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ABSTRACT: This is a retrospective study on MSM diagnosed with rectal LGV, treated with 7 or 21 days of doxycycline between 2015-2022. Overall, 143 MSM were included: 58 (41%) had LGV. 100% microbiologic cure was found among MSM with symptomatic or asymptomatic LGV treated with 7 and 21 days of doxycycline.
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BACKGROUND: To clarify whether next-generation sequencing (NGS) can be useful for resistance assessment in virologically suppressed highly treatment-experienced (HTE) individuals with MDR HIV. METHODS: Ninety-one participants from the PRESTIGIO Registry were included. NGS was performed on HIV-DNA at 1%, 5% and 20% cut-offs; major drug resistance mutations (DRMs) were evaluated and compared with those detected in historical plasma genotypic resistance testing (h-GRT). APOBEC editing was also characterized. RESULTS: Participants had a complex and long treatment history [median 23 (IQR 21-25) years of ART exposure) and had been virologically suppressed since a median of 3 (IQR 2-5) years. Among all major DRMs detected by HIV-DNA NGS and/or h-GRT, 30% were exclusively found through NGS. The highest detection rate of historical major DRMs was reached with NGS set at 1%, but unusual substitutions and extensive APOBEC hypermutations suggest technical issues and poor clinical relevance in the 1%-5% interval. At NGS set at 5%, 67.2% of historical major DRMs were detected. The number of major DRMs detected exclusively by DNA-NGS as minority variants (frequency 5%-20%) was significantly higher in individuals who later experienced virological rebound compared with those who maintained virological control [median 2 (IQR 1-3) versus 1 (0-2), Pâ=â0.030] and positively correlated with viraemia levels at rebound (rhoâ=â0.474, Pâ=â0.030). CONCLUSIONS: In non-viraemic people with an MDR virus, HIV-1 DNA NGS set at 5% is an acceptable technical cut-off that might help to reveal mutations with a potential clinical relevance. Moreover, the number of minority resistance mutations additionally detected by NGS might be associated with loss of virological control.
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Background: The aim of the study was to evaluate the 12-month cumulative probability of treatment discontinuation (TD) in people with human immunodeficiency virus (HIV; PWH) and a long exposure to antiretroviral therapy (ART) switching to long-acting cabotegravir and rilpivirine (CAB/RPV). Methods: SCohoLART is a single-center, prospective, cohort study designed to collect both samples and clinical data from PWH with virological suppression who switched to bimonthly long-acting CAB/RPV. TD occurred at switch to another regimen for any reason including virological failure (VF); VF was defined as HIV RNA levels ≥50 copies/mL at 2 consecutive measurements or a single HIV RNA level ≥1000 copies/mL. Results were reported as median (interquartile range [IQR]) or frequency (percentage). Cumulative probabilities of TD were estimated using Kaplan-Meier curves. Results: We evaluated 514 participants; 467 (90.9%) were male, and their median age (IQR) was 49 (40-56) years. At the time of switching, the median time from HIV diagnosis and the median duration of ART were 14.0 (IQR, 8.8-20.5) and 11.4 (7.9-17.4) years, respectively; before starting CAB/RPV, the median number of antiretroviral regimens was 3 (2-4). During a median study follow-up (IQR) of 13.1 (9.1-15.5) months, 52 PWH (10.1%) experienced TD, including 4 (0.8%) for VF. The 12-month cumulative probability of TD was 11% (95% confidence interval, 8%-14%). The main cause of TD was injection site reaction (15 participants [28.8%]). Conclusions: The 1-year cumulative probability of TD with long-acting CAB/RPV was quite low in this cohort of people with a median exposure to ART of 10 years, in whom injection site reaction was the leading cause of TD. VFs were rare during study follow-up.
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The emergence of new SARS-CoV-2 variants can affect vaccine efficacy, laboratory diagnosis and the therapies already available, triggering interest in the search for antiviral agents for SARS-CoV-2 infections. Ribavirin (RBV) is a broad-spectrum antiviral with demonstrated in vitro activity against multiple viruses, including SARS-CoV-2. This retrospective study evaluated the dynamics and viral clearance of SARS-CoV-2 in hospitalised adult participants (PTs) with COVID-19 pneumonia who received an RBV aerosol within a compassionate use study. The impact of RBV on the clinical outcome and the mutational profile of SARS-CoV-2 was also assessed. The median RNA values measured in nine PTs included in this study decreased from baseline to discharge (at BL, threshold cycle (Ct) = 22.4, IQR 19.84-5.07; at discharge, Ct = 27.92, IQR 26.43-36.11), with a significant decline in the Ct value evaluated by Friedman rank ANOVA analysis, p = 0.032. Seven out of nine PTs experienced a clinical improvement, while two PTs deceased during hospitalisation. In PTs with a favourable outcome, the virus clearance rate at discharge was 28.6%. The cumulative clearance rate was 71.4% within 14 days from discharge. A mutational pattern after RBV was detected in three out of five PTs in whom whole-genome sequencing was available. Our findings suggest that RBV limits SARS-CoV-2 replication, possibly resulting in a favourable clinical outcome. Ribavirin may also contribute to the mutational spectrum of SARS-CoV-2.
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A natural monkeypox virus infection may not induce sufficient neutralizing antibody responses in a subset of healthy individuals. The aim of this study was to evaluate monkeypox virus-neutralizing antibodies six months after infection and to assess the virological factors predictive of a poor immunological response. Antibodies were assessed using a plaque reduction neutralization test at six months from mpox infection; mpox cutaneous, oropharyngeal, and anal swabs, semen, and plasma samples were tested during infection. Overall, 95 people were included in the study; all developed detectable antibodies. People who were positive for the monkeypox virus for more days had higher levels of antibodies when considering all tested samples (p = 0.029) and all swabs (p = 0.005). Mpox cycle threshold values were not predictive of antibody titers. This study found that the overall days of monkeypox virus detection in the body, irrespective of the viral loads, were directly correlated with monkeypox virus neutralizing antibodies at six months after infection.
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Anticuerpos Neutralizantes , Anticuerpos Antivirales , Monkeypox virus , Mpox , Pruebas de Neutralización , Carga Viral , Anticuerpos Neutralizantes/sangre , Anticuerpos Neutralizantes/inmunología , Humanos , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , Monkeypox virus/inmunología , Masculino , Mpox/inmunología , Mpox/virología , Adulto , Femenino , Persona de Mediana Edad , Adulto JovenAsunto(s)
Fármacos Anti-VIH , Farmacorresistencia Viral , Infecciones por VIH , Carga Viral , Humanos , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/virología , Estudios Retrospectivos , Fármacos Anti-VIH/uso terapéutico , Fármacos Anti-VIH/farmacología , Masculino , Femenino , Carga Viral/efectos de los fármacos , Persona de Mediana Edad , Insuficiencia del Tratamiento , Adulto , Sistema de Registros , VIH-1/efectos de los fármacos , VIH-1/genéticaRESUMEN
Objective: To evaluate the virological outcome of darunavir-cobicistat (DRVc)-based regimens in adults living with HIV who had experienced virological failure (VF) on any previous drug combination. Methods: This was a retrospective cohort study (CSLHIV Cohort) of adults living with HIV who started a DRVc-based regimen with HIV-RNA >50 copies/mL after VF on any previous drug combination. Data on demographics, antiretroviral treatment since HIV diagnosis, and immunological and metabolic parameters from baseline (start of DRVc) to 48 weeks were analyzed in order to assess the cumulative proportion of those who achieved virological success (VS), defined as at least one instance of HIV-RNA <50 copies/mL within 12 months from baseline. Follow-up lasted from the start of the DRVc-based regimen (baseline) to the first instance of HIV-RNA <50 copies/mL, last available visit, or loss to follow-up or death, whichever occurred first. Univariate and multivariate Cox proportional-hazard regression models were used to identify baseline factors associated with VS. Results: A total of 176 individuals were included, and 120 (68.2%) achieved <50 HIV-RNA copies/mL within 12 months since baseline. On multivariate analysis, baseline HDL cholesterol was independently associated with the occurrence of VS (adjusted HR 1.021, 95% CI 1.004-1.038; p=0.014). Among the 120 subjects with VS, 27 (22.5%) had had VF during a median follow-up of 20.8 months since the first undetectable HIV-RNA. Resistance testing after VF was available in two cases, which harboured the HIV variant-bearing protease inhibitor-resistance mutations D30N, I50V, and N88D. During a median follow-up of 38.4 months, 65 of 176 (36.9%) individuals discontinued DRVc for any reason (37 of 120, 30.8%) and achieved VS vs. 28 of 56 (50%) without VS (p=0.019). Time to discontinuation was longer in people with VS (41.5 vs. 23.0 months, p=0.0007). No statistically significant changes were observed in immunological or lipid profiles during follow-up. Conclusion: Most individuals in this study achieved VS within 12 months from the beginning of a DRVc-based regimen; therefore, this treatment represent a viable option for people who have experienced VF on other regimens.
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Cobicistat , Darunavir , Infecciones por VIH , Inhibidores de la Proteasa del VIH , Adulto , Humanos , Estudios Retrospectivos , Combinación de Medicamentos , Inhibidores de la Proteasa del VIH/uso terapéutico , ARN , Infecciones por VIH/tratamiento farmacológicoRESUMEN
BACKGROUND: Neisseria gonorrhoeae (Ng) is a public health priority because of the rapid evolution of antimicrobial resistance, the emergence of antibiotic resistance, and the absence of a vaccine against Ng. The aim of this study was to investigate trends in the minimum inhibitory concentration and resistance (R) or reduced susceptibility (DS) of Ng cases to ceftriaxone (CRO), azithromycin (AZM), tetracycline (TET), benzylpenicillin (PenG), and ciprofloxacin (CIP) during a 10-year period. METHODS: We conducted a retrospective analysis on an open cohort of Ng cases diagnosed on rectal, urethral, and pharyngeal samples at San Raffaele Scientific Institute, between September 2012 and February 2023. Minimum inhibitory concentrations of antibiotics were determined by gradient-test strips. Bivariate linear regression models were applied on logarithmic minimum inhibitory concentrations values; Cochran-Armitage test was used to determine a linear trend in the proportions of resistant strains. RESULTS: A total of 436 Ng isolates from 352 individuals were analyzed. Minimum inhibitory concentrations of CRO and PenG reduced over time ( P < 0.001, P = 0.030), AZM increased ( P = 0.001), and CIP and TET did not change ( P = 0.473, P = 0.272). The percentages of resistant strains were as follows: PenG, 89.9%; TET, 90.8%; CIP, 48.2%; AZM, and 4.4%. CRO-DS strains were 8.7%, and only 1 case of CRO-R was identified. The proportion of resistant strains increased over time for AZM ( P = 0.007), TET ( P = 0.001), and CIP ( P < 0.001), whereas it decreased for PenG ( P < 0.001) and CRO-DS/R strains ( P < 0.001). CONCLUSIONS: Ng strains showed high susceptibility to CRO, although we identified cases of DS/R and observed high levels of susceptibility to AZM. Overall, the recommended primary regimen for Ng treatment was confirmed to be effective.
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Antibacterianos , Azitromicina , Gonorrea , Pruebas de Sensibilidad Microbiana , Neisseria gonorrhoeae , Tetraciclina , Neisseria gonorrhoeae/efectos de los fármacos , Neisseria gonorrhoeae/aislamiento & purificación , Humanos , Gonorrea/epidemiología , Gonorrea/microbiología , Gonorrea/tratamiento farmacológico , Estudios Retrospectivos , Antibacterianos/farmacología , Masculino , Adulto , Femenino , Azitromicina/farmacología , Italia/epidemiología , Tetraciclina/farmacología , Farmacorresistencia Bacteriana , Ciprofloxacina/farmacología , Ceftriaxona/farmacología , Uretra/microbiología , Persona de Mediana Edad , Adulto Joven , Penicilina G/farmacología , Faringe/microbiología , Recto/microbiologíaRESUMEN
PURPOSE: The PRESTIGIO Registry was established in 2017 to collect clinical, virological and immunological monitoring data from people living with HIV (PLWH) with documented four-class drug resistance (4DR). Key research purposes include the evaluation of residual susceptibility to specific antiretrovirals and the validation of treatment and monitoring strategies in this population. PARTICIPANTS: The PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry. FINDINGS TO DATE: The open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples. FUTURE PLANS: The registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole. TRIAL REGISTRATION NUMBER: NCT04098315.
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Fármacos Anti-VIH , Infecciones por VIH , VIH-1 , Humanos , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Inhibidores de la Transcriptasa Inversa/farmacología , VIH-1/genética , Inhibidores de Integrasa/farmacología , Inhibidores de Integrasa/uso terapéutico , Péptido Hidrolasas/farmacología , Péptido Hidrolasas/uso terapéutico , Leucocitos Mononucleares , Calidad de Vida , Estudios Retrospectivos , Infecciones por VIH/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico , Sistema de Registros , Italia , ADN Polimerasa Dirigida por ARN/farmacología , ADN Polimerasa Dirigida por ARN/uso terapéuticoRESUMEN
Invasive fungal diseases (IFDs) still represent a relevant cause of mortality in patients affected by hematological malignancies, especially acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) undergoing remission induction chemotherapy, and in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Mold-active antifungal prophylaxis (MAP) has been established as a standard of care. However, breakthrough IFDs (b-IFDs) have emerged as a significant issue, particularly invasive aspergillosis and non-Aspergillus invasive mold diseases. Here, we perform a narrative review, discussing the major advances of the last decade on prophylaxis, the diagnosis of and the treatment of IFDs in patients with high-risk neutropenic fever undergoing remission induction chemotherapy for AML/MDS and allo-HSCT. Then, we present our single-center retrospective experience on b-IFDs in 184 AML/MDS patients undergoing high-dose chemotherapy while receiving posaconazole (n = 153 induction treatments, n = 126 consolidation treatments, n = 60 salvage treatments). Six cases of probable/proven b-IFDs were recorded in six patients, with an overall incidence rate of 1.7% (6/339), which is in line with the literature focused on MAP with azoles. The incidence rates (IRs) of b-IFDs (95% confidence interval (95% CI), per 100 person years follow-up (PYFU)) were 5.04 (0.47, 14.45) in induction (n = 2), 3.25 (0.0013, 12.76) in consolidation (n = 1) and 18.38 (3.46, 45.06) in salvage chemotherapy (n = 3). Finally, we highlight the current challenges in the field of b-IFDs; these include the improvement of diagnoses, the expanding treatment landscape of AML with molecular targeted drugs (and related drug-drug interactions with azoles), evolving transplantation techniques (and their related impacts on IFDs' risk stratification), and new antifungals and their features (rezafungin and olorofim).
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Aim was to investigate the propensity to switch to long-acting injectable HIV pre-exposure prophylaxis (PrEP) with cabotegravir among oral PrEP-experienced men who have sex with men. Out of 377 PrEP users, 325 (86.2%) were interested (would like = 210) or considering (would consider = 115) switch to long-acting PrEP. At multivariable analysis, the odds ratio of interest in long-acting PrEP in non-adherent vs. adherent individuals to oral PrEP was 5.03 (95%CI = 1.73-14.61,p = 0.003) and of consideration 1.63 (95%CI = 0.51-5.23,p = 0.410). We observed very high propensity to switch to long-acting PrEP, particularly among non-adherent users. Rapid availability of long-acting PrEP might address unmet needs of PrEP users in Italy.
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Fármacos Anti-VIH , Dicetopiperazinas , Infecciones por VIH , Profilaxis Pre-Exposición , Piridonas , Minorías Sexuales y de Género , Masculino , Humanos , Homosexualidad Masculina , Infecciones por VIH/epidemiología , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico , Italia/epidemiologíaRESUMEN
Objective: Analysis of bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) efficacy and safety in virologically suppressed people living with HIV (PLWH) in clinical practice. Patients and methods: The retrospective cohort study, which included adult treatment-experienced and virologically suppressed PLWH, switched to BFTAF from June 2019 to June 2021. Efficacy and safety were evaluated as virological failure (VF=2 consecutive HIV-RNA>50 copies/mL or a single HIV-RNA>400 copies/mL) and treatment failure (TF=VF or discontinuation for any reason) until data freezing (August 2022). Results: Of the 1040 PLWH included, 67.8% switched from elvitegravir/cobicistat/FTAF. VF occurred in 4.2% (n=44), with incidence rate of 1.63 per 1000 person-months of follow-up (PMFU) and probability at 24-30 months of 3.8%-4.0%, respectively. Out of the 44 VF, in 75% virological re-suppression was achieved while maintaining BFTAF. Discontinuation occurred in 15% after a median time of 13.5 months of follow-up, with an incidence rate of 5.67 per 1000 PMFU, and a probability at 24-30 months of 11.9%-15.3%, respectively. Main discontinuation reasons were simplification (51.3%) and toxicity (21.8%, involving CNS in half of cases). TF occurred in 18.6% with an incidence rate of 7.01 per 1000 PMFU after a median time of 13.6 observation months; probability at 24-30 months was 14.8%-18.4%, respectively. Conclusion: BFTAF has proven effective and well tolerated in clinical practice.
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Fármacos Anti-VIH , Infecciones por VIH , Adulto , Humanos , Infecciones por VIH/tratamiento farmacológico , Emtricitabina/uso terapéutico , Estudios Retrospectivos , Alanina/efectos adversos , Combinación de Medicamentos , Compuestos Heterocíclicos de 4 o más Anillos/efectos adversos , ARN/uso terapéutico , Fármacos Anti-VIH/efectos adversosRESUMEN
Retrospective, cohort analysis including people with four-class drug-resistant HIV. Bacterial sexually transmitted infections (STIs) had an incidence of 1.3/100-person-years-of-follow-up (PYFU) in men (3.5/100-PYFU in MSM) whereas no STIs were diagnosed in women. The occurrence of STIs in this fragile population might be related to the achievement of good HIV infection control; however, given the remaining risk of virological failure and possible transmission of a multidrug-resistant virus, STI prevention counselling and HIV viremia monitoring should be prioritized.
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Infecciones por VIH , Minorías Sexuales y de Género , Enfermedades de Transmisión Sexual , Masculino , Femenino , Humanos , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Homosexualidad Masculina , Estudios Retrospectivos , Enfermedades de Transmisión Sexual/epidemiología , Enfermedades de Transmisión Sexual/prevención & controlRESUMEN
Mpox caused a worldwide outbreak in 2022, disproportionately affecting MSM reporting high-risk sexual behaviors. The aim of this study was to compare the characteristics of people receiving MVA-BN vaccination with those of individuals diagnosed with mpox to guide future vaccination policies. This was a retrospective study on people with mpox infection or vaccination at San Raffaele Scientific Institute, Milan, Italy, from May to November 2022. Characteristics were compared using Mann-Whitney or chi-square/Fisher's exact tests; multivariable logistic regression and classification tree analysis were applied. Overall, 473 vaccinated individuals and 135 with mpox were included; 472/473 and 134/135 were MSM. People with mpox were more frequently living with HIV (48.9% vs. 22.4%, p < 0.001), had ≥1 previous STI (75.6% vs. 35.7%, p < 0.001), were chemsex users (37.8% vs. 6.34%, p < 0.001), were with a higher number of partners (23.0% vs. 1.69%, p < 0.001), and had engaged in group sex (55.6% vs. 24.1%, p < 0.001). At multivariable analysis, PLWH (aOR = 2.86, 95%CI = 1.59-5.19, p < 0.001), chemsex users (aOR = 2.96, 95%CI = 1.52-5.79, p = 0.001), those with previous syphilis (aOR = 4.11, 95%CI = 2.22-7.72, p < 0.001), and those with >10 partners (aOR = 11.56, 95%CI = 6.60-21.09, p < 0.001) had a higher risk of infection. This study underscores the importance of prioritizing MSM with prior STIs and multiple partners as well as chemsex users in vaccination policies to curb mpox spread. A destigmatized assessment of sexual history is vital for comprehensive sexual health strategies.
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The impact of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection on patients with pre-existing chronic liver diseases (CLD) remains elusive. The aim of this study was to investigate the in-hospital mortality in patients hospitalized for Coronavirus disease of 2019 (COVID-19) with CLD (CLD group) compared to those without CLD (non-CLD group). We performed a retrospective cohort study including patients with confirmed SARS-CoV-2 infection, hospitalized at San Raffaele Hospital (Milan), stratified according to the presence or absence of CLD. A propensity score was estimated and used to match the two groups by age, gender, body mass index, type 2 diabetes mellitus, and hypertension. Predictors of mortality were assessed using univariate and multivariate logistic regression model. Among 1210 patients with COVID-19, 41 (3.4%) were included in the CLD group and 1169 (96.6%) in the non-CLD group. Using a propensity score, we matched 41 patients in the CLD group with 123 in the non-CLD group. At admission, patients in the CLD group had worse liver function, lower platelets count, and lower c-reactive protein levels. By multivariate analysis, the CLD group showed a higher risk of death: OR 4.04 (95% CI 1.29-12.70; p= 0.017). Our study showed that COVID-19 with chronic liver diseases has a higher risk of mortality during hospitalization.
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COVID-19 , Diabetes Mellitus Tipo 2 , Hepatopatías , Humanos , Centros de Atención Terciaria , SARS-CoV-2 , Estudios Retrospectivos , Italia/epidemiología , Hepatopatías/epidemiologíaRESUMEN
OBJECTIVES: The study aim was to evaluate whether mpox vaccination with modified vaccinia Ankara-Bavarian Nordic (MVA-BN) may be associated with viral blips or confirmed virologic failures (CVF) in people with HIV (PWH) receiving antiretroviral therapy and the associated factors. DESIGN: PWH who received MVA-BN, with HIV-RNA less than 50 copies/ml, and CD4 + lymphocytes at least 200âcells/µl in the 6âmonths prior to vaccination and at least 1 HIV-RNA determination within 3âmonths from vaccination. METHODS: The primary outcome was occurrence of viral blips (1 HIV-RNA ≥50âcopies/ml) and CVF (1 HIV-RNA ≥1000âcopies/ml or ≥2 consecutive HIV-RNA ≥50âcopies/ml) following MVA-BN. Changes in CD4 + and CD4 + /CD8 + were secondary outcomes. Residual viremia was defined as detectable HIV-RNA less than 50âcopies/ml. PWH already vaccinated against smallpox received single-dose MVA-BN. Mann--Whitney rank-sum test or chi-square/Fisher's test applied. RESULTS: Overall, 187 PWH were included: 147 received two doses of MVA-BN, 40 single-dose. Six viral blips [incidence rateâ=â1.59/100-person months of follow-up (PMFU), 95% confidence interval (95% CI)â=â0.58-3.47], and three CVFs [incidence rateâ=â0.80/100-PMFU (95% CIâ=â0.16-2.33)] were observed. Two CVFs occurred at second dose with presence of detectable HIV-RNA following first one, with high compliance to antiretroviral therapy (ART). PWH with viral blips or CVFs had, prior to first vaccination, more frequently residual viremia [77% ( n â=â7) versus 35% ( n â=â62), P â=â0.01]. No differences in ART ( P â=â0.42) and number of MBA-BN doses ( P â=â0.40) was found. In two cases of CVFs, ART was changed; all VBs resolved within 1âmonth. CONCLUSION: Although rare, viral blips and CVFs following MVA-BN vaccination among PWH receiving ART were identified. Close monitoring of HIV-RNA during mpox vaccination should be encouraged.
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Infecciones por VIH , Vacuna contra Viruela , Humanos , Vacuna contra Viruela/uso terapéutico , Infecciones por VIH/complicaciones , Viremia/complicaciones , Vacunación , ARN/uso terapéutico , Carga Viral , Vacunas AtenuadasRESUMEN
The aim of the TWODAY Study was to investigate the frequency of early treatment change after rapid start of a tailored ART regimen (a 2-drug regimen - 2DR, when clinically feasible or a 3-drug regimen - 3DR, otherwise). TWODAY was an open-label, prospective, proof-of-concept, single center study. ART-naïve patients started their first-line regimen within a few days from the first laboratory testing with a 2DR of dolutegravir (DTG) and lamivudine (3TC) if CD4+ count >200 cells/mL, HIVRNA <500,000 copies/mL, no transmitted drug resistance to DTG or 3TC and HBsAg undetectable; otherwise, ART was started with a 3DR. The primary endpoint was the proportion of patients who needed to change ART within four week from start, for any reason. Thirty-two patients were enrolled; 19 (59.3%) were deemed eligible for a 2DR. Median time from laboratory testing to ART start was 5 days (5; 5). No regimen modification occurred within one month. In conclusion, no regimen modification was needed within the first month of treatment. Starting a 2DR within a few days after HIV diagnosis was feasible, relying upon complete results of the needed laboratory tests (including resistance testing). A 2DR can be safely proposed provided full laboratory tests are readily available.
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Fármacos Anti-VIH , Infecciones por VIH , Humanos , Fármacos Anti-VIH/uso terapéutico , Estudios Prospectivos , Infecciones por VIH/tratamiento farmacológico , Lamivudine/uso terapéutico , Terapia Antirretroviral Altamente ActivaRESUMEN
BACKGROUND: We evaluated factors associated with lack of triple vaccination (hepatitis A virus [HAV], hepatitis B virus [HBV], and human papillomavirus [HPV]) among men who have sex with men using pre-exposure prophylaxis (PrEP). SETTING: PrEP users at the San Raffaele Scientific Institute, Italy, with ≥1 follow-up visit (May 2017-2022). METHODS: Participants were considered protected if (1) before PrEP access: positive serology (IgG-HAV+, hepatitis B surface antigen >10 mUI/mL) or vaccination history was recorded and (2) after starting PrEP: ≥1 dose of each vaccination was administered. Individuals were considered fully protected if they received the following before/during PrEP access: HAV vaccination/infection, HBV vaccination/infection, and HPV vaccination. χ 2 and Kruskal-Wallis tests were used to compare characteristics of those fully, partially, and not protected. Factors associated with the lack of triple vaccination were assessed by using multivariable logistic regression and classification tree analysis. RESULTS: Overall, 473 men who have sex with men were considered: 146 (31%) were fully protected, 231 (48%) partially, and 96 (20%) were not. Daily-based PrEP users (fully: 93, 63.7%; partially: 107, 46.3%; and not protected: 40, 41.7%; P = 0.001) and those with a sexually transmitted infection at the first visit (43, 29.5%; 55, 23.8%; 15, 15.6%; P = 0.048) were more frequently fully protected. At multivariable analysis, the odds of lack of triple vaccination was lower among daily-based users (adjusted odds ratio = 0.47, 95% confidence interval = 0.31-0.70, P < 0.001). Classification tree analysis showed that among daily-based users, with sexually transmitted infection prior and at the first PrEP visit, there was a lower chance of lack of triple vaccination ( P = 44%). CONCLUSIONS: Strategies targeting PrEP users at risk of missing HAV, HBV, and HPV vaccinations need to be implemented, focusing mostly on event-based users.