A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C

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• 作者：Pham Thi Thu Thuy¹ ; Chalermrat Bunchorntavakul² ; ³ ; Ho Tan Dat¹ ; K. Rajender Reddy³ ; ^{rajender.reddy@uphs.upenn.edu}
• 关键词：HCV ; hepatitis C virus ; ALT ; alanine aminotransferase ; AST ; aspartate aminotransferase ; PEG-IFN ; pegylated interferon ; RBV ; ribavirin ; SVR ; sustained virological response ; RVR ; rapid virological response ; cEVR ; complete early virological response ; ETR ; en
• 刊名：Journal of Hepatology
• 出版年：2012
• 出版时间：May, 2012
• 年：2012
• 卷：56
• 期：5
• 页码：1012-1018
• 全文大小：851 K

文摘

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Background & Aims

Genotype 6 chronic hepatitis C (HCV) is encountered predominantly in Southeast Asia and data on optimal treatment strategy is limited. This study was aimed at assessing the rate and predictors of sustained virological response (SVR) in genotype 6 chronic HCV following 48 and 24 weeks of pegylated interferon and ribavirin therapy.

Methods

This investigator-initiated, open-label randomized trial was conducted in Vietnam between 2008 and 2010. One hundred and five treatment-na?ve HCV genotype 6 patients were randomized to either 48-week (N = 70) or 24-week (N = 35) duration of pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV) 15 mg/kg/day; 92 patients completed the study (63 in the 48-week and 29 in the 24-week group, respectively). Primary outcome was sustained virological response (SVR) as intention-to-treat analysis.

Results

There was no statistical difference in SVR between 48-week and 24-week treated groups (71 % vs. 60 % , respectively; p = 0.24). In the 48-week and 24-week treatment groups, 81 % and 80 % of cases achieved rapid virological response (RVR) (p = 0.86), and 86 % and 80 % achieved complete early virological response (p = 0.45). Among those patients with RVR, SVR was in 86 % (48-weeks), and 75 % (24-weeks) of cases, whereas following non-RVR, only 8 % of cases had an SVR with 48-week treatment duration.

Conclusions

Overall, RVR was achieved in the majority of genotype 6 patients and, in those patients, similar and high rates of SVR were noted following 24-week and 48-week therapy. This observation, however, needs validation in a larger study to demonstrate non-inferiority of the shorter duration therapy. In non-RVR patients, even 48-week therapy achieved low SVR rates.