Abstract
We evaluated the genetic variation in rs8099917, substitutions in core amino acid (aa) 70, and the number of aa substitutions in the interferon sensitivity-determining region (ISDR) on the prediction of sustained virological response (SVR) in treatment-naïve hepatitis C virus (HCV) genotype 1b (G1b) patients. This multicenter study involved 150 Asian treatment-naïve patients infected with HCV G1b who received 12 weeks of telaprevir in combination with 24 weeks of peginterferon-α-2b and ribavirin. The baseline and treatment-related factors potentially associated with SVR were determined by multivariate logistic regression analysis. Virological response was analyzed on an intent-to-treat basis. Cessation of the therapy due to adverse effects occurred in only 2 patients, who discontinued the trial at 10 weeks and at 2 weeks due to cerebral infarction and renal impairment, respectively. Among the 150 patients in whom the final virological response was determined, only genotype TT in rs8099917 was identified as a pretreatment predictor (P = 7.38 × 10−4). Achievement of a rapid virological response (RVR), defined as undetectable HCV RNA at week 4 of treatment, was identified as an after-starting-treatment predictor (P = 2.47 × 10−5). However, neither a substitution in core aa 70 nor the number of substitutions in the ISDR affected treatment outcome.
Highlights
Chronic hepatitis C virus (HCV) infection was generally treated with pegylated interferon (PEG-IFN) and ribavirin combination therapy
The majority of patients in Japan who are infected with HCV genotype 1b (G1b) are older than the patients in the United States and/or Europe and the frequency of patients who discontinued due to adverse events was reported to be as high as 11.1–16.7% [7,8,9]
The patients were persistently seropositive for HCV RNA for >6 months and the amount of serum HCV RNA, as determined by a qualitative realtime polymerase chain reaction (RT-PCR) method (COBAS TaqMan HCV test, Roche Diagnostics, Tokyo, Japan), was ≥5 log10 IU/mL, which has been defined as a “high viral load,” according to the Japanese criteria [13]
Summary
Chronic hepatitis C virus (HCV) infection was generally treated with pegylated interferon (PEG-IFN) and ribavirin combination therapy. This treatment provides rates of sustained virological response (SVR, undetectable serum levels of HCV RNA at least 6 months after completion of therapy) of 40–50% among patients with HCV genotype 1 (G1) who have not received previous treatment (treatment-naıve patients) [1,2,3]. The SVR rates in patients receiving telaprevir with PEG-IFNα and ribavirin (triple therapy) were higher than those in PEGIFNα plus ribavirin (combination therapy) patients, drop-out rates due to increased side effects were higher in the triple therapy patients [4,5,6]. The safety and efficacy of the triple therapy for patients aged >65 has not been established
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