners in Italy.

Purpose The purpose of this paper is to give a description of the clinical conditions and patient demographics of inpatient admissions of human immunodeficiency virus (HIV)-infected inmates in three hospital wards that provide hospital care for inmates in Italy. Design/methodology/approach This is a retrospective review of hospital medical admissions of patients living with HIV from January 1 to December 31, 2014, in three Italian referral centers for hospitalization of inmates. Findings A total of 85 admissions for 85 different HIV-infected inmates occurred in 2014 in the three centers participating to the study. Most patients (54.1 percent) were co-infected with hepatitis C. Discharge diagnosis largely varied ranging from common HIV-related co-morbidities to completely independent diagnosis. The most commonly observed discharge diagnoses were chronic hepatitis C, liver cirrhosis, opiate dependence and thrombocytopenia. Originality/value Discharge diagnosis between HIV-infected inmates and HIV-infected patients in freedom are strikingly and significantly different. A large number of hospitalized HIV-infected inmates were affected by chronic viral hepatitis and liver cirrhosis; this is probably a direct consequence of the high prevalence of HCV and/or HBV co-infections in the inmate population in Italy. In addition, a significantly lower proportion of cancer diagnosis was observed among inmates; this is possibly justified by the fact that in our Italian settings when HIV infection is at advanced stages or if cancer treatment is started those affected are released from prison and can continue their diagnostic and treatment follow-up in freedom.

Detention and incompatibility of HIV patients in Italy. .

In Italy, Law 231/99 and subsequent amendments standardize the conditions allowing or not a HIV positive inmate to remain in jail. Currently such clinical conditions are not automatically associated with the decline of preventive detention and the Court evaluates the incompatibility with detention on the basis of two additional and independent criteria. We have been observing the tendency by jailed HIV-positive patients to manipulate the disease state believing that the rules of incompatibility with the prison system are always applied. The management of HIV positive patients in jail involves significant sanitary and relational efforts, particularly for those suffering AIDS and/or with severe immunodeficiency.

Liver schistosomiasis: an unexpected finding in hepatitis B virus-related chronic hepatitis.

CASE REPORT: We report the unusual case of an African patient who underwent a liver biopsy for a chronic HBV-related hepatitis, whose histological sample also unexpectedly revealed elements diagnostic for schistosomiasis. The patient was only mildly symptomatic for the Schistosoma infestation; stool examination confirmed the presence of parasitic eggs. Hepatitis B virus (HBV)-schistosomiasis co-infection is particularly rare in Western countries. Only the identification of some pathological elements atypical for HBV infection by means of step sections in the liver biopsy sample allowed us to disclose the unsuspected diagnosis. CONCLUSIONS: Since migratory flows have increased, the number of foreign people being referred to our hospitals has increased. Patients coming from areas endemic for infectious diseases that are absent in Western countries must be carefully evaluated, taking into account possible unexpected co-infections, including in the setting of pathological studies of liver biopsies.

Abdominal aortic mycotic aneurysm, psoas abscess, and aorto-bisiliac graft infection due to Salmonella typhimurium.

Infections due to nontyphoidal Salmonella are common and their incidence has been increasing in the last few years. Here, we describe a patient with a rupture of abdominal aortic aneurysm associated with a psoas abscess due to Salmonella typhimurium. Early diagnosis, prompt surgical intervention, and active and prolonged antibiotic therapy are the gold standard for the management of this severe clinical situation.