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Article ; Online: Do we Still Need Eligibility Criteria to Recommend PrEP? Impact of National Prescribing Requirements on Retention in Care and Sexually Transmitted Infections Acquisition.

Rossotti, Roberto / Tavelli, Alessandro / Calzavara, Daniele / De Bona, Anna / Muccini, Camilla / Moschese, Davide / Caruso, Enrico / Soria, Alessandro / Bossolasco, Simona / Lapadula, Giuseppe / Cernuschi, Massimo / Monforte, Antonella d'Arminio

AIDS and behavior

2024

Abstract: Italian guidelines recommend HIV pre-exposure prophylaxis (PrEP) only upon satisfying strict eligibility criteria. The objective of this study is to evaluate if PrEP candidates attending a community-based service comply with these criteria and whether ... ...

Abstract	Italian guidelines recommend HIV pre-exposure prophylaxis (PrEP) only upon satisfying strict eligibility criteria. The objective of this study is to evaluate if PrEP candidates attending a community-based service comply with these criteria and whether these prescribing conditions affect retention in care and sexually transmitted infections (STIs) acquisition. A retrospective analysis was performed on PrEP candidates evaluated from January 2019 to June 2022. Data were collected from self-administered questionnaires and clinical files. The population was divided in subjects with 0/1 (0/1 C) and ≥ 2 (≥ 2 C) criteria. Descriptive statistics and non-parametric tests were employed to describe study population. Incidence of PrEP discontinuation and of STIs was estimated per 100 persons-year of follow up (PYFU), and incidence rate ratio (IRR) was calculated. Univariate and multivariable Cox regression analyses were used to evaluate the association strength between PrEP drop out and other variables. The analyses enrolled 659 individuals: 422 individuals were included in 0/1 C, 237 in ≥ 2 C group, respectively. Inconsistent condom use was the most reported prescribing criteria (399 individuals, 60.6%), followed by a previous STI (186 individuals, 28.2%). 0/1 C exhibited lower STIs incidence. PrEP discontinuation was 29% in 0/1 C and 38% in ≥ 2 C (p = 0.031). Cox model revealed that inconsistent condom use was the only prescribing criteria associated to PrEP persistence. The majority of PrEP candidate did not comply with prescribing conditions. Eligibility criteria failed to identify individuals with better retention in care. Our results suggest that Italian guidelines should be updated removing barriers to prescription.
Language	English
Publishing date	2024-03-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	1339885-4
ISSN	1573-3254 ; 1090-7165
ISSN (online)	1573-3254
ISSN	1090-7165
DOI	10.1007/s10461-024-04320-3
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Article: Gamma-Delta T-Cell Phenotype and Function in DAA-Treated HIV-HCV Co-Infected and HCV-Mono-Infected Subjects

Bono, Valeria / Tincati, Camilla / Van Den Bogaart, Lorena / Cannizzo, Elvira Stefania / Rovito, Roberta / Augello, Matteo / De Bona, Anna / D’Arminio Monforte, Antonella / Milazzo, Laura / Marchetti, Giulia

Viruses. 2022 July 22, v. 14, no. 8

2022

Abstract: HIV-HCV co-infected subjects are at risk of liver fibrosis which may be linked to immune imbalances. Direct-acting antivirals (DAAs) represent the mainstay of HCV treatment in co-infected individuals, yet their effects on immune cell populations playing ... ...

Abstract	HIV-HCV co-infected subjects are at risk of liver fibrosis which may be linked to immune imbalances. Direct-acting antivirals (DAAs) represent the mainstay of HCV treatment in co-infected individuals, yet their effects on immune cell populations playing a role in fibrogenesis is unknown. We assessed γδ T-cell phenotype and function, Treg and Th17 frequencies, as well as γ-globulins and B-cell activation in 47 HIV-HCV co-infected and 35 HCV mono-infected individuals prior to and following DAA treatment (SVR12). Γδ T-cell activation decreased in both groups yet persisted at higher levels in the HIV-HCV co-infected subjects. No differences were registered in terms of γδT-cell function. Of note, the Vδ2/Th17 ratio, inversely linked to liver damage, increased significantly in the two groups upon treatment, yet a negative correlation between the Vδ2/Th17 ratio and liver function enzymes was found in the co-infected subjects alone. B-cell activation and γ-globulin levels decreased in both settings, yet B-cell activation remained higher in the HIV-HCV co-infected individuals. In HIV-HCV co-infected and HCV mono-infected participants, the effect of DAA was limited to γδ T- and B-cell activation as well as γ-globulin concentrations and the Vδ2/Th17 ratio, with no changes in γδ T-cell function and Treg frequencies. Importantly, γδ T- and B-cell activation remained at higher levels in the co-infected individuals than in those with HCV mono-infection alone. The persistence of such alterations within these cell subsets may be associated with the risk of hepatic and extrahepatic complications.
Keywords	B-lymphocytes ; T-lymphocytes ; antiviral agents ; liver ; liver cirrhosis ; liver function ; mixed infection ; phenotype ; risk
Language	English
Dates of publication	2022-0722
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v14081594
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service.

Biasioli, Lorenzo / Rossotti, Roberto / Tavelli, Alessandro / De Bona, Anna / Tincati, Camilla / Calzavara, Daniele / Vinti, Pietro / Baiguera, Chiara / D'Amico, Federico / Nava, Alice / Repossi, Roberto / Bossolasco, Simona / Muccini, Camilla / Mulè, Giovanni / Tesoro, Daniele / d'Arminio Monforte, Antonella / Cernuschi, Massimo

Sexually transmitted infections

2024

Abstract: Objectives: In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its ... ...

Abstract	Objectives: In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. Methods: We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen's kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Results: 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen's kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. Conclusions: POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.
Language	English
Publishing date	2024-04-19
Publishing country	England
Document type	Journal Article
ZDB-ID	1420303-0
ISSN	1472-3263 ; 1368-4973
ISSN (online)	1472-3263
ISSN	1368-4973
DOI	10.1136/sextrans-2023-055939
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Article: HIV-Indicator Condition Guided Testing in a Hospital Setting.

Barbanotti, Diletta / Tincati, Camilla / Tavelli, Alessandro / Santoro, Andrea / Sala, Matteo / Bini, Teresa / De Bona, Anna / d'Arminio Monforte, Antonella / Marchetti, Giulia Carla

Life (Basel, Switzerland)

2023 Volume 13, Issue 4

Abstract: Late diagnosis is still a major issue in HIV infection management, leading to important consequences for both patients and community. In this perspective, HIV screening targeted on some clinical conditions (HIV indicator conditions-HIVICs) emerged as a ... ...

Abstract	Late diagnosis is still a major issue in HIV infection management, leading to important consequences for both patients and community. In this perspective, HIV screening targeted on some clinical conditions (HIV indicator conditions-HIVICs) emerged as a useful strategy, also involving patients not considered at high behavioral risk. We organized an in-hospital HIVICs guided screening campaign named ICEBERG in Milan, Italy, between 2019 and 2021. Among the 520 subjects enrolled, mainly presenting with viral hepatitis or mononucleosis-like syndrome, 20 resulted HIV positive (3.8% prevalence). A significant proportion of them had multiple conditions and advanced immunosuppression, with 40% being AIDS-presenters. As adherence to the screening campaign was modest for non-ID specialists, educational interventions to raise clinicians' sensitivity are urgently needed. HIV-ICs guided testing was confirmed as a useful tool, but a combined approach with other screening strategies seems to be essential for early HIV diagnosis.
Language	English
Publishing date	2023-04-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662250-6
ISSN	2075-1729
ISSN	2075-1729
DOI	10.3390/life13041014
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Article: Detection of Asymptomatic Mpox Carriers among High-Ri Men Who Have Sex with Men: A Prospective Analysis.

Rossotti, Roberto / Calzavara, Daniele / Cernuschi, Massimo / D'Amico, Federico / De Bona, Anna / Repossi, Roberto / Moschese, Davide / Bossolasco, Simona / Tavelli, Alessandro / Muccini, Camilla / Mulé, Giovanni / d'Arminio Monforte, Antonella

Pathogens (Basel, Switzerland)

2023 Volume 12, Issue 6

Abstract: Mpox is traditionally considered a zoonotic disease with endemic circulation in Africa, but the 2022-2023 outbreak reached an unprecedented high number of cases in non-endemic countries, so that it was declared a public health emergency of international ... ...

Abstract	Mpox is traditionally considered a zoonotic disease with endemic circulation in Africa, but the 2022-2023 outbreak reached an unprecedented high number of cases in non-endemic countries, so that it was declared a public health emergency of international concern. The reasons for this extensive global spread, characterized by sexual transmission amongst men who have sex with men (MSM), have not been fully clarified. The existence of asymptomatic carriers with viable viral shedding might be an explanation and is under-debated after retrospective studies suggested that infection without symptoms might have a prevalence of 6.5%. We aimed to prospectively assess the presence of mpox infection in asymptomatic high-risk MSM using HIV pre-exposure prophylaxis and living with HIV. We selected individuals with no signs of active infection nor suggestive symptoms in the previous 21 days. Eligible individuals collected oral and anal swabs to undergo point-of-care testing for mpox and completed a 21-days follow-up. Seventy-two individuals were enrolled, and none tested positive for mpox infection nor developed symptoms during follow-up. We selected a high-risk population with a significant history of sexual exposure, but we failed to detect any asymptomatic infection. This observation might have important consequences in terms of contact management and epidemic control.
Language	English
Publishing date	2023-06-03
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens12060798
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Article ; Online: Gamma-Delta T-Cell Phenotype and Function in DAA-Treated HIV-HCV Co-Infected and HCV-Mono-Infected Subjects.

Bono, Valeria / Tincati, Camilla / Van Den Bogaart, Lorena / Cannizzo, Elvira Stefania / Rovito, Roberta / Augello, Matteo / De Bona, Anna / D'Arminio Monforte, Antonella / Milazzo, Laura / Marchetti, Giulia

Viruses

2022 Volume 14, Issue 8

Abstract	HIV-HCV co-infected subjects are at risk of liver fibrosis which may be linked to immune imbalances. Direct-acting antivirals (DAAs) represent the mainstay of HCV treatment in co-infected individuals, yet their effects on immune cell populations playing a role in fibrogenesis is unknown. We assessed γδ T-cell phenotype and function, Treg and Th17 frequencies, as well as γ-globulins and B-cell activation in 47 HIV-HCV co-infected and 35 HCV mono-infected individuals prior to and following DAA treatment (SVR12). Γδ T-cell activation decreased in both groups yet persisted at higher levels in the HIV-HCV co-infected subjects. No differences were registered in terms of γδT-cell function. Of note, the Vδ2/Th17 ratio, inversely linked to liver damage, increased significantly in the two groups upon treatment, yet a negative correlation between the Vδ2/Th17 ratio and liver function enzymes was found in the co-infected subjects alone. B-cell activation and γ-globulin levels decreased in both settings, yet B-cell activation remained higher in the HIV-HCV co-infected individuals. In HIV-HCV co-infected and HCV mono-infected participants, the effect of DAA was limited to γδ T- and B-cell activation as well as γ-globulin concentrations and the Vδ2/Th17 ratio, with no changes in γδ T-cell function and Treg frequencies. Importantly, γδ T- and B-cell activation remained at higher levels in the co-infected individuals than in those with HCV mono-infection alone. The persistence of such alterations within these cell subsets may be associated with the risk of hepatic and extrahepatic complications.
MeSH term(s)	Antiviral Agents/therapeutic use ; Coinfection/complications ; Coinfection/drug therapy ; HIV Infections/complications ; HIV Infections/drug therapy ; Hepatitis C/complications ; Hepatitis C/drug therapy ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Phenotype ; T-Lymphocytes, Regulatory ; gamma-Globulins/therapeutic use
Chemical Substances	Antiviral Agents ; gamma-Globulins
Language	English
Publishing date	2022-07-22
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v14081594
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Article ; Online: HIV-NAAT use for early detection of HIV infection among high-risk men who have sex with men in Italy.

Raccagni, Angelo Roberto / Bruzzesi, Elena / Calzavara, Daniele / Vinti, Pietro / Cernuschi, Massimo / Bossolasco, Simona / De Bona, Anna / Rossotti, Roberto / D'Arminio Monforte, Antonella / Castagna, Antonella / Nozza, Silvia

HIV medicine

2022 Volume 24, Issue 2, Page(s) 239–241

MeSH term(s)	Male ; Humans ; HIV Infections/diagnosis ; HIV Infections/epidemiology ; Homosexuality, Male ; Sexual and Gender Minorities ; Italy/epidemiology
Language	English
Publishing date	2022-07-15
Publishing country	England
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	2001932-4
ISSN	1468-1293 ; 1464-2662
ISSN (online)	1468-1293
ISSN	1464-2662
DOI	10.1111/hiv.13363
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Article ; Online: Differences in tenofovir trough concentrations between branded and generic formulations in people taking PrEP.

Cattaneo, Dario / Vinti, Pietro / Baldelli, Sara / Fusi, Marta / Zagato, Donatello / De Bona, Anna / Suardi, Elisa / Bossolasco, Simona / Ancona, Giuseppe / Rossotti, Roberto / Cernuschi, Massimo / Gervasoni, Cristina

AIDS (London, England)

2021 Volume 35, Issue 3, Page(s) 522–524

MeSH term(s)	Drugs, Generic ; Emtricitabine ; HIV Infections/drug therapy ; Humans ; Pre-Exposure Prophylaxis ; Tenofovir
Chemical Substances	Drugs, Generic ; Tenofovir (99YXE507IL) ; Emtricitabine (G70B4ETF4S)
Language	English
Publishing date	2021-01-02
Publishing country	England
Document type	Journal Article
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000002758
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Article ; Online: A Comparison of Tenofovir Predose Concentrations in Generic Pre-exposure Prophylaxis Formulations: A Short Communication.

Cattaneo, Dario / Gervasoni, Cristina / Vinti, Pietro / Baldelli, Sara / Fusi, Marta / Zagato, Donatello / De Bona, Anna / Suardi, Elisa / Bossolasco, Simona / Ancona, Giuseppe / Rossotti, Roberto / Cernuschi, Massimo

Therapeutic drug monitoring

2020 Volume 42, Issue 4, Page(s) 643–647

Abstract: Background: There is extensive evidence to show that pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate (TDF)-based formulations dramatically reduces the risk of HIV acquisition among individuals without HIV infection. Here, the authors ...

Abstract	Background: There is extensive evidence to show that pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate (TDF)-based formulations dramatically reduces the risk of HIV acquisition among individuals without HIV infection. Here, the authors aim to compare tenofovir plasma predose concentrations in subjects taking PrEP daily versus on demand and using different TDF-based generic formulations. Methods: Subjects providing informed signed consent for the measurement of tenofovir plasma levels were included in the study. Predose drug concentrations were stratified according to PrEP administration and the type of TDF-based formulation. The control group consisted of patients with HIV infection who were matched for renal function and were administered branded TDF that was not combined with boosted-antiretroviral drugs. Results: The study consisted of 100 subjects (mean age, 39 ± 10 years; body weight, 77 ± 11 kg). A wide distribution in tenofovir predose concentrations was observed, with values ranging from 17 to 297 ng/mL (coefficient of variation 77%). No significant differences were noted in tenofovir predose concentrations between subjects who were administered PrEP daily (n = 75) or on demand (n = 25) [94 (35-255) versus 104 (37-287) ng/mL; P = 0.476]. Comparable tenofovir predose concentrations were found between patients with HIV infection (n = 220) who were administered branded TDF and those without HIV infection who were treated with 5 different generic TDF-based formulations with generics-to-branded ratios. These were always within the range of 80%-125% and were used to define bioequivalence. Conclusions: The marketed generic formulations of TDF delivered tenofovir plasma predose concentrations comparable with those delivered by branded formulations.
MeSH term(s)	Adult ; Anti-HIV Agents/blood ; Anti-HIV Agents/therapeutic use ; Drugs, Generic/metabolism ; Female ; HIV Infections/blood ; HIV Infections/drug therapy ; Humans ; Male ; Pre-Exposure Prophylaxis/methods ; Retrospective Studies ; Tenofovir/blood ; Tenofovir/therapeutic use
Chemical Substances	Anti-HIV Agents ; Drugs, Generic ; Tenofovir (99YXE507IL)
Language	English
Publishing date	2020-07-23
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	424443-6
ISSN	1536-3694 ; 0163-4356
ISSN (online)	1536-3694
ISSN	0163-4356
DOI	10.1097/FTD.0000000000000756
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Article: Real World Estimate of Vaccination Protection in Individuals Hospitalized for COVID-19.

Vaccines

2022 Volume 10, Issue 4

Abstract: Whether vaccination confers a protective effect against progression after hospital admission for COVID-19 remains to be elucidated. Observational study including all the patients admitted to San Paolo Hospital in Milan for COVID-19 in 2021. Previous ... ...

Abstract	Whether vaccination confers a protective effect against progression after hospital admission for COVID-19 remains to be elucidated. Observational study including all the patients admitted to San Paolo Hospital in Milan for COVID-19 in 2021. Previous vaccination was categorized as: none, one dose, full vaccination (two or three doses >14 days before symptoms onset). Data were collected at hospital admission, including demographic and clinical variables, age-unadjusted Charlson Comorbidity index (CCI). The highest intensity of ventilation during hospitalization was registered. The endpoints were in-hospital death (primary) and mechanical ventilation/death (secondary). Survival analysis was conducted by means of Kaplan-Meier curves and Cox regression models. Effect measure modification by age was formally tested. We included 956 patients: 151 (16%) fully vaccinated (18 also third dose), 62 (7%) one dose vaccinated, 743 (78%) unvaccinated. People fully vaccinated were older and suffering from more comorbidities than unvaccinated. By 28 days, the risk of death was of 35.9% (95%CI: 30.1−41.7) in unvaccinated, 41.5% (24.5−58.5) in one dose and 28.4% (18.2−38.5) in fully vaccinated (p = 0.63). After controlling for age, ethnicity, CCI and month of admission, fully vaccinated participants showed a risk reduction of 50% for both in-hospital death, AHR 0.50 (95%CI: 0.30−0.84) and for mechanical ventilation or death, AHR 0.49 (95%CI: 0.35−0.69) compared to unvaccinated, regardless of age (interaction p > 0.56). Fully vaccinated individuals in whom vaccine failed to keep them out of hospital, appeared to be protected against critical disease or death when compared to non-vaccinated. These data support universal COVID-19 vaccination.
Language	English
Publishing date	2022-04-01
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines10040550
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