1,640 results on '"Cozzi ‐ Lepri, A"'
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2. Risk of SARS-CoV-2 infection in patients with hematologic diseases receiving tixagevimab/cilgavimab as pre-exposure prophylaxis in most recent Omicron sublineages era
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Alessandra Vergori, Alessandro Cozzi Lepri, Marta Chiuchiarelli, Valentina Mazzotta, Elisabetta Metafuni, Giulia Matusali, Valentina Siciliano, Jessica Paulicelli, Eleonora Alma, Agostina Siniscalchi, Simona Sica, Elisabetta Abruzzese, Massimo Fantoni, Andrea Antinori, and Antonella Cingolani
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SARS-CoV-2 ,COVID-19 ,Hematologic disease ,Pre-exposure prophylaxis ,Tixagevimab/cilgavimab ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: Whether pre-exposure prophylaxis (PrEP) with tixagevimab/cilgavimab 150 mg/150 mg (T/C) in individuals with hematologic disease (HD) may lead to a reduced risk of SARS-CoV-2 breakthrough infection (BTI)/hospitalization, or death in the Omicron era remains to be established. Methods: An observational study included participants with HD who received PrEP. BTIs were defined as SARS-CoV-2 positivity by reverse transcription-polymerase chain reaction. The incidence of BTIs (95% CI) and of BTIs/hospitalization/death was calculated using the Kaplan-Meier method and as the number of BTIs per 100 person-years of follow-up according to the circulating variant of concern (VoC). A Poisson regression model was used to evaluate the association between the rate of incidence and circulating VoCs after controlling for demographics and clinical factors. Results: We included 550 HD patients: 71% initiated T/C PrEP when BA.5 was the most prevalent, followed by XBB/EG, BA.2, and BA.1 (19%, 7%, and 3%, respectively). Overall, the 1-year incidence estimate of BTIs/hospitalization/death was 24% (18.7-29.4%). A greater risk of incident infections was observed when BA.5 and XBB/EG sub-lineages circulated (aRR 5.05 [2.17, 11.77]; P < .001 and 3.82 [1.50, 9.7]; P = 0.005, compared to BA.1, respectively). Conclusions: The 1-year incidence of SARS-CoV-2 BTIs/hospitalization/death was 24% which is in line with what was observed in other similar studies. The risk appeared to be higher when more recent Omicron sub-lineages were circulating suggesting a reduction of in vitro neutralization.
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- 2024
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3. SARS-CoV-2 mRNA vaccination and short-term changes in viral load and CD4/CD8 T-cell counts in people living with HIV
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Alessandra Vergori, Alessandro Cozzi-Lepri, Alessandro Tavelli, Valentina Mazzotta, Anna Maria Azzini, Roberta Gagliardini, Ilaria Mastrorosa, Alessandra Latini, Giovanni Pellicanò, Lucia Taramasso, Francesca Ceccherini-Silberstein, Maddalena Giannella, Evelina Tacconelli, Giulia Marchetti, Antonella d'Arminio Monforte, and Andrea Antinori
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HIV ,mRNA SARS-CoV-2 vaccine ,CD4 count ,CD8 count ,HIV RNA ,Viro-immunological changes ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: To investigate whether SARS-CoV-2 messenger RNA (mRNA) vaccination has an impact on HIV-related viro-immunological parameters. Methods: People with HIV (PWH) in the VAXICONA-ORCHESTRA cohort who received one or more doses of SARS-CoV-2 mRNA vaccine and for whom paired measures of immuno-virological markers (viral load, clusters of differentiation [CD]4, and CD8 count 1 month before and after a vaccine dose [VD]) were available were included. Paired t-test and generalized estimating equation linear regression analyses were used to study changes over ± 1 month around the VD. Subgroup analyses were performed. Results: A total of 510 PWH were enrolled: the median age was 55 years (interquartile range 46-60 years), the CD4 and CD8 count were 489 (287-719) and 790 (59-1104) cells/mm3, respectively, and 81% received three VDs. After a median of 28 (3-53) days from VD, CD4 count increased by +15 cells/mm3 (SD ± 129.7, P = 0.001) and CD8 by +12 (±250.5, P = 0.199) and the viral load decreased by −0.11 log10 (±0.88, P = 0.001). Similar results were observed after restricting the analysis to viro-suppressed PWH, with CD4 ≤200/mm3, more than 6 months of antiretroviral therapy before VD and after excluding previous COVID-19. Conclusions: A small significant increase in CD4 count and a negligible drop in HIV RNA were observed. Our findings are consistent with the hypothesis that SARS-CoV-2 mRNA vaccine can prime CD4 T spike-specific cells, even in the more immuno-compromised PWH.
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- 2024
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4. Heavily treatment-experienced persons living with HIV currently in care in Italy: characteristics, risk factors, and therapeutic options—the ICONA Foundation cohort study
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Sergio Lo Caputo, Mariacristina Poliseno, Alessandro Tavelli, Roberta Gagliardini, Stefano Rusconi, Giuseppe Lapadula, Andrea Antinori, Daniela Francisci, Loredana Sarmati, Andrea Gori, Vincenzo Spagnuolo, Francesca Ceccherini-Silberstein, Antonella d'Arminio Monforte, and Alessandro Cozzi-Lepri
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Heavily treatment-experienced ,HIV ,Antiretroviral treatment ,Immune-virological failure ,Resistance mutations ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: Heavily treatment-experienced (HTE) people living with HIV (PLWH) pose unique challenges due to limited antiretroviral treatment (ART) options. Our study aimed to investigate the prevalence and features of HTE individuals followed up in the Italian Cohort Naïve Antiretrovirals (ICONA) cohort as of December 31, 2021. Methods: HTE were defined based on meeting specific conditions concerning their current ART and their ART history up to December 31, 2021. Descriptive statistics were performed by HTE status. Regression analyses explored factors associated with becoming HTE based on pre-ART patients' characteristics. Cluster dendrogram analysis provided insights into subgroups with inadequate responses based on clusters of differentiation (CD4) counts and viral load (VL) trajectories. Results: Among the 8758 PLWH actively followed in our cohort, 163 individuals (1.9%), mainly female, younger, Italian, and infected through heterosexual contact, met the HTE criteria. A lower CD4 count at ART initiation (odds ratio [OR] 1.60 per 100 cells/mmc lower CD4, 95% confidence interval [CI] 1.06-2.41, P = 0.03) and hepatitis C virus antibody positivity (OR 1.90, 95% CI 1.16-3.11, P = 0.01) were associated with higher HTE risk. Thirty PLWH exhibited ongoing immune-virological failure (18% of the HTE subgroup and 0.003% of the total population). Thirty PLWH exhibited ongoing immune-virological failure (i.e., with a current CD4 count 200 copies/mL). A cluster analysis identified 13 (43%) with a current CD4 count
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- 2024
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5. Persistent poor clinical outcomes of people living with HIV presenting with AIDS and late HIV diagnosis – results from the ICONA cohort in Italy, 2009-2022
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Annalisa Mondi, Alessandro Cozzi-Lepri, Alessandro Tavelli, Antonella Cingolani, Andrea Giacomelli, Giancarlo Orofino, Gabriella De Girolamo, Carmela Pinnetti, Andrea Gori, Annalisa Saracino, Alessandra Bandera, Giulia Marchetti, Enrico Girardi, Cristina Mussini, Antonella d'Arminio Monforte, and Andrea Antinori
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Late presenters ,AIDS ,Mortality ,HIV ,Immune recovery ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: Limited data are available on the long-term outcomes in recent years for late HIV diagnosis (LD). Methods: All subjects with HIV enrolled in the ICONA cohort in 2009-2022 who started antiretroviral treatment (ART) within 4 months from diagnosis were included and divided into: (i) pre-ART CD4 count ≥350/mm3 without AIDS (non-LD), (ii) pre-ART CD4 count
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- 2024
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6. Risk of COVID-19 in-hospital mortality in people living with HIV compared to general population according to age and CD4 strata: data from the ICONA network
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Andrea Giacomelli, Roberta Gagliardini, Alessandro Tavelli, Sara De Benedittis, Valentina Mazzotta, Giuliano Rizzardini, Annalisa Mondi, Matteo Augello, Spinello Antinori, Alessandra Vergori, Andrea Gori, Marianna Menozzi, Lucia Taramasso, Francesco Maria Fusco, Andrea De Vito, Giulia Mancarella, Giulia Marchetti, Antonella D'Arminio Monforte, Andrea Antinori, and Alessandro Cozzi-Lepri
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SARS-CoV-2 ,Death ,Hospitalization ,Immunodepression ,People living with HIV ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: We aimed to study whether people living with HIV (PLWH) are at higher risk of in-hospital COVID-19 mortality compared to the general population (GenPop). Methods: This was a retrospective study in 19 Italian centers (February 2020 to November 2022) including hospitalized PLWH and GenPop with SARS-CoV-2 infection. The main outcome was in-hospital mortality. Competing risk analyses by Fine-Gray regression model were used to estimate the association between in-hospital mortality and HIV status/age. Results: A total of 7399 patients with COVID-19 were included, 239 (3.2%) PLWH, and 7160 (96.8%) GenPop. By day 40, in-hospital death occurred in 1283/7160 (17.9%) among GenPop and 34/239 (14.2%) among PLWH. After adjusting for potential confounders, compared to GenPop 350 (aSHR 1.11 [95% CI 0.41-2.99]). Conclusions: In PLWH aged
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- 2023
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7. EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project
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Pontus Hedberg, Benedetta Varisco, Francesca Bai, Anders Sönnerborg, Pontus Naucler, Nico Pfeifer, Alessandro Cozzi-Lepri, Francesca Ceccherini-Silberstein, Daniel Naumovas, Francis Drobniewski, Björn-Erik Ole Jensen, Cristina Toscano, Miłosz Parczewski, Gibran Horemheb Rubio Quintanares, Matilu Mwau, Jorge A. Pinto, Francesca Incardona, Chiara Mommo, and Giulia Marchetti
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Hospitalised COVID-19 patients ,COVID-19 mortality ,SARS-CoV-2 variants ,SARS-CoV-2 vaccination and immunity ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), can lead to hospitalisation, particularly in elderly, immunocompromised, and non-vaccinated or partially vaccinated individuals. Although vaccination provides protection, the duration of this protection wanes over time. Additional doses can restore immunity, but the influence of viral variants, specific sequences, and vaccine-induced immune responses on disease severity remains unclear. Moreover, the efficacy of therapeutic interventions during hospitalisation requires further investigation. The study aims to analyse the clinical course of COVID-19 in hospitalised patients, taking into account SARS-CoV-2 variants, viral sequences, and the impact of different vaccines. The primary outcome is all-cause in-hospital mortality, while secondary outcomes include admission to intensive care unit and length of stay, duration of hospitalisation, and the level of respiratory support required. Methods This ongoing multicentre study observes hospitalised adult patients with confirmed SARS-CoV-2 infection, utilising a combination of retrospective and prospective data collection. It aims to gather clinical and laboratory variables from around 35,000 patients, with potential for a larger sample size. Data analysis will involve biostatistical and machine-learning techniques. Selected patients will provide biological material. The study started on October 14, 2021 and is scheduled to end on October 13, 2026. Discussion The analysis of a large sample of retrospective and prospective data about the acute phase of SARS CoV-2 infection in hospitalised patients, viral variants and vaccination in several European and non-European countries will help us to better understand risk factors for disease severity and the interplay between SARS CoV-2 variants, immune responses and vaccine efficacy. The main strengths of this study are the large sample size, the long study duration covering different waves of COVID-19 and the collection of biological samples that allows future research. Trial registration The trial has been registered on ClinicalTrials.gov. The unique identifier assigned to this trial is NCT05463380.
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- 2023
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8. EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
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Benedetta Varisco, Francesca Bai, Sara De Benedittis, Alessandro Tavelli, Alessandro Cozzi-Lepri, Matteo Sala, Federica Gaia Miraglia, Maria Mercedes Santoro, Francesca Ceccherini-Silberstein, Yishai Shimoni, Sivan Ravid, Tal Kozlovski, Florian König, Nico Pfeifer, Elham Shamsara, Milosz Parczewski, Antonella d’Arminio Monforte, Francesca Incardona, Chiara Mommo, and Giulia Marchetti
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Post-COVID-19 condition ,Post Acute Sequelae of SARS CoV-2 infection ,Long COVID ,Residual organ damage in COVID-19 ,Follow-up after COVID-19 ,Persistence of COVID-19 symptoms ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract 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 condition ranges widely across studies, affecting 10–20% of patients and reaching 50–60% in certain cohorts, while the associated risk factors remain poorly understood. Methods This multicentre cohort study, both retrospective and prospective, aims to assess the incidence and risk factors of post-COVID-19 condition in a cohort of recovered patients. Secondary objectives include evaluating the association between circulating SARS-CoV-2 variants and the risk of post-COVID-19 condition, as well as assessing long-term residual organ damage (lung, heart, central nervous system, peripheral nervous system) in relation to patient characteristics and virology (variant and viral load during the acute phase). Participants will include hospitalised and outpatient COVID-19 patients diagnosed between 01/03/2020 and 01/02/2025 from 8 participating centres. A control group will consist of hospitalised patients with respiratory infections other than COVID-19 during the same period. Patients will be followed up at the post-COVID-19 clinic of each centre at 2–3, 6–9, and 12–15 months after clinical recovery. Routine blood exams will be conducted, and patients will complete questionnaires to assess persisting symptoms, fatigue, dyspnoea, quality of life, disability, anxiety and depression, and post-traumatic stress disorders. Discussion This study aims to understand post-COVID-19 syndrome's incidence and predictors by comparing pandemic waves, utilising retrospective and prospective data. Gender association, especially the potential higher prevalence in females, will be investigated. Symptom tracking via questionnaires and scales will monitor duration and evolution. Questionnaires will also collect data on vaccination, reinfections, and new health issues. Biological samples will enable future studies on post-COVID-19 sequelae mechanisms, including inflammation, immune dysregulation, and viral reservoirs. Trial registration This study has been registered with ClinicalTrials.gov under the identifier NCT05531773.
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- 2023
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9. Heavily treatment-experienced persons living with HIV currently in care in Italy: characteristics, risk factors, and therapeutic options—the ICONA Foundation cohort study
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Lo Caputo, Sergio, Poliseno, Mariacristina, Tavelli, Alessandro, Gagliardini, Roberta, Rusconi, Stefano, Lapadula, Giuseppe, Antinori, Andrea, Francisci, Daniela, Sarmati, Loredana, Gori, Andrea, Spagnuolo, Vincenzo, Ceccherini-Silberstein, Francesca, d'Arminio Monforte, Antonella, and Cozzi-Lepri, Alessandro
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- 2024
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10. Persistent poor clinical outcomes of people living with HIV presenting with AIDS and late HIV diagnosis – results from the ICONA cohort in Italy, 2009-2022
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Mondi, Annalisa, Cozzi-Lepri, Alessandro, Tavelli, Alessandro, Cingolani, Antonella, Giacomelli, Andrea, Orofino, Giancarlo, De Girolamo, Gabriella, Pinnetti, Carmela, Gori, Andrea, Saracino, Annalisa, Bandera, Alessandra, Marchetti, Giulia, Girardi, Enrico, Mussini, Cristina, d'Arminio Monforte, Antonella, and Antinori, Andrea
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- 2024
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11. EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project
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Hedberg, Pontus, Varisco, Benedetta, Bai, Francesca, Sönnerborg, Anders, Naucler, Pontus, Pfeifer, Nico, Cozzi-Lepri, Alessandro, Ceccherini-Silberstein, Francesca, Naumovas, Daniel, Drobniewski, Francis, Jensen, Björn-Erik Ole, Toscano, Cristina, Parczewski, Miłosz, Quintanares, Gibran Horemheb Rubio, Mwau, Matilu, Pinto, Jorge A., Incardona, Francesca, Mommo, Chiara, and Marchetti, Giulia
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- 2023
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12. EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
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Varisco, Benedetta, Bai, Francesca, De Benedittis, Sara, Tavelli, Alessandro, Cozzi-Lepri, Alessandro, Sala, Matteo, Miraglia, Federica Gaia, Santoro, Maria Mercedes, Ceccherini-Silberstein, Francesca, Shimoni, Yishai, Ravid, Sivan, Kozlovski, Tal, König, Florian, Pfeifer, Nico, Shamsara, Elham, Parczewski, Milosz, Monforte, Antonella d’Arminio, Incardona, Francesca, Mommo, Chiara, and Marchetti, Giulia
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- 2023
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13. Development and validation of a prediction score for failure to casirivimab/imdevimab in hospitalized patients with COVID-19 pneumonia
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Alessandro Cozzi-Lepri, Vanni Borghi, Salvatore Rotundo, Bianca Mariani, Anna Ferrari, Cosmo Del Borgo, Francesca Bai, Pietro Colletti, Piermauro Miraglia, Carlo Torti, Anna Maria Cattelan, Giovanni Cenderello, Marco Berruti, Carlo Tascini, Giustino Parruti, Simona Coladonato, Andrea Gori, Giulia Marchetti, Miriam Lichtner, Luigi Coppola, Chiara Sorace, Alessandra D'Abramo, Valentina Mazzotta, Giovanni Guaraldi, Erica Franceschini, Marianna Meschiari, Loredana Sarmati, Andrea Antinori, Emanuele Nicastri, and Cristina Mussini
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casirivimab/imdevimab ,COVID-19 ,mechanical ventilation ,mortality ,prediction score ,SARS-CoV-2 ,Medicine (General) ,R5-920 - Abstract
IntroductionCasirivimab and imdevimab (CAS/IMV) are two non-competing, high-affinity human IgG1 anti-SARS-CoV-2 monoclonal antibodies, that showed a survival benefit in seronegative hospitalized patients with COVID-19. This study aimed to estimate the day-28 risk of mechanical ventilation (MV) and death in individuals hospitalized for severe COVID-19 pneumonia and receiving CAS/IMV. Additionally, it aimed to identify variables measured at the time of hospital admission that could predict these outcomes and derive a prediction algorithm.MethodsThis is a retrospective, observational cohort study conducted in 12 hospitals in Italy. Adult patients who were consecutively hospitalized from November 2021 to February 2022 receiving CAS/IMV were included. A multivariable logistic regression model was used to identify predictors of MV or death by day 28 from treatment initiation, and β-coefficients from the model were used to develop a risk score that was derived by means of leave-one-out internal cross-validation (CV), external CV, and calibration. Secondary outcome was mortality.ResultsA total of 480 hospitalized patients in the training set and 157 patients in the test set were included. By day 28, 36 participants (8%) underwent MV and 28 died (6%) for a total of 58 participants (12%) experiencing the composite primary endpoint. In multivariable analysis, four factors [age, PaO2/FiO2 ratio, lactate dehydrogenase (LDH), and platelets] were independently associated with the risk of MV/death and were used to generate the proposed risk score. The accuracy of the score in the area under the curve (AUC) was 0.80 and 0.77 in internal validation and test for the composite endpoint and 0.87 and 0.86 for death, respectively. The model also appeared to be well calibrated with the raw data.ConclusionThe mortality risk reported in our study was lower than that previously reported. Although CAS/IMV is no longer used, our score might help in identifying which patients are not likely to benefit from monoclonal antibodies and may require alternative interventions.
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- 2024
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14. Impact of COVID-19 pandemic on retention in care of native and migrant people with HIV in the ICONA cohort
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Roberta Gagliardini, Andrea Giacomelli, Giorgio Bozzi, Antonella D'Arminio Monforte, Alessandro Tavelli, Valentina Mazzotta, Elena Bruzzesi, Adriana Cervo, Annalisa Saracino, Cristina Mussini, Enrico Girardi, Alessandro Cozzi-Lepri, and Andrea Antinori
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SARS-CoV-2 ,Retention in care ,Loss to follow-up ,Arctic medicine. Tropical medicine ,RC955-962 ,Infectious and parasitic diseases ,RC109-216 - Abstract
Background: COVID-19 pandemic challenged the UNAIDS 90-90-90 targets. How the COVID-19 pandemic affected HIV retention in care and whether it has disproportionally affected migrant people with HIV (PWH) remained to be investigated. Methods: PWH in ICONA Cohort in follow-up in each of the study periods were included: 01/09/2019-29/02/2020 (pandemic period) and 01/03/2018-31/08/2018 (historical period, as a control). Risk of temporary loss to follow-up (LTFU, defined as no data recorded for a person for one year) was analyzed by logistic regression, with migrant status as the main exposure variable. Difference in difference (DID) analysis was applied to evaluate the effect of COVID-19 pandemic in the different risk of LTFU between natives and migrants. Results: 8864 (17.1% migrants) and 8071 (16.8% migrants) PWH constituted the pandemic and the historical period population, respectively.Proportion of PWH defined as LTFU in the pandemic period was 10.5% in native and 19.6% in migrant PWH.After controlling for age, sex and geographical location of enrolling site, risk of temporary LTFU was higher for migrants than native PWH [adjusted odds ratio 1.85 (95%CI 1.54–2.22)] in pandemic period. In PWH contributing to both periods, LTFU was 9.0% (95% CI 8.3–9.8) in natives vs 17.0% (95% CI 14.7–19.4) in migrants during the pandemic. Instead, LTFU was 1.2% (95%CI 0.9, 1.5) in natives vs 2.2% (95% CI 1.3–3.1) in migrants during the historical period, with a resulting DID of 7.0% (95% CI 4.4–9.6). Conclusions: A greater proportion of LTFU in migrant PWH was observed in both periods, which remained unaltered over time. Interventions to reduce LTFU of migrants are necessary.
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- 2024
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15. Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort studyResearch in context
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Valentina Mazzotta, Alessandro Cozzi Lepri, Giulia Matusali, Eleonora Cimini, Pierluca Piselli, Camilla Aguglia, Simone Lanini, Francesca Colavita, Stefania Notari, Alessandra Oliva, Silvia Meschi, Rita Casetti, Vanessa Mondillo, Alessandra Vergori, Aurora Bettini, Germana Grassi, Carmela Pinnetti, Daniele Lapa, Eleonora Tartaglia, Paola Gallì, Annalisa Mondi, Giulia Montagnari, Roberta Gagliardini, Emanuele Nicastri, Miriam Lichtner, Loredana Sarmati, Enrica Tamburrini, Claudio Mastroianni, Christof Stingone, Andrea Siddu, Alessandra Barca, Carla Fontana, Chiara Agrati, Enrico Girardi, Francesco Vaia, Fabrizio Maggi, Andrea Antinori, Enza Anzalone, Marta Camici, Fabio Cannone, Priscilla Caputi, Claudia Cimaglia, Rita Corso, Flavia Cristofanelli, Stefania Cruciani, Nicola De Marco, Chiara De Ponte, Giulia Del Duca, Paolo Faccendini, Francesca Faraglia, Augusto Faticoni, Marisa Fusto, Saba Gebremeskel, Maria Letizia Giancola, Giuseppina Giannico, Simona Gili, Maria Rosaria Iannella, Angela Junea, Alessandra Lamonaca, Alessandra Marani, Erminia Masone, Ilaria Mastrorosa, Stefania Mazzotta, Alessandra Nappo, Giorgia Natalini, Alfredo Parisi, Sara Passacantilli, Jessica Paulicelli, Maria Maddalena Plazzi, Adriano Possi, Gianni Preziosi, Silvia Rosati, Marika Rubino, Pietro Scanzano, Laura Scorzolini, Virginia Tomassi, Maurizio Vescovo, Serena Vita, Luciano Caterini, Luigi Coppola, Dimitra Kontogiannis, Gabriella D'Ettorre, Marco Ridolfi, Simona Di Giambenedetto, Damiano Farinacci, Alessandra Latini, Mauro Marchili, and Raffaella Marocco
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mpox ,MVA-BN immunogenicity ,Reactogenicity ,Cellular response ,Humoral response ,HIV ,Medicine (General) ,R5-920 - Abstract
Summary: 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”.
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- 2024
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16. COVID-19: Online Not Distant—MSc Students’ Feedback on an Alternative Approach to Teaching ‘Research Methods and Introduction to Statistics’ at UCL Queen Square Institute of Neurology
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Islam, Saiful, Ahmed, Saiam, Greiner, Rosamund, Sarker, Shah-Jalal, Akasaki, Mifuyu, Khanom, Masuda, Blundred, David, Cozzi-Lepri, Alessandro, Palmeiro-Silva, Yasna, Farnell, Damian J. J., editor, and Medeiros Mirra, Renata, editor
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- 2023
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17. Long-acting combination of cabotegravir plus rilpivirine: A picture of potential eligible and ineligible HIV-positive individuals from the Italian ARCA cohort
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Adriana Cervo, Antonio Russo, Domenico Di Carlo, Andrea De Vito, Lavinia Fabeni, Stefano D'Anna, Leonardo Duca, Agnese Colpani, Marco Fois, Beatrice Zauli, Giulia Mancarella, Anna Carraro, Antonia Bezenchek, Alessandro Cozzi-Lepri, and Maria Mercedes Santoro
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Long-acting ,Cabotegravir ,Rilpivirine ,HIV ,Antiretroviral therapy ,Drug resistance ,Microbiology ,QR1-502 - Abstract
ABSTRACT: Objectives: We aimed to evaluate the prevalence and characteristics of people living with HIV (PLWH) eligible for the long-acting injectable (LAI) regimen with cabotegravir (CAB) and rilpivirine (RPV), in comparison with ineligible individuals. Methods: This was an observational, cross-sectional study from the ARCA cohort, including virologically suppressed PLWH with at least one genotypic resistance testing (GRT) for reverse transcriptase and integrase from plasma and/or PBMCs. Eligibility criteria for LAI CAB+RPV were: negative HBsAg, absence of previous virological failures and/or resistance-associated mutations for non-nucleoside reverse transcriptase inhibitors (NNRTIs) and/or integrase strand transfer inhibitors. Potential differences between eligible and ineligible individuals were investigated by univariable and multivariable analyses. Results: A total of 514 individuals were included: 377 (73.3%) were male, median age was 51 (IQR: 43–58), on ART for 9 years (IQR: 4–17), virologically suppressed for 63 months (IQR: 35–105). Eligible individuals for CAB+RPV were 229 (44.5%, 95%CI: 40.8–48.8); compared with ineligible individuals, they received a lower number of previous regimens (aOR 0.76, 95% CI 0.71–0.83, P < 0.001) and were on current NNRTIs (aOR 2.16, 95% CI 1.38–3.37, P = 0.001). Conclusions: Less than half of virologically suppressed PLWH in the ARCA cohort were potentially eligible for CAB+RPV. They seem to be “less complicated” with shorter exposure to ART and preferably already on NNRTIs.
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- 2023
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18. Neutralizing activity and T-cell response after bivalent fifth dose of messenger RNA vaccine in people living with HIV
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Alessandra Vergori, Giulia Matusali, Alessandro Cozzi Lepri, Eleonora Cimini, Marisa Fusto, Francesca Colavita, Roberta Gagliardini, Stefania Notari, Valentina Mazzotta, Davide Mariotti, Stefania Cicalini, Enrico Girardi, Francesco Vaia, Fabrizio Maggi, and Andrea Antinori
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AIDS ,mRNA bivalent vaccine ,Omicron sub-variants ,Neutralizing antibodies ,T-specific cell immunity ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: To investigate immunogenicity of SARS-CoV-2 vaccine third booster dose (3BD; fifth dose) with bivalent vaccine original/BA4/5 vaccine in people living with HIV (PLWH). Methods: This is an observational cohort study to evaluate the outcomes of SARS-CoV-2 vaccination (HIV-VAC study). We analyzed microneutralization assay and interferon-γ production in 48 PLWH on antiretroviral therapy with clusters of differentiation (CD4) count
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- 2023
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19. Impact of COVID-19 pandemic on retention in care of native and migrant people with HIV in the ICONA cohort
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Gagliardini, Roberta, Giacomelli, Andrea, Bozzi, Giorgio, D'Arminio Monforte, Antonella, Tavelli, Alessandro, Mazzotta, Valentina, Bruzzesi, Elena, Cervo, Adriana, Saracino, Annalisa, Mussini, Cristina, Girardi, Enrico, Cozzi-Lepri, Alessandro, and Antinori, Andrea
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- 2024
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20. In-hospital mortality during the wild-type, alpha, delta, and omicron SARS-CoV-2 waves: a multinational cohort study in the EuCARE project
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Hedberg, Pontus, Parczewski, Milosz, Serwin, Karol, Marchetti, Giulia, Bai, Francesca, Ole Jensen, Björn-Erik, Pereira, Joana P.V., Drobniewski, Francis, Reschreiter, Henrik, Naumovas, Daniel, Ceccherini-Silberstein, Francesca, Rubio Quintanares, Gibran Horemheb, Mwau, Matilu, Toscano, Cristina, König, Florian, Pfeifer, Nico, Zazzi, Maurizio, Fanti, Iuri, Incardona, Francesca, Cozzi-Lepri, Alessandro, Sönnerborg, Anders, and Nauclér, Pontus
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- 2024
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21. Characterization and outcomes of difficult-to-treat patients starting modern first-line ART regimens: Data from the ICONA cohort
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Gagliardini, Roberta, Tavelli, Alessandro, Rusconi, Stefano, Lo Caputo, Sergio, Spagnuolo, Vincenzo, Santoro, Maria Mercedes, Costantini, Andrea, Vergori, Alessandra, Maggiolo, Franco, Giacomelli, Andrea, Burastero, Giulia, Madeddu, Giordano, Quiros Roldan, Eugenia, d'Arminio Monforte, Antonella, Antinori, Andrea, and Cozzi-Lepri, Alessandro
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- 2024
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22. Efficacy of bezlotoxumab in preventing the recurrence of Clostridioides difficile infection: an Italian multicenter cohort study
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Marianna Meschiari, Alessandro Cozzi-Lepri, Adriana Cervo, Guido Granata, Carlotta Rogati, Erica Franceschini, Stefania Casolari, Paola Tatarelli, Daniele Roberto Giacobbe, Matteo Bassetti, Simone Mornese Pinna, Francesco Giuseppe De Rosa, Francesco Barchiesi, Benedetta Canovari, Carolina Lorusso, Giuseppe Russo, Giovanni Cenderello, Antonio Cascio, Nicola Petrosillo, and Cristina Mussini
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Clostridioides difficile infection ,Recurrence ,Bezlotoxumab ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: Bezlotoxumab (BEZ) is a promising tool for preventing the recurrence of Clostridioides difficile infection (rCDI). The aim of the study was to emulate, in a real-world setting, the MODIFY trials in a cohort of participants with multiple risk factors for rCDI treated with BEZ in addition to the standard of care (SoC) versus SoC alone. Methods: A multicenter cohort study was conducted including 442 patients with Clostridioides difficile infection from 2018 to 2022, collected from 18 Italian centers. The main outcome was the 30-day occurrence of rCDI. The secondary outcomes were (i) all-cause mortality at 30 days (ii) and the composite outcome (30-day recurrence and/or all-cause death). Results: rCDI at day 30 occurred in 54 (12%): 11 in the BEZ + SoC group and 43 treated with SoC alone (8% vs 14%, odds ratio [OR] = 0.58, 95% confidence interval [CI]: 0.31-1.09, P = 0.09). The difference between BEZ + SoC versus SoC was statistically significant after controlling for confounding factors (adjusted OR = 0.40, 95% CI: 018-0.88, P = 0.02) and even more using the composite outcome (adjusted OR = 0.35, 95% CI: 0.17-0.73, P = 0.005). Conclusion: Our study confirms the efficacy of BEZ + SoC for the prevention of rCDI and death in a real-world setting. BEZ should be routinely considered among participants at high risk of rCDI regardless of age, type of Clostridioides difficile infection therapy (vancomycin vs fidaxomicin), and number of risk factors.
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- 2023
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23. Evaluating immunological and inflammatory changes of treatment-experienced people living with HIV switching from first-line triple cART regimens to DTG/3TC vs. B/F/TAF: the DEBATE trial
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Andrea Cossarizza, Alessandro Cozzi-Lepri, Marco Mattioli, Annamaria Paolini, Anita Neroni, Sara De Biasi, Domenico Lo Tartaro, Rebecca Borella, Lucia Fidanza, Lara Gibellini, Barbara Beghetto, Enrica Roncaglia, Giulia Nardini, Jovana Milic, Marianna Menozzi, Gianluca Cuomo, Margherita Digaetano, Gabriella Orlando, Vanni Borghi, Giovanni Guaraldi, and Cristina Mussini
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HIV ,dual regimen ,three-drug regimen ,DTG/3TC ,B/F/TAF ,CD4/CD8 ratio ,Immunologic diseases. Allergy ,RC581-607 - Abstract
BackgroundThe aim of this randomized clinical trial (RCT) was to compare immunological changes in virally suppressed people living with HIV (PLWH) switching from a three-drug regimen (3DR) to a two-drug regimen (2DR).MethodsAn open-label, prospective RCT enrolling PLWH receiving a 3DR who switched to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir/lamivudine (DTG/3TC) was performed. Blood was taken at baseline and months 6 and 12. The primary outcome was the change in CD4+ or CD8+ T-cell counts and CD4/CD8 ratio over time points. The secondary outcomes were the changes in immunological and inflammatory parameters. Parametric mixed-linear models with random intercepts and slopes were fitted separately for each marker after controlling for potential confounders.ResultsBetween the two arms (33 PLWH each), there was no difference in CD4+ or CD8+ T cells, CD4/CD8 ratio, and IL-6 trajectories. PLWH switching to DTG/3TC had increased levels of both transitional memory and terminally differentiated CD4+ T cells (arm–time interaction p-value = 0.02) and to a lesser extent for the corresponding CD8+ T-cell subsets (p = 0.09). Significantly lower levels of non-classical monocytes were detected in the B/F/TAF arm at T6 (diff = −6.7 cells/mm3; 95% CI; −16, +2.6; p-value for interaction between arm and time = 0.03). All differences were attenuated at T12.ConclusionNo evidence for a difference in absolute CD4+ and CD8+ T-cell counts, CD4/CD8 ratio, and IL-6 trajectories by study arm over 12 months was found. PLWH on DTG/3TC showed higher levels of terminally differentiated and exhausted CD4+ and CD8+ T lymphocytes and non-classical monocytes at T6. Further studies are warranted to better understand the clinical impact of our results.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier NCT04054089.
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- 2023
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24. Risk of COVID-19 in-hospital mortality in people living with HIV compared to general population according to age and CD4 strata: data from the ICONA network
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Giacomelli, Andrea, Gagliardini, Roberta, Tavelli, Alessandro, De Benedittis, Sara, Mazzotta, Valentina, Rizzardini, Giuliano, Mondi, Annalisa, Augello, Matteo, Antinori, Spinello, Vergori, Alessandra, Gori, Andrea, Menozzi, Marianna, Taramasso, Lucia, Fusco, Francesco Maria, De Vito, Andrea, Mancarella, Giulia, Marchetti, Giulia, D'Arminio Monforte, Antonella, Antinori, Andrea, and Cozzi-Lepri, Alessandro
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- 2023
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25. Trabecular titanium cups in acetabular revision arthroplasty: analysis of 10-year survivorship, restoration of center of rotation and osteointegration
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Cozzi Lepri, Andrea, Innocenti, Matteo, Galeotti, Alberto, Carulli, Christian, Villano, Marco, and Civinini, Roberto
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- 2022
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26. Efficacy of bezlotoxumab in preventing the recurrence of Clostridioides difficile infection: an Italian multicenter cohort study
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Meschiari, Marianna, Cozzi-Lepri, Alessandro, Cervo, Adriana, Granata, Guido, Rogati, Carlotta, Franceschini, Erica, Casolari, Stefania, Tatarelli, Paola, Giacobbe, Daniele Roberto, Bassetti, Matteo, Pinna, Simone Mornese, De Rosa, Francesco Giuseppe, Barchiesi, Francesco, Canovari, Benedetta, Lorusso, Carolina, Russo, Giuseppe, Cenderello, Giovanni, Cascio, Antonio, Petrosillo, Nicola, and Mussini, Cristina
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- 2023
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27. How to Avoid Complication in the ABMS Total Hip Replacement
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Civinini, Roberto, Cozzi-Lepri, Andrea, Innocenti, Matteo, Villano, Marco, Innocenti, Massimo, Geller, Jeffrey A., editor, and McGrory, Brian J., editor
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- 2022
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28. External validation of the PAGE-B score for HCC risk prediction in people living with HIV/HBV coinfection
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Abela, I., Aebi-Popp, K., Anagnostopoulos, A., Battegay, M., Bernasconi, E., Braun, D.L., Bucher, H.C., Calmy, A., Cavassini, M., Ciuffi, A., Dollenmaier, G., Egger, M., Elzi, L., Fehr, J., Fellay, J., Furrer, H., Fux, C.A., Günthard, H.F., Hachfeld, A., Haerry, D., Hasse, B., Hirsch, H.H., Hoffmann, M., Hösli, I., Huber, M., Jackson-Perry, D., Kahlert, C.R., Kaiser, L., Keiser, O., Klimkait, T., Kouyos, R.D., Kovari, H., Kusejko, K., Labhardt, N., Leuzinger, K., de Tejada B, Martinez, Marzolini, C., Metzner, K.J., Müller, N., Nemeth, J., Nicca, D., Notter, J., Paioni, P., Pantaleo, G., Perreau, M., Rauch, A., Salazar-Vizcaya, L., Schmid, P., Speck, R., Stöckle, M., Tarr, P., Trkola, A., Wandeler, G., Weisser, M., Yerly, S., van der Valk, M., Geerlings, S.E., Goorhuis, A., Harris, V.C., Hovius, J.W., Lempkes, B., Nellen, F.J.B., van der Poll, T., Prins, J.M., Spoorenberg, V., van Vugt, M., Wiersinga, W.J., Wit, F.W.M.N., Bruins, C., van Eden, J., Hylkema-van den Bout, I.J., van Hes, A.M.H., Pijnappel, F.J.J., Smalhout, S.Y., Weijsenfeld, A.M., Back, N.K.T., Berkhout, B., Cornelissen, M.T.E., van Houdt, R., Jonges, M., Jurriaans, S., Schinkel, C.J., Wolthers, K.C., Zaaijer, H.L., Peters, E.J.G., van Agtmael, M.A., Autar, R.S., Bomers, M., Sigaloff, K.C.E., Heitmuller, M., Laan, L.M., van den Berge, M., Stegeman, A., Baas, S., Hage de Looff, L., van Arkel, A., Stohr, J., Wintermans, B., Pronk, M.J.H., Ammerlaan, H.S.M., de Munnik, E.S., Deiman, B., Jansz, A.R., Scharnhorst, V., Tjhie, J., Wegdam, M.C.A., van Eeden, A., Hoornenborg, E., Nellen, J., Alers, W., Elsenburg, L.J.M., Nobel, H., van Kasteren, M.E.E., Berrevoets, M.A.H., Brouwer, A.E., de Kruijf-van de Wiel, B.A.F.M., Adams, A., Rijkevoorsel, M. Pawels-van, Buiting, A.G.M., Murck, J.L., Rokx, C., Anas, A.A., Bax, H.I., van Gorp, E.C.M., de Mendonça Melo, M., van Nood, E., Nouwen, J.L., Rijnders, B.J.A., Schurink, C.A.M., Slobbe, L., de Vries-Sluijs, T.E.M.S., Bassant, N., van Beek, J.E.A., Vriesde, M., van Zonneveld, L.M., de Groot, J., van Kampen, J.J.A., Koopmans, M.P.G., Rahamat-Langendoen, J.C., Branger, J., Douma, R.A., Cents-Bosma, A.S., Duijf-van de Ven, C.J.H.M., Schippers, E.F., van Nieuwkoop, C., Geilings, J., van Winden, S., van der Hut, G., van Burgel, N.D., Leyten, E.M.S., Gelinck, L.B.S., Mollema, F., Wildenbeest, G.S., Nguyen, T., Groeneveld, P.H.P., Bouwhuis, J.W., Lammers, A.J.J., van Hulzen, A.G.W., Kraan, S., Kruiper, M.S.M., van der Bliek, G.L., Bor, P.C.J., Debast, S.B., Wagenvoort, G.H.J., Roukens, A.H.E., de Boer, M.G.J., Jolink, H., Lambregts, M.M.C., Scheper, H., Dorama, W., van Holten, N., Claas, E.C.J., Wessels, E., Hollander, J.G. den, El Moussaoui, R., Pogany, K., Brouwer, C.J., Heida-Peters, D., Mulder, E., Smit, J.V., Struik-Kalkman, D., van Niekerk, T., Pontesilli, O., van Tienen, C., Lowe, S.H., Lashof, A.M.L. Oude, Posthouwer, D., van Wolfswinkel, M.E., Ackens, R.P., Burgers, K., Elasri, M., Schippers, J., Havenith, T.R.A., van Loo, M., van Vonderen, M.G.A., Kampschreur, L.M., van Broekhuizen, M.C., S, Faber, Al Moujahid, A., Kootstra, G.J., Delsing, C.E., van der Burg-van de Plas, M., Scheiberlich, L., Kortmann, W., van Twillert, G., Renckens, R., Wagenaar, J., Ruiter-Pronk, D., van Truijen-Oud, F.A., Stuart, J.W.T. Cohen, Hoogewerf, M., Rozemeijer, W., Sinnige, J.C., Brinkman, K., van den Berk, G.E.L., Lettinga, K.D., de Regt, M., Schouten, W.E.M., Stalenhoef, J.E., Veenstra, J., Vrouenraets, S.M.E., Blaauw, H., Geerders, G.F., Kleene, M.J., Knapen, M., Kok, M., van der Meché, I.B., Toonen, A.J.M., Wijnands, S., Wttewaal, E., Kwa, D., van de Laar, T.J.W., van Crevel, R., van Aerde, K., Dofferhoff, A.S.M., Henriet, S.S.V., Hofstede, H.J.M. ter, Hoogerwerf, J., Richel, O., Albers, M., Grintjes-Huisman, K.J.T., de Haan, M., Marneef, M., McCall, M., Burger, D., Gisolf, E.H., Claassen, M., Hassing, R.J., Beest, G. ter, van Bentum, P.H.M., Gelling, M., Neijland, Y., Swanink, C.M.A., Velderman, M. Klein, van Lelyveld, S.F.L., Soetekouw, R., van der Prijt, L.M.M., van der Swaluw, J., Kalpoe, J.S., Wagemakers, A., Vahidnia, A., Lauw, F.N., Verhagen, D.W.M., van Wijk, M., Bierman, W.F.W., Bakker, M., van Bentum, R.A., van den Boomgaard, M.A., Kleinnijenhuis, J., Kloeze, E., Middel, A., Postma, D.F., Schenk, H.M., Stienstra, Y., Wouthuyzen-Bakker, M., Boonstra, A., de Jonge, H., Maerman, M.M.M., de Weerd, D.A., van Eije, K.J., Knoester, M., van Leer-Buter, C.C., Niesters, H.G.M., T.Mudrikova, Barth, R.E., Bruns, A.H.W., Ellerbroek, P.M., Hensgens, M.P.M., Oosterheert, J.J., Schadd, E.M., Verbon, A., van Welzen, B.J., Berends, H., Santen, B.M.G. Griffioen-van, de Kroon, I., Lunel, F.M. Verduyn, Wensing, A.M.J., Zaheri, S., Boyd, A.C., Bezemer, D.O., van Sighem, A.I., Smit, C., Hillebregt, M.M.J., Woudstra, T.J., Rutkens, T., Bergsma, D., Brétin, N.M., Lelivelt, K.J., van de Sande, L., van der Vliet, K.M. Visser.S.T., Paling, F., de Groot-Berndsen, L.G.M., van den Akker, M., Alexander, R., Bakker, Y., El Berkaoui, A., Bezemer-Goedhart, M., Djoechro, E.A., Groters, M., Koster, L.E., Lodewijk, C.R.E., Lucas, E.G.A., Munjishvili, L., Peeck, B.M., Ree, C.M.J., Regtop, R., van Rijk, A.F., Ruijs-Tiggelman, Y.M.C., Schnörr, P.P., Schoorl, M.J.C., Tuijn, E.M., Veenenberg, D.P., Witte, E.C.M., Bretin, N.M., Karpov, I., Losso, M., Lundgren, J., Rockstroh, J., Aho, I., Rasmussen, L.D., Novak, P., Pradier, C., Chkhartishvili, N., Matulionyte, R., Oprea, C., Kowalska, J.D., Begovac, J., Miró, J.M., Guaraldi, G., Paredes, R., Peters, L., Larsen, J.F., Neesgaard, B., Jaschinski, N., Fursa, O., Raben, D., Kristensen, D., Fischer, A.H., Jensen, S.K., Elsing, T.W., Gardizi, M., Mocroft, A., Phillips, A., Reekie, J., Cozzi-Lepri, A., Pelchen-Matthews, A., Roen, A., Tusch, E.S., Bannister, W., Bellecave, P., Blanco, P., Bonnet, F., Bouchet, S., Breilh, D., Cazanave, C., Desjardin, S., Gaborieau, V., Gimbert, A., Hessamfar, M., Lacaze-Buzy, L., Lacoste, D., Lafon, M.E., Lazaro, E., Leleux, O., Le Marec, F., Le Moal, G., Malvy, D., Marchand, L., Mercié, P., Neau, D., Pellegrin, I., Perrier, A., Petrov-Sanchez, V., Vareil, M.O., Wittkop, L., Bernard, N., Chaussade, D. Bronnimann H., Dondia, D., Duffau, P., Faure, I., Morlat, P., Mériglier, E., Paccalin, F., Riebero, E., Rivoisy, C., Vandenhende, M.A., Barthod, L., Dauchy, F.A., Desclaux, A., Ducours, M., Dutronc, H., Duvignaud, A., Leitao, J., Lescure, M., Nguyen, D., Pistone, T., Puges, M., Wirth, G., Courtault, C., Camou, F., Greib, C., Pellegrin, J.L., Rivière, E., Viallard, J.F., Imbert, Y., Thierry-Mieg, M., Rispal, P., Caubet, O., Ferrand, H., Tchamgoué, S., Farbos, S., Wille, H., Andre, K., Caunegre, L., Gerard, Y., Osorio-Perez, F., Chossat, I., Iles, G., Labasse-Depis, M., Lacassin, F., Barret, A., Castan, B., Koffi, J., Rouanes, N., Saunier, A., Zabbe, J.B., Dumondin, G., Beraud, G., Catroux, M., Garcia, M., Giraud, V., Martellosio, J.P., Roblot, F., Pasdeloup, T., Riché, A., Grosset, M., Males, S., Bell, C. Ngo, Carpentier, C., Bellecave, Virology P., Tumiotto, C., Miremeont-Salamé, G., Arma, D., Arnou, G., Blaizeau, M.J., Camps, P., Decoin, M., Delveaux, S., Diarra, F., Gabrea, L., Lawson-Ayayi, S., Lenaud, E., Plainchamps, D., Pougetoux, A., Uwamaliya, B., Zara, K., Conte, V., Gapillout, M., Surial, Bernard, Ramírez Mena, Adrià, Roumet, Marie, Limacher, Andreas, Smit, Colette, Leleux, Olivier, Mocroft, Amanda, van der Valk, Marc, Bonnet, Fabrice, Peters, Lars, Rockstroh, Jürgen K., Günthard, Huldrych F., Berzigotti, Annalisa, Rauch, Andri, and Wandeler, Gilles
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- 2023
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29. Observational cohort study of rilpivirine (RPV) utilization in Europe
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Alessandro Cozzi-Lepri, Lars Peters, Annegret Pelchen-Matthews, Bastian Neesgaard, Stephane De Wit, Isik Somuncu Johansen, Simon Edwards, Christoph Stephan, Georgios Adamis, Therese Staub, Alexandra Zagalo, Pere Domingo, Daniel Elbirt, Katharina Kusejko, Johanna Brännström, Dzmitry Paduta, Tatyana Trofimova, Janos Szlavik, Kai Zilmer, Marcello Losso, Veerle Van Eygen, Helen Pai, Jens Lundgren, Amanda Mocroft, and for the EuroSIDA Study Group
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Cohort Study ,Europe ,Edurant™ ,Eviplera™ ,Efavirenz ,Real-world effectiveness ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce. Methods Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann–Whitney U test and Chi-square test. A logistic regression model was used to compare participants’ characteristics by treatment group. Kaplan–Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL). Results 1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4.5% (95% CI 3.3–5.7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0.0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).
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- 2022
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30. Immunogenicity to COVID-19 mRNA vaccine third dose in people living with HIV
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Alessandra Vergori, Alessandro Cozzi Lepri, Stefania Cicalini, Giulia Matusali, Veronica Bordoni, Simone Lanini, Silvia Meschi, Roberta Iannazzo, Valentina Mazzotta, Francesca Colavita, Ilaria Mastrorosa, Eleonora Cimini, Davide Mariotti, Lydia De Pascale, Alessandra Marani, Paola Gallì, AnnaRosa Garbuglia, Concetta Castilletti, Vincenzo Puro, Chiara Agrati, Enrico Girardi, Francesco Vaia, Andrea Antinori, and HIV-VAC study group
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Science - Abstract
HIV infection may affect the immune response to vaccination. Here the authors show that humoral response in persons living with HIV after the third dose of a SARS-CoV-2 vaccine is strong and higher than that achieved with the second dose, while cell-mediated immunity remains stable.
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- 2022
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31. Functional Outcomes of Anterior-Based Muscle Sparing Approach Compared to Direct Lateral Approach for Total HIP Arthroplasty Following Acute Femoral Neck Fractures
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Matteo Innocenti MD, Andrea Cozzi Lepri MD, Alessandro Civinini MD, Nicola Mondanelli MD, PhD, Fabrizio Matassi MD, PhD, Davide Stimolo MD, Simone Cerciello MD, and Roberto Civinini MD
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Orthopedic surgery ,RD701-811 ,Geriatrics ,RC952-954.6 - Abstract
Introduction Total hip arthroplasty (THA) performed for femoral neck fractures (FNFs) is becoming a more frequent treatment in the active elderly population. Since there is limited research available presenting clinical outcomes after THA using the anterior-based muscle sparing (ABMS) approach, the aim of this study was to compare this surgical approach to the direct lateral (DL) approach in patients treated by THA for FNFs. Materials and Methods We retrospectively reviewed the data prospectively collected as a part of our “Hip Fracture Unit” and included 163 patients who underwent THA from January 2016 to January 2019 for acute displaced FNFs. Results A total of 132 patients who completed a minimum 2-years follow up (69 in the ABMS group and 63 in DL group) were included. The ABMS group demonstrated significantly shorter time to reach milestone for hospital discharge (1.5 Days vs 2.1 days, P = .018), while no statistically significant differences were detected in peri-operative complications. At 3 months, the timed up and go test, the Harris Hip Score (HHS) and the Oxford ip Score (OHS) were significantly better ( P = .024, .032 and .034, respectively) in the ABMS group compared to the DL group. No differences were found in functional outcomes (HHS and OHS) nor in complication rate at 6, 12 and 24 months. Discussion This is one of the first studies to analyze functional results of THA performed for FNFs through an ABMS approach. Results are in line with those already present in the Literature. Conclusion ABMS approach allows earlier mobilization and better early functional outcomes, compared to DL approach, in patients undergoing THA for acute displaced FNF. No differences are found after 6 months in functional results and complications rate.
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- 2023
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32. Predictive Factors for Pregnancy-Related Persistent Pelvic Girdle Pain (PPGP): A Systematic Review
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Elisa Burani, Sharon Marruganti, Gloria Giglioni, Francesca Bonetti, Daniele Ceron, and Alessandro Cozzi Lepri
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persistent PGP ,PGP postpartum ,pregnancy-related PGP ,predictive factors ,systematic review ,Medicine (General) ,R5-920 - Abstract
Background and Objectives: To identify the most frequently reported predictive factors for the persistency of pregnancy-related pelvic girdle pain (PPGP) at 3–6 months after childbirth in women with PPGP alone or PPGP in association with pregnancy-related lower back pain (PLBP). Methods: Eligibility criteria: Two authors independently selected studies excluding PPGP determined by a specific, traumatic, gynecological/urological cause or isolated PLBP and studies that did not include the presence/absence of PPGP as the the primary outcome. We, instead, included studies with an initial assessment in pregnancy (within 1 month of delivery) and with a follow-up of at least 3 months after delivery. Data sources: The research was performed using the databases of Medline, Cochrane, Pedro, Scopus, Web of Science and Cinahl from December 2018 to January 2022, following the indications of the PRISMA statement 2021 and the MOOSE checklist. It includes observational cohort studies in which data were often collected through prospective questionnaires (all in English). Study appraisal and risk of bias: Two independent authors performed evaluations of the risk of bias (ROB) using the quality in prognostic studies (QUIPS) tool. Synthesis of results: An in-depth qualitative analysis was conducted because, due to a high degree of heterogeneity in the data collection of the included studies and a lack of raw data suitable for quantitative analysis, it was not possible to carry out the originally planned meta-analyses for the subgroups. Results: The research process led to the inclusion of 10 articles which were evaluated using the QUIPS tool: 5 studies were evaluated as low ROB and 5 were evaluated as moderate ROB. High levels of pain in pregnancy, a large number of positive provocation tests, a history of lower back pain and lumbo-pelvic pain, high levels of disability in pregnancy, neurotic behavior and high levels of fear-avoidance belief were identified as strong predictors of long-term PPGP, while there was weak or contradictory evidence regarding predictions of emotional distress, catastrophizing and sleep disturbances. Discussion: The impossibility of carrying out the meta-analysis by subgroups suggests the need for further research with greater methodological rigor in the acquisition of measures based on an already existing PPGP core predictors/outcome sets.
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- 2023
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33. Long Term Assessment of Anti-SARS-CoV-2 Immunogenicity after mRNA Vaccine in Persons Living with HIV
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Alessandra Vergori, Alessandro Cozzi-Lepri, Giulia Matusali, Stefania Cicalini, Veronica Bordoni, Silvia Meschi, Valentina Mazzotta, Francesca Colavita, Marisa Fusto, Eleonora Cimini, Stefania Notari, Veronica D’Aquila, Simone Lanini, Daniele Lapa, Roberta Gagliardini, Davide Mariotti, Giuseppina Giannico, Enrico Girardi, Francesco Vaia, Chiara Agrati, Fabrizio Maggi, and Andrea Antinori
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HIV-1 infection ,SARS-CoV-2 infection ,neutralizing antibodies ,mRNA vaccines ,T cell immunity ,immunity waning ,Medicine - Abstract
(1) Background: Waning of neutralizing and cell-mediated immune response after the primary vaccine cycle (PVC) and the first booster dose (BD) is of concern, especially for PLWH with a CD4 count ≤200 cells/mm3. (2) Methods: Neutralizing antibodies (nAbs) titers by microneutralization assay against WD614G/Omicron BA.1 and IFNγ production by ELISA assay were measured in samples of PLWH at four time points [2 and 4 months post-PVC (T1 and T2), 2 weeks and 5 months after the BD (T3 and T4)]. Participants were stratified by CD4 count after PVC (LCD4, ≤200/mm3; ICD4, 201–500/mm3, and HCD4, >500/mm3). Mixed models were used to compare mean responses over T1–T4 across CD4 groups. (3) Results: 314 PLWH on ART (LCD4 = 56; ICD4 = 120; HCD4 = 138) were enrolled. At T2, levels of nAbs were significantly lower in LCD4 vs. ICD4/HCD4 (p = 0.04). The BD was crucial for increasing nAbs titers above 1:40 at T3 and up to T4 for WD614G. A positive T cell response after PVC was observed in all groups, regardless of CD4 (p = 0.31). (4) Conclusions: Waning of nAbs after PVC was more important in LCD4 group. The BD managed to re-establish higher levels of nAbs against WD614G, which were retained for 5 months, but for shorter time for Omicron BA.1. The T cellular response in the LCD4 group was lower than that seen in participants with higher CD4 count, but, importantly, it remained above detectable levels over the entire study period.
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- 2023
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34. SARS-CoV-2 mRNA Vaccine Response in People Living with HIV According to CD4 Count and CD4/CD8 Ratio
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Alessandra Vergori, Alessandro Tavelli, Giulia Matusali, Anna Maria Azzini, Matteo Augello, Valentina Mazzotta, Giovanni Francesco Pellicanò, Andrea Costantini, Antonio Cascio, Andrea De Vito, Lorenzo Marconi, Elda Righi, Assunta Sartor, Carmela Pinnetti, Fabrizio Maggi, Francesca Bai, Simone Lanini, Stefania Piconi, Gabriel Levy Hara, Giulia Marchetti, Maddalena Giannella, Evelina Tacconelli, Antonella d’Arminio Monforte, Andrea Antinori, Alessandro Cozzi-Lepri, and on behalf of the Vax-ICONA-ORCHESTRA Study
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HIV ,PLWH ,CD4 count ,CD4/CD8 ratio ,SARS-CoV-2 mRNA vaccine ,humoral response ,Medicine - Abstract
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 after the second and third doses of COVID-19 mRNA vaccine as a proportion of not achieving a robust/above-average response using two criteria: (i) a humoral threshold identified as a correlate of protection against SARS-CoV-2 ( 200 cells/mm3 and a ratio > 0.6. Conclusions: A robust humoral response after a booster dose has not been reached by 50% of PLWH with CD4 < 200 cells mm3. In the absence of a validated correlate of protections in the Omicron era, the CD4 count remains the most solid marker to guide vaccination campaigns in PLWH.
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- 2023
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35. SARS-CoV-2 nasopharyngeal viral load in individuals infected with BA.2, compared to Alpha, Gamma, Delta and BA.1 variants: A single-center comparative analysis
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Mastrorosa, Ilaria, Cozzi-Lepri, Alessandro, Colavita, Francesca, Lalle, Eleonora, Mazzotta, Valentina, Cimaglia, Claudia, Paulicelli, Jessica, Matusali, Giulia, Fabeni, Lavinia, Carletti, Fabrizio, Rosati, Silvia, Vita, Serena, Giannico, Giuseppina, Piselli, Pierluca, Biliotti, Elisa, Moghazi, Samir Al, Mosti, Silvia, Girardi, Enrico, Nicastri, Emanuele, Garbuglia, Anna Rosa, Maggi, Fabrizio, Vaia, Francesco, and Antinori, Andrea
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- 2022
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36. The lesser trochanter “Sling fixation technique” in proximal intramedullary nailing of unstable intertrochanteric fractures: A polymer-based cerclage wiring
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Villano, Marco, Innocenti, Matteo, Civinini, Roberto, Carulli, Christian, Civinini, Alessandro, Taha, Zyad Ayman, and Cozzi Lepri, Andrea
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- 2022
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37. Observational cohort study of rilpivirine (RPV) utilization in Europe
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Cozzi-Lepri, Alessandro, Peters, Lars, Pelchen-Matthews, Annegret, Neesgaard, Bastian, De Wit, Stephane, Johansen, Isik Somuncu, Edwards, Simon, Stephan, Christoph, Adamis, Georgios, Staub, Therese, Zagalo, Alexandra, Domingo, Pere, Elbirt, Daniel, Kusejko, Katharina, Brännström, Johanna, Paduta, Dzmitry, Trofimova, Tatyana, Szlavik, Janos, Zilmer, Kai, Losso, Marcello, Van Eygen, Veerle, Pai, Helen, Lundgren, Jens, and Mocroft, Amanda
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- 2022
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38. Immunogenicity to COVID-19 mRNA vaccine third dose in people living with HIV
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Vergori, Alessandra, Cozzi Lepri, Alessandro, Cicalini, Stefania, Matusali, Giulia, Bordoni, Veronica, Lanini, Simone, Meschi, Silvia, Iannazzo, Roberta, Mazzotta, Valentina, Colavita, Francesca, Mastrorosa, Ilaria, Cimini, Eleonora, Mariotti, Davide, De Pascale, Lydia, Marani, Alessandra, Gallì, Paola, Garbuglia, AnnaRosa, Castilletti, Concetta, Puro, Vincenzo, Agrati, Chiara, Girardi, Enrico, Vaia, Francesco, and Antinori, Andrea
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- 2022
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39. Signals were broadly positive for months, but never definitive: the tocilizumab story
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Cozzi-Lepri, Alessandro, Smith, Colette, and Mussini, Cristina
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- 2022
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40. Discrimination of the Veterans Aging Cohort Study Index 2.0 for Predicting Cause-specific Mortality Among Persons With HIV in Europe and North America.
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Ambia, Julie, Ingle, Suzanne M, McGinnis, Kathleen, Pantazis, Nikos, Silverberg, Michael J, Wittkop, Linda, Kusejko, Katharina, Crane, Heidi, Sighem, Ard van, Sarcletti, Mario, Cozzi-Lepri, Alessandro, Domingo, Pere, Jarrin, Inma, Wyen, Christoph, Hessamfar, Mojgan, Zhang, Lei, Cavassini, Matthias, Berenguer, Juan, Sterling, Timothy R, and Reiss, Peter
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AGE discrimination ,SURVIVAL analysis (Biometry) ,DEATH rate ,ANTIRETROVIRAL agents ,MORTALITY - Abstract
Background Predicting cause-specific mortality among people with HIV (PWH) could facilitate targeted care to improve survival. We assessed discrimination of the Veterans Aging Cohort Study (VACS) Index 2.0 in predicting cause-specific mortality among PWH on antiretroviral therapy (ART). Methods Using Antiretroviral Therapy Cohort Collaboration data for PWH who initiated ART between 2000 and 2018, VACS Index 2.0 scores (higher scores indicate worse prognosis) were calculated around a randomly selected visit date at least 1 year after ART initiation. Missingness in VACS Index 2.0 variables was addressed through multiple imputation. Cox models estimated associations between VACS Index 2.0 and causes of death, with discrimination evaluated using Harrell's C-statistic. Absolute mortality risk was modelled using flexible parametric survival models. Results Of 59 741 PWH (mean age: 43 years; 80% male), the mean VACS Index 2.0 at baseline was 41 (range: 0–129). For 2425 deaths over 168 162 person-years follow-up (median: 2.6 years/person), AIDS (n = 455) and non–AIDS-defining cancers (n = 452) were the most common causes. Predicted 5-year mortality for PWH with a mean VACS Index 2.0 score of 38 at baseline was 1% and approximately doubled for every 10-unit increase. The 5-year all-cause mortality C-statistic was.83. Discrimination with the VACS Index 2.0 was highest for deaths resulting from AIDS (0.91), liver-related (0.91), respiratory-related (0.89), non-AIDS infections (0.87), and non–AIDS-defining cancers (0.83), and lowest for suicides/accidental deaths (0.65). Conclusions For deaths among PWH, discrimination with the VACS Index 2.0 was highest for deaths with measurable physiological causes and was lowest for suicide/accidental deaths. [ABSTRACT FROM AUTHOR]
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- 2024
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41. Factors Associated With Persistence of Plasma HIV-1 RNA During Long-term Continuously Suppressive Firstline Antiretroviral Therapy.
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Ruggiero, Alessandra, Cozzi-Lepri, Alessandro, Beloukas, Apostolos, Richman, Douglas, Khoo, Saye, Phillips, Andrew, Geretti, Anna Maria, and ERAS Study Group
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ERAS Study Group ,2-LTR circular DNA ,activation ,drug concentration ,sCD27 ,viral load - Abstract
Background:Persistence of plasma HIV-1 RNA during seemingly effective antiretroviral thereapy (ART) is incompletely understood. Using an ultrasensitive assay, this cross-sectional study investigated residual plasma HIV-1 RNA in subjects maintained on firstline ART with continuous viral load suppression
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- 2018
42. Comparison of Kaposi Sarcoma Risk in Human Immunodeficiency Virus-Positive Adults Across 5 Continents: A Multiregional Multicohort Study
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Judd, Ali, Zangerle, Robert, Touloumi, Giota, Warszawski, Josiane, Meyer, Laurence, Dabis, François, Krause, Murielle Mary, Ghosn, Jade, Leport, Catherine, Wittkop, Linda, Reiss, Peter, Wit, Ferdinand, Prins, Maria, Bucher, Heiner, Gibb, Diana, Fätkenheuer, Gerd, Julia, Del Amo, Obel, Niels, Thorne, Claire, Mocroft, Amanda, Kirk, Ole, Stephan, Christoph, Pérez-Hoyos, Santiago, Hamouda, Osamah, Bartmeyer, Barbara, Chkhartishvili, Nikoloz, Noguera-Julian, Antoni, Antinori, Andrea, Monforte, Antonella d’Arminio, Brockmeyer, Norbert, Prieto, Luis, Conejo, Pablo Rojo, Soriano-Arandes, Antoni, Battegay, Manuel, Kouyos, Roger, Mussini, Cristina, Tookey, Pat, Casabona, Jordi, Miró, Jose M, Castagna, Antonella, Konopnick, Deborah, Goetghebuer, Tessa, Sönnerborg, Anders, Quiros-Roldan, Eugenia, Sabin, Caroline, Teira, Ramon, Garrido, Myriam, Haerry, David, de Wit, Stéphane, Costagliola, Dominique, d’Arminio-Monforte, Antonella, del Amo, Julia, Raben, Dorthe, Chêne, Geneviève, Rojo, Conejo Pablo, Barger, Diana, Schwimmer, Christine, Termote, Monique, Campbell, Maria, Frederiksen, Casper M, Friis-Møller, Nina, Kjaer, Jesper, Brandt, Rikke Salbøl, Berenguer, Juan, Bohlius, Julia, Bouteloup, Vincent, Cozzi-Lepri, Alessandro, Davies, Mary-Anne, Dorrucci, Maria, Dunn, David, Egger, Matthias, Furrer, Hansjakob, Grabar, Sophie, Guiguet, Marguerite, Lambotte, Olivier, Leroy, Valériane, Lodi, Sara, Matheron, Sophie, Miro, Jose M, Monge, Susana, Nakagawa, Fumiyo, Paredes, Roger, Phillips, Andrew, Puoti, Massimo, Rohner, Eliane, and Schomaker, Michael
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Biomedical and Clinical Sciences ,Clinical Sciences ,Sexually Transmitted Infections ,Rare Diseases ,Emerging Infectious Diseases ,Infectious Diseases ,HIV/AIDS ,Infection ,Adolescent ,Adult ,Anti-Retroviral Agents ,CD4 Lymphocyte Count ,Cohort Studies ,Female ,HIV Infections ,HIV-1 ,Humans ,Male ,Middle Aged ,Risk Factors ,Sarcoma ,Kaposi ,Viral Load ,Young Adult ,AIDS-defining Cancer Project Working Group for IeDEA and COHERE in EuroCoord ,HIV ,Kaposi sarcoma ,antiretroviral therapy ,cohort study ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences - Abstract
BackgroundWe compared Kaposi sarcoma (KS) risk in adults who started antiretroviral therapy (ART) across the Asia-Pacific, South Africa, Europe, Latin, and North America.MethodsWe included cohort data of human immunodeficiency virus (HIV)-positive adults who started ART after 1995 within the framework of 2 large collaborations of observational HIV cohorts. We present incidence rates and adjusted hazard ratios (aHRs).ResultsWe included 208140 patients from 57 countries. Over a period of 1066572 person-years, 2046 KS cases were diagnosed. KS incidence rates per 100000 person-years were 52 in the Asia-Pacific and ranged between 180 and 280 in the other regions. KS risk was 5 times higher in South African women (aHR, 4.56; 95% confidence intervals [CI], 2.73-7.62) than in their European counterparts, and 2 times higher in South African men (2.21; 1.34-3.63). In Europe, Latin, and North America KS risk was 6 times higher in men who have sex with men (aHR, 5.95; 95% CI, 5.09-6.96) than in women. Comparing patients with current CD4 cell counts ≥700 cells/µL with those whose counts were
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- 2017
43. COVID-19: Find the Right Questions to be Answered
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Giacomelli, Andrea, primary, Antinori, Spinello, additional, Gori, Andrea, additional, and Cozzi-Lepri, Alessandro, additional
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- 2024
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44. Better prognosis in females with severe COVID-19 pneumonia: possible role of inflammation as potential mediator
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Bacca, Erica, Bedini, Andrea, Borghi, Vanni, Burastero, Giulia, Carli, Federica, Ciusa, Giacomo, Corradi, Luca, Di Gaetano, Margherita, Faltoni, Matteo, Franceschi, Giacomo, Orlando, Gabriella, Pellegrino, Francesco, Puzzolante, Cinzia, Raimondi, Alessandro, Santoro, Antonella, Tutone, Marco, Yaacoub, Dina, Andreotti, Alberto, Biagioni, Emanuela, Bondi, Filippo, Busani, Stefano, Chierego, Giovanni, Scotti, Marzia, Serio, Lucia, Bellinazzi, Caterina, Borella, Rebecca, De Biasi, Sara, De Gaetano, Anna, Fidanza, Lucia, Gibellini, Lara, Iannone, Anna, Lo Tartaro, Domenico, Mattioli, Marco, Paolini, Annamaria, Fogliani, Rossella, Righini, Grazia, Lugli, Mario, Mussini, Cristina, Cozzi-Lepri, Alessandro, Menozzi, Marianna, Meschiari, Marianna, Franceschini, Erica, Rogati, Carlotta, Cuomo, Gianluca, Iadisernia, Vittorio, Volpi, Sara, Milic, Jovana, Tonelli, Roberto, Brugioni, Lucio, Pietrangelo, Antonello, Girardis, Massimo, Cossarizza, Andrea, Clini, Enrico, and Guaraldi, Giovanni
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- 2021
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45. Estimating the effectiveness of remdesivir on risk of COVID-19 mortality: The role of observational data
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Andrea Giacomelli, Alessandro Cozzi-Lepri, Giacomo Casalini, Letizia Oreni, Anna Lisa Ridolfo, and Spinello Antinori
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Therapeutics. Pharmacology ,RM1-950 - Published
- 2022
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46. Inflammation and microbial translocation measured prior to combination antiretroviral therapy (cART) and long-term probability of clinical progression in people living with HIV
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Esther Merlini, Alessandro Cozzi-lepri, Antonella Castagna, Andrea Costantini, Sergio Lo Caputo, Stefania Carrara, Eugenia Quiros Roldan, Maria A. Ursitti, Andrea Antinori, Antonella D’Arminio Monforte, and Giulia Marchetti
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HIV-infection ,Inflammation ,Microbial translocation ,Clinical progression ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Despite the effectiveness of cART, people living with HIV still experience an increased risk of serious non-AIDS events, as compared to the HIV negative population. Whether pre-cART microbial translocation (MT) and systemic inflammation might predict morbidity/mortality during suppressive cART, independently of other known risk factors, is still unclear. Thus, we aimed to investigate the role of pre-cART inflammation and MT as predictors of clinical progression in HIV+ patients enrolled in the Icona Foundation Study Cohort. Methods We included Icona patients with ≥2 vials of plasma stored within 6 months before cART initiation and at least one CD4 count after therapy available. Circulating biomarker: LPS, sCD14, EndoCab, hs-CRP. Kaplan-Meier curves and Cox regression models were used. We defined the endpoint of clinical progression as the occurrence of a new AIDS-defining condition, severe non-AIDS condition (SNAEs) or death whichever occurred first. Follow-up accrued from the data of starting cART and was censored at the time of last available clinical visit. Biomarkers were evaluated as both binary (above/below median) and continuous variables (logescale). Results We studied 486 patients with 125 clinical events: 39 (31%) AIDS, 66 (53%) SNAEs and 20 (16%) deaths. Among the analyzed MT and pro-inflammatory markers, hs-CRP seemed to be the only biomarker retaining some association with the endpoint of clinical progression (i.e. AIDS/SNAEs/death) after adjustment for confounders, both when the study population was stratified according to the median of the distribution (1.51 mg/L) and when the study population was stratified according to the 33% percentiles of the distribution (low 0.0–1.1 mg/L; intermediate 1.2–5.3 mg/L; high > 5.3 mg/L). In particular, the higher the hs-CRP values, the higher the risk of clinical progression (p = 0.056 for median-based model; p = 0.002 for 33% percentile-based model). Conclusions Our data carries evidence for an association between the risk of disease progression after cART initiation and circulating pre-cART hs-CRP levels but not with levels of MT. These results suggest that pre-therapy HIV-driven pro-inflammatory milieu might overweight MT and its downstream immune-activation.
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- 2021
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47. Determinants of loss to care and risk of clinical progression in PLWH who are re-engaged in care after a temporary loss
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Cristina Mussini, Patrizia Lorenzini, Alessandro Cozzi-Lepri, Alessia Mammone, Giovanni Guaraldi, Giulia Marchetti, Miriam Lichtner, Giuseppe Lapadula, Sergio Lo Caputo, Andrea Antinori, Antonella d’Arminio Monforte, and Enrico Girardi
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Medicine ,Science - Abstract
Abstract The risk of developing AIDS is elevated not only among those with a late HIV diagnosis but also among those lost to care (LTC). The aims were to address the risk of becoming LTC and of clinical progression in LTC patients who re-enter care. Patients were defined as LTC if they had no visit for ≥ 18 months. Of these, persons with subsequent visits were defined as re-engaged in care (RIC). Factors associated with becoming LTC and RIC were investigated. The risk of disease progression was estimated by comparing RIC with patients continuously followed. Over 11,285 individuals included, 3962 became LTC, and of these, 1062 were RIC. Older age, presentation with AIDS and with higher HIV-RNA were associated with a reduced risk of LTC. In contrast, lower education level, irregular job, being an immigrant and injecting-drug user were associated with an increased LTC probability. Moreover, RIC with HIV-RNA > 200 copies/mL at the re-entry had a higher risk of clinical progression, while those with HIV-RNA ≤ 200 copies/mL had a higher risk of only non-AIDS progression. Patients re-entering care after being LTC appeared to be at higher risk of clinical progression than those continuously in care. Active strategies for re-engagement in care should be promoted.
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- 2021
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48. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia
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Alessandra Vergori, Patrizia Lorenzini, Alessandro Cozzi-Lepri, Davide Roberto Donno, Gina Gualano, Emanuele Nicastri, Fabio Iacomi, Luisa Marchioni, Paolo Campioni, Vincenzo Schininà, Stefania Cicalini, Chiara Agrati, Maria Rosaria Capobianchi, Enrico Girardi, Giuseppe Ippolito, Francesco Vaia, Nicola Petrosillo, Andrea Antinori, Fabrizio Taglietti, and The ReCOVeRI Study Group
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Medicine ,Science - Abstract
Abstract Prophylactic low molecular weight heparin (pLMWH) is currently recommended in COVID-19 to reduce the risk of coagulopathy. The aim of this study was to evaluate whether the antinflammatory effects of pLMWH could translate in lower rate of clinical progression in patients with COVID-19 pneumonia. Patients admitted to a COVID-hospital in Rome with SARS-CoV-2 infection and mild/moderate pneumonia were retrospectively evaluated. The primary endpoint was the time from hospital admission to orotracheal intubation/death (OTI/death). A total of 449 patients were included: 39% female, median age 63 (IQR, 50–77) years. The estimated probability of OTI/death for patients receiving pLMWH was: 9.5% (95% CI 3.2–26.4) by day 20 in those not receiving pLMWH vs. 10.4% (6.7–15.9) in those exposed to pLMWH; p-value = 0.144. This risk associated with the use of pLMWH appeared to vary by PaO2/FiO2 ratio: aHR 1.40 (95% CI 0.51–3.79) for patients with an admission PaO2/FiO2 ≤ 300 mmHg and 0.27 (0.03–2.18) for those with PaO2/FiO2 > 300 mmHg; p-value at interaction test 0.16. pLMWH does not seem to reduce the risk of OTI/death mild/moderate COVID-19 pneumonia, especially when respiratory function had already significantly deteriorated. Data from clinical trials comparing the effect of prophylactic vs. therapeutic dosage of LMWH at various stages of COVID-19 disease are needed.
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- 2021
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49. Durability of rilpivirine- versus integrase inhibitor-based regimens in a large cohort of naïve HIV-infected patients starting antiretroviral therapy
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Gagliardini, Roberta, Gianotti, Nicola, Maggiolo, Franco, Cozzi-Lepri, Alessandro, Antinori, Andrea, Nozza, Silvia, Lapadula, Giuseppe, De Luca, Andrea, Mussini, Cristina, Gori, Andrea, Saracino, Annalisa, Andreoni, Massimo, and Monforte, Antonella d'Arminio
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- 2021
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50. Using observational data to emulate a randomized trial of dynamic treatment-switching strategies: an application to antiretroviral therapy
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Cain, Lauren E, Saag, Michael S, Petersen, Maya, May, Margaret T, Ingle, Suzanne M, Logan, Roger, Robins, James M, Abgrall, Sophie, Shepherd, Bryan E, Deeks, Steven G, Gill, M John, Touloumi, Giota, Vourli, Georgia, Dabis, François, Vandenhende, Marie-Anne, Reiss, Peter, van Sighem, Ard, Samji, Hasina, Hogg, Robert S, Rybniker, Jan, Sabin, Caroline A, Jose, Sophie, del Amo, Julia, Moreno, Santiago, Rodríguez, Benigno, Cozzi-Lepri, Alessandro, Boswell, Stephen L, Stephan, Christoph, Pérez-Hoyos, Santiago, Jarrin, Inma, Guest, Jodie L, Monforte, Antonella D’Arminio, Antinori, Andrea, Moore, Richard, Campbell, Colin NJ, Casabona, Jordi, Meyer, Laurence, Seng, Rémonie, Phillips, Andrew N, Bucher, Heiner C, Egger, Matthias, Mugavero, Michael J, Haubrich, Richard, Geng, Elvin H, Olson, Ashley, Eron, Joseph J, Napravnik, Sonia, Kitahata, Mari M, Van Rompaey, Stephen E, Teira, Ramón, Justice, Amy C, Tate, Janet P, Costagliola, Dominique, Sterne, Jonathan AC, Hernán, Miguel A, and Systems, and the HIV-CAUSAL Collaboration on behalf of the Antiretroviral Therapy Cohort Collaboration the Centers for AIDS Research Network of Integrated Clinical
- Subjects
Epidemiology ,Health Sciences ,Clinical Trials and Supportive Activities ,Infectious Diseases ,Sexually Transmitted Infections ,HIV/AIDS ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,Adult ,Anti-HIV Agents ,CD4 Lymphocyte Count ,Female ,HIV Infections ,HIV-1 ,Humans ,Male ,Middle Aged ,Observational Studies as Topic ,Randomized Controlled Trials as Topic ,Survival Analysis ,United Kingdom ,Viral Load ,HIV ,antiretroviral therapy ,inverse-probability weighting ,observational studies ,mortality ,dynamic strategies ,Antiretroviral Therapy Cohort Collaboration ,the Centers for AIDS Research Network of Integrated Clinical Systems ,and the HIV-CAUSAL Collaboration ,Statistics ,Public Health and Health Services ,Public health - Abstract
BackgroundWhen a clinical treatment fails or shows suboptimal results, the question of when to switch to another treatment arises. Treatment switching strategies are often dynamic because the time of switching depends on the evolution of an individual's time-varying covariates. Dynamic strategies can be directly compared in randomized trials. For example, HIV-infected individuals receiving antiretroviral therapy could be randomized to switching therapy within 90 days of HIV-1 RNA crossing above a threshold of either 400 copies/ml (tight-control strategy) or 1000 copies/ml (loose-control strategy).MethodsWe review an approach to emulate a randomized trial of dynamic switching strategies using observational data from the Antiretroviral Therapy Cohort Collaboration, the Centers for AIDS Research Network of Integrated Clinical Systems and the HIV-CAUSAL Collaboration. We estimated the comparative effect of tight-control vs. loose-control strategies on death and AIDS or death via inverse-probability weighting.ResultsOf 43 803 individuals who initiated an eligible antiretroviral therapy regimen in 2002 or later, 2001 met the baseline inclusion criteria for the mortality analysis and 1641 for the AIDS or death analysis. There were 21 deaths and 33 AIDS or death events in the tight-control group, and 28 deaths and 41 AIDS or death events in the loose-control group. Compared with tight control, the adjusted hazard ratios (95% confidence interval) for loose control were 1.10 (0.73, 1.66) for death, and 1.04 (0.86, 1.27) for AIDS or death.ConclusionsAlthough our effective sample sizes were small and our estimates imprecise, the described methodological approach can serve as an example for future analyses.
- Published
- 2016
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