Antonella d'Arminio Monforte

• University of Milan

Objectives Most treatment switches are for simplification from three‐drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR. Methods We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI‐ba...

In Italy, an estimated 13 000–15 000 people have undiagnosed HIV, and in 2020, 60% of new diagnoses were late-stage (CD4 < 350 cells/mm3). In hospitals, including emergency departments (EDs), testing is largely limited to indicator-condition-guided testing (IC), with written consent universally required. We developed a closed-cohort hybrid decision...

Background Variant-adapted vaccines are recommended in vulnerable populations to address the waning immunity and the emergence of immune-escaping SARS-CoV-2 variants, yet data about immune responses to such vaccines in people living with HIV (PLWH) are limited. We therefore aimed to assess long-term immune responses to an original–BA.4/5 mRNA boost...

Background Tuberculosis remains the leading cause of death among people with HIV. The aim of this study was to describe the incidence of tuberculosis (TB), explore risk factors and to calculate their population attributable fractions (PAF) in people with HIV across Europe, stratified by region. Method Longitudinal study of people with HIV aged>18...

Objective People with HIV-HCV co-infection need antiretroviral treatment (ART) to suppress HIV and direct-acting antivirals (DAAs) to cure HCV. ART is typically prioritized, but delays in DAA initiation may increase the risk of liver-related events and HCV transmission to others. Design Target trial emulation with observational data collected in r...

Background HIV viremia has been considered a cardiovascular disease (CVD) risk factor, but many studies have had insufficient data on potential confounders. We explored the association between viremia and CVD after adjusting for established risk factors and analyzed whether consideration of viremia would improve CVD prediction. Methods Adults from...

Rationale Doravirine (DOR) is an attractive new option both for ART‐naïve people with HIV (PWH) and those with suppressed HIV‐RNA who seek treatment simplification. We used real‐world data to examine the pattern of use of DOR‐containing regimens in these settings. Methods All PWH enrolled in the Icona cohort after January 2020 who initiated a thre...

Background The best therapeutic management for people with HIV who have a history of pre-exposure prophylaxis (PrEP) is still debated. Objectives The aim of this study was to describe recent HIV infections in PrEP users compared with people never exposed to PrEP. Methods Multicentre retrospective analysis evaluating all recent HIV infections from...

Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neurop...

Background: This study examined the impact of the COVID-19 lockdown on antiretroviral therapy (ART) prescriptions among persons living with HIV (PWH) in Italy. Methods: Data from the ICONA cohort included ART-naïve individuals who started ART between January 2019 and December 2022, and ART-experienced individuals who started new ART with HIV RNA ≤5...

What is this summary about?: This is a summary of an article about an ongoing study called the BICSTaR study.The BICSTaR study includes people with HIV (human immunodeficiency virus) who are taking a medicine called bictegravir/emtricitabine/tenofovir alafenamide (shortened to B/F/TAF). B/F/TAF is a single tablet that contains 3 different drugs fo...

Background Severe and prolonged mpox courses have been described during the 2022–2023 outbreak. Identifying predictors of severe evolution is crucial for improving management and therapeutic strategies. We explored the predictors of mpox severity and tested the association between mpox severity and viral load in biological fluids. We also analysed...

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...

Background With integrase strand transfer inhibitor (INSTI) use associated with increased body mass index (BMI) and BMI increases associated with higher diabetes mellitus (DM) risk, this study explored the relationship between INSTI/non-INSTI regimens, BMI changes, and DM risk. Methods RESPOND participants were included if they had CD4, HIV RNA, a...

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 ou...

Background Little is still known about the impact of INSTI minority resistant variants detected through next generation sequencing (NGS) on virological response to first-line regimens based on second-generation INSTI. Material and methods This is a case-control study involving ART-naïve individuals from the ICONA cohort with an available plasma HI...

Background Understanding the evolution and dynamics of deaths in people with HIV (PWH) is crucial to tailor interventions aiming at improving PWH long term wellbeing. Therefore, we assessed all-cause mortality in the multicentre ICONA cohort. Material and methods We included all people enrolled in the ICONA cohort who were diagnosed with HIV in 19...

Background Aim of this study is to characterize socio-demographic, clinical and therapeutic features of PWH currently in care in 61 Italian Infectious Diseases centers belonging to the ICONA cohort. Material and Methods All the PWH enrolled in ICONA with at >= follow-up in 2022–2023 are included. Data from the ICONA database including age, sex, na...

Background Toxoplasmosis is the most common opportunistic infection affecting the CNS in AIDS, resulting from reactivation of latent infection. Around 30% of T. gondii-seropositive PWH with CD4 T cell counts <100/mcL, not receiving effective prophylaxis and antiretroviral therapy, develops neurotoxoplasmosis. T. gondii-seroprevalence, in turn, depe...

Background HIV pre-exposure prophylaxis (PrEP) is considered a high-priority strategy in preventing HIV and reducing the incidence of new HIV diagnoses. In Italy, free of charge PrEP availability started in May 2023. We designed and submitted to ethical committee a protocol to implement PrEP in the ICONA national network (PrIDE protocol- Implementa...

Background Dual drug regimens (2DR) have been proposed to reduce the emergence of toxicities in individuals with viral load (VL)≤50 copies/mL. A possible drawback of 2DR is greater inflammation, possibly leading to higher incidence of cardiovascular disease (CVD) and cancer. There are no randomised trials with clinical endpoints comparing 2DR vs. 3...

Background The lack of national Guidelines on DoxyPEP leaves a gap in STI prevention where individuals with perceived high risk of exposure are informally self-administering doxycycline as PEP. This study aims to describe knowledge, use, temporal trends, and impact of doxyPEP in a cohort of PrEP-clients attending a community-based service. Methods...

Background In Italy, an estimated 13,000–15,000 people live with undiagnosed HIV infection. Italy also has one of the highest late diagnosis (CD4< 350) rates in Europe. Alternative testing strategies are urgently needed to progress towards achieving UNAIDS targets. Recently, several studies demonstrated the clinical effectiveness of opt-out emergen...

Background Two-drug regimens (2DR) [lamivudine (3TC)/dolutegravir(DTG) or rilpivirine(RPV/DTG)] are generally well tolerated but there is a proportion of people with HIV (PWH) who develops toxicity/intolerance to these regimens and are switched back to three-drug regimens (3DR) or dual PI-based therapies (2DR-PI/b). The frequency and factors associ...

Background Long-acting injectable cabotegravir (ICAB) has been recently approved by FDA and EMA as pre-exposure prophylaxis (PrEP). Despite the greater efficacy, ICAB represents an issue for PrEP management given the higher economic cost and the relevant burden on clinics workload. Aims of the present study are: (i) to describe the proportion of Pr...

Background PrEP implementation in Italy faced initial challenges until the AIFA reimbursement and national data were limited. The study aimed to report HIV and other sexually transmitted infections (STIs) rates in a PrEP multicentric access program in Italy, along with rates and predictors of poor adherence and discontinuation. Methods Prospective...

Background Higher long-term antiretroviral treatment (ART) success is reported in People living with HIV (PLWH) remaining on their first-line ART over an extended period. This study estimates the current incidence and the leading causes for first-line ART discontinuation among ART-naive PWH after the advent of Integrase Strand Transfer Inhibitors (...

There is solid evidence that there is zero risk of HIV transmission from an HIV positive partner with VL ≤200 copies/ml (the Undetectable=Untransmittable, U=U status). Previous data reported that female sex at birth (FSAB) vs. MSAB is associated with higher risk of not maintaining the U=U status. Mechanisms leading to this observed difference have...

Background There is increasing concern about the occurrence of breakthrough/relapse of hepatitis B (HBV) and transaminase flare among anti-HBV core-positive (HBcAb) people living with HIV (PWH) who discontinue anti-HBV-containing antiretroviral drugs. Materials and Methods PWH antigen S of HBV (HBsAg) negative and HBcAb-positive, irrespectively of...

Background Cabotegravir (CAB) + rilpivirine (RPV) Long Acting (LA) has shown its efficacy and tolerability in Phase 3 studies and has been commercialized since 2022 in Italy for virally suppressed people with HIV-1 (PWH). Real life clinical data on the effectiveness and discontinuation of CAB+RPV LA is scarce. Methods All PWH enrolled in the Icona...

Background The ‘undetectable equals untransmittable’ (U=U) message should contribute to reduce stigma affecting PWH, who can live without the fear of transmitting HIV once they have reached undetectable HIV-RNA. Nevertheless, still many PWH are unaware of this concept. To spread the U=U message in Italy, an awareness campaign designed by the commun...

Background While use of some older antiretroviral drugs (ARVs) is associated with chronic liver enzyme elevation (cLEE), the impact of newer ARVs remains unknown. Methods People with HIV enrolled in the RESPOND cohort who started an ARV after January 1, 2012 were included (baseline). The primary outcome was first cLEE individuals were censored at...

Background Women with HIV are globally underrepresented in clinical research. Existing studies often focus on reproductive outcomes, seldom focus on older women, and are often underpowered to assess sex/gender differences. We describe CD4, HIV viral load (VL), clinical characteristics, comorbidity burden, and use of antiretroviral therapy (ART) amo...

Objectives The aim of this analysis was to investigate the impact of hepatitis B virus (HBV) coinfection on the risk of HIV viral rebound (VR) after achieving suppression for the first time following initiation of antiretroviral therapy (ART) in the real‐world setting. Design Patients living with HIV (PLWH) who were enrolled in the ICONA Foundatio...

Introduction: We compared the effectiveness and virological clearance (VC) at day 7 (T7) post-treatment with molnupiravir, nirmatrelvir/ritonavir, and remdesivir in SARS-CoV-2-infected patients at high risk (HR) for clinical progression. Methods: We conducted a retrospective study enrolling HR patients with mild-to-moderate COVID-19 (Jan–Oct 2022)...

Background HIV-associated neurocognitive disorders (HAND) still affects persons living with HIV (PLWH) and their pathogenesis isn’t completely understood. We aimed to explore the association between plasma and CSF markers of blood-brain barrier (BBB) impairment and HAND in untreated PLWH. Design Cross-sectional study. Methods We enrolled untreate...

Background Mortality among people with HIV declined with the introduction of combination antiretroviral therapy. We investigated trends over time in all-cause and cause-specific mortality in people with HIV from 1999—2020. Methods Data were collected from the D:A:D cohort from 1999 through January 2015 and RESPOND from October 2017 through 2020. A...

Objectives In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. Methods We enrolled PrEP users from a local community-based PrEP service. Each participant se...

Objectives To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response to ART. Methods Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as swit...

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) a...

Introduction Mortality rates for people living with HIV (PLHIV) on antiretroviral therapy (ART) in high-income countries continue to decline. We compared mortality rates among PLHIV on ART in Europe for 2016–2020 with Spectrum's estimates. Methods The AIDS Impact Module in Spectrum is a compartmental HIV epidemic model coupled with a demographic p...

Background Real‐world evidence is an essential component of evidence‐based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment‐naïve (TN) and treatment‐experienced (TE) people with HIV. Methods BICST...

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...

Objectives We aimed to study hepatitis D virus (HDV) prevalence and risk of progression to severe liver‐related events (SLRE) in HBsAg positive people living with HIV (PLWH) in Italy; role of HDV‐RNA copy levels, HCV coinfection and nadir CD4 counts were also investigated. Methods People living with HIV (PLWH) from Italian Foundation cohort Naïve...

Background Human immunodeficiency virus (HIV) infection leads to chronic immune activation/inflammation that can persist in virally suppressed persons on fully active antiretroviral therapy (ART) and increase risk of malignancies. The prognostic role of low CD4:CD8 ratio and elevated CD8 cell counts on the risk of cancer remains unclear. Methods W...

Objectives People with HIV and extensive antiretroviral exposure may have limited/exhausted treatment options (LExTO) due to resistance, comorbidities, or antiretroviral-related toxicity. Predictors of LExTO were investigated in the RESPOND cohort. Methods Participants on ART for at least 5 years were defined as having LExTO when switched to at le...

Severe COVID-19 outcomes have been reported in people living with HIV (PLWH), yet the underlying pathogenetic factors are largely unknown. We therefore aimed to assess SARS-CoV-2 RNAemia and plasma cytokines in PLWH hospitalized for COVID-19 pneumonia, exploring associations with magnitude and functionality of SARS-CoV-2–specific immune responses....

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...

Background: Our aim was to estimate the rates of not achieving a robust/above-average humoral response to the COVID-19 mRNA vaccine in people living with HIV (PLWH) who received ≥2 doses and to investigate the role of the CD4 and CD4/CD8 ratio in predicting the humoral response. Methods: We evaluated the humoral anti-SARS-CoV-2 response 1-month aft...

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 to MpoxVax and signed the informed consent were prospectively enrolled in the MPOX-VAC Study and were asked to fill out...

Background Post-COVID-19 condition refers to persistent or new onset symptoms occurring three months after acute COVID-19, which are unrelated to alternative diagnoses. Symptoms include fatigue, breathlessness, palpitations, pain, concentration difficulties ("brain fog"), sleep disorders, and anxiety/depression. The prevalence of post-COVID-19 cond...

Polymorphonuclear cell influx into the interstitial and bronchoalveolar spaces is a cardinal feature of severe coronavirus disease 2019 (COVID-19), principally mediated by interleukin-8 (IL-8). We sought to determine whether reparixin, a novel IL-8 pathway inhibitor, could reduce disease progression in patients hospitalized with severe COVID-19 pne...

Objectives: To study whether people living with HIV (PLWH) are at higher risk of in-hospital COVID-19 mortality compared to general population (GenPop). Methods: Retrospective study in 19 Italian centres (Feb2020-Nov2022) including hospitalized PLWH and GenPop with SARS-CoV-2 infection. Main outcome: in-hospital mortality. Competing risk analyses b...

Background and aims: Whether the HCV test-and-treat strategy impacted on the rate of new HCV infections among PLWH in Italy is unknown. Methods: Prospective study of PLWH in the ICONA network. At baseline, PLWH were tested for HCV-Ab; HCV-RNA (if HCV-Ab positive) and, if positive, treated with DAA. SVR12 indicated eradication. Seroconversions an...

Background COVID pandemic had a significant impact on most social and medical activities, including sexual habits and access to pre-exposure prophylaxis (PrEP). The aim of our study is to describe the number of subjects who discontinued PrEP after the first lockdown, and the change of sexual behaviors in those who continued despite social restricti...

Simple Summary Cancer is a leading cause of death, both in the general population and in people with HIV. We aimed to assess temporal trends of cancer from 2006 to 2021 in two international HIV cohort collaborations (D:A:D and RESPOND). We assessed overall cancer, AIDS-defining cancers (ADCs), non-ADCs (NADCs), infection-related cancers, body mass...

Aims: HIV infection is associated with dyslipidemia and an increased risk for cardiovascular diseases. HIV Nef protein downregulates the generation of nascent HDL. The interplay between HIV-RNA, HDL-c level and CD4/CD8 ratio in naïve HIV patients remains to be elucidated. Methods: We included untreated persons living with HIV (PLWH) of the ICONA Fo...

Among persons with HIV (PWH), higher alcohol use and having hepatitis C virus (HCV) are separately associated with increased morbidity and mortality. We investigated whether the association between alcohol use and mortality among PWH is modified by HCV. Data were combined from European and North American cohorts of adult PWH who started antiretrovi...

Mpox is traditionally considered a zoonotic disease with endemic circulation in Africa, but the 2022–2023 outbreak reached an unprecedented high number of cases in non-endemic countries, so that it was declared a public health emergency of international concern. The reasons for this extensive global spread, characterized by sexual transmission amon...

We appreciated the letter sent by Ciccullo and Colleagues¹ in response to our paper recently published in your Journal.² They shared the data from their cohort of DTG-treated PLWH, carrying no evidence for a difference in the risk of DTG discontinuation due to toxicity according to sex. Reproducibility in epidemiological studies is of great importa...

Objective: Immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines in people with HIV (PWH) with a history of late presentation (LP) and their durability have not been fully characterized. Design: In this prospective, longitudinal study, we sought to assess T-cell and humoral responses to SARS-CoV-2 mRNA vacc...

Late diagnosis is still a major issue in HIV infection management, leading to important consequences for both patients and community. In this perspective, HIV screening targeted on some clinical conditions (HIV indicator conditions—HIVICs) emerged as a useful strategy, also involving patients not considered at high behavioral risk. We organized an...

Background: The widespread use of the integrase strand transfer inhibitor (INSTI) dolutegravir (DTG) in first- and second-line antiretroviral therapy (ART) may facilitate emerging resistance. We combined data from HIV cohorts to examine patterns of drug resistance mutations (DRMs) and identify risk factors for DTG resistance. Methods: Eight cohorts...

Background: To evaluate the differences in the clinical characteristics and severity of lung impairment, assessed by quantitative lung CT scan, between vaccinated and non-vaccinated hospitalized patients with COVID-19; and to identify the variables with best prognostic prediction according to SARS-CoV-2 vaccination status. We recorded clinical, la...

Background: Higher risk of cerebrospinal fluid escape (CVE) has been associated with the use of specific antiretroviral (ARV) classes, such as protease inhibitors. We assessed whether archived resistance-associated mutations (RAMs) can mediate this relationship by identifying patients treated with incompletely active antiretroviral regimens. Method...

Background Randomized trials (RCTs) from low- and middle-income settings suggested early initiation of antiretroviral therapy (ART) leads to higher mortality among people with HIV (PWH) who present with cryptococcal meningitis (CM). There is limited information about impact of ART timing on mortality in similar people in high-income settings. Meth...

Background: Among interleukin-6 inhibitors suggested for use in COVID-19, there are few robust evidences for the efficacy of sarilumab. Herein, we evaluated the efficacy and safety of sarilumab in severe COVID-19. Methods: In this phase 3, open-labeled, randomized clinical trial, conducted at 5 Italian hospitals, adults with severe COVID-19 pneu...

Background: The life expectancy of people with HIV taking antiretroviral therapy (ART) has increased substantially over the past 25 years. Most previous studies of life expectancy were based on data from the first few years after starting ART, when mortality is highest. However, many people with HIV have been successfully treated with ART for many...

Objectives: To compare the long-term risk of treatment failure of dolutegravir-based ART in men and women in a real-life setting. Patients and methods: Persons living with HIV (PLWH) from the ICONA cohort were included if they had started dolutegravir in a two- or three-drug regimen as ART-naive or as virologically controlled ART-experienced. Th...

Background: People living with HIV have accounted for 38-50% of those affected in the 2022 multicountry mpox outbreak. Most reported cases were in people who had high CD4 cell counts and similar outcomes to those without HIV. Emerging data suggest worse clinical outcomes and higher mortality in people with more advanced HIV. We describe the clinic...

Introduction: Randomized trials and observational studies have consistently reported rates of sustained virological response (SVR), equivalent to hepatitis C virus (HCV) cure, as high as 95% following treatment with direct-acting antiviral (DAA) treatment in individuals with HIV and HCV co-infection. However, large studies assessing whether SVR ra...

A cytokine storm drives the pathogenesis of severe COVID-19 infection and several biomarkers have been linked to mortality. Chronic kidney disease (CKD) emerged as a risk factor for severe COVID-19. We investigated the association between selected biomarkers and mortality in 77 patients hospitalized for COVID-19, and whether they differ in patients...

This study aimed to develop a new approach to manage people living with HIV (PLWH), investigating preferences of clinicians and PLWH in order to improve linkage to care of PLWH. A survey was performed with the Discrete Choice Experiment (DCE) method to investigate the preferences of two categories, clinicians and PLWH, for attributes of HIV care pa...

Severe/critical COVID‑19 is associated with immune dysregulation and plasmatic SARS‑CoV‑2detection (i.e. RNAemia). We detailed the association of SARS‑CoV‑2 RNAemia with immune responses in COVID‑19 patients at the end of the first week of disease. We enrolled patients hospitalized in acute phase of ascertained SARS‑CoV‑2 pneumonia, and evaluated S...