DDW 2007:  Wednesday Abstracts:

 

Topic:  Current treatment - Pegasys

W1013. Predictive factors of sustained virological response to peginterferon alpha-2a therapy in the patients with chronic hepatitis C despite the discontinuation of peginterferon alpha-2a therapy due to adverse events. 

K. Sato; K. Hosonuma; T. Itikawa; S. Kakizaki; H. Takagi; M. Mori

 

Background:

Interferon (IFN) therapy in the patients with chronic hepatitis C is occasionally discontinued due to various adverse events and ends up failing. However we encounter the patients who achieved sustained virological response (SVR) despite the discontinuation of IFN due to adverse events. We herein clarify predictive factors of SVR to peginterferon alpha-2a therapy in the cases of chronic hepatitis C despite the discontinuation of peginterferon alpha-2a therapy due to adverse events.

 

Methods:

Thirty-two patients with the discontinuation of peginterferon alpha-2a due to adverse events such as depression and appetite loss were enrolled in this study. The cases with the intended short periods of peginterferon alpha-2a therapy were excluded. The definition of the discontinuation of peginterferon alpha-2a is that peginterferon alpha-2a is discontinued at least four weeks shorter than the standard therapies (48 weeks) which are approved in Japan. The definition of SVR is that serum HCV-RNA level remains negative for 24 weeks after the discontinuation of peginterferon alpha-2a therapy.

 

Results:

SVR and Non-SVR (NR) were achieved in 14 and 16 cases, respectively. The sex ratio (M/F) in the cases with SVR and NR was 7/7 and 3/13, respectively. The average age in the cases with SVR and NR were 59 years (range 25-74) and 59 (range 49-74), respectively. The average periods of peginterferon alpha-2a therapy in the cases with SVR and NR were 21 (range 5-32) and 16 weeks (range 2-38), respectively.

 

Average pretreatment serum HCV-RNA in the cases with SVR and NR was 183 (range 4-1760) and 869 (range 15-2100) KIU/ml, respectively. The HCV genotypes included 1b (n = 4 and 7), 2a (n = 8 and 4) and 2b (n = 2 and 5) in the patients achieving SVR and NR, respectively. The numbers of the patients achieving SVR and NR with serum HCV-RNA level below 0.5KIU/ml within 4 weeks after peginterferon alpha-2a therapy were all 14 and 5, respectively. Univariate analysis showed pretreatment serum HCV-RNA level and the periods of disappearance of serum HCV-RNA were significant predictive factors of SVR. In addition, by multivariate analysis, pretreatment serum HCV-RNA level (p=0.0059) and the periods of disappearance of serum HCV-RNA (p=0.0004) were independent predictors of SVR in all patients.

 

Conclusions:

Pretreatment serum HCV-RNA level and the periods of disappearance of serum HCV-RNA behave as predictive factors of SVR to peginterferon alpha-2a therapy in the patients with chronic hepatitis C. Thus, these factors may enable us to shorten the periods of peginterferon alpha-2a therapy by design.

 


Topic:  Current HCV Treatment – General

W1150. Antiviral treatment in Crohn ’s patients with chronic hepatitis C is well tolerated and effective. 

T. Scherzer; K. Staufer; C. Gurguta; G. Novacek; P. Ferenci; H. Vogelsang

 

Introduction: 

Due to surgery and/or blood transfusions patients with Crohn ’s disease (CD) are at risk to be infected with hepatitis C. The potential side effect profile of antiviral combination therapy in patients with CD is unknown. Therefore hepatitis C is rarely treated in CD.

 

Aim:

was to analyze the efficacy and tolerability of antiviral IFN/ribavirin therapy in patients with CD. End of treatment response (ETR) and sustained virologic response (SVR; undetectable virus PCR at 6 month follow up) rates, were evaluated.

 

Methods:  

Nine CD patients (29-56a; f:5,m:4; colon disease: 1, ileum disease: 2, ileocolon disease: 6; disease duration: mean 23.4a (range 5-33) and hepatitis C (genotype 1:7, 1 with genotype 3:1, unknown:1) received either interferon α-2b monotherapy (n=2) or 180µg/week peginterferon α-2a (PEGASYS®, Roche, Basel, CH) and 800-1200 mg/d ribavirin (COPEGUS®, Roche, Basel, CH) combination therapy (n=7) for 24 to 54 weeks. CD specific therapy (mesalazin: 4, azathioprin: 2, mycophenolate-mofetil:1) was maintained throughout antiviral therapy. Before treatment CDAI was <150 for more than 2 years. Routine blood samples including CRP, α1-acid glycoprotein and HCV-PCR were taken monthly during therapy and for 6 months follow up. The CDAI was evaluated at baseline (BL) and one month follow up in seven patients.

 

Results:  

Of the 9 patients, 8 have finished treatment. All 8 had an ETR; the remaining patient is HCV-RNA negative on therapy. So far, 6 patients completed follow up, 4 achieved a SVR, 2 relapsed.

 

Overall, therapy was well tolerated. Due to mildly increased CD activity (rise of α1-acid glycoprotein: n=5; diarrhea: n=4, increased CRP: n=1) CD specific treatment was modified in 5 (55%) patients, including 3 requiring glucocorticoids (2 per os, 1 topical). One patient received antibiotics for exacerbation of preexisting fistula. No clinically significant major flares in CD activity were noted.

 

The typical side effects of antiviral therapy required the administration of hemopoetic growth factors: four patients became anemic (Hb ≤8.1 mg/dl) and were treated with erythropoetin, one patient received filgrastim because of neutropenia. CDAI was similar at BL (10.5 – 86.8) and 1 months after end of antiviral treatment (45 - 103). Due to the typical side effects of antiviral therapy (haematocrit decrease, fever, arthralgia, reduced general condition, loss of weight) the CDAI cannot be assessed during treatment.

 

Conclusion:  

Hepatitis C treatment is effective and well tolerated in CD patients. Since immunosuppression favours progression of chronic hepatitis C, antiviral combination therapy should be offered to patients with inactive CD.