- Email: [email protected]
3 HCV GENOTYPES WITH LOW AND HIGH VIREMIA
POSTERS
S218
The SVR for the A group was 49 5% (50/101) and 44 I % (49/1 1 1 ) in group B with no significant difference between the groups (TTT M=F p = 0.43) Differences in virologic response in both groups probably are caused by structure of the two types of interferon
15731 COMPARISON OF EARLY VlROLOGlC RESPONSE AMONG PATIENTS WITH CHRONIC HEPATITIS C INFECTED WITH GENOTYPE NON 2/3 TREATED WITH PEGYLATED INTERFERON ALFA-2b AND RlBAVlRlN IN DEPENDENCE WITH HEPATIC FIBROSIS STAGES H. Beralc’ , A. Kokakowska-Rzqizlca’, M. Wasilewski’ , J. Kowalska’, J.J. Stanczak’ , K. Bardadin2, A. Horban’ . ‘Hospital o f I n f d i o u s Diseases, Warsaw; 2Medicul Centre.fbr Postgraduate Education, Warsaw, Poland E-mail: [email protected] Early virologic response (EVR) depending on various hepatic fibrosis was analyzed at 12 week of pegylated interferon a-2b (Pegintron, 12 KD) with ribavirin treatment among chronic hepatitis C patients (pts) infected with genotype non 213. Patients and Methods: 134 patients (pts) were allocated to four groups depending on latest available staging score (S), group A (reference), S:0; B, S: I ; C, S:2; D, S:3 and4. Liver biopsies were analyzed according to the Knodell’s and Scheuer’s scores. All patients received standard treatment. Main study outcome was defined as decrease of VL >2 log or undetectable HCV RNA. Viral load (VL) was determined with HCV RNA Assay and CA HCV Monitor Test (Roche Diagn. Sys.). Statistical analysis was performed with Chi-squared with continuity correction of 0.5 and Fisher’s exact tests as appropriate. The 95% confidence interval (CI) was accepted. All analysis were performed using SAS 9.1. Results: There were 134 pts: 29 in group A, 47 in B, 33 in C and 25 in D, respectively. Baseline characteristics of the groups are shown in Table 1. In group A 86.2% [95%CT 79.8-92.61 of patients responded to treatment. There was no significant difference either between groups A and B (p=0.77 [95%CT: -10.6 to 21.21) or A and C (p=0.47 [95%CT: -6.5 to 27.331). Groups A and D differed significantly with p=0.035 [95% C1: 5.8 to 46.61). Conclusions: The results seems to support hypothesis, that patients with chronic hepatitis C should be treated in early stage of disease.
15741 COMPARISON OF EFFICACY OF TREATMENT WITH PEGINTERFERON ALFA PLUS RlBAVlRlN AMONG PATIENTS CHRONICALLY INFECTED WITH NON 2/3 HCV GENOTYPES WITH LOW AND HIGH VlREMlA H. Beralc’ , A. Kokakowska-Rzqizlca’, M. Wasilewski’ , J. Kowalska’, J.J. Stanczak’ , K. Bardadin2, A. Horban’ . ‘Hospital of I n f d i o u s Diseases; 2Medic.al Centre ,fbr Postgraduate Educution, Warsaw, Poland E-mail: [email protected]
Background and Aim: 212 patients chronically infected with HCV non 2/3 genotypes treated 48 weeks with peginterferon a with nbavirin (101 pts with Pegasys + Copegus and I 1 I pts with Pegintron + Rebetol) were divided into two groups with low (& 600,000 TUimL) and high (>600,000 TU/rnL) pretreatment viremia to compare the etficacy of treatment Methods: Liver biopsies were analyzed according to the Knodell’s and Scheuer’s scores The levels of ALT activity were determined with routine tests. Patients’ age and body weight were determined and their influence on treatment etficiency was analyzed On week 12, 48 and 24 weeks after end of treatment HCV RNA was performed, determined with HCV RNA ASSAY and viral load (VL) with CA HCV MONITOR TEST (both
of ROCHE DTAGN SYS.). The main study outcome was undetectable HCVRNA on week 12 (EVR) and 72 (SVR). Statistical analysis was performed with Chi-squared, Kruskal-Wallis and unpaired t-tests as appropriate. To compare the difference between the intervention groups an intention to treat missing equals failure analysis (ITT M=F) was performed. Results: Ninty nine pts had positive SVR, 96 patients had detectable HCVRNA and 17 were lost to observation. Using ITT M=F (991113) statistically significant difference in staging (0.006), weight (0.03) and ALT measured on SVR (<0.0001) between the groups were found. The SVR for the group with low pretreatment viremia was 58% (37164) and 42% (62/148) in group with high baseline VL. There was significant difference between the groups (TTT M=F: p = 0.43). In both group SVR is connected with response in 12 week oftreatment. There was no significant difference between low pretreatment viremia for two types of interferon: Pegasys 60% (20/33) vs Pegintron 54% ( 1 7/3 I ) . -
-
Relationship between EVR and SVR
in
patients with low pretreatment viremia
SVR n (“3) EVR n (“3) Baseline viremia HCVRNA HCVRNA P value HCVRNA HCVRNA P value <600,000 >600.000
(-1
(+I
38 (59.4) 73 (49.3)
26 (40.6) 75 (50.7)
0.18 0.18
(-)
(+)
37(37.4) 62 (62.6)
27 (23.9) 86 (76.1).
0.03
Chi-squared test was used to compare the groups, n 56
15751 WEEKS PREDICTION OF TREATMENT RESPONSE TO 72 OF PEGYLATED INTERFERON ALFA-2a PLUS RlBAVlRlN FOR CHRONIC HEPATITIS C AFTER LIVER TRANSPLANTATION A. Bergk’, U.P. Neumann2, F, van Boemmel’ , B. Wiedenmann’ , T. Berg’, R. Neuhaus’. ‘Gu.str-ornterolog?,,.2Department of Tr-LEnsplantSurgery, Churite, Cumpix Virchow Klinikum, Berlin, Germany E-mail: [email protected]
Background: Prediction of treatment response to combination therapy with pegylated interferon (PeglFN) and ribavirin (RBV) in chronic hepatitis C virus (HCV) infected and treatment-naive patients is well established. In contrast, treatment guidelines in the setting of HCV reinfection after liver transplantation are still missing. Aims: We aimed at analyzing viral kinetics during PegTFN/RBV therapy in order to develop recommendations for the management of this special patient subgroup. Methods: We retrospectively analyzed viral decline kinetics in 55 HCV infected liver transplant recipients (35 male, 20 female; mean age 55 years (35-70), who received combination therapy with pegylated interferon a-2a (initially 135 @week) and ribavirin (initially 600mgid) for 72 weeks. Treatment was stopped when HCV-RNA remained detectable at week 48. Results: 18 patients (33%) prematurely discontinued therapy due to adverse events. 59% (22/37) of the patients who completed treatment showed an end-of-treatment response with undetectable HCV-RNA after 48 weeks of therapy. Sustained virological response could be achieved in 11 patients (30%). A viral decline of at least 2loglo at week 12 (EVR) was significantly associated with an EOT response, but failed to discriminate between SVR and viral relapse (911 I and 8/11 patients, respectively). In contrast, 4 EVR patients were not able to clear HCVRNA on treatment, whereas 2 patients without a 2log-decline achieved an SVR. Likewise a cut-oft‘ of 30.000 TU/mL was able to predict nonresponse in 100% but failed to predict relapse. The positive predictive value for SVR in patients with undetectable HCVRNA by Amplicor PCR (i50TU/mL) at week 12 was 67%. By re-analyzing week 12 sera with highly sensitive TaqMan PCR, 10 were undetectable and the SVR rate in these patients was 70%.
S218
The SVR for the A group was 49 5% (50/101) and 44 I % (49/1 1 1 ) in group B with no significant difference between the groups (TTT M=F p = 0.43) Differences in virologic response in both groups probably are caused by structure of the two types of interferon
15731 COMPARISON OF EARLY VlROLOGlC RESPONSE AMONG PATIENTS WITH CHRONIC HEPATITIS C INFECTED WITH GENOTYPE NON 2/3 TREATED WITH PEGYLATED INTERFERON ALFA-2b AND RlBAVlRlN IN DEPENDENCE WITH HEPATIC FIBROSIS STAGES H. Beralc’ , A. Kokakowska-Rzqizlca’, M. Wasilewski’ , J. Kowalska’, J.J. Stanczak’ , K. Bardadin2, A. Horban’ . ‘Hospital o f I n f d i o u s Diseases, Warsaw; 2Medicul Centre.fbr Postgraduate Education, Warsaw, Poland E-mail: [email protected] Early virologic response (EVR) depending on various hepatic fibrosis was analyzed at 12 week of pegylated interferon a-2b (Pegintron, 12 KD) with ribavirin treatment among chronic hepatitis C patients (pts) infected with genotype non 213. Patients and Methods: 134 patients (pts) were allocated to four groups depending on latest available staging score (S), group A (reference), S:0; B, S: I ; C, S:2; D, S:3 and4. Liver biopsies were analyzed according to the Knodell’s and Scheuer’s scores. All patients received standard treatment. Main study outcome was defined as decrease of VL >2 log or undetectable HCV RNA. Viral load (VL) was determined with HCV RNA Assay and CA HCV Monitor Test (Roche Diagn. Sys.). Statistical analysis was performed with Chi-squared with continuity correction of 0.5 and Fisher’s exact tests as appropriate. The 95% confidence interval (CI) was accepted. All analysis were performed using SAS 9.1. Results: There were 134 pts: 29 in group A, 47 in B, 33 in C and 25 in D, respectively. Baseline characteristics of the groups are shown in Table 1. In group A 86.2% [95%CT 79.8-92.61 of patients responded to treatment. There was no significant difference either between groups A and B (p=0.77 [95%CT: -10.6 to 21.21) or A and C (p=0.47 [95%CT: -6.5 to 27.331). Groups A and D differed significantly with p=0.035 [95% C1: 5.8 to 46.61). Conclusions: The results seems to support hypothesis, that patients with chronic hepatitis C should be treated in early stage of disease.
15741 COMPARISON OF EFFICACY OF TREATMENT WITH PEGINTERFERON ALFA PLUS RlBAVlRlN AMONG PATIENTS CHRONICALLY INFECTED WITH NON 2/3 HCV GENOTYPES WITH LOW AND HIGH VlREMlA H. Beralc’ , A. Kokakowska-Rzqizlca’, M. Wasilewski’ , J. Kowalska’, J.J. Stanczak’ , K. Bardadin2, A. Horban’ . ‘Hospital of I n f d i o u s Diseases; 2Medic.al Centre ,fbr Postgraduate Educution, Warsaw, Poland E-mail: [email protected]
Background and Aim: 212 patients chronically infected with HCV non 2/3 genotypes treated 48 weeks with peginterferon a with nbavirin (101 pts with Pegasys + Copegus and I 1 I pts with Pegintron + Rebetol) were divided into two groups with low (& 600,000 TUimL) and high (>600,000 TU/rnL) pretreatment viremia to compare the etficacy of treatment Methods: Liver biopsies were analyzed according to the Knodell’s and Scheuer’s scores The levels of ALT activity were determined with routine tests. Patients’ age and body weight were determined and their influence on treatment etficiency was analyzed On week 12, 48 and 24 weeks after end of treatment HCV RNA was performed, determined with HCV RNA ASSAY and viral load (VL) with CA HCV MONITOR TEST (both
of ROCHE DTAGN SYS.). The main study outcome was undetectable HCVRNA on week 12 (EVR) and 72 (SVR). Statistical analysis was performed with Chi-squared, Kruskal-Wallis and unpaired t-tests as appropriate. To compare the difference between the intervention groups an intention to treat missing equals failure analysis (ITT M=F) was performed. Results: Ninty nine pts had positive SVR, 96 patients had detectable HCVRNA and 17 were lost to observation. Using ITT M=F (991113) statistically significant difference in staging (0.006), weight (0.03) and ALT measured on SVR (<0.0001) between the groups were found. The SVR for the group with low pretreatment viremia was 58% (37164) and 42% (62/148) in group with high baseline VL. There was significant difference between the groups (TTT M=F: p = 0.43). In both group SVR is connected with response in 12 week oftreatment. There was no significant difference between low pretreatment viremia for two types of interferon: Pegasys 60% (20/33) vs Pegintron 54% ( 1 7/3 I ) . -
-
Relationship between EVR and SVR
in
patients with low pretreatment viremia
SVR n (“3) EVR n (“3) Baseline viremia HCVRNA HCVRNA P value HCVRNA HCVRNA P value <600,000 >600.000
(-1
(+I
38 (59.4) 73 (49.3)
26 (40.6) 75 (50.7)
0.18 0.18
(-)
(+)
37(37.4) 62 (62.6)
27 (23.9) 86 (76.1).
0.03
Chi-squared test was used to compare the groups, n 56
15751 WEEKS PREDICTION OF TREATMENT RESPONSE TO 72 OF PEGYLATED INTERFERON ALFA-2a PLUS RlBAVlRlN FOR CHRONIC HEPATITIS C AFTER LIVER TRANSPLANTATION A. Bergk’, U.P. Neumann2, F, van Boemmel’ , B. Wiedenmann’ , T. Berg’, R. Neuhaus’. ‘Gu.str-ornterolog?,,.2Department of Tr-LEnsplantSurgery, Churite, Cumpix Virchow Klinikum, Berlin, Germany E-mail: [email protected]
Background: Prediction of treatment response to combination therapy with pegylated interferon (PeglFN) and ribavirin (RBV) in chronic hepatitis C virus (HCV) infected and treatment-naive patients is well established. In contrast, treatment guidelines in the setting of HCV reinfection after liver transplantation are still missing. Aims: We aimed at analyzing viral kinetics during PegTFN/RBV therapy in order to develop recommendations for the management of this special patient subgroup. Methods: We retrospectively analyzed viral decline kinetics in 55 HCV infected liver transplant recipients (35 male, 20 female; mean age 55 years (35-70), who received combination therapy with pegylated interferon a-2a (initially 135 @week) and ribavirin (initially 600mgid) for 72 weeks. Treatment was stopped when HCV-RNA remained detectable at week 48. Results: 18 patients (33%) prematurely discontinued therapy due to adverse events. 59% (22/37) of the patients who completed treatment showed an end-of-treatment response with undetectable HCV-RNA after 48 weeks of therapy. Sustained virological response could be achieved in 11 patients (30%). A viral decline of at least 2loglo at week 12 (EVR) was significantly associated with an EOT response, but failed to discriminate between SVR and viral relapse (911 I and 8/11 patients, respectively). In contrast, 4 EVR patients were not able to clear HCVRNA on treatment, whereas 2 patients without a 2log-decline achieved an SVR. Likewise a cut-oft‘ of 30.000 TU/mL was able to predict nonresponse in 100% but failed to predict relapse. The positive predictive value for SVR in patients with undetectable HCVRNA by Amplicor PCR (i50TU/mL) at week 12 was 67%. By re-analyzing week 12 sera with highly sensitive TaqMan PCR, 10 were undetectable and the SVR rate in these patients was 70%.