Refined prediction of week 12 response and SVR based on week 4 response in HCV genotype 1 patients treated with peginterferon alfa-2a (40KD) and ribavirin

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• 作者：Patrick Marcellin¹ ; ^{patrick.marcellin@bjn.aphp.fr} ; Nancy Reau² ; Peter Ferenci³ ; Stephanos Hadziyannis⁴ ; Diethelm Messinger⁵ ; Fernando Tatsch⁶ ; Donald Jensen⁷
• 关键词：RVR ; rapid virological response ; SVR ; sustained virological response ; HCV ; hepatitis C virus ; EVR ; early virological response ; PCR ; polymerase chain reaction ; cEVR ; complete early virological response
• 刊名：Journal of Hepatology
• 出版年：2012
• 期刊代码：162_01688278
• 类别：med
• 出版时间：June, 2012
• 卷：56
• 期：6
• 页码：1276-1282
• 文件大小：1040 K

摘要

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Background & Aims

It is unclear whether the magnitude of reduction in hepatitis C virus (HCV) RNA between baseline and week 4 of treatment influences the probability of achieving a sustained virological response (SVR) in patients without a week 4 rapid virological response (RVR).

Methods

Data were retrospectively analyzed from two studies in which treatment-naive patients received peginterferon alfa-2a (40KD) 180 渭g/week plus ribavirin 1000/1200 mg/day for 48 weeks. Five hundred and fifty-eight genotype 1 patients with evaluable HCV RNA at baseline and week 4 were grouped according to RVR status: RVR (HCV RNA <50 IU/ml) or no RVR. Non-RVR patients were subdivided into discrete mutually exclusive categories according to week 4 HCV RNA; the proportion of patients with undetectable HCV RNA at week 12 was calculated per each category, and among them, the proportion with an SVR.

Results

Overall, 88%of RVR patients and 43%of non-RVR patients achieved an SVR (p <0.0001). Among non-RVR patients, SVR rates were 77%, 61%, 43%, 27%and 13%, respectively (trend test p <0.0001) in those with unquantifiable HCV RNA or 猢? log₁₀, 猢? log₁₀, 猢? log₁₀, or <1 log₁₀ drop to week 4. In patients HCV RNA positive at week 4, SVR rates were 67%for those negative at week 12 vs. 17%(HCV RNA positive patients or who had missing values at week 12 [p <0.0001]).

Conclusions

The probability of achieving SVR is graded in relation to the magnitude of reduction in HCV RNA at week 4 and 12. Patients with a 猢? log₁₀ drop in HCV RNA at week 4 have a high probability of achieving an SVR.