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Objectives: Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir to prevent HIV in individuals with hepatitis B virus (HBV) raises concerns about HBV reactivation when stopping event-driven PrEP or redundancy in HBV treatment for continuous PrEP (since tenofovir alone would be enough for HBV). Real-world data from PrEP services could provide useful epidemiological information on HBV prevalence in PrEP attendees in low-prevalence countries. Methods: A retrospective analysis on PrEP attendees of three services in northern Italy were conducted to assess HBV prevalence among PrEP attendees and the need for primary cycle/booster dose HBV vaccination despite previous vaccination during childhood (at birth or 12 years). Risk factors possibly associated with HBV exposure were evaluated with a binary logistic regression analysis, controlling for age, gender, place of birth (Italy vs abroad) and chemsex use (as a proxy of high-risk sexual behaviour for contracting sexually transmitted infections). Results: Among 10 hepatitis B surface antigen (HBsAg)-positive out of 2152 PrEP attendees (0.46%), PrEP was started in 7 subjects mainly with a daily schedule, 1 has declined after counselling, 2 were lost to follow-up. Around three-fourth of the 2152 PrEP attendees were born in Italy after 1979, thus were previously vaccinated during childhood. The probability of needing a booster for low-titre HBs antibodies was higher among those vaccinated at birth with respect to those vaccinated at 12 years (OR 2.30, 95% CI 1.80 to 2.96). The risk of previous HBV exposure (resulting in either HBsAg+ or antibodies against HBV core antigen [HBcAb]+) was higher for increasing age (OR 3.07, 95% CI 2.49 to 3.78 per 10 years more) and lower for being born in Italy (OR 0.23, 95% CI 0.14 to 0.36). Conclusions: Our real-world data on a large PrEP cohort suggest that, although uncommon, HBV infection in PrEP users in low-prevalence countries should be considered and managed. In addition, HBV scr

Nonostante la marcata riduzione della mortalità per malattie correlate all'AIDS tra le persone che vivono con l'HIV (PWH) durante l'era della terapia antiretrovirale (ART), l'incidenza dell'AIDS nel mondo è ancora significativa. Le infezioni opportunistiche e i tumori correlati all'HIV si verificano soprattutto nelle persone che non ricevono l'ART e rappresentano una sfida significativa per la gestione dei pazienti. Riportiamo il caso di un paziente con HIV e scarsa aderenza alla ART che si presenta alla nostra attenzione con una grave compromissione dello stato di salute generale e molteplici condizioni AIDS definenti. Questo caso evidenzia le sfide delle persone che vivono con HIV e hanno difficoltà ad aderire al trattamento ed è emblematico di come ci si imbatta ancora oggi in forme di AIDS estremamente aggressive e difficili da curare. In questi casi, a volte, nemmeno la diagnosi precoce, il trattamento adeguato e la massima assistenza fino al ricovero in terapia intensiva garantiscono un esito favorevole., Despite the marked reduction of mortality from AIDSrelated illnesses among people living with HIV (PWH) during the antiretroviral therapy (ART) era, the incidence of AIDS worldwide is still significant. Opportunistic infections and HIV-related tumors occur particularly in patients not receiving ART and pose a significant challenge for patient management. Here we present the case of a patient with HIV and poor adherence to ART who comes to our attention with a severe impairment of general health status and multiple AIDS-defining conditions. This case highlights the challenges of those individuals who have difficulty engaging in care and is emblematic of how we still encounter extremely aggressive and difficult to treat forms of AIDS. In these cases, sometimes, not even early diagnosis, adequate treatment, and maximal supportive care up to intensive care unit guarantee a favorable outcome.

Objective Monoclonal antibodies (mAbs) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reduced Coronavirus Disease 2019 (COVID-19) hospitalizations in people at risk of clinical worsening. Real-world descriptions are limited. Methods CONDIVIDIAMO, a two-year multicenter observational study, consecutively enrolled SARS-CoV-2 outpatients with ≥1 risk factor for COVID-19 progression receiving mAbs. Demographic data, underlying medical condition, type of mAbs combination received, duration of symptoms before mAbs administration, COVID-19 vaccination history, were collected upon enrolment and centrally recorded. Data on outcomes (hospitalizations, reasons of hospitalization, deaths) were prospectively collected. The primary endpoint was the rate of hospitalization or death in a 28-day follow-up, whichever occurred first; subjects were censored at the day of last follow-up or up to 28 days. The Kaplan-Meier method was used to estimate the incidence rate curve in time. The Cox regression model was used to assess potential risk factors for unfavorable outcome. Results were shown as hazard ratio (HR) along with the corresponding 95 % Confidence Interval (95%CI). Results Among 1534 subjects (median [interquartile range, IQR] age 66.5 [52.4–74.9] years, 693 [45.2 %] women), 632 (41.2 %) received bamlanivimab ± etesevimab, 209 (13.6 %) casirivimab/imdevimab, 586 (38.2 %) sotrovimab, 107 (7.0 %) tixagevimab/cilgavimab. After 28-day follow-up, 87/1534 (5.6 %, 95%CI: 4.4%–6.8 %) met the primary outcome (85 hospitalizations, 2 deaths). Hospitalizations for COVID-19 (52, 3.4 %) occurred earlier than for other reasons (33, 2.1 %), after a median (IQR) of 3.5 (1–7) versus 8 (3–15) days (p = 0.006) from mAbs administration. In a multivariable Cox regression model, factors independently associated with increased hospitalization risk were age (hazard ratio [HR] 1.02, 95%CI 1.00–1.03, p = 0.021), immunodeficiency (HR 1.78, 95%CI 1.11–2.85, p = 0.017), pre-Omicron cale

Objectives: To investigate whether efavirenz (EFV) or 8-hydroxy-EFV (8-OH-EFV) plasma levels are associated with neurocognitive impairment and central nervous system (CNS) side effects. Methods: We conducted a cross-sectional analysis to explore the potential links between EFV/8-OH-EFV levels and cognitive performance or CNS-related side effects in patients screened within a randomized trial involving a switch from EFV to rilpivirine. The Mann–Whitney test was employed to compare drug levels in patients with or without cognitive impairment, depression, anxiety, sleep disorder or CNS symptoms. Additionally, Spearman's test was used to assess correlations between drug levels and test scores. Results: Among 104 patients, neither EFV nor 8-OH-EFV levels were linked to cognitive impairment, although trends towards higher EFV levels were observed in those with impaired executive function (p = 0.055) and language performances (p = 0.021). On the other hand, elevated 8-OH-EFV levels, but not EFV levels, were associated with more CNS side effects (222 vs. 151 ng/mL, p = 0.027), depressive symptoms (247 vs. 164 ng/mL, p = 0.067) and sleep impairment (247 vs. 164 ng/mL, p = 0.078). Consistently, a trend towards a correlation between EFV levels and lower z-scores in executive function and motor function was observed, while 8-OH-EFV levels, but not EFV levels, were directly correlated with symptom scores. Conclusions: Higher levels of 8-OH-EFV were associated with CNS side effects, while EFV levels were only marginally associated with cognitive performance, thus suggesting that EFV and its metabolite may act differently in determining detrimental neurological effects.

Italian guidelines recommend HIV pre-exposure prophylaxis (PrEP) only upon satisfying strict eligibility criteria. The objective of this study is to evaluate if PrEP candidates attending a community-based service comply with these criteria and whether these prescribing conditions affect retention in care and sexually transmitted infections (STIs) acquisition. A retrospective analysis was performed on PrEP candidates evaluated from January 2019 to June 2022. Data were collected from self-administered questionnaires and clinical files. The population was divided in subjects with 0/1 (0/1 C) and >= 2 (>= 2 C) criteria. Descriptive statistics and non-parametric tests were employed to describe study population. Incidence of PrEP discontinuation and of STIs was estimated per 100 persons-year of follow up (PYFU), and incidence rate ratio (IRR) was calculated. Univariate and multivariable Cox regression analyses were used to evaluate the association strength between PrEP drop out and other variables. The analyses enrolled 659 individuals: 422 individuals were included in 0/1 C, 237 in >= 2 C group, respectively. Inconsistent condom use was the most reported prescribing criteria (399 individuals, 60.6%), followed by a previous STI (186 individuals, 28.2%). 0/1 C exhibited lower STIs incidence. PrEP discontinuation was 29% in 0/1 C and 38% in >= 2 C (p = 0.031). Cox model revealed that inconsistent condom use was the only prescribing criteria associated to PrEP persistence. The majority of PrEP candidate did not comply with prescribing conditions. Eligibility criteria failed to identify individuals with better retention in care. Our results suggest that Italian guidelines should be updated removing barriers to prescription.

L’Hotspot COVID di Monza è stato inaugurato a dicembre 2020, per la valutazione e monitoraggio dei pazienti con infezione da COVID-19 lieve o moderata, al fine di fornire ai medici di medicina generale uno strumento di supporto territoriale atto a ridurre il numero di accessi in pronto soccorso (PS) e la pressione sulle strutture ospedaliere. I pazienti sono stati valutati da un medico infettivologo o geriatra e da un infermiere di famiglia. Il quadro clinico è stato valutato tramite lo score National Early Warning Score 2 (NEWS-2) e secondo la stadiazione NIH (infezione asintomatica, malattia lieve, moderata, grave, critica). I dati anagrafici e clinici sono stati registrati su un database Excel. Tra dicembre 2020 e luglio 2022 sono stati visitati 1442 pazienti, per un totale di 2319 accessi (835 visite di controllo, 36,1%). I periodi di maggior affluenza sono risultati essere marzo-maggio 2021 (877 accessi), dicembre-febbraio 2021 (432 accessi) ed infine maggio-luglio 2022 (495 accessi). Il 23,3% dei pazienti ha necessitato di 1 o più rivalutazioni (541/2319); solo il 5,3% (123/2319) è stato inviato in PS. Da maggio a luglio 2022 la maggior parte delle visite si è concentrata sulla prescrizione e dispensazione delle terapie antivirali precoci (314/495 accessi, 63,4%): la maggior parte dei pazienti valutati in questo periodo aveva infatti un quadro clinico lieve. L’attività clinica svolta presso l’Hotspot è stata efficace per la gestione di un elevato numero di pazienti, mantenendo un numero limitato di accessi in PS. L’utilizzo dell’Hotspot è stato adattato secondo le necessità legate alle diverse fasi pandemiche e si è dimostrato un punto di cura che va nella direzione della riforma della sanità territoriale prevista dal Piano Nazionale Ripresa e Resilienza., The COVID Hotspot opened in December 2020 in the city of Monza. It aimed to evaluate patients with mildmoderate COVID-19, to avoid the overcrowding of the provincial emergency departments, and to aid general practitioner in the management of mild-moderate COVID-19. Patients were evaluated by an infective disease specialist or by a geriatric specialist and a nurse. NEWS2 score and NIH COVID staging (asymptomatic infection, mild, moderate, and severe disease) were used to assess patients’ clinical status. Patients’ data were registered in an Excel database. From December 2020 to July 2022, we examined 1442 patients and performed 2319 visits, with a follow-up rate of 36.1% (835 visits). Most of the assessments were performed during the following periods: March to May 2020 (877), December 2021 to February 2022 (432), May to July 2022 (495). During the observation period, a low proportion of patients was sent to the Emergency Department (5.3%), while about a quarter of all patients needed more than one visit (23.3%). From May to July 2022, most of the patients evaluated received an antiviral treatment (63.4%, 314/495); most patients evaluated during this period had mild COVID-19. Our COVID Hotspot evaluated a large number of patients and reduced the number of inappropriate Emergency Department visits. The COVID Hotspot is a flexible model ready to adapt to the different phases of COVID-19 pandemic and represents a local point of care in accordance with the new Italian health care system reorganization.

Background Transgender women sex workers (TGW-SW) are disproportionally affected by HIV and have reduced access to testing. Moreover, information regarding their behaviours and health needs is scarce. Methods A behavioural survey and a targeted testing programme in prostitution sites were conducted in Milan and Monza areas. The non-profit organisation 'ALA Milano Onlus' and 'San Gerardo' Hospital (Monza) implemented a mobile HIV testing unit involving a TGW peer educator, four physicians, a counsellor, a psychologist and a cultural mediator. All TGW-SW were offered anonymous HIV and hepatitis C virus (HCV) oral testing and asked to fill a questionnaire on sexual habits, drug abuse, and knowledge and attitudes towards HIV and STDs. Results Between May and July 2017, 130 TGW-SW, predominantly migrants, were contacted during 15 street visits; among them, 78 (60%) were interviewed. HIV and HCV testing were accepted by 53 (42%) and 67 (52%) TGW-SW, respectively. Twenty-five (19.8%) subjects who reported already established HIV infection were not retested. Seven patients received a new diagnosis of HIV, while nobody tested positive for HCV. Overall, HIV prevalence was 13.2% (25% including those with already known HIV infection). Recent arrival in Italy and young age were associated with risk of undiagnosed HIV infection. Inconsistent condom use was commonly reported during commercial sex (27%) and with non-commercial partners (64%). Alcohol and cocaine abuse were common problems which facilitated risky behaviours. Conclusions Oral rapid HIV and HCV testing for TGW-SW in outreach settings were feasible and acceptable and led to a considerable number of new diagnoses. Interventions tailored to TGW-SW, focused on HIV prevention, testing and engagement in care, are fundamental.

Background During the Coronavirus disease 2019 (COVID-19) pandemic, advanced health systems have come under pressure by the unprecedented high volume of patients needing urgent care. The impact on mortality of this “patients' burden” has not been determined. Methods and findings Through retrieval of administrative data from a large referral hospital of Northern Italy, we determined Aalen-Johansen cumulative incidence curves to describe the in-hospital mortality, stratified by fixed covariates. Age- and sex-adjusted Cox models were used to quantify the effect on mortality of variables deemed to reflect the stress on the hospital system, namely the time-dependent number of daily admissions and of total hospitalized patients, and the calendar period. Of the 1225 subjects hospitalized for COVID-19 between February 20 and May 13, 283 died (30-day mortality rate 24%) after a median follow-up of 14 days (interquartile range 5-19). Hospitalizations increased progressively until a peak of 465 subjects on March 26, then declined. The risk of death, adjusted for age and sex, increased for a higher number of daily admissions (adjusted hazard ratio [AHR] per an incremental daily admission of 10 patients: 1.13, 95% Confidence Intervals [CI] 1.05-1.22, p = 0.0014), and for a higher total number of hospitalized patients (AHR per an increase of 50 patients in the total number of hospitalized subjects: 1.11, 95%CI 1.04-1.17, p = 0.0004), while was lower for the calendar period after the peak (AHR 0.56, 95%CI 0.43-0.72, p<0.0001). A validation was conducted on a dataset from another hospital where 500 subjects were hospitalized for COVID-19 in the same period. Figures were consistent in terms of impact of daily admissions, daily census, and calendar period on in-hospital mortality. Conclusions The pressure of a high volume of severely ill patients suffering from COVID-19 has a measurable independent impact on in-hospital mortality.

Objectives: The aim of the present study was too investigate prevalence and persistence of human papilloma virus (HPV) and cytological abnormalities (CAs) in the anal swabs of people living with HIV (PLWH): men who have sex with men (MSM), men who have sex with women (MSW) and women (W). Methods: Between March 2010 and January 2019, an anal swab for cytological and HPV genotyping tests was offered to all PLWH attending our clinic. Logistic regression analysis was conducted to identify predictors of infection. Results: In all, 354 PLWH were screened: 174 MSM, 90 MSW and 61 W. Prevalence of at least one high-risk (HR) HPV was higher in MSM (91%) and W (85%) than in MSW (77%) (P < 0.05). Cytological abnormalities were found in 21.1% of the entire population. At multivariable regression analysis a lower risk for HPV infection was found for W than for MSM [odds ratio = 0.24 (95% confidence interval: 0.115–0.513)] and for MSW than for MSM [0.37 (0.180–0.773)] and there was a significantly higher risk of CAs in PLWH with HPV 16 and 18 [3.3 (1.04–10.49)]. A total of 175 PLWH (103 MSM, 33 MSW and 26 W) had at least one follow-up visit (T1) after a median (interquartile range) follow-up of 3.6 (2.1–5.7) years. The acquisition rate of HR-HPV was high, with 66.7% of PLWH negative for HR-HPV at T0 who became positive at T1 (P < 0.001). The prevalence of CAs was stable (20.6%). A significant association between CAs at T1 and persistence of HPV-16 and/or 18 was found (P < 0.05). Conclusions: HPV 16 and 18 are associated with the presence and development of CAs irrespective of sexual orientation.

Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI).