Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort study.

Background: Pre-exposure vaccination with MVA-BN has been widely used against mpox to contain the 2022 outbreak. Many countries have defined prioritized strategies, administering a single dose to those historically vaccinated for smallpox, to achieve quickly adequate coverage in front of low supplies. Using epidemiological models, real-life effectiveness was estimated at approximately 36%-86%, but no clinical trials were performed. Few data on MVA-BN immunogenicity are currently available, and there are no established correlates of protection. Immunological response in PLWH in the context of the 2022 outbreak was also poorly described. Methods: Blood samples were collected from participants eligible for pre-exposure MVA-BN vaccination before (T1) receiving a full course of vaccine (single-dose for vaccine-experienced or smallpox-primed and two-dose for smallpox vaccine-naïve or smallpox non-primed) and one month after the last dose (T2 and T3, respectively). MPXV-specific IgGs were measured by in-house immunofluorescence assay, using 1:20 as screening dilution, MPXV-specific nAbs by 50% plaque reduction neutralization test (PRNT50, starting dilution 1:10), and IFN-γ-producing specific T cells to MVA-BN vaccine, by ELISpot assay. Paired or unpaired t-test and Wilcoxon or Mann-Whitney test were used to analyse IgG and nAbs, and T-cell response, as appropriate. The probability of IgG and nAb response in vaccine-experienced vs. vaccine-naïve was estimated in participants not reactive at T1. The McNemar test was used to evaluate vaccination's effect on humoral response both overall and by smallpox vaccination history. In participants who were not reactive at T1, the proportion of becoming responders one month after full-cycle completion by exposure groups was compared by logistic regression and then analysed by HIV status strata (interaction test). The response was also examined in continuous, and the Average Treatment Effect (ATE) of the difference from baseline to schedule completion according to previous smallpox vaccination was estimated after weighting for HIV using a linear regression model. Self-reports of adverse effects following immunization (AEFIs) were prospectively collected after the first MVA-BN dose (T1). Systemic (S-AEFIs: fatigue, myalgia, headache, GI effects, chills) and local (L-AEFIs: redness, swelling, pain) AEFIs were graded as absent (grade 0), mild (1), moderate (2), or severe (3). The maximum level of severity for S-AEFIs and L-AEFIs ever experienced over the 30 days post-dose by vaccination exposure groups were analysed using a univariable multinomial logistic regression model and after adjusting for HIV status; for each of the symptoms, we also compared the mean duration by exposure group using an unpaired t-test. Findings: Among the 164 participants included, 90 (54.8%) were smallpox vaccine-experienced. Median age was 49 years (IQR 41-55). Among the 76 (46%) PLWH, 76% had a CD4 count >500 cells/µL. There was evidence that both the IgG and nAbs titers increased after administration of the MVA-BN vaccine. However, there was no evidence for a difference in the potential mean change in humoral response from baseline to the completion of a full cycle when comparing primed vs. non-primed participants. Similarly, there was no evidence for a difference in the seroconversion rate after full cycle vaccination in the subset of participants not reactive for nAbs at T1 (p = 1.00 by Fisher's exact test). In this same analysis and for the nAbs outcome, there was some evidence of negative effect modification by HIV (interaction p-value = 0.17) as primed people living with HIV (PLWH) showed a lower probability of seroconversion vs. non-primed, and the opposite was seen in PLWoH. When evaluating the response in continuous, we observed an increase in T-cell response after MVA-BN vaccination in both primed and non-primed. There was evidence for a larger increase when using the 2-dose vs. one-dose strategy with a mean difference of -2.01 log2 (p ≤ 0.0001), after controlling for HIV. No evidence for a difference in the risk of developing any AEFIs of any grade were observed by exposure group, except for the lower risk of grade 2 (moderate) fatigue, induration and local pain which was lower in primed vs. non-primed [OR 0.26 (0.08-0.92), p = 0.037; OR 0.30 (0.10-0.88), p = 0.029 and OR 0.19 (0.05-0.73), p = 0.015, respectively]. No evidence for a difference in symptom duration was also detected between the groups. Interpretation: The evaluation of the humoral and cellular response one month after the completion of the vaccination cycle suggested that MVA-BN is immunogenic and that the administration of a two-dose schedule is preferable regardless of the previous smallpox vaccination history, especially in PLWH, to maximize nAbs response. MVA-BN was safe as well tolerated, with grade 2 reactogenicity higher after the first administration in vaccine-naïve than in vaccine-experienced individuals, but with no evidence for a difference in the duration of these adverse effects. Further studies are needed to evaluate the long-term duration of immunity and to establish specific correlates of protection. Funding: The study was supported by the National Institute for Infectious Disease Lazzaro Spallanzani IRCCS "Advanced grant 5 × 1000, 2021" and by the Italian Ministry of Health "Ricerca Corrente Linea 2".

Risk Awareness as a Key Determinant of Early Vaccine Uptake in the Mpox Vaccination Campaign in an Italian Region: A Cross-Sectional Analysis.

BACKGROUND: we aim to investigate attitudes toward vaccination by analyzing empirical factors associated with vaccine acceptance in the Lazio region mpox vaccination (MpoxVax) campaign in Italy. METHODS: all subjects who accessed MpoxVax and signed the informed consent were prospectively enrolled in the MPOX-VAC Study and were asked to fill out an anonymous survey. Two endpoints were selected: 'delayed acceptance' and 'early acceptance', defined as access for vaccination >60 and ≤30 days from the vaccination campaign starting (VCS), respectively. RESULTS: over the study period, 1717 individuals underwent vaccination: 129 (7%) > 60 [1588 (92.5%) ≤ 60] and 676 (60%) ≤ 30 days from VCS. A bisexual orientation, a lower education level and a worse perceived physical and mental health were associated with delayed access to vaccination. Being pre-exposure prophylaxis (PrEP) users and, marginally, HIV positive; having a high perceived risk for mpox infection; and reporting high-risk behaviors like the use of recreational drugs/chems, sex under the influence of drugs and/or alcohol and having a higher number of principal sexual partners, were associated with early access to vaccination. CONCLUSIONS: according to our data, risk awareness was a major determinant of early MpoxVax acceptance. Conversely, worse perceived health status and a low educational level were critical factors associated with delayed vaccination.

Clinical presentation of human monkeypox virus infection during the 2022 outbreak: descriptive case series from a large italian Research Hospital.

BACKGROUND: In May 2022, a new case of Monkeypox Virus (MPX) was reported in a non-endemic area, the United Kingdom, and since then, the number of confirmed cases in Europe has been increasing until WHO, on May 10 2023, declared that MPOX is no longer a public health emergency of international concern. We aimed to describe the clinical and microbiological characteristics of sixteen patients with a confirmed diagnosis of MPX followed by a single Italian clinical centre, the Fondazione Policlinico Universitario Agostino Gemelli, between May 20 and August 30. MATERIALS AND METHODS: A prospective observational study has been conducted, collecting microbiological samples during the time of the infection, as well as epidemiological and clinical data of the patients. All patients provided written informed consent. RESULTS: During clinical practice, 16 individuals presenting with consistent symptoms tested positive for MPX on a polymerase chain reaction. All patients were men having sex with men (MSM). The most frequent clinical presentation was a vesicular erythematous cutaneous rash, mainly distributed on the genital and perianal area, but also regarding limbs, face, neck, chest and back in some of the patients. Systemic symptoms, such as fever or lymphadenopathy, involved eight patients. The symptom most frequently reported by patients was pruritus in the area of the vesicles. Thirteen patients also reported pain. Nine patients were HIV-1 coinfected, but no significant differences have been observed compared to other cohort patients. The median time between the onset of symptoms and the healing was 19.5 days (IQR 14.0-20.3). CONCLUSIONS: Our cohort of patients presented a mild manifestation of the disease with no complications and no need for antiviral therapy nor hospitalization. This population seems different from the ones reported in the literature during the previous outbreaks in endemic areas in epidemiological data and clinical manifestations but also from a cohort of patients described in the literature from the 2022 outbreak, suggesting the importance for healthcare workers to keep in mind the possibility of an MPX infection in the differential diagnosis of patients presenting with consistent symptoms, even in non-endemic areas, to ensure efficient isolation of the patient for infection control purposes and effective management of the infection preventing the development of MPOX-related complications.

Blood telomere length gain in people living with HIV switching to dolutegravir plus lamivudine versus continuing triple regimen: a longitudinal, prospective, matched, controlled study.

BACKGROUND: Blood telomere length (BTL) is a validated biomarker of aging. ART reduces immunosenescence and has benefits in terms of BTL in people living with HIV (PLWH). However, it has also been observed that ART containing NRTIs, such as tenofovir or abacavir, which are potent inhibitors of human telomerase activity in vitro, might negatively affect BTL. Here we investigated the effects on BTL 1 year after switching to a dual therapy (DT) with dolutegravir + lamivudine versus maintaining a standard triple therapy (TT) with a two-NRTI backbone and an anchor drug. METHODS: This was a longitudinal, prospective, matched, controlled study that included virologically suppressed adults on stable three-drug ART who either switched at baseline (BL) to DT or maintained TT. The DT and TT groups were 1:1 matched for age, sex, years since HIV diagnosis, years on ART and anchor drug. BTL was assessed by a monochrome multiplex qPCR at BL and after 48 weeks (W48). RESULTS: We enrolled 120 PLWH, i.e. 60 participants in each group. At BL, the BTL means were comparable between the two groups (P = 0.973). At W48, viro-immunological status was stable and an overall increase in the mean BTL was observed, i.e., +0.161 (95%CI, 0.054-0.268) (P = 0.004). However, the within-group analysis showed a significant mean BTL gain in the DT group (P = 0.003) but not in the TT group (P = 0.656). CONCLUSIONS: In this setting of virologically suppressed PLWH, simplifying to dolutegravir + lamivudine was associated with a higher gain in BTL than maintaining triple therapy after the 1 year follow-up. These findings suggest that as a simplification strategy dolutegravir + lamivudine might have a positive effect on BTL.

Differences in the Long-term Impact of the COVID-19 Pandemic on the Mental Health and Professional Quality of Life of Resident and Specialist Physicians.

BACKGROUND: The COVID-19 pandemic created an extremely difficult situation for healthcare workers (HCWs) worldwide. We aimed to compare the mental health and professional quality of life of residents and specialist physicians in a cohort of Italian HCWs caring for patients with COVID-19 about two years after the start of the COVID-19 pandemic. METHODS: In November 2021, an online survey investigating the emotional states of depression, anxiety, stress, compassion satisfaction and compassion fatigue was administered to HCWs (N= 78) at the Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. RESULTS: Our findings suggest that from 5 to 20% of our cohort of HCWs still showed the effects of the adverse psychological impact of the pandemic and more than half of them experienced medium levels of compassion fatigue as well as a medium level of compassion satisfaction. Our results also show that those with fewer years of clinical practice might be at greater risk of burnout (p= 0.021), anxiety and stress symptoms (both ps= 0.027) and might develop a lower level of compassion satisfaction (p=0.018). Moreover, the factors that potentially contribute to poor mental health, compassion fatigue and compassion satisfaction seem to differ between residents and specialist physicians. CONCLUSIONS: This overview presents one of the first pictures of the long-term effects of the pandemic on the mental health and professional quality of life of an Italian sample of HCWs. Moreover, it also helps identify professionals who are most in need of support and emphasises the importance of improving the psychological and professional wellbeing of these individuals especially during a pandemic-like crisis with long lasting effects.

Evaluation of Everolimus Activity against Mycobacterium tuberculosis Using In Vitro Models of Infection.

Even though Everolimus has been investigated in a phase II randomized trial as a host-directed therapy (HDT) to treat tuberculosis (TB), an oncological patient treated with Everolimus for a neuroendocrine pancreatic neoplasia developed active TB twice and a non-tuberculous mycobacterial (NTM) infection in a year and a half time span. To investigate this interesting case, we isolated and genotypically characterized the Mycobacterium tuberculosis (Mtb) clinical strain from the patient and tested the effect of Everolimus on its viability in an axenic culture and in a peripheral blood mononuclear cell (PBMCs) infection model. To exclude strain-specific resistance, we tested the activity of Everolimus against Mtb strains of ancient and modern lineages. Furthermore, we investigated the Everolimus effect on ROS production and autophagy modulation during Mtb infection. Everolimus did not have a direct effect on mycobacteria viability and a negligible effect during Mtb infection in host cells, although it stimulated autophagy and ROS production. Despite being a biologically plausible HDT against TB, Everolimus does not exert a direct or indirect activity on Mtb. This case underlines the need for a careful approach to drug repurposing and implementation and the importance of pre-clinical experimental studies.

Healthcare associated infections in gynecologic oncology: clinical and economic impact.

OBJECTIVE: The purpose of this study was to assess the rate and type of infections in gynecological cancer patients. We also performed an economic analysis to provide an overview of costs related to healthcare associated infections. METHODS: We retrospectively collected data from culture samples at the site of infection from patients undergoing surgery or chemotherapy, admitted to the Gynecologic Oncology Unit, Fondazione Policlinico Agostino Gemelli IRCCS, from January 2017 to December 2018. We performed univariate and multivariate analyses to calculate potential risk factors for prolonged length of hospitalization. The average cost per patient was calculated, including the cost of hospital stay, operating room, medications, and diagnostic and invasive procedures. RESULTS: Among 5682 patients, 322 (5.6%) gynecological cancer patients with healthcare associated infections were identified. A total of 249 patients (77.3%) had undergone surgery in the previous 30 days and 73 (22.7%) patients were receiving chemotherapy. In the whole population, the most common healthcare associated infections were urinary infections (58%) and surgical wound infections (42.1%). In addition, 14.5% of patients had central venous catheter infections and 21.7% had blood stream infections. Median length of stay was 20 days (range 1-100). Among surgical patients, advanced age (odds ratio (OR) 1.233, 95% confidence interval (CI) 1.001 to 1.519, p=0.049), bowel resection (OR 2.659, 95% CI 1.493 to 4.735, p=0.001), surgical site infection (OR 10.447, 95% CI 1.143 to 95.5, p=0.038), and central venous catheter infection (OR 9.856, 95% CI 1.139 to 85.319, p=0.038) were independently associated with an increased risk of prolonged hospital stay (>20 days). The overall direct cost of healthcare associated infections was $6 273 852 per year. CONCLUSIONS: The infection rate in our population was 5.6%. The most common healthcare associated infections were urinary and surgical wound infections. Among surgical patients, advanced age, bowel resection, surgical site, and central venous catheter infection were associated with an increased length of hospitalization. Healthcare associated infections cause an increase in the length of stay after surgery and hospital costs.

Home Care Assistance: Has Covid-19 had an Impact on the Complex Management of HIV Patients?

During the COVID-19 pandemic, people living with HIV (PLWH) could have had to face problems with treatment adherence because of the difficulty of accessing services connected with antiretroviral therapy (ART) dispensation, which could have undermined their health. In this article, we described, over the period 2015-2020, both the activities of our home care assistance unit, the "Unità di Trattamento Domiciliare (UTD)", and the characteristics of the comorbid HIV patients followed-up. To determine whether the COVID-19 pandemic affected this service, we compared the number/type of services provided in 2020 with those provided in the preceding 5 years, i.e., 2015-2019. We also compared the proportion of monthly interventions carried out in 2018, 2019 and 2020. We found comparable values with some differences in the types of performances due to the heterogeneity of the population and their medical assistance needs. We also observed a stable viro-immunological status of the patients. All of these data suggest that the UTD was consistently active during the lockdown months and pandemic waves preventing therapy discontinuation, and was able to maintain optimal control of patients' HIV infections.

Cardiovascular Disease Risk in a Cohort of Virologically Suppressed People Living with HIV Switching to Doravirine: Preliminary Data from the Real Life.

Aim of this study is to assess the impact of doravirine (DOR)-based regimens on cardiovascular risk in treatment-experienced people living with HIV (PLWHIV). We retrospectively analyzed a cohort of 40 treatment-experienced PLWHIV switching to a DOR-based three-drug regimen, evaluating 10-year risk of manifesting clinical cardiovascular diseases (CD) through the Framingham Risk Score at baseline, 12, and 24 weeks of follow-up. At baseline, median predicted 10-year risk of cardiovascular disease (10Y-CD) was 8.0% (interquartile range 4.0-13.0). After 12 weeks, we observed a significant reduction in 10Y-CD (mean decrease -2.21, p = .012); similarly, we observed a nonsignificant reduction at week 24 (p = .336). Regarding metabolic parameters, after 24 weeks we observed a significant reduction in total cholesterol (median change -8.8 mg/dL, p = .018), low-density lipoprotein cholesterol (median -9.5 mg/dL, p = .007), and triglycerides (median -19.8 mg/dL, p < .001). Our results show a favorable metabolic impact of DOR-based regimens along with a promising reduction in 10-year risk of cardiovascular disease.

Difference in the neurocognitive functions of WLWH and MLWH in an Italian cohort of people living with HIV.

Based on the available literature, women living with HIV (WLWH) seem to show greater cognitive and emotional disadvantages than men living with HIV (MLWH). Our aim was to compare the cognitive performance of MLWH and WLWH in an Italian cohort of People Living With HIV (PLWH) and to analyse factors potentially contributing to sex differences in cognitive function. We ran a retrospective, cross-sectional analysis of a monocentric dataset of PLWH who were administered a standardized neuropsychological test battery (SNB) during routine clinical care. We enrolled 161 Italian PLWH who are on combined antiretroviral therapy (cART): 114 (70.8%) MLWH and 47 (29.2%) WLWH.Global cognitive performance (composite z score) (GCP) was significantly higher in MLWH than WLWH [mean 0.19 (SD 0.85) vs - 0.13 (SD 0.96); p = 0.039]. Moreover, WLWH obtained significantly higher scores on the Zung Depression Scale than MLWH [mean 41.8 (SD 10.9) vs 36.7 (SD 9.2); p = 0.003]. However, there was no statistically significant direct effect between male sex and better GCP (p = 0.692) in the context of a mediation model. On the contrary, the associations between male sex and better GCP were mediated by higher level of education (a*b = + 0.15, Bootstrap CI95 = 0.05 and 0.27) and a lower Zung depression score (a*b = + 0.10, Bootstrap CI95 = 0.02 and 0.21).In conclusion, the global cognitive performance of WLWH is lower than that of MLWH. However, other demographic and clinical factors besides sex might help explain differences in their neurocognitive functions and make it possible for us to monitor them and identify those patients most in need.

Use of Long-Acting Therapies for HIV Care in Italy: Are People Living with HIV Prepared for Change? A Cross-Sectional Study.

Two hundred two people living with HIV (PLWH) selected from outpatients at the Infectious Disease Institute, Fondazione Policlinico Universitario A. Gemelli IRCCS, in Rome (Italy) were consecutively enrolled from May to July 2021. We used an anonymous telephone questionnaire to investigate opinions of PLWH about combined antiretroviral (ARV) therapy and long-acting (LA) formulations of ARVs. All invited participants completed the questionnaire (100%). We found that most PLWH evaluated taking HIV pills for the rest of their life as a continuous, but undemanding commitment (61.4%; n = 124), although they were willing to stop the daily intake of HIV drugs (78.2%, n = 158). Moreover, most PLWH were unaware of the existence of LA therapies at the time of the investigation (60.4%, n = 122). Almost half the PLWH evaluated the need for injections in the hospital as an obstacle (51.4%, n = 104). Regarding the preference between monthly injections and taking pills everyday, most PLWH (68.8%, n = 139) stated that the injection was more advantageous than pills even if they had some pain/swelling at the injection site. The concern about LA therapy indicated most by PLWH was the possible lower efficacy of the drug (83.7%, n = 169). Regarding the possible benefits of LA therapy, those reported most by PLWH were feeling freer because they did not have to remember to take pills everyday (68,8%, n = 139). In conclusion, to date, PLWH in our cohort seem willing to accept LA therapy, but still show some concern about the efficacy of the new therapy and the obligation to come to the hospital to receive it. Thus, clinicians must take into account the needs of their patients and help them overcome their concerns to facilitate the transition to this new therapeutic modality. Clinical Trial Registration Number ID: 2424.

Are we ready for long-acting? A feasibility evaluation of long-acting cabotegravir-rilpivirine in clinical practice.

Cabotegravir and rilpivirine are the first drugs to be approved as injectable therapy to treat individuals with HIV. Despite encouraging results, the guidelines specify strict criteria for eligibility that could limit the feasibility of this strategy. We collected the clinical data of HIV-positive patients who were being treated at a single, third-level center in Italy. All patients were on stable therapy and showed suppressed viral load on their most recent analyses. We performed a cross-sectional analysis of the clinical and viro-immunological characteristics of this population and excluded patients who had previous virological failures, resistance-associated mutations (RAMs) to rilpivirine or integrase inhibitors in the historical genotype, hepatitis B infection, absence of previous genotypes, and the coexistence of HIV-subtype A and obesity. Our aim was to evaluate the proportion of patients who could be eligible for switching to this strategy. one thousand seven hundred fifty-two patients were eligible. One hundred and forty-eight were excluded because of a detectable viral load. With regard to the exclusion criteria, 48 patients had coinfection with hepatitis B virus, and 744 had a history of previous virological failures. Of the 896 patients with at least one genotypic resistance test, 161 had one or more RAMs to rilpivirine and 3 had RAMs to cabotegravir. None of the patients presented the combination of obesity and the A viral subtype. Overall, 31.2% of the patients were ineligible for cabotegravir-rilpivirine, and the proportion increased to 47.3% when we considered only patients with all available information concerning resistance tests. Approximately half of our cohort of patients did not fulfill the criteria and even more patients were potentially ineligible for cabotegravir-rilpivirine due to the lack of genotypic resistance tests. Also, fertile women had to be excluded due to the lack of data about this combination during pregnancy and breastfeeding.

Implementing a Personalized Antimicrobial Stewardship Program for Women with Gynecological Cancers and Healthcare-Associated Infections.

Healthcare-associated infections (HCAIs) represent a major cause of morbidity and mortality in gynecologic cancer patients, requiring personalized cures. A retrospective study on gynecologic patients with HCAIs, managed through an antimicrobial stewardship program, was performed, focusing on rates of clinical cure, breakthrough/relapse of infections, death, and time of hospital stay (THS). In total, 27 patients (median 60 years, mainly suffering from ovarian, cervical, and uterine cancer) were evaluated by a specialist in infectious diseases and were mainly diagnosed with complicated urinary tract (cUTIs, 12 cases, 44.4%) and bloodstream infections (BSIs, 9 cases, 33.3%). A total of 15 cases (11 cUTIs, 73.3%) were managed with no need for hospitalization and received a median of 11 days of outpatient parenteral antimicrobial therapy (OPAT). In the remaining 12 cases (BSIs in 8 cases, 66.7%), the median THS was 11 days, with 15 days median overall duration of antimicrobial therapy (median 5-day reduction in THS). The management of patients also included source control and wound care. All patients reached clinical cure, with no case of breakthrough infection, one case of relapse, and one death within 30 days (not attributable to the infection). HCAIs in patients with gynecologic tumors can be managed through a patient-centered, multidisciplinary antimicrobial stewardship program.

Minimal prevalence of HPV vaccination and common occurrence of high-risk HPV types in pregnant women with HIV: data from a national study in Italy.

Among 733 pregnant women with HIV followed between 2013 and 2021, only 8 (1.1%) had prior HPV vaccination. One had low-grade squamous intraepithelial lesions [LSIL], and none had HPV type information. Among the 725 non-vaccinated women, 578 (79.7%) had information on cervical cytology. Rate of cytologic abnormalities in this group was 20.6% (0.2% atypical glandular cells of undetermined significance [AGC], 1.7% atypical squamous cells of undetermined significance [ASC-US], 11.1% LSIL, and 7.6% high-grade squamous intraepithelial lesions [HSIL]). Among 56 women with HPV type information, 75.0% carried high risk types, with similar occurrence in women with and without cytologic abnormalities, 30.4% had multiple high-risk types, and 75.9% carried at least one of the types included in the currently recommended 9-valent vaccine.

Use of telehealth for HIV care in Italy: Are doctors and patients on the same page? A cross-sectional study.

BACKGROUND: The COVID-19 pandemic has changed outpatient clinical practice, which has led to the need defining digital healthcare modalities to provide telehealth services. The aim of our study was to explore opinions about HIV management via telehealth in a representative, southern central Italian cohort of individuals with HIV (PLWH) and doctors involved in the treatment process. METHODS: We enrolled 80 PLWH who have never used telehealth tools and 60 doctors, who administered an anonymous self-report questionnaire to investigate their opinions about telehealth service use. RESULTS: Most of the doctors and patients indicated that they would use telehealth services; however, 88.3% of the doctors and 40% of the PLWH did not want to substitute personal visits with telehealth services. Unlike PLWH, physicians seemed to agree with most of the possible risks of telehealth, such as patients' isolation from the hospital system (71.7%), interaction difficulty (46.7%) and lower quality of patient assessment (63.3%). The doctors focused on the qualitative aspects of telehealth services reducing patients' exposure to stigma (61.7%), improving quality of patient care (41.7%), and improving privacy (58.3%). By contrast, patients focused on the quantitative aspects of telehealth services improving timely access to care (44%), time saving (63%) and improving interaction with doctor (43%). CONCLUSIONS: Both PLWH (especially older patients and those with longer experience of disease management) and doctors welcome the use of telehealth services but disagree using it to substitute medical consultation in person focusing on different possible benefits and risks of telehealth depending on the needs expressed. Thus, our results suggest the need to initiate and expand communication about telehealth between doctors and patients.

Seroprevalence of SARS-CoV-2 Antibodies in HIV-Infected Patients in Rome, Italy during the COVID-19 Outbreak.

BACKGROUND: this study aimed to determine the proportion of people living with HIV (PLWH) with anti-SARS-CoV-2 IgG antibodies in a large sample from a single HIV referral center in Rome, Italy; the time-frame included both the first and the second wave of the Italian COVID-19 pandemic; Methods: we conducted a cross-sectional study on stored cryopreserved samples from 1 March 2020 to 30 November 2020. Total antibodies against SARS-CoV-2 were preliminarily tested using a chemiluminescent immunoassay. Positive results were re-tested with an ELISA assay as an IgG confirmatory test; Results: overall, 1389 samples were analyzed from 1106 PLWH: 69% males, median age 53 years, 94% on antiretroviral treatment, 93% with HIV-RNA < 50 copies/mL, median CD4 cell count 610 cell/µL. Our analysis revealed a total of n = 8 patients who tested IgG positive during the study period. Seroprevalence was equal to 0% in the first months (March-June); this started to increase in July and reached a maximum rate of 1.59% in October 2020. The overall seroprevalence was 0.72% (8/1106, 95% CI 0.37-1.42). CONCLUSION: our findings from this setting show a low IgG SARS-CoV-2 prevalence among PLWH as compared to data available from the general population.

CD4/CD8 ratio in pregnant women with HIV and its association with pregnancy outcome: data from a national study in Italy.

PURPOSE: To evaluate associations between CD4/CD8 ratio and pregnancy outcomes in women with HIV. METHODS: We evaluated, in a national study of pregnant women with HIV receiving antiretroviral treatment (ART), values of CD4/CD8 ratio at entry in pregnancy, changes between first and third trimester, and possible associations with preterm delivery, low birthweight, and HIV-RNA < 50 copies/ml at third trimester in univariate and multivariate analyses. RESULTS: Among 934 women, 536 (57.4%) were already on ART at conception. CD4/CD8 ratio (baseline value 0.570) increased significantly between the first and third trimesters, particularly in women who started ART in pregnancy (+ 0.163, vs. + 0.036 in women already on treatment). The rate of CD4/CD8 ratio normalization, defined by achieving a ratio ≥ 1 at the third trimester, was 13.2%. In multivariable analyses, women who entered pregnancy with a CD4/CD8 ratio < 0.3, compared to women with ratio ≥ 1, were almost four-times less likely to have third-trimester HIV-RNA < 50 copies/ml (AOR 0.258, 95%CI 0.111-0.601), and more than twice as likely to have preterm delivery (AOR 2.379, 95%CI 1.082-5.232). For preterm delivery, also a baseline CD4/CD8 ratio between 0.3 and 0.45 was significantly associated with an increased risk (AOR: 3.415, 95%CI 1.690-6.900). CONCLUSION: We described for the first time independent associations of low CD4/CD8 ratio with preterm delivery and HIV-RNA suppression.