- Email: [email protected]
[565] SUSTAINED VIROLOGICAL RESPONSE OF PEGINTERFERON o>2a PLUS RIBAVIRIN FOR CHRONIC HEPATITIS C VIRUS GENOTYPE 4
05G. VIRAL HEPATITIS
G) HEPATITIS C
CLINICAL (THERAPZ NEW COMPOUNDS, RESISTANCE)
05G. VIRAL HEPATITIS G) HEPATITIS C - CLINICAL (THERAPY, NEW COMPOUNDS, RESISTANCE)
15651 SUSTAINED VIROLOGICAL
RESPONSE OF PEGINTERFERON a-2a PLUS RlBAVlRlN FOR CHRONIC HEPATITIS C VIRUS GENOTYPE 4
G. Shiha’, E. Abdel Khalek’, B. Ahbas’, H. Elshemawy3, K.H. Zalata4. ‘Liuer Unit, SIieciulized Medicul Hospitul, Munsouru Uniuersity, Munsouru; Gustroenterolgy Depurtment, Airfiirce Militury Hospitul, Cuiro; ‘Menofiu Liuer Institute, Men&; 4Puthology Depurtment, Munsouru Uniuersity, Elmunsouru, E g j p E-mail: [email protected] Background: Treatment with peginterferon a-2a alone produces significantly higher sustained virologic responses than treatment with interferon u-2a alone or plus ribavirin in patients with chronic hepatitis C virus (HCV) infection. Data regarding the efficacy of these drugs in Genotype 4, are very limited. Objective: To compare the efficacy of peginterferon u-2a plus ribavirin administered for 48 weeks and the same dose administered for 24 weeks in the initial treatment of chronic hepatitis C (Genotype TV). Methods: Ninety seven patients with chronic HCV Genotype TV (89 males and 8 females) randomly in a 2:l ratio assigned to receive peginterferon a-2a (Pegasys) plus daily ribavirin ( 1 000 or 1200 mg, depending on body weight) for 24 weeks or peginterferonu-2a (Pegasys) plus daily ribavirin for 48 weeks respectively. Results: A significantly higher proportion of patients who received peginterferona-2a plus ribavirin for 48 weeks had a sustained virologic response (defined as the absence of detectable HCVRNA 24 weeks after cessation of therapy) than of patients who received peginterferon u-2a plus ribavirin for 24 weeks (70.8 percent vs. 47 percent, P 0.001). The overall safety profiles of the two treatment regimens were similar. Conclusion: In patients with chronic hepatitis C (Genotype TV), onceweekly peginterferon u-2a plus ribavirin administered for 48 weeks produced significant improvements in the rate of sustained virologic response, as compared with peginterferon a-2a plus ribavirin administered for 24 weeks.
15661 PRE-TREATMENT FACTORS PREDICTING SUSTAINED VIROLOGICAL RESPONSE IN TREATMENT-NAIVE HCV GENOTYPE 1 PATIENTS PARTICIPATING IN A LARGE, PRACTICE-BASED NATIONWIDE OBSERVATIONAL STUDY A. Alberti’, A. Ascione’, M. Colombo3, A. Craxi4, F, Piccinino5, M. Rizzetto‘, M. Sarracino7. For the Prohe Study Group. ‘Enetiun Institnte fbr Mobcnlur Medicine (VIMM), Pudoou; ’Depuvtnzent of‘ Gustroenterology, Hepatology Unit, Ospedub Cuvduvelli Nupoli; Dioision of’ Gustvoenterology, Fonduzione IRCCS Muggiore Hospitul Mungiugulli and Regina Elenu, Unioevsity of Milun, Mibn; ‘GI & Lioev Unit, DiBi.M.LS, Uniuer~sit?,of Pulermo; -5ClinicuMuluttie lnf+ttiue 11 Uniuer~situdi Nupoli; Gustroenterolog?, Diuision, Uniuersih~of Turin; 7Roche, Monzu, Italy E-mail: [email protected] ,
’
Background: Although pre-treatment factors such as HCV genotype and HCV-RNA predict SVR in selected clinical trial populations, limited knowledge exists regarding predictive factors in a general patient population in routine clinical practice. Here we assessed factors predictive of
s215
SVR in HCV genotype I patients receiving peginterferon (PEG-TFN) plus ribavirin (RBV) in a large practice-based, nationwide observational study (PROBE). Methods: 147 Italian centres each enrolled 25 consecutive HCV genotype 1 patients treated with PEG-IFNa-2a or PEG-IFNa-2b (both plus RBV). All patients who received 2 1 dose of the drugs were included. Data from 3025 patients were collected; 1055 were treatment-naive. This study included patients normally excluded from clinical studies, such as older patients and those with co-morbidities (compensated cirrhosis & portal hypertension, obesity, diabetes, psychiatric disorders, methadone use, thyroid disease, cryoglobulinaemia, iron overload, autoimmunity markers). Potential predictors of SVR (gender, age [< vs. >65y], BMT [< vs. >25kg/m2], HCV genotype [ l a vs. Ib], HCV-RNA [< vs.~1,000,000 TU/mL], ALT [< vs. > 3 x upper limit of normal], cirrhosis [absence vs. presence], co-morbidities [absence vs. presence] and PEG-IFN type [PEG-TFNu-2a vs. PEG-TFNu-2bl) were assessed by logistic regression analysis. Results: Complete data were available for 837 treatment-naive genotype 1 patients: 64% male; 11‘X cirrhosis; mean&SD age = 50f12y; bodyweight = 7 2 f l lkg. 479 patients received PEG-IFNa-2b 1.5 pglkgiweek plus RBV 0.8-1.4 giday and 358 patients received PEG-TFNa-2a I80 pg/week plus RBV 1 - I .2 giday, all for 48 weeks. 41.2% of treated patients achieved an SVR. Factors significantly associated with SVR are shown in the Table.
Predictor
SVR rates (univariate)
Odds ratio [95% CT]
P value
(multivariate)
(multivariate) Genotype l a vs. l b Baseline HCV-RNA ~1.000.000vs.
51.1% vs. 38.5% 43.3% vs. 36.6%
1.6 [1.1-2.21 1.4 [ 1 .O-1.91
0.01 0.05
47.2% vs. 34.3%
1.6 [1.1-2.3]
0.01
45.2%
1.4 [1.0-1.91
0.04
>1.000.000 I U / d
Co-morbidities Absence vs. presence Type of treatment PEG-IFNa-2a vs.
VS.
38.4%
PEG-IFNn-2b
Conclusions: This large real-life study shows that HCV treatment in genotype 1 patients without co-morbidities results in SVR rates comparable to those in randomised clinical trials. Although SVR rates in patients with co-morbidities are lower than in patients with HCV infection as the sole medical condition, treatment in these patients appears to be feasible and is well-tolerated.
15671 HCV HEPATITIS AND INTERFERON-RELATED DEPRESSION: AN ANALYSIS OF THE RETROSPECTIVE PHASE OF THE PROBE STUDY
P. Amodiol, S. Montebianco Abenavoli’, L. Cosco’, C. Ferrari’, R. Patriarch?, C. Coppola’, F. Piccinino’, S. S a d , N. Passariello’, S. Babudieri’, M. Sarracino3, A. Albertil . ‘Clinic oflnternul Medicine 5, Uniuer~sit?,of Pudouu; 2PROBE Study G ~ o u ‘Roche ~; Monzu, ltuly E-mail: [email protected] Background and Aims: Depression is an important and frequent complication of interferon (TFN) treatment. The detection of risk factors is reasonably may improve patients’ treatment. Methods: To improve insight into depressive reaction related to TFN treatment, we examined data pertaining to the PROBE study, a post marketing surveillance study on the use of IFN to treat HCV hepatitis that enrolled 3025 patients.
G) HEPATITIS C
CLINICAL (THERAPZ NEW COMPOUNDS, RESISTANCE)
05G. VIRAL HEPATITIS G) HEPATITIS C - CLINICAL (THERAPY, NEW COMPOUNDS, RESISTANCE)
15651 SUSTAINED VIROLOGICAL
RESPONSE OF PEGINTERFERON a-2a PLUS RlBAVlRlN FOR CHRONIC HEPATITIS C VIRUS GENOTYPE 4
G. Shiha’, E. Abdel Khalek’, B. Ahbas’, H. Elshemawy3, K.H. Zalata4. ‘Liuer Unit, SIieciulized Medicul Hospitul, Munsouru Uniuersity, Munsouru; Gustroenterolgy Depurtment, Airfiirce Militury Hospitul, Cuiro; ‘Menofiu Liuer Institute, Men&; 4Puthology Depurtment, Munsouru Uniuersity, Elmunsouru, E g j p E-mail: [email protected] Background: Treatment with peginterferon a-2a alone produces significantly higher sustained virologic responses than treatment with interferon u-2a alone or plus ribavirin in patients with chronic hepatitis C virus (HCV) infection. Data regarding the efficacy of these drugs in Genotype 4, are very limited. Objective: To compare the efficacy of peginterferon u-2a plus ribavirin administered for 48 weeks and the same dose administered for 24 weeks in the initial treatment of chronic hepatitis C (Genotype TV). Methods: Ninety seven patients with chronic HCV Genotype TV (89 males and 8 females) randomly in a 2:l ratio assigned to receive peginterferon a-2a (Pegasys) plus daily ribavirin ( 1 000 or 1200 mg, depending on body weight) for 24 weeks or peginterferonu-2a (Pegasys) plus daily ribavirin for 48 weeks respectively. Results: A significantly higher proportion of patients who received peginterferona-2a plus ribavirin for 48 weeks had a sustained virologic response (defined as the absence of detectable HCVRNA 24 weeks after cessation of therapy) than of patients who received peginterferon u-2a plus ribavirin for 24 weeks (70.8 percent vs. 47 percent, P 0.001). The overall safety profiles of the two treatment regimens were similar. Conclusion: In patients with chronic hepatitis C (Genotype TV), onceweekly peginterferon u-2a plus ribavirin administered for 48 weeks produced significant improvements in the rate of sustained virologic response, as compared with peginterferon a-2a plus ribavirin administered for 24 weeks.
15661 PRE-TREATMENT FACTORS PREDICTING SUSTAINED VIROLOGICAL RESPONSE IN TREATMENT-NAIVE HCV GENOTYPE 1 PATIENTS PARTICIPATING IN A LARGE, PRACTICE-BASED NATIONWIDE OBSERVATIONAL STUDY A. Alberti’, A. Ascione’, M. Colombo3, A. Craxi4, F, Piccinino5, M. Rizzetto‘, M. Sarracino7. For the Prohe Study Group. ‘Enetiun Institnte fbr Mobcnlur Medicine (VIMM), Pudoou; ’Depuvtnzent of‘ Gustroenterology, Hepatology Unit, Ospedub Cuvduvelli Nupoli; Dioision of’ Gustvoenterology, Fonduzione IRCCS Muggiore Hospitul Mungiugulli and Regina Elenu, Unioevsity of Milun, Mibn; ‘GI & Lioev Unit, DiBi.M.LS, Uniuer~sit?,of Pulermo; -5ClinicuMuluttie lnf+ttiue 11 Uniuer~situdi Nupoli; Gustroenterolog?, Diuision, Uniuersih~of Turin; 7Roche, Monzu, Italy E-mail: [email protected] ,
’
Background: Although pre-treatment factors such as HCV genotype and HCV-RNA predict SVR in selected clinical trial populations, limited knowledge exists regarding predictive factors in a general patient population in routine clinical practice. Here we assessed factors predictive of
s215
SVR in HCV genotype I patients receiving peginterferon (PEG-TFN) plus ribavirin (RBV) in a large practice-based, nationwide observational study (PROBE). Methods: 147 Italian centres each enrolled 25 consecutive HCV genotype 1 patients treated with PEG-IFNa-2a or PEG-IFNa-2b (both plus RBV). All patients who received 2 1 dose of the drugs were included. Data from 3025 patients were collected; 1055 were treatment-naive. This study included patients normally excluded from clinical studies, such as older patients and those with co-morbidities (compensated cirrhosis & portal hypertension, obesity, diabetes, psychiatric disorders, methadone use, thyroid disease, cryoglobulinaemia, iron overload, autoimmunity markers). Potential predictors of SVR (gender, age [< vs. >65y], BMT [< vs. >25kg/m2], HCV genotype [ l a vs. Ib], HCV-RNA [< vs.~1,000,000 TU/mL], ALT [< vs. > 3 x upper limit of normal], cirrhosis [absence vs. presence], co-morbidities [absence vs. presence] and PEG-IFN type [PEG-TFNu-2a vs. PEG-TFNu-2bl) were assessed by logistic regression analysis. Results: Complete data were available for 837 treatment-naive genotype 1 patients: 64% male; 11‘X cirrhosis; mean&SD age = 50f12y; bodyweight = 7 2 f l lkg. 479 patients received PEG-IFNa-2b 1.5 pglkgiweek plus RBV 0.8-1.4 giday and 358 patients received PEG-TFNa-2a I80 pg/week plus RBV 1 - I .2 giday, all for 48 weeks. 41.2% of treated patients achieved an SVR. Factors significantly associated with SVR are shown in the Table.
Predictor
SVR rates (univariate)
Odds ratio [95% CT]
P value
(multivariate)
(multivariate) Genotype l a vs. l b Baseline HCV-RNA ~1.000.000vs.
51.1% vs. 38.5% 43.3% vs. 36.6%
1.6 [1.1-2.21 1.4 [ 1 .O-1.91
0.01 0.05
47.2% vs. 34.3%
1.6 [1.1-2.3]
0.01
45.2%
1.4 [1.0-1.91
0.04
>1.000.000 I U / d
Co-morbidities Absence vs. presence Type of treatment PEG-IFNa-2a vs.
VS.
38.4%
PEG-IFNn-2b
Conclusions: This large real-life study shows that HCV treatment in genotype 1 patients without co-morbidities results in SVR rates comparable to those in randomised clinical trials. Although SVR rates in patients with co-morbidities are lower than in patients with HCV infection as the sole medical condition, treatment in these patients appears to be feasible and is well-tolerated.
15671 HCV HEPATITIS AND INTERFERON-RELATED DEPRESSION: AN ANALYSIS OF THE RETROSPECTIVE PHASE OF THE PROBE STUDY
P. Amodiol, S. Montebianco Abenavoli’, L. Cosco’, C. Ferrari’, R. Patriarch?, C. Coppola’, F. Piccinino’, S. S a d , N. Passariello’, S. Babudieri’, M. Sarracino3, A. Albertil . ‘Clinic oflnternul Medicine 5, Uniuer~sit?,of Pudouu; 2PROBE Study G ~ o u ‘Roche ~; Monzu, ltuly E-mail: [email protected] Background and Aims: Depression is an important and frequent complication of interferon (TFN) treatment. The detection of risk factors is reasonably may improve patients’ treatment. Methods: To improve insight into depressive reaction related to TFN treatment, we examined data pertaining to the PROBE study, a post marketing surveillance study on the use of IFN to treat HCV hepatitis that enrolled 3025 patients.