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Article: Torquetenovirus Loads in Peripheral Blood Predict Both the Humoral and Cell-Mediated Responses to SARS-CoV-2 Elicited by the mRNA Vaccine in Liver Transplant Recipients.

Minosse, Claudia / Matusali, Giulia / Meschi, Silvia / Grassi, Germana / Francalancia, Massimo / D'Offizi, Gianpiero / Spezia, Pietro Giorgio / Garbuglia, Anna Rosa / Montalbano, Marzia / Focosi, Daniele / Girardi, Enrico / Vaia, Francesco / Ettorre, Giuseppe Maria / Maggi, Fabrizio

Vaccines

2023 Volume 11, Issue 11

Abstract: Three years into the COVID-19 pandemic, mass vaccination campaigns have largely controlled the disease burden but have not prevented virus circulation. Unfortunately, many immunocompromised patients have failed to mount protective immune responses after ... ...

Abstract	Three years into the COVID-19 pandemic, mass vaccination campaigns have largely controlled the disease burden but have not prevented virus circulation. Unfortunately, many immunocompromised patients have failed to mount protective immune responses after repeated vaccinations, and liver transplant recipients are no exception. Across different solid organ transplant populations, the plasma levels of Torquetenovirus (TTV), an orphan and ubiquitous human virus under control of the immune system, have been shown to predict the antibody response after COVID-19 vaccinations. We show here a single-institution experience with TTV viremia in 134 liver transplant recipients at their first or third dose. We found that TTV viremia before the first and third vaccine doses predicts serum anti-SARS-CoV-2 Spike receptor-binding domain (RBD) IgG levels measured 2-4 weeks after the second or third dose. Pre-vaccine TTV loads were also associated with peripheral blood anti-SARS-CoV-2 cell-mediated immunity but not with serum SARS-CoV-2 neutralizing antibody titers.
Language	English
Publishing date	2023-10-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines11111656
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Article ; Online: Third dose of SARS-CoV2 mRNA vaccination produces robust persistent cellular and humoral immune responses in liver transplant recipients.

Montalbano, Marzia / Piccolo, Paola / Lionetti, Raffaella / Visco-Comandini, Ubaldo / Agrati, Chiara / Grassi, Germana / Meschi, Silvia / Matusali, Giulia / Conte, Federica / Angelone, Federica / Ettorre, Giuseppe Maria / Guglielmo, Nicola / Maggi, Fabrizio / Francalancia, Massimo / Mereu, Tiziana / Puro, Vincenzo / Girardi, Enrico / D'Offizi, Gianpiero

Liver international : official journal of the International Association for the Study of the Liver

2023 Volume 43, Issue 5, Page(s) 1120–1125

Abstract: Weaker responses have been described after two doses of anti-SARS-CoV2 vaccination in liver transplant recipients (LTRs). At the Italian National Institute for Infectious Diseases, 122 LTRs (84% males, median age 64 years) were tested for humoral and ... ...

Abstract	Weaker responses have been described after two doses of anti-SARS-CoV2 vaccination in liver transplant recipients (LTRs). At the Italian National Institute for Infectious Diseases, 122 LTRs (84% males, median age 64 years) were tested for humoral and cell-mediated immune response after a third doses of anti-SARS-CoV2 mRNA vaccines. Humoral response was measured by quantifying anti-receptor binding domain and neutralizing antibodies; cell-mediated response was measured by quantifying IFN-γ after stimulation of T cells with SARS-CoV-2-specific peptides. Humoral and cellular responses improved significantly compared to the second vaccine dose; 86.4% of previous non-responders to the first 2 vaccine doses (N = 22) became responders. Mycophenolate mofetil-containing regimens were not associated with lower response rates to a third vaccine; shorter time since transplantation (<6 years) was associated with lower humoral and cellular responses to third vaccine. Protective antibodies against Omicron variant were detected in 60% of patients 12 weeks after third vaccine dose.
MeSH term(s)	Male ; Humans ; Middle Aged ; Female ; Immunity, Humoral ; Liver Transplantation ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccination ; RNA, Messenger ; Antibodies, Viral ; Transplant Recipients
Chemical Substances	RNA, Messenger ; Antibodies, Viral
Language	English
Publishing date	2023-04-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.15557
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Article ; Online: "Real world" efficacy of bulevirtide in HBV/HDV-related cirrhosis including people living with HIV: Results from the compassionate use programme at INMI Spallanzani in Rome, Italy.

Visco Comandini, Ubaldo / De Santis, Emanuela / De Maria, Francesco / Lionetti, Raffaella / Taibi, Chiara / Montalbano, Marzia / Rianda, Alessia / Piccolo, Paola / De Ponte, Chiara / Mazzotta, Stefania / Caioli, Alessandro / Garbuglia, Anna Rosa / Maggi, Fabrizio / D'Offizi, Gianpiero

HIV medicine

2023 Volume 24, Issue 10, Page(s) 1075–1082

Abstract: Objectives: We describe the preliminary results of bulevirtide compassionate use in patients with hepatitis B and delta virus (HBV/HDV)-related cirrhosis and clinically significant portal hypertension, including those living with HIV.: Methods: We ... ...

Abstract	Objectives: We describe the preliminary results of bulevirtide compassionate use in patients with hepatitis B and delta virus (HBV/HDV)-related cirrhosis and clinically significant portal hypertension, including those living with HIV. Methods: We conducted a prospective observational study of consecutive patients. Clinical evaluation, liver function tests, bile acid levels, HDV-RNA, HBV-DNA, hepatitis B surface antigen, and liver and spleen stiffness were assessed at baseline and after treatment months 1, 2, 3, 4, 6, 9, and 12. HIV-RNA and CD4+/CD8+ count were assessed in people living with HIV. The first drug injection was administered under nurse supervision, and counselling was provided and adherence reviewed at each visit. Results: In total, 13 patients (61.5% migrants) were enrolled. The median treatment duration was 11 months. At month 6, mean alanine aminotransferase (ALT) levels fell by 64.5% and mean liver and spleen stiffness decreased by 8.6 and 0.9 kPa, respectively. The mean baseline HDV-RNA was 3.34 log IU/mL and 5.10 log IU/mL in people without and with HIV (n = 5) (p = 0.28), respectively. A similar mean decline was observed in both groups: -2.06 log IU/mL and -1.93 log IU/mL, respectively (p = 0.87). A combined response (undetectable HDV RNA or ≥ -2 log IU/mL decline vs. baseline, with ALT normalization) was achieved in 66% of subjects without and in 60% of patients with HIV. Patients with HIV showed persistently undetectable HIV-RNA and a progressive increase in CD4+/CD8+ cells during treatment. No patient discontinued bulevirtide because of adverse effects. Conclusions: Preliminary results suggest that bulevirtide is feasible and well-tolerated in populations with difficult-to-treat conditions, such as those with HIV/HBV/HDV co-infection and migrants, when special attention is given to patient education. HDV-RNA decline during treatment was similar in people living with and without HIV.
MeSH term(s)	Humans ; Compassionate Use Trials ; Hepatitis B virus/genetics ; HIV Infections/complications ; HIV Infections/drug therapy ; Italy ; Liver Cirrhosis/drug therapy ; RNA ; Rome
Chemical Substances	bulevirtide ; RNA (63231-63-0)
Language	English
Publishing date	2023-06-07
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	2001932-4
ISSN	1468-1293 ; 1464-2662
ISSN (online)	1468-1293
ISSN	1464-2662
DOI	10.1111/hiv.13518
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Article ; Online: Severe drug-induced liver injury (DILI) associated with benznidazole therapy for Chagas' disease.

Giancola, Maria Letizia / Corpolongo, Angela / Comandini, Ubaldo Visco / Del Nonno, Franca / Montalbano, Marzia / Petrone, Ada / Carrara, Stefania / Mariano, Andrea / Beccacece, Alessia / Maffongelli, Gaetano / Nicastri, Emanuele

The Journal of antimicrobial chemotherapy

2022 Volume 77, Issue 12, Page(s) 3515–3517

MeSH term(s)	Humans ; Nitroimidazoles/adverse effects ; Chagas Disease/drug therapy ; Chemical and Drug Induced Liver Injury/etiology ; Trypanocidal Agents/adverse effects ; Trypanosoma cruzi ; Chagas Cardiomyopathy/drug therapy
Chemical Substances	benzonidazole (YC42NRJ1ZD) ; Nitroimidazoles ; Trypanocidal Agents
Language	English
Publishing date	2022-09-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkac310
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Zs.A 1197: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 124: Show issues

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Article ; Online: Late Relapse and Reinfection in HCV Patients Treated with Direct-Acting Antiviral (DAA) Drugs.

Minosse, Claudia / Gruber, Cesare E M / Rueca, Martina / Taibi, Chiara / Zaccarelli, Mauro / Grilli, Elisabetta / Montalbano, Marzia / Capobianchi, Maria R / Antinori, Andrea / D'Offizi, Gianpiero / McPhee, Fiona / Garbuglia, Anna Rosa

Viruses

2021 Volume 13, Issue 6

Abstract: The risk of hepatitis C virus (HCV) recurrence after direct-acting antiviral (DAA) treatment is <0.5%. However, the distinction between HCV RNA late relapse and reinfection still represents a challenge in virological diagnostics. The aim of this study ... ...

Abstract	The risk of hepatitis C virus (HCV) recurrence after direct-acting antiviral (DAA) treatment is <0.5%. However, the distinction between HCV RNA late relapse and reinfection still represents a challenge in virological diagnostics. The aim of this study was to employ next-generation sequencing (NGS) to investigate HCV RNA recurrence in patients achieving a sustained virologic response (SVR) at least six months post-treatment. NGS was performed on plasma samples from six HCV-positive patients (Pt1-6) treated with DAA. NGS of HCV NS5B was analyzed before treatment (T0), after HCV RNA rebound (T1), and, for Pt3, after a second rebound (T2). Reinfection was confirmed for Pt5, and for the first rebound observed in Pt3. Conversely, viral relapse was observed when comparing T0 and T1 for Pt6 and T1 and T2 for Pt3. Z-scores were calculated and used to predict whether HCV-positive patient samples at different time points belonged to the same quasispecies population. A low
MeSH term(s)	Amino Acid Sequence ; Antiviral Agents/therapeutic use ; Base Sequence ; Female ; Genotype ; Hepacivirus/classification ; Hepacivirus/drug effects ; Hepacivirus/genetics ; Hepatitis C/diagnosis ; Hepatitis C/drug therapy ; Hepatitis C/virology ; High-Throughput Nucleotide Sequencing ; Humans ; Male ; Middle Aged ; Phenotype ; Phylogeny ; RNA, Viral ; Recurrence ; Reinfection ; Treatment Outcome
Chemical Substances	Antiviral Agents ; RNA, Viral
Language	English
Publishing date	2021-06-16
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/v13061151
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Article ; Online: High prevalence of asymptomatic SARS-CoV-2 infection in a cohort of liver transplant recipients in central Italy.

Visco-Comandini, Ubaldo / Castilletti, Concetta / Lionetti, Raffaella / Meschi, Silvia / Montalbano, Marzia / Rianda, Alessia / Taibi, Chiara / Sorace, Chiara / Guglielmo, Nicola / Piccolo, Paola / Paci, Paola / Ettorre, Giuseppe Maria / Gianpiero, D'Offizi

Journal of liver transplantation

2021 Volume 5, Page(s) 100064

Abstract: Asymptomatic subjects account for 25 to 45% of SARS-CoV-2 infections, and in particular, subjects on mild immunosuppressive therapy may have symptoms masked and could spread virus for an extended period of time. To determine the cumulative incidence of ... ...

Abstract	Asymptomatic subjects account for 25 to 45% of SARS-CoV-2 infections, and in particular, subjects on mild immunosuppressive therapy may have symptoms masked and could spread virus for an extended period of time. To determine the cumulative incidence of symptomatic and asymptomatic SARS-CoV-2 infections and associated risk factors, we conducted a prospective clinical and serological survey in a cohort of 278 liver transplant recipients (LTRs) from Central Italy. Three different serology tests were performed every 4 months in 259 LTRs between April 2020 and April 2021: one based on raw extract of whole SARS-CoV-2 virus and two on specific viral antigens (nucleoprotein and receptor binding domain) to detect specific IgG, IgM and IgA. Hundred fifteen LTRs who reported symptoms or close contact with a SARS-CoV-2-positive subject, or had a positive serological result underwent molecular testing by standard screening procedures (RT-PCR on naso-pharyngeal swab). Thirty-one past or active SARS-CoV-2 infections were identified: 14 had positive molecular test (64% symptomatic), and 17 had positive serology only (18% symptomatic). SARS-CoV-2 infection was not statistically related to gender, age, obesity, diabetes, renal impairment, type of anti-rejection therapy or time from transplant. Asymptomatic SARS-CoV-2 cases (61.3%) were more frequent in males and in those with glomerular filtrate rate >50 ml/min. Overall, the addition of repeated serology to standard diagnostic molecular protocols increased detection of SARS-CoV-2 infection from 5.1% to 10.9%. Anti-SARS-CoV-2 seroprevalence among our LTRs (11.2%) is comparable to the general population of Central Italy, considered a medium-impact area. Only one asymptomatic subject (6%) was found to carry SARS-CoV-2 in respiratory tract at the time of serological diagnosis.
Language	English
Publishing date	2021-12-18
Publishing country	France
Document type	Journal Article
ISSN	2666-9676
ISSN (online)	2666-9676
DOI	10.1016/j.liver.2021.100064
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Article: Late Relapse and Reinfection in HCV Patients Treated with Direct-Acting Antiviral (DAA) Drugs

Minosse, Claudia / Gruber, Cesare E. M. / Rueca, Martina / Taibi, Chiara / Zaccarelli, Mauro / Grilli, Elisabetta / Montalbano, Marzia / Capobianchi, Maria R. / Antinori, Andrea / D’Offizi, Gianpiero / McPhee, Fiona / Garbuglia, Anna Rosa

Viruses. 2021 June 16, v. 13, no. 6

2021

Abstract	The risk of hepatitis C virus (HCV) recurrence after direct-acting antiviral (DAA) treatment is <0.5%. However, the distinction between HCV RNA late relapse and reinfection still represents a challenge in virological diagnostics. The aim of this study was to employ next-generation sequencing (NGS) to investigate HCV RNA recurrence in patients achieving a sustained virologic response (SVR) at least six months post-treatment. NGS was performed on plasma samples from six HCV-positive patients (Pt1–6) treated with DAA. NGS of HCV NS5B was analyzed before treatment (T0), after HCV RNA rebound (T1), and, for Pt3, after a second rebound (T2). Reinfection was confirmed for Pt5, and for the first rebound observed in Pt3. Conversely, viral relapse was observed when comparing T0 and T1 for Pt6 and T1 and T2 for Pt3. Z-scores were calculated and used to predict whether HCV-positive patient samples at different time points belonged to the same quasispecies population. A low Z-score of <2.58 confirmed that viral quasispecies detected at T0 and T1 were closely related for both Pt1 and Pt2, while the Z-score for Pt4 was suggestive of possible reinfection. NGS data analyses indicate that the Z-score may be a useful parameter for distinguishing late relapse from reinfection.
Keywords	Hepatitis C virus ; RNA ; diagnostic techniques ; patients ; relapse ; risk
Language	English
Dates of publication	2021-0616
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v13061151
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: The impact of the coronavirus disease 2019 pandemic on a central Italy transplant center.

Montalbano, Marzia / Levi Sandri, Giovanni Battista / Visco Comandini, Ubaldo / Lionetti, Raffaella / Vincenzi, Laura / Berardi, Giammauro / Guglielmo, Nicola / Pellicelli, Adriano / Ettorre, Giuseppe Maria / D'Offizi, Gianpiero

Medicine

2020 Volume 99, Issue 41, Page(s) e22174

Abstract: Coronavirus disease 2019 (COVID-19) is challenging health care systems worldwide, raising the question of reducing the transplant program due to the shortage of intensive care unit beds and to the risk of infection in donors and recipients.We report the ... ...

Abstract	Coronavirus disease 2019 (COVID-19) is challenging health care systems worldwide, raising the question of reducing the transplant program due to the shortage of intensive care unit beds and to the risk of infection in donors and recipients.We report the positive experience of a single Transplant Center in Rome, part of the National Institute for Infectious Diseases Lazzaro Spallanzani, one of the major national centers involved in the COVID-19 emergency.
MeSH term(s)	COVID-19 ; Coronavirus Infections ; Hospitals/statistics & numerical data ; Humans ; Italy ; Liver Transplantation/statistics & numerical data ; Pandemics ; Pneumonia, Viral
Keywords	covid19
Language	English
Publishing date	2020-10-08
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000022174
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Article ; Online: Coordinated cellular and humoral immune responses after two-dose SARS-CoV2 mRNA vaccination in liver transplant recipients.

D'Offizi, Gianpiero / Agrati, Chiara / Visco-Comandini, Ubaldo / Castilletti, Concetta / Puro, Vincenzo / Piccolo, Paola / Montalbano, Marzia / Meschi, Silvia / Tartaglia, Eleonora / Sorace, Chiara / Leone, Sara / Lapa, Daniele / Grassi, Germana / Goletti, Delia / Ippolito, Giuseppe / Vaia, Francesco / Ettorre, Giuseppe Maria / Lionetti, Raffaella

Liver international : official journal of the International Association for the Study of the Liver

2021 Volume 42, Issue 1, Page(s) 180–186

Abstract: Limited data are available on risks and benefits of anti-SARS-CoV2 vaccination in solid organ transplant recipients, and weaker responses have been described. At the Italian National Institute for Infectious Diseases, 61 liver transplant recipients ... ...

Abstract	Limited data are available on risks and benefits of anti-SARS-CoV2 vaccination in solid organ transplant recipients, and weaker responses have been described. At the Italian National Institute for Infectious Diseases, 61 liver transplant recipients underwent testing to describe the dynamics of humoral and cell-mediated immune response after two doses of anti-SARS-CoV2 mRNA vaccines and compared with 51 healthy controls. Humoral response was measured by quantifying both anti-spike and neutralizing antibodies; cell-mediated response was measured by PBMC proliferation assay with IFN-γ and IL-2 production. Liver transplant recipients showed lower response rates compared with controls in both humoral and cellular arms; shorter time since transplantation and multi-drug immunosuppressive regimen containing mycophenolate mofetil were predictive of reduced response to vaccination. Specific antibody and cytokine production, though reduced, were highly correlated in transplant recipients.
MeSH term(s)	Antibodies, Viral ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Immunity, Humoral ; Leukocytes, Mononuclear ; Liver Transplantation ; RNA, Messenger ; RNA, Viral ; SARS-CoV-2 ; Transplant Recipients ; Vaccination
Chemical Substances	Antibodies, Viral ; COVID-19 Vaccines ; RNA, Messenger ; RNA, Viral
Language	English
Publishing date	2021-11-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.15089
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Article: Management of recurrent viral hepatitis B and C after liver transplantation.

Montalbano, Marzia / Neff, Guy W

Current gastroenterology reports

2003 Volume 8, Issue 1, Page(s) 60–66

Abstract: Liver transplant teams are often faced with the challenges of managing viral recurrence after liver transplantation. Hepatitis C virus (HCV) remains the most challenging viral disease in the transplant community. Strategies to prevent and delay viral ... ...

Abstract	Liver transplant teams are often faced with the challenges of managing viral recurrence after liver transplantation. Hepatitis C virus (HCV) remains the most challenging viral disease in the transplant community. Strategies to prevent and delay viral recurrence have slowly developed over the past 5 years. Hepatitis B virus (HBV), previously a contraindication for liver transplantation due to recurrence and cholestasis with allograft failure, is now one of the more favorable indications for liver transplantation as a result of current therapeutic options. This review investigates the up-to-date information on treatment outcomes for HCV and HBV in the period following liver transplant.
MeSH term(s)	Angiotensin-Converting Enzyme Inhibitors/therapeutic use ; Antiviral Agents/therapeutic use ; Hepatitis B/surgery ; Hepatitis B/virology ; Hepatitis C/surgery ; Hepatitis C/virology ; Humans ; Immunosuppressive Agents/therapeutic use ; Liver Transplantation ; Patient Selection ; Postoperative Complications/drug therapy ; Recurrence ; Treatment Outcome
Chemical Substances	Angiotensin-Converting Enzyme Inhibitors ; Antiviral Agents ; Immunosuppressive Agents
Language	English
Publishing date	2003-02-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2041376-2
ISSN	1522-8037
ISSN	1522-8037
DOI	10.1007/s11894-006-0065-x
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