- Email: [email protected]
P710 EFFECT OF ALISPORIVIR (ALV) ON THE PHARMACOKINETICS (PK), SAFETY, AND TOLERABILITY OF METHADONE IN HEALTHY SUBJECTS AND OPIOID-DEPENDENT PATIENTS ON STABLE METHADONE MAINTENANCE THERAPY (MMT)
POSTERS P707 CHRONIC KIDNEY DISEASE INCREASES NON-LIVER-RELATED MORTALITY IN HIV-NEGATIVE PATIENTS WITH CHRONIC HEPATITIS B INFECTION: A FRENCH NATIONWIDE HOSPITAL COHORT STUDY 3 V. Mallet1,2 , S. Thiebaut ´ , A. Trylesinski4 , M. Schwarzinger3 . 1 Universit´e Paris Descartes, Assistance Publique – Hˆ opitaux de Paris, Inserm, 2 Lingha ‘Links for Global Health Assessment’, Paris Biotech Sant´e, 3 THEN ‘Translational Health Economics Network’, Paris, France; 4 Novartis Pharma AG, Basel, Switzerland E-mail: [email protected] Background and Aims: Chronic kidney disease (CKD) is associated with chronic hepatitis B virus (CHB) infection at all liver disease stages. Our aim was to determine the role of CKD in non-liverrelated mortality in CHB patients. Methods: We conducted a retrospective, longitudinal analysis of the 2010–2012 French National Hospital database. CHB adult patients were identified by ICD-10 medical coding (B18.0/B18.1). CKD was defined by a glomerular filtration rate below 60 mL/min, dialysis or kidney transplant. Exclusion criteria involved: HIV co-infection; and, at cohort inception, CKD, organ transplant, or end stage liver disease (ESLD) including hepatocellular carcinoma. Prognosis factors of non-liver-related death were estimated in a proportional hazards model stratified by gender and obesity status, using age as the time-scale and ESLD as a competing risk. Results: Of 25,881 CHB patients (male: 54.8%; mean (SD) age: 46.3 (16.9) years), 2,602 (10.1%) progressed to ESLD (case-fatality rate: 32.2%) and 628 (2.4%) died from non-liver-related causes during 48,653 patient-years. CKD occurred in 51/628 (8.2%) patients who died from non-liver-related causes, 150/2,602 (5.8%) patients before ESLD, and 507/22,651 (2.2%) patients otherwise (p < 0.001). Independent prognostic factors of non-liver-related mortality were: chronic alcoholism (HR = 1.39, p < 0.001), progression to CKD (HR = 4.24, p < 0.0001), and other major Charlson Comorbidities (Index = 1: HR = 4.90; Index = 2: HR = 9.48; Index ≥ 3: HR = 24.02, p < 0.0001). Independent risk factors of ESLD were: chronic alcoholism (HR = 3.31, p < 0.0001), co-infection with delta virus (HR = 1.39, p < 0.0001) or chronic hepatitis C (HR = 1.59, p < 0.0001), and insulin-dependent diabetes (HR = 1.27, p < 0.0001). Conclusions: CKD is an independent prognostic factor of non-liverrelated mortality in CHB patients. P708 CHRONIC HEPATITIS E – THE SPECTRUM OF HISTOPATHOLOGY A. Beer1 , S. Pischke2 , P. Behrendt2 , J. Schlue2 , U. Drebber3 , H. Kreipe2 , H. Wedemeyer2 , M. Manns2 , H.P. Dienes1 . 1 University of Vienna, Vienna, Austria; 2 Hannover Medical School, Hannover, 3 University of Cologne, Cologne, Germany E-mail: [email protected] Background and Aims: Sporadic hepatitis E is an emerging indigenous disease in Europe induced by genotype III of the virus. Whereas in immunocompetent individuals it takes an acute selflimited course, under immunocompromised conditions chronic hepatitis may develop. Histopathology of acute hepatitits E has been published whereas histology of the chronic hepatitis E has not been evaluated. Methods: We collected liver biopsies from 14 patients (13 male, 1 female; age 10–66 years) who had undergone solid organ transplantation (4 liver, 5 kidney, 4 heart). One HIV negative patient had CD4 lymphocyte impairment. Biopsies were stained with H&E, Prussian Blue, van Gieson and PASD. Evaluation of histologic activity and fibrosis was performed applying Ishak score. Results: Biochemical data showed a considerable increase with ALT mean levels 326 U/L (35–1410), AST mean 442 U/L (25–2574), gGT 192 (42–606), bilirubin 36 mg/dl (9–146). Histopathology displayed typical features of chronic hepatitis of mild to moderate activity
(histological activity index of 8, mild fibrosis stage 2). In two biopsies a conspicuous central vein sclerosis and perisinusoidal fibrosis was present that first lead to misdiagnosis of NASH. The number of PMN leucocytes was increased. Bile ducts were involved with a mild reactive cholangitis. Significant cholestasis was absent. Conclusions: Chronic hepatitis E runs a similar course as hepatitis B and C. Histopathology shows a pattern of mild to moderate histologic activity with an increased presence of PMN leucocytes and reactive cholangitis. Fibrosis showed stage 2 in the patients studied with a pattern resembling NASH in some. P709 LIVER HISTOLOGICAL INFLAMMATION OF CHRONIC HEPATITIS B VIRUS CARRIERS WITH PERSISTENTLY NORMAL ALANINE TRANSAMINASE D. He, Q. Shang, Y. An, Q. Yi, Y. Zhang, M. Ding. The 88th Hospital of Chinese PLA, Tai’an, China E-mail: [email protected] Background and Aims: A new upper limits normal of ALT (30 U/L for males and 19 U/L for females, relative to the current 40 U/L) is recommended. We aimed to observe the difference of liver histological inflammation in chronic hepatitis B virus carriers with persistently normal ALT classified by the two standards. Methods: 326 chronic HBV carriers with persistently normal ALT (202 immune tolerance state and 124 inactive HBsAg carrier state) were divided into low ALT group (≤30 U/L for males and ≤19 U/L for females) and high ALT group (31–40 U/L for males and 20–40 U/L for females). According to Ishak scoring system and Metavir grading algorithm, liver histological inflammation were evaluated. Results: Significant differences of Ishak inflammation score were seen between low ALT group and high ALT group (immune tolerance state: p = 1.55×10−11 ; inactive HBsAg carrier state: p = 1.06×10−8 ). In low ALT group, the proportion of Metavir mild inflammation in immune tolerance state and inactive HBsAg carrier state was 100% and 96.8%, respectively. In high ALT group, the proportion was 63.8% and 50.8%, respectively. A significant difference of Metavir mild, moderate, and severe distribution was seen in age and sex for immune tolerance state and in sex for inactive HBsAg carrier state. Conclusions: In conclusions, there is a significant difference of liver histological inflammation between the two standards of ALT. The new standard should be better than the current one in evaluating the mild histological inflammation. Sex and age are associated with histological inflammation in high ALT group.
8B. VIRAL HEPATITIS: HEPATITIS C – CLINICAL (EXCEPT THERAPY) P710 EFFECT OF ALISPORIVIR (ALV) ON THE PHARMACOKINETICS (PK), SAFETY, AND TOLERABILITY OF METHADONE IN HEALTHY SUBJECTS AND OPIOID-DEPENDENT PATIENTS ON STABLE METHADONE MAINTENANCE THERAPY (MMT) S.J. Kovacs1 , J. Ke1 , A. Barve1 , L.R. Webster2 , Y. Cheng3 , J. Zhang1 , R. Maietta4 , G. Sunkara1 , D.S. Stein1 . 1 Novartis Institutes for BioMedical Research, East Hanover, NJ, 2 CRI Lifetree, Salt Lake City, UT, United States; 3 Beijing Novartis Pharma Co. Ltd, Shanghai, China; 4 Novartis Institutes for Biomedical Research, Cambridge, MA, United States E-mail: [email protected] Background and Aims: HCV-infected patients requiring MMT represent an important population with specific needs. Methadone, a substrate for CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, does not require active transport to cross membranes. ALV is an
Journal of Hepatology 2014 vol. 60 | S215–S359
S305
POSTERS irreversible CYP3A4 inhibitor, and inhibitor of multiple cellular uptake and efflux transporters. This study evaluated the interaction between ALV and methadone to assess potential clinical risks for methadone withdrawal or toxicity. Methods: Open-label screening (Part 1) and randomized, placebocontrolled, double blind (Part 2) investigation. Healthy subjects received a single 5 mg dose of methadone before and after ALV (Part 1). Then, opioid-dependent patients on stable MMT (≤150 mg daily) were randomized (2:1) to receive ALV 600 mg BID or placebo for 7 days (Part 2). Safety assessments included daily vitals and 12lead ECGs, laboratory tests, and continuous pulse oximetry. Blood samples were collected for R- and S-methadone concentrations prior to and after dose administration on D1 (before ALV) and D8. Non-compartmental PK analysis was performed. Results: 16 healthy and 22 MMT subjects (14 active; 8 placebo) were enrolled. Two healthy and 2 MMT subjects withdrew consent before study completion. Dizziness (37.5%), headache (18.8%), and nausea (18.8%) were the most commonly reported AEs among healthy subjects; somnolence (30.8% vs. 25.0%), headache (30.8% vs. 12.5%), nausea (15.4% vs. 0%), and tremor (15.4% vs. 0%) among MMT subjects receiving ALV vs. placebo. Table: Summaries of the dose-normalized methadone exposure parameters from Part 2 Analyte R-methadone S-methadone
Dose-normalized parameter
Methadone (D1)
ALV+methadone (D8)
Geometric mean ratios (90% CI)
AUC0–24,ss [(ng·h/mL)/mg] Cmax,ss [(ng/mL)/mg] AUC0–24,ss [(ng·h/mL)/mg]
60.4±25.2*
64.0±24.5
1.071 (0.958, 1.196)
3.69±1.27 60.9±32.4
3.68±1.13 61.1±29.8
1.001 (0.904, 1.109) 1.014 (0.895, 1.150)
Cmax,ss [(ng/mL)/mg]
4.24±1.81
4.21±1.57
1.002 (0.889, 1.129)
*Arithmetic mean ± SD.
Conclusions: Alisporivir does not affect the in vivo disposition of R- or S-methadone suggesting there is no relevant interaction that would complicate its use in the treatment of opioid-dependent patients infected with HCV. P711 A NOVEL GENETIC MAKER TO IMPROVE THE PREDICTION OF HCV SPONTANEOUS CLEARANCE: POLYMORPHISMS CONSISTING OF (TA)N DINUCLEOTIDE REPEAT NEAR IL28B GENE M. Sugiyama1 , S. Hiramine2 , N. Furusyo2 , A. Ido3 , H. Tsubouchi3 , H. Watanabe4 , Y. Ueno4 , M. Korenaga1 , K. Murata1 , N. Masaki1 , J. Hayashi2 , M. Mizokami1 . 1 National Center for Global Health and Medicine, Ichikawa, 2 Kyushu University, Hakata, 3 Kagoshima University, Kagoshima, 4 Yamagata University, Yamagata, Japan E-mail: [email protected] Background and Aims: Recent GWAS revealed that SNPs around IL-28B were associated with spontaneous clearance (SC). However, the effect of IL28B SNPs was lower than the results observed in the study of SC. We previously reported that the length of the TA dinucleotide repeat in the promoter region of IL28B has a wide variation, and the transcriptional activity increased gradually in a TA repeat length-dependent manner. In the present study, we determined the length of the TA repeat to investigate the correlation to with SC. Methods: Total 2041 Japanese genomic samples were enrolled (274 with HCV spontaneous clearance, 457 with chronic HCV infection and 1310 healthy donors). IL28B SNPs and the length of TA repeat were genotyped using Invader assay and GeneMapper software, respectively. Results: A univariate analysis showed significant differences between SC and chronic infection in sex (men 51.4% vs. women 67.0%), age (68.1±11.1 vs. 64.0±10.8 years), IL28B (rs8099917) genotypes (TT 92.0% vs. non-TT 67.4%), and TA repeat number (≥12/12, 99.6% vs. <12/11, 95.0%) (all p < 0.01). Multiple logistic regression model showed women (OR = 2.05; 95% CI: 1.47– 2.87), older age (OR = 1.03; 95% CI: 1.01–1.04), IL28B genotypes S306
TT (OR = 5.40; 95% CI: 3.31–8.80), and TA repeat number ≥12/12 (OR = 10.7; 95% CI: 1.40–82.4) as independently significant factors for SC. Analyzing these 4 factors by decision tree model, among women aged ≥68 years with IL28B TT, those with TA repeat genotype ≥12/12 had a high probability of SC. Conclusions: TA repeat number ≥12/12 was associated to SC. It could be the novel genetic factor to improve the predictive value for SC. P712 RISK FACTORS OF HEPATITIS C VIRUS INFECTION (HCV) IN SUEZ CANAL REGION, EGYPT: A CASE–CONTROL STUDY H. El-Sayed1 , S. Mehanna2 , A. Hassan3 , M. Shedid3 , Z. Khedr2 . 1 Pediatrics & Clinical Epidemiology, Faculty of Medicine, Suez Canal University, Ismailia, 2 Social Research Center, American University in Cairo, Cairo, 3 Tropical Medicine, Suez Canal University, Ismailia, Egypt E-mail: [email protected] Background and Aims: Egypt has very high prevalence of HCV infection, with more than 150,000 new cases every year, but few data are available about risk factors of the disease. The aim of this study was to identify risk factors for the spread of HCV infection in the Suez Canal region, to provide insight into the control and prevention program. Methods: A case–control study was conducted among HCV positive individuals referred to the hospitals and tropical diseases centers in Suez Canal Region, in the period from October 2012 to March 2013. The control group consisted of blood donors referred to the regional blood transfusion centers. Age-adjusted Odds Ratio (OR), based on multivariate logistic-regression model, was used to identify risk factors. Results: A total of 1179 subjects were studied for HCV, of which 541were HCV-positive and 638 HCV-negative blood donors comprised the control group. HCV was more common among circumcised males and those who had wet cupping “Hegama” by informal health provider. It was also more common among persons having history of schistosomiasis infection, and diabetics receiving frequent injections. HCV patients were more likely than controls to be exposed to injections when hospitalized (OR = 1.41, CI 1.02–1.95), having endoscopy (OR = 3.62, CI 2.01–6.52), and receiving blood transfusion (OR = 3.47, CI 2.18–5.54). Conclusions: Our data indicate that history of blood transfusion; endoscopy and multiple injections are important risk factors for HCV infection in Egypt. Therefore, focusing on medical practices and infection control in health facilities is essential for HCV transmission prevention. P713 ELIGIBILITY 1: A PROSPECTIVE, OBSERVATIONAL, MULTICENTRE STUDY EVALUATING HCV PATIENTS’ CHARACTERISTICS OF ELIGIBILITY FOR ANTIVIRAL THERAPY IN REAL CLINICAL PRACTICE N. Gamal, R. Vukotic, P. Andreone, on behalf of Eligibility Study Group. Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy E-mail: [email protected] Background and Aims: Chronic HCV infection is the leading cause of mortality from liver cirrhosis and hepatocellular carcinoma. Pegylated interferon (Peg-IFN) and ribavirin (RBV) can prevent the disease progression in chronic hepatitis C (CHC). This prospective study investigated treatment eligibility for Peg-IFN+RBV in CHC in the Italian clinical practice. Methods: Overall, 1.128 CHC patients referred to 45 centers were prospectively enrolled in the study. HCV-RNA-negative and previously treated patients were excluded. Non-eligibility criteria were analyzed.
Journal of Hepatology 2014 vol. 60 | S215–S359
(histological activity index of 8, mild fibrosis stage 2). In two biopsies a conspicuous central vein sclerosis and perisinusoidal fibrosis was present that first lead to misdiagnosis of NASH. The number of PMN leucocytes was increased. Bile ducts were involved with a mild reactive cholangitis. Significant cholestasis was absent. Conclusions: Chronic hepatitis E runs a similar course as hepatitis B and C. Histopathology shows a pattern of mild to moderate histologic activity with an increased presence of PMN leucocytes and reactive cholangitis. Fibrosis showed stage 2 in the patients studied with a pattern resembling NASH in some. P709 LIVER HISTOLOGICAL INFLAMMATION OF CHRONIC HEPATITIS B VIRUS CARRIERS WITH PERSISTENTLY NORMAL ALANINE TRANSAMINASE D. He, Q. Shang, Y. An, Q. Yi, Y. Zhang, M. Ding. The 88th Hospital of Chinese PLA, Tai’an, China E-mail: [email protected] Background and Aims: A new upper limits normal of ALT (30 U/L for males and 19 U/L for females, relative to the current 40 U/L) is recommended. We aimed to observe the difference of liver histological inflammation in chronic hepatitis B virus carriers with persistently normal ALT classified by the two standards. Methods: 326 chronic HBV carriers with persistently normal ALT (202 immune tolerance state and 124 inactive HBsAg carrier state) were divided into low ALT group (≤30 U/L for males and ≤19 U/L for females) and high ALT group (31–40 U/L for males and 20–40 U/L for females). According to Ishak scoring system and Metavir grading algorithm, liver histological inflammation were evaluated. Results: Significant differences of Ishak inflammation score were seen between low ALT group and high ALT group (immune tolerance state: p = 1.55×10−11 ; inactive HBsAg carrier state: p = 1.06×10−8 ). In low ALT group, the proportion of Metavir mild inflammation in immune tolerance state and inactive HBsAg carrier state was 100% and 96.8%, respectively. In high ALT group, the proportion was 63.8% and 50.8%, respectively. A significant difference of Metavir mild, moderate, and severe distribution was seen in age and sex for immune tolerance state and in sex for inactive HBsAg carrier state. Conclusions: In conclusions, there is a significant difference of liver histological inflammation between the two standards of ALT. The new standard should be better than the current one in evaluating the mild histological inflammation. Sex and age are associated with histological inflammation in high ALT group.
8B. VIRAL HEPATITIS: HEPATITIS C – CLINICAL (EXCEPT THERAPY) P710 EFFECT OF ALISPORIVIR (ALV) ON THE PHARMACOKINETICS (PK), SAFETY, AND TOLERABILITY OF METHADONE IN HEALTHY SUBJECTS AND OPIOID-DEPENDENT PATIENTS ON STABLE METHADONE MAINTENANCE THERAPY (MMT) S.J. Kovacs1 , J. Ke1 , A. Barve1 , L.R. Webster2 , Y. Cheng3 , J. Zhang1 , R. Maietta4 , G. Sunkara1 , D.S. Stein1 . 1 Novartis Institutes for BioMedical Research, East Hanover, NJ, 2 CRI Lifetree, Salt Lake City, UT, United States; 3 Beijing Novartis Pharma Co. Ltd, Shanghai, China; 4 Novartis Institutes for Biomedical Research, Cambridge, MA, United States E-mail: [email protected] Background and Aims: HCV-infected patients requiring MMT represent an important population with specific needs. Methadone, a substrate for CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, does not require active transport to cross membranes. ALV is an
Journal of Hepatology 2014 vol. 60 | S215–S359
S305
POSTERS irreversible CYP3A4 inhibitor, and inhibitor of multiple cellular uptake and efflux transporters. This study evaluated the interaction between ALV and methadone to assess potential clinical risks for methadone withdrawal or toxicity. Methods: Open-label screening (Part 1) and randomized, placebocontrolled, double blind (Part 2) investigation. Healthy subjects received a single 5 mg dose of methadone before and after ALV (Part 1). Then, opioid-dependent patients on stable MMT (≤150 mg daily) were randomized (2:1) to receive ALV 600 mg BID or placebo for 7 days (Part 2). Safety assessments included daily vitals and 12lead ECGs, laboratory tests, and continuous pulse oximetry. Blood samples were collected for R- and S-methadone concentrations prior to and after dose administration on D1 (before ALV) and D8. Non-compartmental PK analysis was performed. Results: 16 healthy and 22 MMT subjects (14 active; 8 placebo) were enrolled. Two healthy and 2 MMT subjects withdrew consent before study completion. Dizziness (37.5%), headache (18.8%), and nausea (18.8%) were the most commonly reported AEs among healthy subjects; somnolence (30.8% vs. 25.0%), headache (30.8% vs. 12.5%), nausea (15.4% vs. 0%), and tremor (15.4% vs. 0%) among MMT subjects receiving ALV vs. placebo. Table: Summaries of the dose-normalized methadone exposure parameters from Part 2 Analyte R-methadone S-methadone
Dose-normalized parameter
Methadone (D1)
ALV+methadone (D8)
Geometric mean ratios (90% CI)
AUC0–24,ss [(ng·h/mL)/mg] Cmax,ss [(ng/mL)/mg] AUC0–24,ss [(ng·h/mL)/mg]
60.4±25.2*
64.0±24.5
1.071 (0.958, 1.196)
3.69±1.27 60.9±32.4
3.68±1.13 61.1±29.8
1.001 (0.904, 1.109) 1.014 (0.895, 1.150)
Cmax,ss [(ng/mL)/mg]
4.24±1.81
4.21±1.57
1.002 (0.889, 1.129)
*Arithmetic mean ± SD.
Conclusions: Alisporivir does not affect the in vivo disposition of R- or S-methadone suggesting there is no relevant interaction that would complicate its use in the treatment of opioid-dependent patients infected with HCV. P711 A NOVEL GENETIC MAKER TO IMPROVE THE PREDICTION OF HCV SPONTANEOUS CLEARANCE: POLYMORPHISMS CONSISTING OF (TA)N DINUCLEOTIDE REPEAT NEAR IL28B GENE M. Sugiyama1 , S. Hiramine2 , N. Furusyo2 , A. Ido3 , H. Tsubouchi3 , H. Watanabe4 , Y. Ueno4 , M. Korenaga1 , K. Murata1 , N. Masaki1 , J. Hayashi2 , M. Mizokami1 . 1 National Center for Global Health and Medicine, Ichikawa, 2 Kyushu University, Hakata, 3 Kagoshima University, Kagoshima, 4 Yamagata University, Yamagata, Japan E-mail: [email protected] Background and Aims: Recent GWAS revealed that SNPs around IL-28B were associated with spontaneous clearance (SC). However, the effect of IL28B SNPs was lower than the results observed in the study of SC. We previously reported that the length of the TA dinucleotide repeat in the promoter region of IL28B has a wide variation, and the transcriptional activity increased gradually in a TA repeat length-dependent manner. In the present study, we determined the length of the TA repeat to investigate the correlation to with SC. Methods: Total 2041 Japanese genomic samples were enrolled (274 with HCV spontaneous clearance, 457 with chronic HCV infection and 1310 healthy donors). IL28B SNPs and the length of TA repeat were genotyped using Invader assay and GeneMapper software, respectively. Results: A univariate analysis showed significant differences between SC and chronic infection in sex (men 51.4% vs. women 67.0%), age (68.1±11.1 vs. 64.0±10.8 years), IL28B (rs8099917) genotypes (TT 92.0% vs. non-TT 67.4%), and TA repeat number (≥12/12, 99.6% vs. <12/11, 95.0%) (all p < 0.01). Multiple logistic regression model showed women (OR = 2.05; 95% CI: 1.47– 2.87), older age (OR = 1.03; 95% CI: 1.01–1.04), IL28B genotypes S306
TT (OR = 5.40; 95% CI: 3.31–8.80), and TA repeat number ≥12/12 (OR = 10.7; 95% CI: 1.40–82.4) as independently significant factors for SC. Analyzing these 4 factors by decision tree model, among women aged ≥68 years with IL28B TT, those with TA repeat genotype ≥12/12 had a high probability of SC. Conclusions: TA repeat number ≥12/12 was associated to SC. It could be the novel genetic factor to improve the predictive value for SC. P712 RISK FACTORS OF HEPATITIS C VIRUS INFECTION (HCV) IN SUEZ CANAL REGION, EGYPT: A CASE–CONTROL STUDY H. El-Sayed1 , S. Mehanna2 , A. Hassan3 , M. Shedid3 , Z. Khedr2 . 1 Pediatrics & Clinical Epidemiology, Faculty of Medicine, Suez Canal University, Ismailia, 2 Social Research Center, American University in Cairo, Cairo, 3 Tropical Medicine, Suez Canal University, Ismailia, Egypt E-mail: [email protected] Background and Aims: Egypt has very high prevalence of HCV infection, with more than 150,000 new cases every year, but few data are available about risk factors of the disease. The aim of this study was to identify risk factors for the spread of HCV infection in the Suez Canal region, to provide insight into the control and prevention program. Methods: A case–control study was conducted among HCV positive individuals referred to the hospitals and tropical diseases centers in Suez Canal Region, in the period from October 2012 to March 2013. The control group consisted of blood donors referred to the regional blood transfusion centers. Age-adjusted Odds Ratio (OR), based on multivariate logistic-regression model, was used to identify risk factors. Results: A total of 1179 subjects were studied for HCV, of which 541were HCV-positive and 638 HCV-negative blood donors comprised the control group. HCV was more common among circumcised males and those who had wet cupping “Hegama” by informal health provider. It was also more common among persons having history of schistosomiasis infection, and diabetics receiving frequent injections. HCV patients were more likely than controls to be exposed to injections when hospitalized (OR = 1.41, CI 1.02–1.95), having endoscopy (OR = 3.62, CI 2.01–6.52), and receiving blood transfusion (OR = 3.47, CI 2.18–5.54). Conclusions: Our data indicate that history of blood transfusion; endoscopy and multiple injections are important risk factors for HCV infection in Egypt. Therefore, focusing on medical practices and infection control in health facilities is essential for HCV transmission prevention. P713 ELIGIBILITY 1: A PROSPECTIVE, OBSERVATIONAL, MULTICENTRE STUDY EVALUATING HCV PATIENTS’ CHARACTERISTICS OF ELIGIBILITY FOR ANTIVIRAL THERAPY IN REAL CLINICAL PRACTICE N. Gamal, R. Vukotic, P. Andreone, on behalf of Eligibility Study Group. Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy E-mail: [email protected] Background and Aims: Chronic HCV infection is the leading cause of mortality from liver cirrhosis and hepatocellular carcinoma. Pegylated interferon (Peg-IFN) and ribavirin (RBV) can prevent the disease progression in chronic hepatitis C (CHC). This prospective study investigated treatment eligibility for Peg-IFN+RBV in CHC in the Italian clinical practice. Methods: Overall, 1.128 CHC patients referred to 45 centers were prospectively enrolled in the study. HCV-RNA-negative and previously treated patients were excluded. Non-eligibility criteria were analyzed.
Journal of Hepatology 2014 vol. 60 | S215–S359