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Early identification of achieving a sustained virological response in chronic hepatitis C patients without a rapid virological response.
Huang, Chung-Feng *,+,++,[S][S],1; Yang, Jeng-Fu *,++++,1; Huang, Jee-Fu ++,[S],[P]; Dai, Chia-Yen *,+,[S]; Chiu, Chang-Fu ++; Hou, Nai-Jen [P]; Hsieh, Ming-Yen *; Lin, Zu-Yau *,[S]; Chen, Shinn-Cherng *,[S]; Hsieh, Ming-Yuh *,[S]; Wang, Liang-Yen *,[S]; Chang, Wen-Yu *,[S]; Chuang, Wan-Long *,[S]; Yu, Ming-Lung *,[S],[S][S]
[Miscellaneous Article] Journal of Gastroenterology & Hepatology. 25(4):758-765, April 2010.

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Background and Aim: A number of hepatitis C virus (HCV) patients without a rapid virological response (RVR) achieved a sustained virological response (SVR) with peginterferon-[alpha]-2a/ribavirin. The aim of this study was to identify factors associated with SVR in non-RVR patients.

Methods: Baseline and on-treatment factors were used to explore the prognostic factors for SVR in 113 HCV genotype-1 (HCV-1) and 20 HCV-2 non-RVR patients in two randomized trials.

Results: The SVR rate in HCV-1 patients with a complete early virological response (cEVR) and partial early virological response was 91.9% versus 45% (P < 0.001) and 21.4% versus 10% (P = 0.62), respectively, after 48 and 24 weeks of treatment. The SVR rate in HCV-2 patients with a cEVR was 90.9% versus 57.1% (P = 0.25), respectively, after 24 and 16 weeks of treatment. Multivariate analysis showed that cEVR and standard regimen were independently associated with SVR. Viral kinetic study revealed that HCV viral loads < 10 000 IU/mL at week 4 were the best predictor of cEVR for both HCV-1 and HCV-2 non-RVR patients with the accuracy of 81% and 95%, respectively, and also of SVR with the accuracy of 78% and 92%, respectively, in patients receiving standard of care. The most important independent predictors for cEVR were HCV viral loads < 104 IU/mL at week 4, followed by increased ribavirin dose within 12 weeks of treatment.

Conclusions: Achieving a cEVR with standard of care is the most important predictor of SVR in non-RVR patients. Week 4 viral loads < 10 000 IU/mL could accurately predict cEVR early and following SVR in non-SVR patients.