Combination Interferon α-2b Plus Ribavirin Therapy in Patients with Chronic Hepatitis C with Resistance to or Relapse after Interferon Monotherapy

合併干擾素及口服ribavirin治療單用干擾素無效或復發之慢性C型肝炎

黃信彰(Shinn-Jang Hwang) ； 王苑貞(Yuan-Jan Wang) ； 李壽東(Shou-Dong Lee) ； 朱啟仁(Chi-Jen Chu) ； 張扶揚(Full-Young Chang)

《北市醫學雜誌》 2卷3期 (2005/03) Pp. 254-264

https://doi.org/10.6200/TCMJ.2005.2.3.04

摘要

Backgrounds and Objective: Previous studies in Caucasian patients showed treatment of chronic hepatitis C (CHC) patients with interferon and ribavirin was well tolerated, and produced a higher response rate in patients non-responded or relapsed to previous interferon monotherapy. However, it is unknown whether this conclusion can be extrapolated to patients with Chinese ethnic origin. The objective of this clinical trial is to evaluate the efficacy and tolerability of the combination of interferon α-2b plus Ribavirin in CHC patients who relapsed from or not responding to previous interferon therapy. Methods: Twenty-one Chinese CHC patients (19 males, 2 females, mean age: 47.5±9.2 years) who were non-responded or relapsed from previous interferon treatment received 3 MU of interferon α-2b, three times a week. plus ribavirin (1000 mg/day if body weight ＜75kg or 1200mg/day if body weight ＞75kg) for 24 weeks. Sustained virological response was defined as disappearance of serum HCV RNA at 24 weeks after the end of treatment by polymerase chain reaction assay. Results: Among 21 CHC patients, 20 patients completed the treatment and one withdrew from the study due to adverse event. Using intent-to-treat analysis, 11 patients (52%) had undetectable HCV RNA at the end of treatment. However, the sustained virological response was achieved in 2 patients (9.5%) 24 weeks after stopping of treatment. These two patients with sustained virological response were both genotype non-1 and pretreatment serum HCV RNA level ＜5 million copies/mL by branched DNA signal amplification assay, while the other 19 patients without sustained virological response were either HCV genotype 1 or pretreatment serum HCV RNA level ＞5 million copies/mL (P＜0.01). Conclusions: The sustained virological response rate was 9.5% in CHC patients non-responded or relapsed from previous interferon therapy and re-treated with interferon α-2b and ribavirin. HCV genotype and pretreatment HCV RNA level were important factors in predicting the retreatment sustained virological response.

關鍵字

C型肝炎 ； 甲型干擾素α-2b ； 抗病毒藥物(ribavirin) ； 持續性病毒反應

並列摘要

Backgrounds and Objective: Previous studies in Caucasian patients showed treatment of chronic hepatitis C (CHC) patients with interferon and ribavirin was well tolerated, and produced a higher response rate in patients non-responded or relapsed to previous interferon monotherapy. However, it is unknown whether this conclusion can be extrapolated to patients with Chinese ethnic origin. The objective of this clinical trial is to evaluate the efficacy and tolerability of the combination of interferon α-2b plus Ribavirin in CHC patients who relapsed from or not responding to previous interferon therapy. Methods: Twenty-one Chinese CHC patients (19 males, 2 females, mean age: 47.5±9.2 years) who were non-responded or relapsed from previous interferon treatment received 3 MU of interferon α-2b, three times a week. plus ribavirin (1000 mg/day if body weight ＜75kg or 1200mg/day if body weight ＞75kg) for 24 weeks. Sustained virological response was defined as disappearance of serum HCV RNA at 24 weeks after the end of treatment by polymerase chain reaction assay. Results: Among 21 CHC patients, 20 patients completed the treatment and one withdrew from the study due to adverse event. Using intent-to-treat analysis, 11 patients (52%) had undetectable HCV RNA at the end of treatment. However, the sustained virological response was achieved in 2 patients (9.5%) 24 weeks after stopping of treatment. These two patients with sustained virological response were both genotype non-1 and pretreatment serum HCV RNA level ＜5 million copies/mL by branched DNA signal amplification assay, while the other 19 patients without sustained virological response were either HCV genotype 1 or pretreatment serum HCV RNA level ＞5 million copies/mL (P＜0.01). Conclusions: The sustained virological response rate was 9.5% in CHC patients non-responded or relapsed from previous interferon therapy and re-treated with interferon α-2b and ribavirin. HCV genotype and pretreatment HCV RNA level were important factors in predicting the retreatment sustained virological response.

並列關鍵字

adverse effects ； Hepatitis C ； interferon α-2b ； ribavirin ； sustained virological response