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Intron A + ribavirin induction therapy for treatment of community patients with chronic hepatitis C not previously treated with interferon
Al440 AASLD ABSTRACTS
GASTROENTEROLOGY Vol. 118, No.4
6531
6533
TRANSJUGULAR PORTAL SYSTEMIC SHUNTS IMPROVE SYMPTOMS OF LIVER DISEASE: EXPERIENCE OF PATIENTS HAVING TIPS AT LEAST 3 YEARS. Susan Beth Fredstrom, Jeffrey M. Rank, John R. Lake, Univ of Minnesota, Minneapolis, MN.
COMBINATION THERAPY WITH RIBA VIRIN AND INTERFERON ALPHA 2B (INTRON) FOR INTERFERON FAILURE PATIENTS WITH CHRONIC HEPATITIS C IN THE COMMUNITY SETTING. Bradley L. Freilich, M. Nightengale, A. Treibling, P. McCormick, T. Rogers, 1. Kissinger, K. Harrell, R. Cade, K. Cornish, BAPTIST Med Ctr, Kansas City, MO.
Transjugular portal systemic shunts (TIPS) have been shown effective in the short-term (i.e. 6-18 months) management of complications of portal hypertension. However, there is little information about the long-term outcome. We now report our experience with TIPS in-patients with patent shunts for >36 months. METHOD: Between 1991 and 1996, 133 patients underwent TIPS procedures at our institution. Clinical data including echography, lab studies and physical exam was collected prospectively prior to and at intervals of 3-6 months post procedure. RESULTS: Of the 133 patients, 64, or 48%, expired (days surviving 3-884, ST group), 19 (14%) underwent OLT, 3 shunts occluded (2%) and 10 were lost to follow-up (8%). Thus, 37 patients (28%) survived with patent shunts> 36 months, (days surviving 1029-2771, LT group). Eighteen are alive, 7 died and 12 were lost after> 36 mo follow-up. Cause of death was hepatic failure in 4, hepatic carcinoma in 1 and other causes in 2. The LT group was similar to the ST group in age (ave±SD, 54± lly), gender (45% female, 55% male), and diagnosis (55% alcoholic cirrhosis in each). Child-Pugh score (CPS) was lower (9±2 v. 1l±2, p =0.004) in the LT group, with significant differences, all given LT v. ST (p
Recent studies indicate combination therapy with interferon alpha 2b plus ribavirin is more efficacious than interferon alone in the treatment of chronic hepatitis C. Aims: To determine the benefit of 6 vs 12 mos combination therapy for interferon failure patients in the community setting. Methods: 138 hepatitis C failure patients were randomly assigned into one of two groups. Group 1: Intron A, 3 mu TIW + ribavirin 1000 mg x 6 months. Group 2: Intron A, 3 mu TIW + ribavirin x 12 months. The NGI superquant assay was utilized. This investigation is still in progress. The results after 18 months of study, with an intention to treat analysis: (See table below) Conclusions: Twelve months of combination therapy did not improve upon sustained response rates in either nonresponders or relapsers compared to six months of therapy in these same groups. Sustained response rates for the 12 versus 6 month treatment groups were not statistically different for either genotype 1 or nongenotype I patients in this study. Three month follow-up data in this study are slightly worse than historical controls. This could possibly be related to the high number of patients who discontinued treatment secondary to side effects. The sustained response rates may ultimately improve as patients matriculate through this study.
3 Mo flu:Genotype 1 Nongenotype 1 SR: Genotype 1 Relapsers Nonresponders Nongenotype 1 Relapsers Nonresponders # pts 6 mos flu data pnd # stopped 2' intolerance
Group 1 (6months)
Group 2 (12 months)
6/47 (13%) 6/13(46%) 6/47 (13%) 3/12 (25%) 3/35 (9%) 5/12(42%) 3/7 (43%) 215 (40%) 15/62 14/62 (23%)
9/50 (18%) 13/22 (59%) 7/49 (14%) 4/16 (25%) 3/33 (9%) 10/20 (50%) 6/11 (55%) 4/9 (44%) 27(76 12(76 (16%)
6532 INTRON A + RIBAVIRIN INDUCTION THERAPY FOR TREATMENT OF COMMUNITY PATIENTS WITH CHRONIC HEPATITIS C NOT PREVIOUSLY TREATED WITH INTERFERON. Bradley L. Freilich, M. Nightengale, A. Treibling, P. McCormick, T. Rogers, 1. Kissinger, K. Harrell, R. Cade, K. Cornish, BAPTIST Med Ctr, Kansas City, MO. Recent studies have indicated that induction dosing (higher initial daily dosing of interferon) in combination with ribavirin may be superior to standard combination therapy in terms of early virilogical response rates and that it is well tolerated. Aim: obtain additional information on the benefit and tolerability of different regimens of induction dosing for naive hepatitis C patients. Methods: 124 adult patients with compensated chronic HCY, naive to interferon treatment, were randomly assigned into two groups. Group 1: Intron A, 5 mu qD x 1 month, then Intron A, 3 mu qod + ribavirin 1000 mg qD for months 2-12. Group 2: Intron A, 5 mu qD + ribavirin 1000 mg daily X 1 mos, then Intron A, 3 mu qod and ribavirin 1000 mg daily for months 2-12. NGI superquant assay was utilized. This investigation is still in progress. The results after 18 months of study, with an intention to treat analysis (see table below): Conclusions: There is no significant difference between sustained response rates for combination induction therapy versus Intron alone induction. Both regimens appear to be equally tolerated. Induction therapy in this study does not seem to improve upon sustained response rates compared to historical controls utilizing standard therapy. The high rate of discontinued therapy secondary to the side effects of treatment may account for our overall sustained response rates being slightly lower that those of historical controls.
ETR Genotype 1 Non Genotype 1 SR Genotype 1 Non Genotype 1 # Discontinued due to intolerance
Group 1 (lntron Alone Induction)
Group 2 (Combination Induction)
22/50 (44%) 13/35 (37%) 9/15 (60%) 14/42 (33%) 8/30 (27%) 6/12 (50%) 13/54 (24%)
26/62 (42%) 11/37 (30%) 15/25 (60%) 11/46 (24%) 6/33 (18%) 5/13 (38%) 20(70 (29%)
6534 UNIQUE CLINICAL PROFILES OF PATIENTS WITH HEPATOCELLULAR CARCINOMA LESS THAN 50 YEARS OLD. Tomonori Fujishima, Yukihiro Koike, Shinpei Sato, Shuntaro Obo, Masatoshi Imamura, Keisuke Hamamura, Yosiyuki Dan, Takuma Teratani, Shuuichiro Shiina, Haruhiko Yoshida, Yasushi Shiratori, Masao Ornata, Univ of Tokyo, Tokyo, Japan. PURPOSE. To clarify the difference of clinical features of hepatocellular carcinoma (HCC) in relation to the age, we examined 845 consecutive patients with HCC. METHOD. We analyzed the clinical profiles of the 845 patients (mean 62 years old, range 36-87) who admitted to our hospital between March 1987 and May 1999. The patients were divided into two groups, patients with age <50 (80 patients) and >50 (765 patients). The clinical profiles of the patients were compared between these two groups using parameters of viral markers, sex, alcohol intake (>50g/day), serum levels of alpha-fetoprotein(AFP), Des-carboxy-prothrombin(DCP), Alphafetoprotein like the Lens culinaris agglutinin-reactive fraction(AFP-L3), albumin, bilirubin, AST, ALT, prothrombin time(PT), platelet count(Plt), and back ground liver disease using biopsy specimens. RESULTS. Markedly male preponderance (men:women=77:3; <50 y.o. vs. 550:215; >50 y.o.) and high HBsAg positive rate (45percent vs. 8percent) was demonstrated in patients with age <50 in compare with age >50. Increased AFP, AFP-L3, bilirubin, and ALT levels and decreased PT and Pit levels in patients with age <50 y.o. in comparison with those >50 y.o .. These data suggest that HCC in patients <50 y.o. showed advanced stage of HCC and that back ground liver disease was advanced liver cirrhosis. Among the patients with HCYAb positive, the portion of alcohol habitue in young patients was higher in older patients (52percent vs. 26percent, P=0.004). Among the HBY related HCC patients, mild stage of back ground liver disease «Child A) was demonstrated in the group of <50 y.o. (76percent) compared with the group of >50 y.o. (50percent). No difference was found in the tumor character of Edmondson grades. CONCLUSION. Compared with older patients (age >50 y.o.), preponderance of male, HBsAg carrier, and alcohol intake (>50g/day) are the characteristics of hepatocellular carcinoma in patients with age <50 y.o.. High level of ALT and low level of PT among the young group may reflect progression of background liver disease especialy in HCY-related HCC patients.
GASTROENTEROLOGY Vol. 118, No.4
6531
6533
TRANSJUGULAR PORTAL SYSTEMIC SHUNTS IMPROVE SYMPTOMS OF LIVER DISEASE: EXPERIENCE OF PATIENTS HAVING TIPS AT LEAST 3 YEARS. Susan Beth Fredstrom, Jeffrey M. Rank, John R. Lake, Univ of Minnesota, Minneapolis, MN.
COMBINATION THERAPY WITH RIBA VIRIN AND INTERFERON ALPHA 2B (INTRON) FOR INTERFERON FAILURE PATIENTS WITH CHRONIC HEPATITIS C IN THE COMMUNITY SETTING. Bradley L. Freilich, M. Nightengale, A. Treibling, P. McCormick, T. Rogers, 1. Kissinger, K. Harrell, R. Cade, K. Cornish, BAPTIST Med Ctr, Kansas City, MO.
Transjugular portal systemic shunts (TIPS) have been shown effective in the short-term (i.e. 6-18 months) management of complications of portal hypertension. However, there is little information about the long-term outcome. We now report our experience with TIPS in-patients with patent shunts for >36 months. METHOD: Between 1991 and 1996, 133 patients underwent TIPS procedures at our institution. Clinical data including echography, lab studies and physical exam was collected prospectively prior to and at intervals of 3-6 months post procedure. RESULTS: Of the 133 patients, 64, or 48%, expired (days surviving 3-884, ST group), 19 (14%) underwent OLT, 3 shunts occluded (2%) and 10 were lost to follow-up (8%). Thus, 37 patients (28%) survived with patent shunts> 36 months, (days surviving 1029-2771, LT group). Eighteen are alive, 7 died and 12 were lost after> 36 mo follow-up. Cause of death was hepatic failure in 4, hepatic carcinoma in 1 and other causes in 2. The LT group was similar to the ST group in age (ave±SD, 54± lly), gender (45% female, 55% male), and diagnosis (55% alcoholic cirrhosis in each). Child-Pugh score (CPS) was lower (9±2 v. 1l±2, p =0.004) in the LT group, with significant differences, all given LT v. ST (p
Recent studies indicate combination therapy with interferon alpha 2b plus ribavirin is more efficacious than interferon alone in the treatment of chronic hepatitis C. Aims: To determine the benefit of 6 vs 12 mos combination therapy for interferon failure patients in the community setting. Methods: 138 hepatitis C failure patients were randomly assigned into one of two groups. Group 1: Intron A, 3 mu TIW + ribavirin 1000 mg x 6 months. Group 2: Intron A, 3 mu TIW + ribavirin x 12 months. The NGI superquant assay was utilized. This investigation is still in progress. The results after 18 months of study, with an intention to treat analysis: (See table below) Conclusions: Twelve months of combination therapy did not improve upon sustained response rates in either nonresponders or relapsers compared to six months of therapy in these same groups. Sustained response rates for the 12 versus 6 month treatment groups were not statistically different for either genotype 1 or nongenotype I patients in this study. Three month follow-up data in this study are slightly worse than historical controls. This could possibly be related to the high number of patients who discontinued treatment secondary to side effects. The sustained response rates may ultimately improve as patients matriculate through this study.
3 Mo flu:Genotype 1 Nongenotype 1 SR: Genotype 1 Relapsers Nonresponders Nongenotype 1 Relapsers Nonresponders # pts 6 mos flu data pnd # stopped 2' intolerance
Group 1 (6months)
Group 2 (12 months)
6/47 (13%) 6/13(46%) 6/47 (13%) 3/12 (25%) 3/35 (9%) 5/12(42%) 3/7 (43%) 215 (40%) 15/62 14/62 (23%)
9/50 (18%) 13/22 (59%) 7/49 (14%) 4/16 (25%) 3/33 (9%) 10/20 (50%) 6/11 (55%) 4/9 (44%) 27(76 12(76 (16%)
6532 INTRON A + RIBAVIRIN INDUCTION THERAPY FOR TREATMENT OF COMMUNITY PATIENTS WITH CHRONIC HEPATITIS C NOT PREVIOUSLY TREATED WITH INTERFERON. Bradley L. Freilich, M. Nightengale, A. Treibling, P. McCormick, T. Rogers, 1. Kissinger, K. Harrell, R. Cade, K. Cornish, BAPTIST Med Ctr, Kansas City, MO. Recent studies have indicated that induction dosing (higher initial daily dosing of interferon) in combination with ribavirin may be superior to standard combination therapy in terms of early virilogical response rates and that it is well tolerated. Aim: obtain additional information on the benefit and tolerability of different regimens of induction dosing for naive hepatitis C patients. Methods: 124 adult patients with compensated chronic HCY, naive to interferon treatment, were randomly assigned into two groups. Group 1: Intron A, 5 mu qD x 1 month, then Intron A, 3 mu qod + ribavirin 1000 mg qD for months 2-12. Group 2: Intron A, 5 mu qD + ribavirin 1000 mg daily X 1 mos, then Intron A, 3 mu qod and ribavirin 1000 mg daily for months 2-12. NGI superquant assay was utilized. This investigation is still in progress. The results after 18 months of study, with an intention to treat analysis (see table below): Conclusions: There is no significant difference between sustained response rates for combination induction therapy versus Intron alone induction. Both regimens appear to be equally tolerated. Induction therapy in this study does not seem to improve upon sustained response rates compared to historical controls utilizing standard therapy. The high rate of discontinued therapy secondary to the side effects of treatment may account for our overall sustained response rates being slightly lower that those of historical controls.
ETR Genotype 1 Non Genotype 1 SR Genotype 1 Non Genotype 1 # Discontinued due to intolerance
Group 1 (lntron Alone Induction)
Group 2 (Combination Induction)
22/50 (44%) 13/35 (37%) 9/15 (60%) 14/42 (33%) 8/30 (27%) 6/12 (50%) 13/54 (24%)
26/62 (42%) 11/37 (30%) 15/25 (60%) 11/46 (24%) 6/33 (18%) 5/13 (38%) 20(70 (29%)
6534 UNIQUE CLINICAL PROFILES OF PATIENTS WITH HEPATOCELLULAR CARCINOMA LESS THAN 50 YEARS OLD. Tomonori Fujishima, Yukihiro Koike, Shinpei Sato, Shuntaro Obo, Masatoshi Imamura, Keisuke Hamamura, Yosiyuki Dan, Takuma Teratani, Shuuichiro Shiina, Haruhiko Yoshida, Yasushi Shiratori, Masao Ornata, Univ of Tokyo, Tokyo, Japan. PURPOSE. To clarify the difference of clinical features of hepatocellular carcinoma (HCC) in relation to the age, we examined 845 consecutive patients with HCC. METHOD. We analyzed the clinical profiles of the 845 patients (mean 62 years old, range 36-87) who admitted to our hospital between March 1987 and May 1999. The patients were divided into two groups, patients with age <50 (80 patients) and >50 (765 patients). The clinical profiles of the patients were compared between these two groups using parameters of viral markers, sex, alcohol intake (>50g/day), serum levels of alpha-fetoprotein(AFP), Des-carboxy-prothrombin(DCP), Alphafetoprotein like the Lens culinaris agglutinin-reactive fraction(AFP-L3), albumin, bilirubin, AST, ALT, prothrombin time(PT), platelet count(Plt), and back ground liver disease using biopsy specimens. RESULTS. Markedly male preponderance (men:women=77:3; <50 y.o. vs. 550:215; >50 y.o.) and high HBsAg positive rate (45percent vs. 8percent) was demonstrated in patients with age <50 in compare with age >50. Increased AFP, AFP-L3, bilirubin, and ALT levels and decreased PT and Pit levels in patients with age <50 y.o. in comparison with those >50 y.o .. These data suggest that HCC in patients <50 y.o. showed advanced stage of HCC and that back ground liver disease was advanced liver cirrhosis. Among the patients with HCYAb positive, the portion of alcohol habitue in young patients was higher in older patients (52percent vs. 26percent, P=0.004). Among the HBY related HCC patients, mild stage of back ground liver disease «Child A) was demonstrated in the group of <50 y.o. (76percent) compared with the group of >50 y.o. (50percent). No difference was found in the tumor character of Edmondson grades. CONCLUSION. Compared with older patients (age >50 y.o.), preponderance of male, HBsAg carrier, and alcohol intake (>50g/day) are the characteristics of hepatocellular carcinoma in patients with age <50 y.o.. High level of ALT and low level of PT among the young group may reflect progression of background liver disease especialy in HCY-related HCC patients.