- Email: [email protected]
A survey of current liver biopsy practice patterns
AJG – September, 2000
Abstracts
to be cost effective in reducing the need for evaluating suspected PLBrelated complications. (Dig Dis Sci 1998:43:46). We reviewed the last 200 diagnostic outpatient PLB’s performed at each of our institutions. USG/ conscious sedation is routinely used at GUMC, while neither one is routinely used at the VAMC. Based on complication rate, we performed cost-effectiveness analyses using charges currently in place at GUMC. Additional studies because of persistent pain or hypotension
USG
No-USG
Cost of Procedure
CBC with differential Hb/Hct alone Ultrasound CT Scan of abdomen Exploratory Laparotomy Unschedules overnight stay
8/200 8/200 3/200 0/200 0/200 1
37/200 37/200 25/200 4/200 1/200 13/200
$42 $25.25 $496 $1,136.50 $5,760 $1,265
The overall price of a PLB without USG or sedation is approximately $700, and with USG ⫹ sedation is approximately $1300. However, the cost of evaluating a pt. with a suspected complication after PLB can be as much as $2839(excluding surgery and other consultations). The actual cost to evaluate the 37 pts in the No-USG group with suspected complications was $37,000 compared to $2,026 for the 8 pts in the USG group. The overall cost for performing 200 PLB using USG is approximately $242,000 compared to $177,000 in the No-USG group. This represents an additional cost of $325 per patient when USG is used, which is less than the cost of an US and does not reflect the intangible cost-benefits of added safety, and tolerability using USG plus conscious sedation. Conclusions: If the price of USG can be reduced by the use of portable equipment, GI-staff-performed USG etc, cost effectiveness can be further improved.
769 Infliximab therapy for fistulizing Crohn’s disease Mirza Zafar M.D., Kosa Emily R.N., Prasad Saket M.D., Griffel Louis M.D., Das Kiron M.D., FACG. Crohn’s & Colitis Center of New Jersey, UMDNJ/Robert Wood Johnson Medical School and RWJUH, New Brunswick, NJ. Aim: We assessed our clinical experience with Infliximab (anti TNF-␣) therapy in thirteen patients with Crohn’s Disease associated with fistula. Ten patients had external and 4 had internal fistulae (one had both). Methods: Since October 1998, thirteen patients with fourteen fistulae received Infliximab (5mg/kg) IV infusions at 0, 2 & 6 weeks. We studied demographics, concurrent medications, duration of disease, response to Infliximab, number of infusions for response, and duration of remission for fistulae. Results: Mean age of the patients was 33 years (range 16 – 67). Seven were males and 6 females. Average disease duration was 7 years (range 1–9). All patients were treated earlier with systemic steroids and 9 of 13 were on concurrent 6-MP. All received 5-ASA medications. Nine of 10 external fistulae closed completely after Infliximab therapy (7 within 1 week & 2 at 6 weeks). Five (55%) of these patients had sustained response without further Infliximab therapy, with mean follow-up of 6 months (range 1–18 months). Four remaining patients relapsed after an average of 2.5 weeks and had limited response to further Infliximab therapy. None of the 4 internal fistulae responded to the 3 infusions. Conclusions: 1) Infliximab resulted in closure of 9 out of 10 external fistulae after an average of 1.7 infusions per patient. 2) Forty-five percent of the initial responders relapsed and did not respond adequately to further treatment with Infliximab. 3) None of the 4 internal fistulae responded to Infliximab.
2635
770 5-A5A Drugs, metronidazole, ciprofloxacin, prednisone, 6mercaptopurine and azathioprine use in pregnant patients with inflammatory bowel disease Moskovitz David N. B.Sc., Scherl Ellen M.D., Chapman Mark L. M.D., Marion James F M.D., Rubin Peter H. M.D., Present Daniel H. M.D. Department of Medicine, Mount Sinai School of Medicine, New York, New York. Purpose: The purpose of this study was to investigate the effect of 5-A5A drugs, metronidazole, ciprofloxacin, prednisone, 6-mercaptopurine, and azathioprine on pregnancy outcomes in patients with inflammatory bowel disease. Method: From our database of 2800 patients diagnosed with inflammatory bowel disease we selected 220 patients who had one or more documented pregnancies and conducted a short review. Information included; year of diagnosis, year symptoms started, smoking history in patient and spouse, dates of conception, dates of termination, and outcome of pregnancy. Both univariate and multivariate analysis (Chi Square) evaluated the effect of medication on pregnancy outcome. Results: Complete data was available for 220 patients (120 female and 86 male patients). There were 231 female conceptions and 165 male conceptions. One-hundred and seventy conceptions occurred on 5-A5A drugs, 49 on prednisone, 101 on either azathioprine or 6-mercaptopurine, 27 on metronidazole, and 18 on ciprofloxacin. The mean doses of medications were: mesalamine 2.77g (range 0.6 – 4.8g), sulfasalzine 2.36g (1.5– 4.0), pentasa 2.66g (0.75– 4), olsalazine 1.23g (1–2), metronidazole 0.83g (0.5– 1), ciprofloxacin 1.04g (0.5–1.5), prednisone 19.08g (5– 60), 6-mercaptopurine 58.75g (25–150), azathioprine 86.19g (50 –125). There were no significant difference (p values ranging from 0.091 to 0.9) with each drug with respect to spontaneous abortions, ectopic pregnancies, major deformities, or prematurity. Conclusions: Neither 5-A5A, metronidazole ciprofloxacin, prednisone, or immunomodulators are associated with poor pregnancy outcomes.
771 A survey of current liver biopsy practice patterns Muir Andrew J*, Trotter James F. Duke University, Durham, North Carolina, United States. Purpose: Although the hepatitis C epidemic has increased the proportion of hepatology in general gastroenterology practice, many clinicians express concern regarding the risk associated with percutaneous liver biopsy. In addition, recent work has questioned the role of liver biopsy in the care of patients with hepatitis C. We therefore decided to survey clinicians regarding their current liver biopsy practice patterns. Methods: We sent a questionnaire about liver biopsy practice to members of the Duke University Digestive Epidemiological Studies Consortium. Consortium members are in gastroenterology and hepatology practices in both academic and community settings throughout North America. Results: The response rate to the survey was 112/157 or 71%. Most respondents (88.4%) are in community practice. Thirty-three (29.5%) reported that they do NOT perform liver biopsies. In general, radiologists performed the liver biopsies for these clinicians. Reasons cited for not performing biopsies included concern about risks in 24/33 (72.7%), the low reimbursement for the biopsy in 22/33 (66.7%), and logistical issues with space and recovery time in 15/33 (45.4%). Of the 79 performing percutaneous liver biopsies, their routine practice was biopsy without ultrasound in 42 (53.2%), ultrasound marking at the time of biopsy by a radiologist or technician in 19 (24.0%), prior ultrasound marking in 14 (17.7%), and ultrasound marking by the gastroenterologist in 4 (5.1%). Of those who do not use ultrasound for marking, only 5 of 42 (11.9%) obtain an ultrasound to rule hemangioma or other mass prior to the biopsy. The needles used included an aspiration-type needle (Jamshidi or Menghini) in 57/79 (72.2%) and an automated, spring-loaded needle in 22/79 (27.8%). The mean recovery time after biopsy was 5.6 hours (range 3 to 24), and 14/79
2636
Abstracts
(17.7%) routinely use conscious sedation during the biopsy. For patients with hepatitis C, 86/112 (76.8%) routinely biopsy all patients prior to treatment. Other clinicians biopsy only selected patients to assist in management decisions (22/112, 19.6%), while 4/112 (3.6%) do not biopsy patients prior to treatment. After treatment, 104/112 (92.8%) do not routinely biopsy patients. Conclusions: 1. A significant proportion of clinicians do not perform liver biopsies. 2. Common reasons for not performing biopsies include the concern about the risks of the procedure and the low reimbursement for biopsy. 3. The use of ultrasound prior to or at the time of liver biopsy has become common. 4. Conscious sedation is less commonly utilized for liver biopsies. 5. Most clinicians routinely biopsy all patients prior to treatment for hepatitis C.
772 Patient educational touch screen kiosk Niemer Sally J, Perini Rafael F, Mauldin Mary P, Cotton Peter B*. Medical University of South Carolina, Charleston, South Carolina, United States. Purpose: Patient education is presumed to increase confidence and compliance with tests and treatments. To assist our staff, an interactive touchscreen computer program was designed to deliver useful information to clinic patients. Entitled ‘ED’ (for education), this device gathers data on patients’ symptoms, provides patient preparation instructions, and educates about digestive health and disease. Methods: The center director created the concept while the program manager oversaw production. Clinic staff were involved in the writing and filming. The MUSC Educational Technology Lab utilized Adobe’s Photoshop and Premier along with Macromedia’s Authorware and Sound Edit 16 to create the program that runs on a Pentium II hard drive with a touch screen monitor. The device was placed in a private exam room for patients to use before and/or after seeing the physician. Results: ‘ED‘ provides the following functions: Maps- animated maps with speech instruction offer directions around the hospital; Doctors and roomspatients may see pictures of their physicians or view examination or procedure rooms, creating a familiar surrounding that may decrease anxiety; Procedures- patients may watch and listen to instructions on how to prepare for their procedure, are shown exactly what to expect during and after procedures, and interactive questions are asked to evaluate their understanding; Heath information- patients may browse our website (www.ddc.musc.edu) and learn about digestive health, diseases, symptoms, and tests; Tell us about you- specific questionnaires survey the patients’ quality of life, pain characteristics and patient satisfaction anonymously, providing accurate data which is automatically captured and entered into a database to be used for administrative and research purposes. Conclusions: ‘ED’ has provided a cost- and time-effective means of patient education for our staff. By using sound, visuals, and touch, ‘ED’ provides an interactive, multimedia-learning environment that reaches visual and auditory learners, as well as illiterate patients. Patients’ education on ‘ED’ can be documented, printed and charted to meet JCAHO requirements. Program modifications can be made easily with little cost because of the web-based program design. Registration and consent forms will be added with future improvements.
773 Efficacy of rebetron (interferon and ribavirin) combination therapy in the treatment of patients with chronic hepatitis C not previously treated with interferon Geenen Joseph E. M.D, Geenen Daniel J M.D, Catalano Marc F. M.D., Schmalz Michael J. M.D. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States. Purpose: This pilot study assessed the efficacy and tolerance of Rebetron treatment in naive patients with chronic hepatitis C.
AJG – Vol. 95, No. 9, 2000
Methods: The treatment protocol consisted of Intron-A (IFN-A) 5mu sq. and Ribavirin 1000 –1200mg/day (based on weight) for 24 weeks. Viral levels determined by quantitative PCR (sens. ⬍100 copies/ml) were drawn at weeks 6, 12, and 24 weeks post treatment, in addition to standard laboratory parameters, including LFT’s. Genotyping was also performed on all patients. Results: A total of 6 patients entered the study, 3/6 completing 5 or 6 months of treatment. Only one patients stopped treatment due to sideeffects (rash). 4/6 patients had evaluable viral levels 6 months post treatment. 4/6 had Type Ia/Ib genotypes. The remainder had Type IIb genotypes. 2/4 or 50% of the evaluable patients demonstrated sustained response (SR) with undetectable viral levels 6 months post treatment. All had Type IIb genotypes. 2/4 non-responders did not complete six months treatment. Side-effects were predominantly due to IFN-A, with one patient having a side-effect attributable to Ribavirin (rash). Conclusions: (1) Combination treatment with Rebetron in naive patients with chronic hepatitis C is generally well tolerated with side-effects predominantly related to IFN-A. (2) A rash was seen in one patient presumably secondary to Ribavirin, emphasizing the need to be aware of dermatologic side-effects. (3) In this study, an overall efficacy of 50% was found, all in Type IIb genotypes, indicating genotype is an important predictor of outcome.
774 Efficacy of rebetron (interferon and ribavirin) combination therapy in the treatment of patients with interferon-refractory or interferonrelapsed chronic hepatitis C Greenen Joseph E. M.D., Greenen Daniel J. M.D., Catalano Marc F. M.D., Schmalz Michael J. M.D. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States. Purpose: A treatment study designed to assess the effectiveness and tolerance of Rebetron treatment for 24 up to 48 weeks in patients with chronic hepatitis C who had either failed previous treatment with Interferon (IFN-A) or relapsed after initial response. Methods: Treatment protocol consisted of IFN-A 3 mu sq. tiw and Ribavirin 1000mg/day from 24 – 48 weeks. Viral levels were checked weeks; 12, 24, 26, 48 weeks and 24 weeks post treatment using quantitative PCR assay (sens. ⬍100 copies/ml). At week 12, if patients were still viremic, IFN-A was increased to 4 mu sq. tiw ⫹ Ribavirin 1000mg/day. Treatment continued until patients were no longer viremic or until week 48. Results: A total of 54 patients with chronic hepatitis C entered the study, 45 patients completed 6 months of treatment. Thirty-seven patients had evaluable viral levels at the end of 48 weeks of treatment or six months post-treatment follow-up. Overall tolerance was good with only 9/54 unable to complete six months of treatment, 43/54 patients had genotyping with predominance of Type I/Ia/Ib 37/43 (86%), II/IIa/IIb 3/43 (7%), III/IIIa 3/43 (7%). A six months treatment response (undectable viral levels) were observed in 21/45 or 47%. However, a sustained response (SR) defined as undetectable viral levels at either end of 48 weeks treatment or six months post-treatment were seen in only 6/37 or 16%. Type IIIa genotype had the highest proportion of sustained responders in 3/6 with a SR also seen in one Ia, one IIa, and one Ib genotype. Extending the duration of treatment or escalation of IFN-A dose did not seem to effect outcome in patients with persistent viremia. Conclusions: (1) Combination therapy with Rebetron is generally well tolerated with side-effects predominantly secondary to IFN-A. (2) A 47% initial response was observed after six months treatment. (3) However, a SR was seen in only 16%. This low response may be in part due to the high percentage of Type I genotypes (86%) in our study. (4) As in other studies, Type III genotypes were most responsive to treatment, indicating genotype, rather than duration of treatment on IFN-A dose, best predicting outcome. Due to study design, the date does not permit an assessment of the efficacy of extending tx beyond 24 weeks in responders nonviremic at 24 weeks.
Abstracts
to be cost effective in reducing the need for evaluating suspected PLBrelated complications. (Dig Dis Sci 1998:43:46). We reviewed the last 200 diagnostic outpatient PLB’s performed at each of our institutions. USG/ conscious sedation is routinely used at GUMC, while neither one is routinely used at the VAMC. Based on complication rate, we performed cost-effectiveness analyses using charges currently in place at GUMC. Additional studies because of persistent pain or hypotension
USG
No-USG
Cost of Procedure
CBC with differential Hb/Hct alone Ultrasound CT Scan of abdomen Exploratory Laparotomy Unschedules overnight stay
8/200 8/200 3/200 0/200 0/200 1
37/200 37/200 25/200 4/200 1/200 13/200
$42 $25.25 $496 $1,136.50 $5,760 $1,265
The overall price of a PLB without USG or sedation is approximately $700, and with USG ⫹ sedation is approximately $1300. However, the cost of evaluating a pt. with a suspected complication after PLB can be as much as $2839(excluding surgery and other consultations). The actual cost to evaluate the 37 pts in the No-USG group with suspected complications was $37,000 compared to $2,026 for the 8 pts in the USG group. The overall cost for performing 200 PLB using USG is approximately $242,000 compared to $177,000 in the No-USG group. This represents an additional cost of $325 per patient when USG is used, which is less than the cost of an US and does not reflect the intangible cost-benefits of added safety, and tolerability using USG plus conscious sedation. Conclusions: If the price of USG can be reduced by the use of portable equipment, GI-staff-performed USG etc, cost effectiveness can be further improved.
769 Infliximab therapy for fistulizing Crohn’s disease Mirza Zafar M.D., Kosa Emily R.N., Prasad Saket M.D., Griffel Louis M.D., Das Kiron M.D., FACG. Crohn’s & Colitis Center of New Jersey, UMDNJ/Robert Wood Johnson Medical School and RWJUH, New Brunswick, NJ. Aim: We assessed our clinical experience with Infliximab (anti TNF-␣) therapy in thirteen patients with Crohn’s Disease associated with fistula. Ten patients had external and 4 had internal fistulae (one had both). Methods: Since October 1998, thirteen patients with fourteen fistulae received Infliximab (5mg/kg) IV infusions at 0, 2 & 6 weeks. We studied demographics, concurrent medications, duration of disease, response to Infliximab, number of infusions for response, and duration of remission for fistulae. Results: Mean age of the patients was 33 years (range 16 – 67). Seven were males and 6 females. Average disease duration was 7 years (range 1–9). All patients were treated earlier with systemic steroids and 9 of 13 were on concurrent 6-MP. All received 5-ASA medications. Nine of 10 external fistulae closed completely after Infliximab therapy (7 within 1 week & 2 at 6 weeks). Five (55%) of these patients had sustained response without further Infliximab therapy, with mean follow-up of 6 months (range 1–18 months). Four remaining patients relapsed after an average of 2.5 weeks and had limited response to further Infliximab therapy. None of the 4 internal fistulae responded to the 3 infusions. Conclusions: 1) Infliximab resulted in closure of 9 out of 10 external fistulae after an average of 1.7 infusions per patient. 2) Forty-five percent of the initial responders relapsed and did not respond adequately to further treatment with Infliximab. 3) None of the 4 internal fistulae responded to Infliximab.
2635
770 5-A5A Drugs, metronidazole, ciprofloxacin, prednisone, 6mercaptopurine and azathioprine use in pregnant patients with inflammatory bowel disease Moskovitz David N. B.Sc., Scherl Ellen M.D., Chapman Mark L. M.D., Marion James F M.D., Rubin Peter H. M.D., Present Daniel H. M.D. Department of Medicine, Mount Sinai School of Medicine, New York, New York. Purpose: The purpose of this study was to investigate the effect of 5-A5A drugs, metronidazole, ciprofloxacin, prednisone, 6-mercaptopurine, and azathioprine on pregnancy outcomes in patients with inflammatory bowel disease. Method: From our database of 2800 patients diagnosed with inflammatory bowel disease we selected 220 patients who had one or more documented pregnancies and conducted a short review. Information included; year of diagnosis, year symptoms started, smoking history in patient and spouse, dates of conception, dates of termination, and outcome of pregnancy. Both univariate and multivariate analysis (Chi Square) evaluated the effect of medication on pregnancy outcome. Results: Complete data was available for 220 patients (120 female and 86 male patients). There were 231 female conceptions and 165 male conceptions. One-hundred and seventy conceptions occurred on 5-A5A drugs, 49 on prednisone, 101 on either azathioprine or 6-mercaptopurine, 27 on metronidazole, and 18 on ciprofloxacin. The mean doses of medications were: mesalamine 2.77g (range 0.6 – 4.8g), sulfasalzine 2.36g (1.5– 4.0), pentasa 2.66g (0.75– 4), olsalazine 1.23g (1–2), metronidazole 0.83g (0.5– 1), ciprofloxacin 1.04g (0.5–1.5), prednisone 19.08g (5– 60), 6-mercaptopurine 58.75g (25–150), azathioprine 86.19g (50 –125). There were no significant difference (p values ranging from 0.091 to 0.9) with each drug with respect to spontaneous abortions, ectopic pregnancies, major deformities, or prematurity. Conclusions: Neither 5-A5A, metronidazole ciprofloxacin, prednisone, or immunomodulators are associated with poor pregnancy outcomes.
771 A survey of current liver biopsy practice patterns Muir Andrew J*, Trotter James F. Duke University, Durham, North Carolina, United States. Purpose: Although the hepatitis C epidemic has increased the proportion of hepatology in general gastroenterology practice, many clinicians express concern regarding the risk associated with percutaneous liver biopsy. In addition, recent work has questioned the role of liver biopsy in the care of patients with hepatitis C. We therefore decided to survey clinicians regarding their current liver biopsy practice patterns. Methods: We sent a questionnaire about liver biopsy practice to members of the Duke University Digestive Epidemiological Studies Consortium. Consortium members are in gastroenterology and hepatology practices in both academic and community settings throughout North America. Results: The response rate to the survey was 112/157 or 71%. Most respondents (88.4%) are in community practice. Thirty-three (29.5%) reported that they do NOT perform liver biopsies. In general, radiologists performed the liver biopsies for these clinicians. Reasons cited for not performing biopsies included concern about risks in 24/33 (72.7%), the low reimbursement for the biopsy in 22/33 (66.7%), and logistical issues with space and recovery time in 15/33 (45.4%). Of the 79 performing percutaneous liver biopsies, their routine practice was biopsy without ultrasound in 42 (53.2%), ultrasound marking at the time of biopsy by a radiologist or technician in 19 (24.0%), prior ultrasound marking in 14 (17.7%), and ultrasound marking by the gastroenterologist in 4 (5.1%). Of those who do not use ultrasound for marking, only 5 of 42 (11.9%) obtain an ultrasound to rule hemangioma or other mass prior to the biopsy. The needles used included an aspiration-type needle (Jamshidi or Menghini) in 57/79 (72.2%) and an automated, spring-loaded needle in 22/79 (27.8%). The mean recovery time after biopsy was 5.6 hours (range 3 to 24), and 14/79
2636
Abstracts
(17.7%) routinely use conscious sedation during the biopsy. For patients with hepatitis C, 86/112 (76.8%) routinely biopsy all patients prior to treatment. Other clinicians biopsy only selected patients to assist in management decisions (22/112, 19.6%), while 4/112 (3.6%) do not biopsy patients prior to treatment. After treatment, 104/112 (92.8%) do not routinely biopsy patients. Conclusions: 1. A significant proportion of clinicians do not perform liver biopsies. 2. Common reasons for not performing biopsies include the concern about the risks of the procedure and the low reimbursement for biopsy. 3. The use of ultrasound prior to or at the time of liver biopsy has become common. 4. Conscious sedation is less commonly utilized for liver biopsies. 5. Most clinicians routinely biopsy all patients prior to treatment for hepatitis C.
772 Patient educational touch screen kiosk Niemer Sally J, Perini Rafael F, Mauldin Mary P, Cotton Peter B*. Medical University of South Carolina, Charleston, South Carolina, United States. Purpose: Patient education is presumed to increase confidence and compliance with tests and treatments. To assist our staff, an interactive touchscreen computer program was designed to deliver useful information to clinic patients. Entitled ‘ED’ (for education), this device gathers data on patients’ symptoms, provides patient preparation instructions, and educates about digestive health and disease. Methods: The center director created the concept while the program manager oversaw production. Clinic staff were involved in the writing and filming. The MUSC Educational Technology Lab utilized Adobe’s Photoshop and Premier along with Macromedia’s Authorware and Sound Edit 16 to create the program that runs on a Pentium II hard drive with a touch screen monitor. The device was placed in a private exam room for patients to use before and/or after seeing the physician. Results: ‘ED‘ provides the following functions: Maps- animated maps with speech instruction offer directions around the hospital; Doctors and roomspatients may see pictures of their physicians or view examination or procedure rooms, creating a familiar surrounding that may decrease anxiety; Procedures- patients may watch and listen to instructions on how to prepare for their procedure, are shown exactly what to expect during and after procedures, and interactive questions are asked to evaluate their understanding; Heath information- patients may browse our website (www.ddc.musc.edu) and learn about digestive health, diseases, symptoms, and tests; Tell us about you- specific questionnaires survey the patients’ quality of life, pain characteristics and patient satisfaction anonymously, providing accurate data which is automatically captured and entered into a database to be used for administrative and research purposes. Conclusions: ‘ED’ has provided a cost- and time-effective means of patient education for our staff. By using sound, visuals, and touch, ‘ED’ provides an interactive, multimedia-learning environment that reaches visual and auditory learners, as well as illiterate patients. Patients’ education on ‘ED’ can be documented, printed and charted to meet JCAHO requirements. Program modifications can be made easily with little cost because of the web-based program design. Registration and consent forms will be added with future improvements.
773 Efficacy of rebetron (interferon and ribavirin) combination therapy in the treatment of patients with chronic hepatitis C not previously treated with interferon Geenen Joseph E. M.D, Geenen Daniel J M.D, Catalano Marc F. M.D., Schmalz Michael J. M.D. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States. Purpose: This pilot study assessed the efficacy and tolerance of Rebetron treatment in naive patients with chronic hepatitis C.
AJG – Vol. 95, No. 9, 2000
Methods: The treatment protocol consisted of Intron-A (IFN-A) 5mu sq. and Ribavirin 1000 –1200mg/day (based on weight) for 24 weeks. Viral levels determined by quantitative PCR (sens. ⬍100 copies/ml) were drawn at weeks 6, 12, and 24 weeks post treatment, in addition to standard laboratory parameters, including LFT’s. Genotyping was also performed on all patients. Results: A total of 6 patients entered the study, 3/6 completing 5 or 6 months of treatment. Only one patients stopped treatment due to sideeffects (rash). 4/6 patients had evaluable viral levels 6 months post treatment. 4/6 had Type Ia/Ib genotypes. The remainder had Type IIb genotypes. 2/4 or 50% of the evaluable patients demonstrated sustained response (SR) with undetectable viral levels 6 months post treatment. All had Type IIb genotypes. 2/4 non-responders did not complete six months treatment. Side-effects were predominantly due to IFN-A, with one patient having a side-effect attributable to Ribavirin (rash). Conclusions: (1) Combination treatment with Rebetron in naive patients with chronic hepatitis C is generally well tolerated with side-effects predominantly related to IFN-A. (2) A rash was seen in one patient presumably secondary to Ribavirin, emphasizing the need to be aware of dermatologic side-effects. (3) In this study, an overall efficacy of 50% was found, all in Type IIb genotypes, indicating genotype is an important predictor of outcome.
774 Efficacy of rebetron (interferon and ribavirin) combination therapy in the treatment of patients with interferon-refractory or interferonrelapsed chronic hepatitis C Greenen Joseph E. M.D., Greenen Daniel J. M.D., Catalano Marc F. M.D., Schmalz Michael J. M.D. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States. Purpose: A treatment study designed to assess the effectiveness and tolerance of Rebetron treatment for 24 up to 48 weeks in patients with chronic hepatitis C who had either failed previous treatment with Interferon (IFN-A) or relapsed after initial response. Methods: Treatment protocol consisted of IFN-A 3 mu sq. tiw and Ribavirin 1000mg/day from 24 – 48 weeks. Viral levels were checked weeks; 12, 24, 26, 48 weeks and 24 weeks post treatment using quantitative PCR assay (sens. ⬍100 copies/ml). At week 12, if patients were still viremic, IFN-A was increased to 4 mu sq. tiw ⫹ Ribavirin 1000mg/day. Treatment continued until patients were no longer viremic or until week 48. Results: A total of 54 patients with chronic hepatitis C entered the study, 45 patients completed 6 months of treatment. Thirty-seven patients had evaluable viral levels at the end of 48 weeks of treatment or six months post-treatment follow-up. Overall tolerance was good with only 9/54 unable to complete six months of treatment, 43/54 patients had genotyping with predominance of Type I/Ia/Ib 37/43 (86%), II/IIa/IIb 3/43 (7%), III/IIIa 3/43 (7%). A six months treatment response (undectable viral levels) were observed in 21/45 or 47%. However, a sustained response (SR) defined as undetectable viral levels at either end of 48 weeks treatment or six months post-treatment were seen in only 6/37 or 16%. Type IIIa genotype had the highest proportion of sustained responders in 3/6 with a SR also seen in one Ia, one IIa, and one Ib genotype. Extending the duration of treatment or escalation of IFN-A dose did not seem to effect outcome in patients with persistent viremia. Conclusions: (1) Combination therapy with Rebetron is generally well tolerated with side-effects predominantly secondary to IFN-A. (2) A 47% initial response was observed after six months treatment. (3) However, a SR was seen in only 16%. This low response may be in part due to the high percentage of Type I genotypes (86%) in our study. (4) As in other studies, Type III genotypes were most responsive to treatment, indicating genotype, rather than duration of treatment on IFN-A dose, best predicting outcome. Due to study design, the date does not permit an assessment of the efficacy of extending tx beyond 24 weeks in responders nonviremic at 24 weeks.