Mpox, caused by Monkeypox virus (MPXV), is associated with mucosal involvement and immune modulation that may influence viral coinfections. Merkel Cell Polyomavirus (MCPyV), a ubiquitous virus capable of lifelong persistence, was investigated in 66 Mpox patients enrolled at Lazzaro Spallanzani National Institute for Infectious Diseases (Rome, Italy; 2022-2025). Oropharyngeal and anal swabs collected during acute Mpox and, at 9-month follow-up, were analyzed by quantitative PCR, sequencing, transcript, and microRNA assays. MCPyV DNA was detected in 23/66 (34.8%) individuals, with higher prevalence and load in anal (31.8%, 2.1 × 103 copies/mL) than in oropharyngeal swabs (24.4%, 1.3 × 102 copies/mL; p < 0.001). MCPyV persisted in 4/10 (40%) oropharyngeal samples at follow-up. No viral integration was observed, and full-length Large Tumor Antigen was amplified in all samples. Transcript analysis revealed early and late genes; viral microRNAs were found in 3/10 (30%) oropharyngeal and 5/14 (35.7%) anal acute-phase swabs, and persisted in 3/4 (75%) MCPyV-positive oropharyngeal samples at follow-up. Among the 12 MCPyV-positive people living with human immunodeficiency virus (HIV), MCPyV load was lower in oropharyngeal but higher in anal swabs compared to MCPyV/MPXV cases. This study provides the first evidence of MCPyV detection in Mpox-positive individuals and supports further investigation of its clinical relevance in coinfection settings.

OBJECTIVES:Italy introduced reimbursement for oral HIV pre-exposure prophylaxis (PrEP) in 2023. We examined PrEP implementation in Italy from 2023 to 2024 to evaluate regional uptake. METHODS:A nationwide survey within the scope of the PrIDE cohort (NCT07186244) was conducted across 62 infectious diseases and community-based centers in Italy in 2023 and 2024. Data were collected on individuals who started PrEP and those in follow-up, demographics, and the people with HIV (PWH) to PrEP users ratio, as proxy for unmet prevention need. We compared metrics before and after PrEP reimbursement and analyzed regional disparities. RESULTS:PrEP uptake increased substantially in 2024, with a cumulative number of users increasing by 51.6% (10,697 in 2023, 16,220 in 2024). Growth was uneven across regions: Sardinia (+71.4%), Friuli (+65.4%), and Emilia-Romagna (+54.7%) experienced the most significant increases. Most PrEP users remain concentrated in certain regions (Lombardy, Lazio, and Emilia-Romagna accounting for 75.6%) and were male (95.7%). Overall, 11,785/16,220 (72.7%) individuals were retained in care through 2024. The PWH/PrEP ratio improved nationally in 2024, but remained high in some areas. CONCLUSION:The PrIDE survey shows an increase in PrEP uptake and services expansion after reimbursement in Italy. However, significant regional disparities and structural barriers endure.

Background:Italian oral pre-exposure prophylaxis (PrEP) implementation faced challenges until the drug reimbursement approval in 2023. National real-life data on effectiveness are lacking. This study aimed to report incidence rates (IR) of HIV and other sexually transmitted infections (STIs), along with probabilities and predictors of poor adherence and PrEP discontinuation. Methods:Prospective national cohort study (ItaPrEP) on oral PrEP users (PrUs) in eight Italian centers (September 2017-November 2023) that could partially provide free drug supplies. IRs of HIV and STIs, and Kaplan-Meier estimated probabilities of poor adherence and discontinuation were evaluated. Mixed-effect logistic models with random intercept on the center were used to explore the association between risk factors and poor adherence and discontinuation. Results:About 1758 PrUs were included, 98% MSM; five HIV seroconversions were observed with an IR 0.187/100 person-year follow-up (PYFU; 95% CI: 0.061-0.436). IR/100 PYFU were 13.1 (95%CI:11.7-14.5) for syphilis, 23.8 (95% CI: 22-25.7) for chlamydia, and 24.2 (95% CI: 22.4-26.1) for gonorrhea. The 2-year probability of poor adherence and discontinuation was 57.9% (95% CI: 54.8-61.0) and 37.1% (95% CI: 34.3-40.1), respectively.Chemsex and switching schedule were associated with poor adherence, unlike a high educational level. Age >40 years, free drug supplies, and laboratory monitoring were associated with a lower risk of discontinuation, while chemsex was associated with a higher risk. Conclusions:In this Italian oral PrEP program, the HIV incidence was lower than that observed in pivotal clinical trials in high-risk populations and close to that of observational real-life studies. Identifying fragile groups (youngest, low educational level, and chemsex users) and addressing barriers (free drugs and monitoring) are key to targeting strategies to improve oral PrEP implementation.

OBJECTIVES:To compare the 12-month immunogenicity of Nuvaxovid XBB.1.5 (protein-based) and Pfizer-BioNTech monovalent mRNA XBB.1.5 boosters in people with HIV (PWH) on stable antiretroviral therapy, assessing humoral and cellular immune responses against ancestral and emerging SARS-CoV-2 variants. METHODS:Fifty participants with a median age of 58 years (interquartile range, IQR 52, 66), all previously primed with at least four monovalent mRNA doses, received either Nuvaxovid (n = 24) or mRNA vaccine (n = 26), depending on availability. Anti-receptor binding domain (RBD) IgG, neutralizing antibodies (nAbs) against D614G, XBB.1.16, JN.1, LP.8.1, and IFN-γ T-cell activity were measured at baseline (T0), 1 month (T1), and 12 months (T2) post-booster. RESULTS:At T1, anti-receptor binding domain (RBD) IgG titers were higher in the mRNA group than in the Nuvaxovid group (6942 vs 4143 BAU/mL; P = 0.01), but nAbs and T-cell responses showed no significant differences. At T2, humoral responses were comparable, with a trend toward higher LP.8.1 nAb titers in Nuvaxovid recipients (P = 0.06). Mixed-model analyses confirmed stronger short-term LP.8.1 nAb responses with mRNA, but slower waning with Nuvaxovid. No consistent differences were observed for other variants. DISCUSSION:Overall, mRNA boosters provided a stronger early humoral response, while Nuvaxovid may promote more sustained T-cell immunity. Both maintained robust responses over 12 months, supporting their use in people with HIV (PWH). Given its thermostability and accessibility, Nuvaxovid is a practical alternative when mRNA vaccines are unavailable or contraindicated.

Rejection of new anti-SARS-CoV-2 booster doses among immunosuppressed and elderly individuals may be a concern, especially as the intention to vaccinate does not always translate into actual behavior. Few studies have addressed this issue in people living with HIV (PWH). We investigated attitudes of PWH toward SARS-CoV-2 vaccination, focusing on factors associated with noncompliance with additional vaccine doses (AVDs, 4th and 5th). We analyzed participants of the prospective observational HIV-VAC study conducted at the National Institute for Infectious Diseases "L. Spallanzani" IRCCS, Rome (September 2022-June 2023). Eligible patients with complete vaccination schedules were voluntarily recruited and completed a 13-item survey on demographics and vaccination attitudes. Multivariate logistic regression was used to describe the relationship between "compliant" vs. "non-compliant" groups. Of 316 participants, 240 (75.9%) were compliant and 76 (24.1%) non-compliant. Compliance was 70% for the fourth and 30% for the fifth dose; noncompliance was 19.9% and 4.1%, respectively. Older age (p = .012) and information from non-institutional sources (p < .0001) were associated with higher noncompliance. Among non-compliant participants, 34.4% reported concerns about side effects. In PWH aged >50, fear of side effects and reliance on unofficial information sources are major barriers to AVD uptake. Non-compliant individuals tend to persist in their refusal over time. Tailored communication and healthcare professional training are crucial to improve vaccine adherence, and further multicenter studies are warranted.

BACKGROUND:Implementation level of long-acting injectable agents cabotegravir/rilpivirine (LAI CAB/RPV) for human immunodeficiency virus (HIV) treatment in Italy is still not known. The aim of this study is to identify the status of implementation of LAI CAB-RPV and its barriers. MATERIALS AND METHODS:A cross-sectional online survey was conducted among infectious diseases (ID) physicians and nurses belonging to the ICONA network in Italy. Three validate 4-items measures were used: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). RESULTS:Out of 61 ICONA centres, 38 (62%) completed the survey: 57.9% were academic centres, 42.1% were hospital-based. In total, 104 respondents were ID physicians (57.4%), 77 were nurses (42.5%); 4.5% of all PWH followed at the 38 centres started LAI CAB/RPV at time of study. Centres taking care of >1000 PWH reported 95% application of procedures for LA implementation, higher than other centres (P = 0.009). Mean score of AIM was (16.0, standard deviation, SD, 3.3), of IAM (16.0, SD 3.0) and FIM (16.0, SD 2.9). A linear correlation was found between AIM and the number of people with HIV who started LAI CAB/RPV (25-50 versus <25, coefficient of correlation [b] 2.57, 95%CI 0.91-4.60, P = 0.004), academic versus hospital-based centres (b -1.59, 95%CI -2.76-0.110044, P = 0.007) and the absence of preliminary systematic assessment of staff (b -1.98, 95%CI -3.31-0.65, P = 0.004). Implementation barriers were not significantly different according to the number of PWH/centre. CONCLUSIONS:LAI CAB/RPV implementation was low, with a great variability according to centre size. Tailored and centre-specific interventions to address barriers and to optimize the LA treatment implementation should be designed.