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Article ; Online: Amantadine for treatment of hepatitis C: time to say "enough is enough"?

Piccolo, Paola

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

2010 Volume 42, Issue 7, Page(s) 468–469

MeSH term(s)	Amantadine/administration & dosage ; Antiviral Agents/administration & dosage ; Drug Therapy, Combination ; Evidence-Based Medicine ; Hepatitis C, Chronic/drug therapy ; Humans ; Interferon-alpha/administration & dosage ; Polyethylene Glycols/administration & dosage ; Recombinant Proteins ; Ribavirin/administration & dosage ; Treatment Failure
Chemical Substances	Antiviral Agents ; Interferon-alpha ; Recombinant Proteins ; Polyethylene Glycols (30IQX730WE) ; interferon alfa-2b (43K1W2T1M6) ; Ribavirin (49717AWG6K) ; Amantadine (BF4C9Z1J53) ; peginterferon alfa-2b (G8RGG88B68)
Language	English
Publishing date	2010-07
Publishing country	Netherlands
Document type	Journal Article ; Comment
ZDB-ID	1459373-7
ISSN	1878-3562 ; 1125-8055
ISSN (online)	1878-3562
ISSN	1125-8055
DOI	10.1016/j.dld.2010.04.009
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Article ; Online: Real-world use of remdesivir for the treatment of patients admitted to Italian hospitals with COVID-19: the nationwide retrospective FADOI-RECOVER study.

Pieralli, Filippo / Pomero, Fulvio / Dentali, Francesco / Norbiato, Claudio / Attardo, Tiziana / Vicari, Susanna / Magnani, Elena / Marzilli, Maria Antonietta / Piccolo, Paola / Valerio, Antonella / Manfellotto, Dario

BMC infectious diseases

2023 Volume 23, Issue 1, Page(s) 454

Abstract: Background: Remdesivir is widely used for treatment of SARS-CoV-2 pneumonia. The aim of this study was to evaluate the characteristics of patients with moderate-to-severe COVID-19 treated with remdesivir, and their outcomes during hospitalization.: ... ...

Abstract	Background: Remdesivir is widely used for treatment of SARS-CoV-2 pneumonia. The aim of this study was to evaluate the characteristics of patients with moderate-to-severe COVID-19 treated with remdesivir, and their outcomes during hospitalization. Methods: This retrospective observational multicenter study included consecutive patients, hospitalized for moderate-to-severe COVID-19 (September 2020-September 2021), who were treated with remdesivir. Results: One thousand four patients were enrolled, all with onset of symptoms occurring less than 10 days before starting remdesivir; 17% of patients had 4 or more concomitant diseases. Remdesivir was well tolerated, adverse drug reactions (ADRs) being reported in 2.3% of patients. In-hospital death occurred in 80 patients (8.0%). The median timing of the first remdesivir dose was 5 days after symptom onset. The following endpoints did not differ according to the time span from the onset of symptoms to the first dose: length of hospitalization, in-hospital death, composite outcome (in-hospital death and/or endotracheal intubation). Advanced age, number of comorbidities ≥ 4, and severity of respiratory failure at admission were associated with poor in-hospital outcomes. Conclusion: In a real-world setting, remdesivir proved to be a safe and well-tolerated treatment for moderate-to-severe COVID-19. In patients receiving remdesivir less than 3 or 5 days from the onset of SARS-CoV-2 symptoms, mortality and the need for mechanical ventilation did not differ from the rest of the sample.
MeSH term(s)	Humans ; COVID-19 ; SARS-CoV-2 ; Retrospective Studies ; Hospital Mortality ; COVID-19 Drug Treatment ; Hospitalization ; Hospitals ; Antiviral Agents/adverse effects
Chemical Substances	remdesivir (3QKI37EEHE) ; Antiviral Agents
Language	English
Publishing date	2023-07-08
Publishing country	England
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	2041550-3
ISSN	1471-2334 ; 1471-2334
ISSN (online)	1471-2334
ISSN	1471-2334
DOI	10.1186/s12879-023-08422-6
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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: 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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Zs.A 1632: Show issues

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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 ; 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 ; Online: Severe drug induced acute hepatitis associated with use of St John's wort (Hypericum perforatum) during treatment with pegylated interferon α.

Piccolo, Paola / Gentile, Silvia / Alegiani, Filippo / Angelico, Mario

BMJ case reports

2009 Volume 2009

Abstract: A 61-year-old woman with chronic hepatitis C received peginterferon α 180 μg/week, and obtained undetectable qualitative hepatitis C virus (HCV) RNA (lower limit of detection 50 IU/ml) after 8 weeks of treatment. Shortly thereafter aminotransferase ... ...

Abstract	A 61-year-old woman with chronic hepatitis C received peginterferon α 180 μg/week, and obtained undetectable qualitative hepatitis C virus (HCV) RNA (lower limit of detection 50 IU/ml) after 8 weeks of treatment. Shortly thereafter aminotransferase values greatly increased (>20 × upper limit of normal) and did not decline after treatment suspension. The patient admitted taking St John's wort (Hypericum perforatum) for depressed mood, recommended by a friend, during the preceding 6 weeks. Liver function tests continued to worsen and international normalised ratio (INR) prolongation developed; the patient was hospitalised. Test for antinuclear antibody was positive (1:320) and treatment with methylprednisolone was started; bilirubin and aminotransferase levels slowly declined, though a new flare occurred when steroids were tapered. After 6 months of prednisone treatment, the liver function tests returned to baseline levels. The combination of peginterferon α and St John's wort resulted in a severe acute hepatitis in this patient. Patients should be advised of this potential toxic effect of this herbal remedy.
Language	English
Publishing date	2009-04-14
Publishing country	England
Document type	Journal Article
ISSN	1757-790X
ISSN (online)	1757-790X
DOI	10.1136/bcr.08.2008.0761
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Article: Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis: A real-life study.

Lionetti, Raffaella / Piccolo, Paola / Lenci, Ilaria / Siciliano, Massimo / Visco-Comandini, Ubaldo / De Santis, Adriano / Pompili, Maurizio / Milana, Martina / Taibi, Chiara / Dell'Isola, Serena / Montalbano, Marzia / Mastroianni, Claudio / Begini, Paola / Garbuglia, Anna Rosa / Angelico, Mario / D'Offizi, Gianpiero

Annals of hepatology

2019 Volume 18, Issue 3, Page(s) 434–438

Abstract: Introduction and aim: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat ... ...

Abstract	Introduction and aim: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. Materials and methods: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. Results: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). Conclusion: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.
MeSH term(s)	Adult ; Aged ; Antiviral Agents/therapeutic use ; Cohort Studies ; Confidence Intervals ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Genetic Profile ; Hepacivirus/drug effects ; Hepacivirus/genetics ; Hepatitis C, Chronic/diagnosis ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/genetics ; Humans ; Imidazoles/administration & dosage ; Italy ; Liver Cirrhosis/epidemiology ; Liver Cirrhosis/pathology ; Liver Cirrhosis/virology ; Liver Function Tests ; Male ; Middle Aged ; Prospective Studies ; Ribavirin/administration & dosage ; Risk Assessment ; Severity of Illness Index ; Sofosbuvir/administration & dosage ; Sustained Virologic Response ; Time Factors ; Treatment Outcome
Chemical Substances	Antiviral Agents ; Imidazoles ; Ribavirin (49717AWG6K) ; daclatasvir (LI2427F9CI) ; Sofosbuvir (WJ6CA3ZU8B)
Language	English
Publishing date	2019-04-15
Publishing country	Mexico
Document type	Comparative Study ; Journal Article ; Multicenter Study
ZDB-ID	2188733-0
ISSN	1665-2681
ISSN	1665-2681
DOI	10.1016/j.aohep.2018.09.005
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Article ; Online: A randomized controlled trial of sequential pegylated interferon-α and telbivudine or vice versa for 48 weeks in hepatitis B e antigen-negative chronic hepatitis B.

Piccolo, Paola / Lenci, Ilaria / di Paolo, Daniele / Demelia, Luigi / Sorbello, Orazio / Nosotti, Lorenzo / Angelico, Mario

Antiviral therapy

2013 Volume 18, Issue 1, Page(s) 57–64

Abstract: Background: Short-term treatment for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B remains unsatisfactory. The aim of our study was to compare the efficacy and safety of two sequential regimens of pegylated interferon (PEG-IFN)-α and ... ...

Abstract	Background: Short-term treatment for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B remains unsatisfactory. The aim of our study was to compare the efficacy and safety of two sequential regimens of pegylated interferon (PEG-IFN)-α and telbivudine (LdT). Methods: Adult patients with biopsy-proven HBeAg-negative chronic hepatitis B, elevated alanine aminotransferase (ALT) and serum HBV DNA ≥ 2,000 IU/ml were randomized 1:1 at baseline to receive PEG-IFN 180 μg/week for 24 weeks followed by LdT 600 mg/day for 24 weeks (PEG-IFN first), or vice versa (LdT first), plus 24-week follow-up; individuals with HCV, HDV or HIV coinfections and lamivudine resistance were excluded. Primary end points were serum HBV DNA<2,000 IU/ml and normal ALT at week 72. Results: A total of 30 patients (86% male, median age 48 years) were enrolled: mean ±sd baseline serum HBV DNA was 5.56 ± 1.4 log IU/ml and ALT was 2.9 ± 2.5× upper limit of normal. At end of follow-up (week 72), HBV DNA<2,000 IU/ml was achieved in 13.3% of participants in the PEG-IFN first group versus 46.7% of those in the LdT first group (P=0.046). Mean ±sd ALT levels were significantly lower in the LdT first group (1.3 ± 0.9 versus 3.2 ± 2.7× upper limit of normal; P=0.03). PEG-IFN dose was reduced in 2 (7%) patients and 1 (7%) patient dropped out due to myalgia. Conclusions: Sequential treatment with 24 weeks PEG-IFN followed or preceded by 24 weeks of LdT is safe. Virological response rate at week 72 was significantly higher in patients treated with LdT followed by PEG-IFN than vice versa. A sequential antiviral regimen of LdT followed by PEG-IFN, if confirmed in larger series, could improve response rates compared with standard PEG-IFN monotherapy.
MeSH term(s)	Adult ; Alanine Transaminase/blood ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; DNA, Viral/blood ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Hepatitis B e Antigens/blood ; Hepatitis B virus/drug effects ; Hepatitis B, Chronic/drug therapy ; Hepatitis B, Chronic/virology ; Humans ; Interferon-alpha/administration & dosage ; Interferon-alpha/adverse effects ; Interferon-alpha/therapeutic use ; Italy ; Male ; Middle Aged ; Polyethylene Glycols/administration & dosage ; Polyethylene Glycols/adverse effects ; Polyethylene Glycols/therapeutic use ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Thymidine/administration & dosage ; Thymidine/adverse effects ; Thymidine/analogs & derivatives ; Thymidine/therapeutic use ; Treatment Outcome
Chemical Substances	Antiviral Agents ; DNA, Viral ; Hepatitis B e Antigens ; Interferon-alpha ; Recombinant Proteins ; telbivudine (2OC4HKD3SF) ; Polyethylene Glycols (30IQX730WE) ; Alanine Transaminase (EC 2.6.1.2) ; peginterferon alfa-2a (Q46947FE7K) ; Thymidine (VC2W18DGKR)
Language	English
Publishing date	2013
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1339842-8
ISSN	2040-2058 ; 1359-6535
ISSN (online)	2040-2058
ISSN	1359-6535
DOI	10.3851/IMP2281
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Article ; Online: Sofosbuvir plus daclatasvir with or without ribavirin is safe and effective for post-transplant hepatitis C recurrence and severe fibrosis and cirrhosis: A prospective study.

Lionetti, Raffaella / Calvaruso, Vincenza / Piccolo, Paola / Mancusi, Rossella Letizia / Mazzarelli, Chiara / Fagiuoli, Stefano / Montalbano, Marzia / Lenci, Ilaria / Carrai, Paola / Guaraldi, Giovanni / Visco-Comandini, Ubaldo / Milana, Martina / Biolato, Marco / Loiacono, Laura / Valente, Giovanna / Craxì, Antonio / Angelico, Mario / D'offizi, Gianpiero

Clinical transplantation

2017 Volume 32, Issue 2

Abstract: Background: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this ...

Abstract	Background: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this "real-life" study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). Methods: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). Results: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ± 7.2 years, 83.9% genotype 1, 81.6% cirrhosis); 52 (59.8%) received RBV. Overall, 79 obtained SVR12 (90.8%): 100% in F3 and 88.7% in cirrhotics (91.5% in Child-Pugh A, 83.3% in Child-Pugh B and C). According to the treatment group, SVR was 80% in DCV + SOF group and 98.1% in SOF + DCV + RBV. Two virological relapses occurred during follow-up in cirrhotic patients who received DCV + SOF. Four cirrhotic patients in DCV + SOF group and 1 in DCV + SOF + RBV group died on treatment. Conclusion: An extended course of SOF plus DCV for 24 weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.
MeSH term(s)	Antiviral Agents/therapeutic use ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Hepacivirus/isolation & purification ; Hepatitis C/complications ; Hepatitis C/surgery ; Hepatitis C/virology ; Humans ; Imidazoles/therapeutic use ; Italy ; Liver Cirrhosis/drug therapy ; Liver Cirrhosis/etiology ; Liver Transplantation/adverse effects ; Male ; Middle Aged ; Prognosis ; Prospective Studies ; Recurrence ; Ribavirin/therapeutic use ; Sofosbuvir/therapeutic use
Chemical Substances	Antiviral Agents ; BMS-790052 ; Imidazoles ; Ribavirin (49717AWG6K) ; Sofosbuvir (WJ6CA3ZU8B)
Language	English
Publishing date	2017-12-18
Publishing country	Denmark
Document type	Journal Article
ZDB-ID	639001-8
ISSN	1399-0012 ; 0902-0063
ISSN (online)	1399-0012
ISSN	0902-0063
DOI	10.1111/ctr.13165
Database	MEDical Literature Analysis and Retrieval System OnLINE

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