CHESSA, LUCHINO

Cinzia, Balestrieri

Eliana, Lai Maria

FIGORILLI, FRANCESCO

Giancarlo, Serra

ONALI, SIMONA

Stefania, Casu

English

Archivio istituzionale della ricerca - Università di Cagliari

POSTERSP1154EFFECT OF VITAMIN D SUPPLEMENTATION ON SUSTAINEDVIROLOGICAL RESPONSE TO PEGINTERFERON ALFA-2b/RIBAVIRINCOMBINATION IN CHRONIC HEPATITIS C GENOTYPE 4M. Hassany1, G. Esmat2, M. El Raziky2, W. Doss1, D. Sabry3,A. Ahmed4, N. Assem5, A. El Sharkawy2, M. El Kassas1. 1TropicalMedicine Department, National Hepatology and Tropical MedicineResearch Institute, 2Endemic Medicine Department, 3BiochemistryDepartment, Cairo University, 4Biochemistry Department, NationalHepatology and Tropical Medicine Research Institute, 5Public Healthand Community Medicine Department, Cairo University, Cairo, EgyptE-mail: mohamadhassany@yahoo.comBackground and Aims: The current treatment for chronic HCVis not satisfactory with the moderate response and high sideeffects. Coming reports showed the possible role of vitamin Dsupplementation in augmenting the response to standard of care(SOC) therapy of HCV. we aimed to evaluate the impact ofvitamin D supplementation on the (SVR) results and to determinethe incidence of Vit D deficiency in chronic HCV patients and itspossible relation to the degree of hepatic fibrosis.Methods: 101 chronic HCV patients classified into two groups:Group 1: received the SOC therapy consisting of Peg-Interferon/Ribavirin (51 patients),Group 2: received the SOC therapy consisting of Peg-Interferon/Ribavirin + Vitamin D3 (50 patients).Results: Vitamin D deficiency was found in 90% of cases group andin 100% of the control group. After vitamin D supplementation andoptimization of the serum levels, no positive impact was observedon treatment outcome where SVR was achieved in 51.2% in casesgroup and 71.4% in control group by per-protocol analysis and in44% in cases group and in 68.6% in control group by intention totreat analysis with no statistically significant difference, also nocorrelation was found between 25(OH)D levels and fibrosis scoreat baseline assessment of the whole population of 101 studied.Conclusions: Though the optimistic data previously documentedabout the results of vitamin D supplementation on HCV treatment,in the current study no significant impact on SVR rates and no solidcorrelation was found between vitamin D levels and degree of liverfibrosis.P1155SAFETY AND EFFICACY OF PEG-IFNa2a AND RIBAVIRIN FORTREATMENT OF HEPATITIS C IN SARDINIAN ADULT PATIENTSWITH THALASSEMIA MAJOR: A SINGLE CENTRE REAL LIFEEXPERIENCES. Casu1, C. Balestrieri1, F. Figorilli1, S. Onali1, G. Serra1, L. Chessa1,2,M.E. Lai3. 1Medicina Interna, AOU Cagliari, Monserrato CA,2Dipartimento di Scienze Mediche Internistiche M.Aresu, Universitàdegli Studi di Cagliari, 3Ospedale Regionale per le Microcitemie,Università degli Studi di Cagliari, Cagliari, ItalyE-mail: casustefania@gmail.comBackground and Aims: Treatment of chronic hepatitis C virus(HCV) infection in transfusion-dependent thalassaemia patientsis complicated by existing hepatic siderosis and the ribavirin-associated haemolysis. We aimed to describe response to antiviralstandard of care therapy with Peg-interferona2a and ribavirin in asingle centre real life cohort.Methods: Thirty-two patients with beta-thalassemia major andchronic HCV infection underwent treatment with PEG-IFNa2a andRibavirin. Dose of Ribavirin was established on HCV genotype andpatient weight. Liver iron load by MRI was detected in all patientsat baseline and in 84% a percutaneous liver biopsy was performed.Side effects and transfusion rate have been collected.Results: A total of 32 patients (M/F=13/19) were treated with meanage of 37.5 years. Among them 56% had a genotype 1 and 78%reached SVR. EVR (early virological response) was observed in allSVR patients (n = 23). No treatment discontinuation was requireddue to side effects. Seven patients developed neutropenia requiringreduction of Interferon dose and treatment with neutrophil growthfactor. Three patients had history of previous treatment and onlyone of them reached SVR.Conclusions: This is the largest thalassemic cohort treated withPeg-IFNa and Ribavirin studied so far. Our study provides evidencethat Peg-IFNa2a and Ribavirin is safe and effective in patients withbeta thalassemia major and HCV chronic hepatitis. Overall SVR was72%. The most striking result is that SVR was observed in 78%among genotype 1 patients. Moreover treatment was safe and welltolerated.P1156DACLATASVIR, ASUNAPREVIR, AND BMS-791325 IN AFIXED-DOSE COMBINATION: A PHASE 1 BIOAVAILABILITY STUDYIN HEALTHY VOLUNTEERSR. Adamczyk1, K. Sims1, I. Chang1, D. Filoramo2, J. Pursley2,S. Charlton3, O. Koo4, R. Bertz1, B. Rege1, M. AbuTarif5. 1Research andDevelopment, Bristol-Myers Squibb, Hopewell, 2Bristol-Myers Squibb,Lawrenceville, NJ, United States; 3Bristol-Myers Squibb, Moreton,United Kingdom; 4Bristol-Myers Squibb, New Brunswick, 5Researchand Development, Bristol-Myers Squibb, Princeton, NJ, United StatesE-mail: malaz.abutarif@bms.comBackground and Aims: The antiviral activity of daclatasvir,asunaprevir, and BMS-791325 in combination for the treatmentof chronic hepatitis C virus infection has been demonstrated inclinical studies. This study assessed the bioavailability of thisregimen in fixed-dose combination (FDC) relative to single-agentsadministered concomitantly. The regimen will be administeredtwice-daily with food in phase 3 studies.Methods: Healthy volunteers (male/female, n = 18/6; age,18–49 years; BMI, 18–32 kg/m2) received a single dose of daclatasvir30mg, asunaprevir 200mg, and BMS-791325 75mg as single-agent tablets on Day 1 and a FDC on Day 4 or vice versa witha standard meal. Non-compartmental pharmacokinetic parameterswere derived from blood samples collected up to 72h post-dose.Linear mixed effect models were used to derive ratios of geometricmeans with associated 90% confidence intervals (CIs).Results: Relative to single-agent tablets, the FDC produced similarexposure of daclatasvir, asunaprevir, and BMS-791325; with theexception of asunaprevir CMAX, all AUCINF and CMAX 90% CIs werecontained entirely within the boundary of bioequivalence (0.8–1.25). The slight increase (approximately 30%) in asunaprevir CMAXTable (abstract P1156).GMR (90% CI)aFormulation Asunaprevir Daclatasvir BMS-791325CMAX AUCINF CMAX AUCINF CMAX AUCINFpFDC 1.30 (1.07, 1.58) 1.14 (1.04, 1.24) 0.95 (0.88, 1.02) 0.98 (0.93, 1.04) 0.96 (0.90, 1.03) 0.99 (0.95, 1.04)GMR, geometric mean ratio; CMAX, maximum observed serum concentration; AUCINF, area under the serum-concentration time curve extrapolated toinfinity.a Relative to single-tablets administered concomitantly.S468 Journal of Hepatology 2014 vol. 60 | S361–S522

SAFETY AND EFFICACY OF PEG-IFN alpha 2a AND RIBAVIRIN FOR TREATMENT OF HEPATITIS C IN SARDINIAN ADULT PATIENTS WITH THALASSEMIA MAJOR: A SINGLE CENTRE REAL LIFE EXPERIENCE

https://iris.unica.it/bitstream/11584/197180/1/J%20Hepatology%202015.pdf

SAFETY AND EFFICACY OF PEG-IFN alpha 2a AND RIBAVIRIN FOR TREATMENT OF HEPATITIS C IN SARDINIAN ADULT PATIENTS WITH THALASSEMIA MAJOR: A SINGLE CENTRE REAL LIFE EXPERIENCE

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