Characteristics and outcomes of HCV genotype-1-infected patients treated with peginterferon and ribavirin combination therapy with discordant HCV responses 4 and 12 weeks after starting therapy.

OBJECTIVE Some patients with chronic hepatitis C virus (HCV) infection fail to achieve complete early virologic response (EVR) despite a marked decrease in HCV RNA at 4 weeks. We investigated the characteristics and final treatment outcomes of this patient subpopulation. METHODS A total of 516 patients with HCV genotype 1 were enrolled. Background characteristics and final outcomes were compared between patients who achieved complete EVR and those who did not among patients whose HCV RNA levels decreased 3.0 log10 or more at 4 weeks. RESULTS 78 of 334 patients (23.4%) with a ≥3.0 log10 reduction in HCV RNA levels at 4 weeks failed to achieve complete EVR. Female sex, higher pretreatment HCV RNA levels and lower baseline alanine aminotransferase (ALT) activity were independently associated with failure of complete EVR. The rate of sustained virologic response (SVR) in patients without complete EVR was 47.4%, significantly lower than that in patients with complete EVR (89.7%, p < 0.0001). CONCLUSIONS Female patients, patients with higher pretreatment HCV RNA levels and patients with lower baseline ALT have a high likelihood of failure of complete EVR even when they had a ≥3 log10 reduction of HCV RNA at 4 weeks, resulting in a significantly lower SVR rate.